X100 with Full Field Peripheral Blood Smear (PBS) Application

by Scopio Labs  · Based in Israel → — See more. Do more. Diagnose faster.
Hematology Laboratory Medicine
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Regulatory Status Disclosed

Overview

The Scopio X100 with Full Field Peripheral Blood Smear (PBS) Application is an AI-driven, full-field digital cell morphology platform designed to revolutionize hematology diagnostics. It replaces traditional manual microscopy by providing high-resolution (100X oil immersion) full-field images of peripheral blood smears, including the monolayer and feathered edge. This breakthrough computational photography combined with an AI-powered Decision Support System (DSS) enables comprehensive analysis of tens of thousands of cells at a time. [1, 7, 8, 15, 17, 18, 32]

The system offers an end-to-end digital workflow, significantly reducing turnaround time for sample reviews by up to 60%. It automates the imaging and analysis process, providing pre-estimations and pre-classifications for white blood cells (WBCs), red blood cell (RBC) morphology evaluation, and platelet estimations. [15, 17, 18, 30]

Key benefits include enhanced workflow efficiency, greater consistency and standardization in diagnostic results, and the ability for remote review and collaboration through a secure hospital or laboratory network. This tele-hematology capability allows lab professionals and clinicians to access, review, and share digital images from anywhere, facilitating faster diagnoses and expediting patient access to life-saving treatments. [10, 14, 15, 17, 27, 30]

The Scopio X100 is specifically designed for small and medium-sized laboratories, while the Scopio X100HT caters to high-throughput requirements. Both platforms are FDA-cleared and CE-marked, ensuring compliance with stringent medical device safety standards. [8, 15, 17, 25, 29]

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Full-Field Digital Imaging (100X oil immersion resolution)
  • AI-Powered Decision Support System (DSS)
  • Remote Connectivity / Tele-hematology
  • Adaptive Monolayer Detection
  • Automated WBC Pre-classification (up to 16 classes)
  • Automated Platelet Pre-estimation
  • RBC Morphology Evaluation
  • End-to-End Digital Workflow
  • Reduced Turnaround Time for Sample Reviews
  • Secure Hospital Network Access

Use Cases

  • Peripheral blood smear analysis
  • WBC differentials
  • RBC morphology evaluation
  • Platelet estimations
  • Detection and diagnosis of cancers, anemia, infections, and other hematological diseases
  • Remote review and collaboration among lab professionals and clinicians
  • Training and education in hematology

What Physicians Need to Know

LIS/LIMS Integration
The Scopio X100 with Full-Field PBS Application offers integration with clinical Laboratory Information Systems (LIS) for seamless data exchange and workflow.
Supported Assay Types
Primarily supports comprehensive Peripheral Blood Smear (PBS) analysis, including WBC differentials (pre-classification into 14-16 classes), Red Blood Cell (RBC) morphology evaluation (from 1000 Fields of View with AI-driven grading for 23 parameters), and platelet detection and pre-estimation (from 10 Fields of View, including clump detection).
QC/QA Features
The system provides fully traceable and reproducible results and documentation. Repeatability and reproducibility (R&R) studies have shown high levels of agreement for WBC and platelet measurements.
Result Interpretation AI
Features an AI-powered Decision Support System (DSS) that performs pre-classification and pre-estimation of cells, assisting lab professionals with intelligent analysis and grading. This system requires operator review and verification, maintaining essential human oversight.
Critical Value Alerts
While the system itself focuses on analysis, its efficiency and remote review capabilities enable faster delivery of critical medical information, supporting timely clinical decision-making. Specific automated critical value *alerts* are typically managed by the integrated LIS.
Instrument Interfaces
The X100 system is operated via a browser-based application, allowing access from any workstation within the secure medical facility network or securely connected remotely.
Reference Range Intelligence
The system incorporates reference range intelligence by marking WBC cell types with counts outside their defined normal ranges as abnormal, aiding in the identification of significant findings.
Turnaround Time Impact
Significantly reduces Peripheral Blood Smear (PBS) review turnaround times (TAT). Studies show reductions of 41.4% on the first day of the weekend, 33.1% on the second day, and 59.1% on the first weekday by eliminating backlogs. Overall morphology TAT can drop by 15.8%.
Physician Tip

The Scopio X100 with Full-Field PBS Application provides a comprehensive, high-resolution digital view of peripheral blood smears, including the monolayer and feathered edge, at 100X magnification. This enables confident remote review and consultation, accelerating diagnosis and treatment initiation. The AI-powered Decision Support System offers consistent pre-classification and analysis, enhancing diagnostic efficiency and accuracy while preserving expert human oversight. This can be particularly beneficial for time-sensitive diagnoses and managing workload, especially during off-hours or with staffing shortages.

The system is designed for seamless integration with existing clinical LIS/LIMS, facilitating a fully digital workflow from sample processing to report generation. Its browser-based access allows for flexible deployment within secure hospital networks, supporting remote review and collaboration among hematology experts without requiring specific software installations on individual workstations.

Details

Category Lab & Diagnostics, Pathology AI
Pricing Contact for pricing
DeploymentBrowser-based access through secure hospital/laboratory network
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Scopio X100 and X100HT with Full-Field Peripheral Blood Smear Application are FDA-cleared and CE-marked. The clearance covers full-field imaging and an AI-powered Decision Support System for WBC, RBC, and platelet morphology reviews. [17, 18, 25, 29, 30]
Integrations
EHR Not specified
Specialties Hematology, Laboratory Medicine

What the Web Says

The Scopio Labs X100 with Full Field Peripheral Blood Smear (PBS) Application is an FDA-cleared and CE-approved digital microscopy solution designed to automate and enhance peripheral blood smear analysis. It utilizes computational photography and AI to provide full-field, high-resolution imaging of blood samples, aiming to replace traditional manual microscopy. Studies suggest it significantly improves workflow efficiency, reduces turnaround time, and enables remote analysis by morphology experts.

Overall: Positive

Strengths

  • Enables full-field, high-resolution digital imaging of blood smears at 100X magnification, including the feathered edge.
  • Significantly reduces turnaround time for PBS analysis (e.g., 15.8% overall decrease, up to 59.1% on the first workday after weekends).
  • Improves workflow efficiency by up to 60% compared to manual review.
  • Facilitates remote review and analysis by morphology experts and clinicians, allowing for faster delivery of critical information outside working hours and beyond the medical center.
  • AI-powered decision support system assists with WBC detection and preclassification into 16 classes, RBC morphology evaluation, and automated platelet location and pre-estimation.
  • Shows a high degree of correlation with manual microscopy for all tested parameters, including WBC accuracy (96.29% efficiency), RBC morphology (99.77% agreement), and platelet estimation (94.89% efficiency).

Limitations

  • Information on specific cons from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra is not readily available in the provided search results.
  • The system is intended for use by skilled users trained in the identification of blood cells, indicating a need for specialized expertise.
  • While it aims to eliminate manual microscopy, some initial digital cell imaging systems still required manual support.

Based on reviews from: Beckman Coulter, PubMed, PMC, ResearchGate, Association for Pathology Informatics, Clinical Lab Products, PR Newswire, FDA (accessdata.fda.gov), Convenzis

Last updated: 2026-07-20

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Press & Coverage

accessdata.fda.gov
X100 with Full Field Peripheral Blood Smear (PBS) Application - FDA 510(k) Clearance (K201301)
The FDA granted 510(k) clearance for Scopio Labs' X100 with Full Field Peripheral Blood Smear (PBS) Application on October 2, 2020. This device is intended to assist qualified technologists in conducting WBC differentials, RBC morphology evaluations, and platelet estimates from peripheral blood smears.
2020-10
FDA
510(k) Premarket Notification for X100 with Full Field Peripheral Blood Smear (PBS) Application
This FDA document details the 510(k) premarket notification for Scopio Labs' X100 with Full Field Peripheral Blood Smear (PBS) Application, listing Scopio Labs as the applicant and providing regulatory information.
2026-01
510k Monitor
K243144 u2014 X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
This entry on 510k Monitor lists the FDA clearance for Scopio Labs' X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application, among other recent clearances in the 'Automated Cell-Locating' device category.
2025-06
J-Stage
Future trends in AI (artificial intelligence) technology in clinical lab testing
This article discusses future trends in AI technology in clinical lab testing, mentioning Scopio Labs' X100 with Full Field Peripheral Blood Smear (PBS) Application as an AI/ML-enabled medical device used to locate and display images of blood cells.
unknown
accessdata.fda.gov
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application - Substantial Equivalence Determination Decision Summary
This FDA decision summary details the substantial equivalence determination for Scopio Labs' X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application, noting its shared intended use with the previously cleared X100 Full Field PBS (K201301).
unknown
RAPS
FDA 510(k) Decisions During October, 2020
This RAPS article lists FDA 510(k) decisions during October 2020, including the clearance of Scopio Labs LTD.'s X100 with Full Field Peripheral Blood Smear (PBS) Application.
2020-10
Tartu u00dclikool
DIGI
This academic work from Tartu u00dclikool discusses the Scopio X100 digital morphology assessment system, highlighting its potential to transform blood smear evaluation through accelerated workflow and remote assessment capabilities.
2026-05

Videos

Product demos, reviews, and walkthroughs for X100 with Full Field Peripheral Blood Smear (PBS) Application.

View all on YouTube

Frequently Asked Questions

The X100 AI is designed to seamlessly integrate by digitizing blood smears, automatically scanning, and pre-classifying cells. It can identify and quantify various abnormalities, including atypical lymphocytes, blasts, immature granulocytes, and red blood cell morphological changes, flagging critical cases for pathologist review.
The X100 system is designed to meet regulatory standards, with Scopio Labs having received FDA clearance for its Full-Field Peripheral Blood Smear (PBS) Application. It incorporates robust data encryption, access controls, and anonymization features to ensure compliance with patient data privacy regulations like HIPAA and GDPR.
The X100 aims to significantly improve efficiency by automating cell pre-classification and reducing manual review time, often surpassing manual methods in consistency and throughput. Its AI algorithms are trained to achieve high accuracy, comparable to or exceeding expert pathologists for common findings, while offering a comprehensive digital record.
The cost structure typically includes an initial capital expenditure for the hardware and software license, followed by annual subscription fees for software updates, AI model enhancements, and technical support. Pricing models may vary based on lab volume and specific feature requirements.
While highly accurate, the X100 AI may have limitations with extremely rare cell types, highly degraded samples, or artifacts not present in its training data. In such cases, the system is designed to flag the slide for mandatory pathologist review, ensuring no critical findings are missed.
Labs typically need to perform an internal validation study to confirm the system's performance against their specific patient population and protocols, as per regulatory guidelines. The vendor provides comprehensive training, technical support, and validation protocols to assist with this process.
The X100 AI model undergoes periodic updates to enhance its accuracy, expand its detection capabilities, and incorporate feedback. These updates are deployed securely, often remotely, with thorough validation to ensure seamless integration and maintained performance.

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Contact vendor for pricing
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application
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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19

Investors who backed X100 with Full Field Peripheral Blood Smear (PBS) Application

Funded through the company that built this tool.

Danaher Ventures
Corporate VC T3
Washington, United States
$5M-$25M
Danaher Ventures is the venture capital entity of Danaher Corporation, the Washington, D.C. based diversified science and technology conglomerate. The arm funds…
Diagnostics Life Sciences Tools
Mivtach Shamir Holdings
PE T3
Tel Aviv, Israel
$5M-$25M
Mivtach Shamir Holdings is a diversified public holding company based in Tel Aviv that deploys growth capital into mature medical technology operations…
Medical Devices / MedTech Pharma / Therapeutics
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