CELLAVISION DM96 WITH THE BODY FLUID APPLICATION

by CELLAVISION AB  · Based in Sweden → — Elevating healthcare through digital microscopy and automated cell morphology analysis.
Hematology Laboratory Medicine

Contact vendor for pricing
Regulatory Status Disclosed

Overview

The CellaVision DM96 with the Body Fluid Application is an advanced automated digital morphology system designed to streamline and standardize the analysis of blood and body fluid samples in clinical laboratories. Leveraging artificial intelligence, deep learning, and digital imaging, the system automatically locates, captures high-quality images, and pre-classifies cells from peripheral blood smears and cytocentrifuged body fluid preparations, including cerebrospinal fluid, synovial fluid, and pleural fluid. This technology aims to improve diagnostic accuracy, enhance efficiency, and provide a more ergonomic working environment for medical technologists. It supports digital archiving of samples and patient records, as well as facilitating remote review and collaboration among healthcare professionals.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated digital image capture of cells from blood and body fluid preparations
  • AI-powered pre-classification of white blood cells (WBCs)
  • Characterization of red blood cell (RBC) morphology
  • Platelet estimation
  • Analysis of various body fluids (cerebrospinal, synovial, pleural)
  • Digital archiving of cell images and patient records
  • Remote review station capability with network access
  • Bi-directional Laboratory Information System (LIS) support (ASTM)
  • High-speed robotics and continuous slide feed for high-volume labs
  • User-definable WBC count for analysis (100-400 cells)

Use Cases

  • Routine differential count of white blood cells in peripheral blood and body fluids
  • Characterization of red blood cell morphology
  • Platelet estimation
  • Assisting in the diagnosis and classification of hematological diseases
  • Quality assurance and competency assessment in laboratories
  • Educational purposes for medical technologists and students

What Physicians Need to Know

LIS/LIMS Integration
The CellaVision DM96 integrates with Laboratory Information Systems (LIS) to query patient demographics and order data via barcode scanning. It supports digital archiving of samples with patient records and offers Remote Review Station capability for network access and supervisory review.
Supported Assay Types
The Body Fluid Application automates and standardizes morphological examination and WBC differential counts in various body fluid preparations, including cerebrospinal fluid, serous fluid, synovial fluid, and pleural fluid. It provides pre-classification of Neutrophils, Eosinophils, Lymphocytes, Macrophages (including Monocytes), and 'Other' (e.g., Basophils, Lymphoma cells, Atypical lymphocytes, Blasts, Tumor cells), as well as Non-WBCs like Smudge cells and Artefacts. Users can add custom cell categories.
QC/QA Features
The system promotes consistency through standardized operational procedures and validation processes. It enhances analysis accuracy with innovative functionalities and integrated tools. Digital archiving of patient records and cell images supports quality assurance. The pre-classification requires review and verification by a Medical Technologist, allowing for corrections and ensuring quality control. CellaVision also provides proficiency software for competency assessment.
Result Interpretation AI
Utilizing Artificial Neural Network technology, the software extracts cell features from digital images to deliver a pre-classification of cells. This AI-assisted pre-classification acts as a decision support system, which is then reviewed and verified by a Medical Technologist. The accuracy of pre-classification is generally high for common cell types.
Critical Value Alerts
While the CellaVision DM96 Body Fluid Application itself focuses on cell morphology and pre-classification, its LIS integration facilitates the management of critical values. The system's ability to identify and present images of abnormal cells aids technologists in recognizing critical findings, which can then be flagged and managed according to laboratory protocols and LIS functionalities.
Instrument Interfaces
The DM96 is an automated cell-locating device comprising a slide feeder unit, an optical unit (microscope and camera), and a computer system with acquisition and classification software. It handles barcode-labeled slides loaded into magazines, with a capacity of 96 slides (eight 12-slide magazines), allowing for continuous feed.
Reference Range Intelligence
The system provides pre-classification data for WBCs and non-WBCs and presents the Ru00fcmke table of cell counter and cell morphology data. This information supports medical technologists in interpreting results against established reference ranges, although the final interpretation and flagging of out-of-range values are typically performed by the technologist or pathologist in conjunction with the LIS.
Turnaround Time Impact
The automated pre-classification and digital workflow significantly speed up the review process, leading to faster and more standardized results compared to manual microscopy. The DM9600 (a related model) can process up to 15 body fluid slides per hour for differentials, improving laboratory efficiency. Digital archiving and image sharing also streamline consultations.
Physician Tip

For physicians, the CellaVision DM96 with the Body Fluid Application offers standardized and accelerated morphological analysis of body fluids, leading to more consistent and timely results. The AI-assisted pre-classification provides a robust initial assessment, but final verification by a skilled medical technologist remains crucial, especially for rare or highly abnormal cells. The digital images and archiving capabilities facilitate remote review and consultation with specialists, enhancing diagnostic confidence and inter-departmental collaboration. Be aware that while the system flags cellular abnormalities, direct microbial identification is not its primary function.

The CellaVision DM96 is designed for seamless integration with existing Laboratory Information Systems (LIS) through barcode scanning for patient and order data. This connectivity is vital for a streamlined digital workflow, enabling efficient data transfer, supervisory review, and digital archiving of cell images alongside patient records. Its open interface allows for integration into various laboratory environments, enhancing overall automation and data management in hematology and body fluid analysis.

Details

Category Lab & Diagnostics, Pathology AI
Pricing Contact vendor for pricing — N/A - Capital equipment, pricing not publicly disclosed.
DeploymentOn-premise (hardware device in laboratory setting)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

Cleared by the FDA on December 5, 2008 (K080595) as an automated cell-locating device for differential count of white blood cells in cytocentrifuged body fluid preparations, for in-vitro diagnostic use.

Integrations
EHR Not specified
Specialties Hematology, Laboratory Medicine

What the Web Says

The CellaVision DM96 with the Body Fluid Application is an automated system designed to streamline and standardize the morphological examination of various body fluid preparations, such as cerebrospinal fluid, pleural fluid, and synovial fluid. It leverages digital imaging and AI technology to pre-classify cells, which are then reviewed and verified by a medical technologist. The system aims to improve efficiency, consistency, and the ability to share digital images for consultation and archiving.

Overall: Mixed

Strengths

  • Faster and more standardized results for body fluid analysis.
  • Digital archiving of test results with cell images and patient records.
  • Ability to share digital images with experts for collaboration and consultation, regardless of physical location.
  • Reduced eyestrain and physical fatigue for medical technologists compared to manual microscopy.
  • Automated pre-classification of white blood cells, speeding up the review process.
  • Improved consistency among patient results and advantages in training personnel.

Limitations

  • Challenges with body fluids having low white blood cell counts, potentially leading to analysis failures and backlogs.
  • Limitations in accurately estimating platelets and red cell morphology.
  • Difficulty in identifying certain red blood cell inclusions (e.g., HJ bodies) due to the inability to focus up and down on the digital slide.
  • The system may sometimes select suboptimal areas of the slide for red blood cell morphology analysis.
  • Some experienced morphologists may have trouble trusting the system, leading to manual reviews that negate efficiency benefits.
  • Potential for over-highlighting granules or misclassifying cells (e.g., monocytes as promyelocytes, or normal cells as blasts/sickle cells) by the AI, requiring careful technologist verification.

Based on reviews from: New Body Fluid Application for the CellaVision DM96 now cleared for sale in the US, A critical analysis of CellaVision systems in the modern hematology laboratory - PMC - NIH, CellaVision expands the utility of the CellaVision DM96 digital morphology system, A Survey Study of Benefits and Limitations of using CellaVisionTM DM96 for Peripheral Blood Differentials - Clinical Laboratory Science Journal, CellaVisionu00ae DM9600, CellaVisionu00ae Body Fluid Application, CellaVisionu00ae DM9600, Helping Labs become Best Practice in Cell Morphology, CellaVisionu00ae Body Fluid Application, Performance evaluation and relevance of the CellaVisionu2122 DM96 system in routine analysis and in patients with malignant hematological diseases - PMC, REVIEW MEMORANDUM - FDA, Introducing: CellaVisionu00ae Peripheral Blood Application - YouTube, REVIEW MEMORANDUM - FDA, Does your lab have Cellavision? What do you like or dislike about it? - Reddit, Cellavision... : r/medlabprofessionals - Reddit, Upgrading the Differential u2026 CellaVision DM96 - Pathology Blogs, Performance of the CellaVisionu00ae DM96 system for detecting red blood cell morphologic abnormalities - PMC

Last updated: 2026-07-17

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Press & Coverage

PubMed
Automated morphological analysis of cells in body fluids by the digital microscopy system DM96 - PubMed
This study investigated the CellaVision DM96's ability to automatically classify cells in various body fluids, demonstrating its reliability and efficiency in morphological analysis and automated cell classification.
2010-06
CellaVision
New Body Fluid Application for the CellaVision DM96 now cleared for sale in the US
CellaVision announced FDA clearance for its Body Fluid Application for the CellaVision DM96, expanding the analyzer's utility for US laboratories and increasing the product portfolio for new and existing customers.
2008-12
CellaVision
CellaVision expands the utility of the CellaVision DM96 digital morphology system
CellaVision introduced a new application for body fluids for the DM96, enabling clinical laboratories to analyze cells in spinal, synovial, and pleural fluid with benefits like faster results and digital archiving.
2007-11
FDA
510(k) Summary DEC 0 5 2008
This FDA 510(k) summary details the clearance of the CellaVision DM96 with the body fluid application, stating its substantial equivalence to existing devices and its intended use for differential count of white blood cells in body fluid preparations.
2008-02
CellaVision
CellaVisionu00ae Body Fluid Application
The CellaVision Body Fluid Application automates, standardizes, and simplifies the morphological examination of body fluid preparations, offering WBC differential pre-classification using AI technology.
unknown
Innolitics
AI/ML in Digital Pathology and the Software-as-an-IVD Paradigm: 2026 Snapshot - Innolitics
This article discusses the regulatory landscape of AI/ML in digital pathology, noting that CellaVision's automated white-blood-cell classifier, including the DM96 with body fluid application, has been iterating on FDA clearances since 2001.
2026-04
American Journal of Clinical Pathology
critical analysis of CellaVision systems in the modern hematology laboratory | American Journal of Clinical Pathology | Oxford Academic
A critical analysis of CellaVision systems highlights their role in hematology laboratories, noting that the DM96 system has been used to analyze body fluid samples with high preclassification accuracy.
2025-05
Japanese Journal of Medical Technology
Future trends in AI (artificial intelligence) technology in clinical lab testing - J-Stage
This article discusses future trends in AI technology in clinical lab testing, listing the CellaVision DM96 with the body fluid application as an example of an AI-enabled medical device for white blood cell counts in body fluids.
2026-01

Videos

Product demos, reviews, and walkthroughs for CELLAVISION DM96 WITH THE BODY FLUID APPLICATION.

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Frequently Asked Questions

The CellaVision DM96 utilizes innovative Artificial Neural Network (AI) technology to automatically locate and pre-classify white blood cells in cytocentrifuged body fluid preparations, streamlining the differential count process. Physicians and medical technologists then review and verify these AI-generated pre-classifications, retaining ultimate diagnostic responsibility and the ability to reclassify cells as needed.
The CellaVision DM96 with the Body Fluid Application is designed for the morphological examination of various body fluid preparations, including cerebrospinal fluid (CSF) and ascitic fluid. Its AI primarily focuses on pre-classifying white blood cells into categories such as neutrophils, eosinophils, lymphocytes, macrophages, and other nucleated cells, thereby standardizing and speeding up the initial review.
The CellaVision DM96 system has received FDA clearance, and its body fluid application is also cleared for in-vitro diagnostic use. It also complies with European regulations such as IVDR (EU) 2017/746, ensuring adherence to quality management and risk management standards for medical devices.
While the AI demonstrates high accuracy for common cell types like neutrophils and lymphocytes, its pre-classification accuracy can be lower for less common cells such as eosinophils, basophils, immature granulocytes, and blast cells. Therefore, human oversight by skilled operators remains crucial for detecting and accurately classifying rare or pathologically significant cells, especially in doubtful cases.
The CellaVision DM96 significantly automates and standardizes the body fluid review process, reducing manual microscopic review rates and improving consistency among technical staff, unlike traditional manual microscopy which is prone to eye fatigue and variability. While other automated systems exist, CellaVision's AI-driven pre-classification aims to enhance efficiency and turnaround time by providing digital images and suggested classifications for technologist verification.
The CellaVision DM96 represents a significant capital investment, and its cost has been noted as a major limitation by some users. While specific pricing varies, the system aims to provide ROI through increased efficiency, reduced turnaround times, standardization of results, and decreased staff eye fatigue, ultimately optimizing laboratory resources.
Yes, the CellaVision DM96 system supports remote review stations, allowing pathologists and hematologists to view slide images and verify results from different locations, facilitating collaboration and consultation. This digital workflow enhances efficiency and can save time for clinicians, while data security is managed through network integration and archiving capabilities, allowing for secure access to patient image history.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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