Lumify Diagnostic Ultrasound

by Philips Ultrasound  · Based in Netherlands → — App-based mobile ultrasound, ready when you are.
Critical Care Emergency Medicine Radiology

Subscription or outright purchase
Regulatory Status Disclosed

Overview

The Philips Lumify Diagnostic Ultrasound system transforms compatible smart devices into a high-quality, portable ultrasound solution, bringing diagnostic capabilities directly to the point of care. Leveraging decades of Philips’ ultrasound innovation, Lumify offers advanced imaging with exceptional clarity, enabling clinicians to make fast, informed decisions.

The system features lightweight, battery-free transducers (S4-1 phased array, L12-4 linear array, and C5-2 curved array) optimized for various clinical scenarios, including abdominal, cardiac, OB/GYN, lung, FAST, soft tissue, vascular, superficial, and musculoskeletal applications. The intuitive app-based interface is compatible with both Android and iOS devices, offering easy navigation, automation for quick workflow, and real-time updates.

Lumify is designed for durability, featuring military-grade hardware that is shock and vibration tested, and compatible with various disinfecting methods for infection control. It supports advanced imaging capabilities such as Tissue Harmonic Imaging, SonoCT, xRes, Pulse Wave Doppler, and AI-powered Auto B-line Quantification for lung assessment, and AI-powered Auto EF for cardiac scanning. Data security is a priority, with features compatible with the latest encryption and data security systems, and options for sharing studies via email, DICOM to PACS, a shared network, or a local directory.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • App-based ultrasound on smart devices (iOS/Android)
  • High-quality 2D, Color Doppler, M-mode imaging
  • Multiple transducer options (S4-1 phased array, L12-4 linear array, C5-2 curved array)
  • Optimized presets for various clinical applications
  • Military-grade durability (shock, vibration, water resistant)
  • Data security and encryption
  • DICOM to PACS, email, and network sharing capabilities
  • Pulse Wave Doppler and early OB measurements
  • AI-powered Auto EF (cardiac) and Auto B-line Quantification (lung)
  • Tissue Harmonic Imaging, SonoCT, and xRes image enhancement

Use Cases

  • Point-of-care diagnostics in emergency and critical care
  • Bedside examinations and office practice
  • Abdominal and cardiac assessments
  • OB/GYN and lung imaging
  • Vascular, soft tissue, and musculoskeletal evaluations
  • Guidance for procedures like central line placement

What Physicians Need to Know

DICOM Support & Standards
Philips Lumify systems support DICOM services for downloading worklists (Modality Worklist - MWL), saving acquired US images to a network storage device, and informing the information system about completed work. DICOM Conformance Statements are available for various Lumify software versions.
PACS Integration Method
Lumify integrates with PACS via cloud-enabled technology, allowing easy connection to patient PACS, shared networks, or local directories for sharing images, video, and notes from the handheld ultrasound device.
Reading Room Workflow Impact
Lumify's app-based, portable design enables point-of-care diagnostics, reducing the need for traditional ultrasound carts and streamlining workflow with quick setup and optimized presets. Its integrated tele-ultrasound solution, Lumify with Reacts, facilitates real-time remote collaboration and virtual guidance.
AI Model Architecture (deep learning approach)
Lumify incorporates AI-powered features, including Auto EF (Ejection Fraction) for standardizing cardiac scanning and Auto B-line Quantification for assessing critically ill lung patients. It also features AI-guided algorithms for obstetrics, particularly to assist non-expert users in maternal health. The B-lines algorithm uses machine learning, and the AI algorithms are 'locked' post-commercialization.
Processing Speed (per study)
Specific processing speed metrics per study for Lumify's AI features are not publicly detailed in the provided information.
FDA Clearance Pathway (510k/De Novo)
Philips Lumify has received multiple 510(k) clearances from the U.S. Food and Drug Administration (FDA) for various features, including the B-mode feature and the S4-1 cardiac transducer.
Supported Modalities (CT/MRI/X-ray/US)
Lumify is a diagnostic ultrasound system, supporting B(2D), Color Doppler, Combined (B+Color), Pulsed Wave Doppler, and M-modes.
Sensitivity & Specificity Data
While Lumify is noted for advanced sensitivity, high-resolution 2D image quality, and reproducible/reliable results for B-line quantification, specific sensitivity and specificity percentages for its AI features or overall diagnostic performance are not explicitly provided in the available information.
Physician Tip

Leverage Lumify's portability for rapid point-of-care assessments, especially in emergency, critical care, and remote settings. Utilize the AI-powered Auto EF and B-line quantification for enhanced cardiac and lung assessments, and the AI-guided obstetrics features to support non-expert users in maternal health. The tele-ultrasound capabilities (Reacts) are invaluable for real-time remote consultations and training, extending expert reach. Ensure compatible smart devices are used for optimal performance.

Lumify offers robust integration capabilities through DICOM support for Modality Worklist and image storage to PACS. It also allows for easy sharing of images and data to shared networks or local directories. The system operates as an app on compatible Android and Apple smart devices, ensuring broad connectivity and ease of data transfer within existing healthcare IT infrastructures.

Details

Category Radiology & Imaging AI
Pricing Subscription or outright purchase
  • Monthly subscription: $199/month; 1-Year subscription: $2,388/12 mos; 2-Year subscription: $4,776/24 mos
  • Outright purchase: approximately $12,027 per transducer (S4-1, L12-4, C5-2)
DeploymentMobile app on compatible Android and iOS smart devices
Compliance
BAA Available Yes AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

The Lumify Diagnostic Ultrasound system received 510(k) clearance from the U.S. Food and Drug Administration (FDA) as a Class II medical device in October 2015. The S4-1 cardiac transducer received separate FDA approval in October 2016. More recently, an automated merged B-lines feature for lung assessment also received 510(k) clearance in June 2023. The K252557 number noted in the prompt appears in a future FDA approval timeline for December 22, 2025, likely indicating a new or updated clearance.

Integrations
EHR Not specified
Specialties Critical Care, Emergency Medicine, Radiology

What the Web Says

The Philips Lumify is a portable ultrasound system that connects to a compatible Android smartphone or tablet, offering high-quality imaging for various medical applications. It's praised by physicians for its portability, ease of use, and image quality, making it suitable for point-of-care ultrasound (POCUS) in diverse settings like hospitals, remote clinics, and even in the field during humanitarian missions. While generally well-received, some users have noted concerns regarding its pricing, the need for multiple probes for different applications, and issues with the subscription model impacting basic features like image saving.

Overall: Positive

Strengths

  • High image quality for a handheld device, often comparable to more expensive cart-based systems.
  • Excellent portability and lightweight design, enhancing clinical practice in various settings.
  • Intuitive and easy-to-use interface, making it accessible for both experienced and beginner ultrasound users.
  • Does not overheat, allowing for longer scanning durations.
  • Ability to save scans and export files easily, aiding with credentialing and maintaining evidence of practice.
  • Monthly rental options available, which can be ideal for short-term use or humanitarian missions.

Limitations

  • Higher price point compared to some other handheld ultrasound devices.
  • Requires separate transducers for different applications, which can add to the cost and carrying burden.
  • App functionality can have minor challenges, such as adjusting depth/gain in full-screen mode or accessing saved images easily.
  • Not compatible with Apple (iOS) devices, limiting its use for some users.
  • Some users have reported issues with image quality degrading over time and concerns about customer support regarding defective probes.
  • Subscription model may disable basic features like saving images if not maintained, impacting billing capabilities.

Based on reviews from: MedicalSearch, Emergency Physicians Monthly, Critical Care Northampton, Sports Medicine Ultrasound Group, Which Medical Device, The Medical Futurist, Reddit, The Ultrasound Journal

Last updated: 2026-07-23

Ratings & Reviews

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Press & Coverage

FDA
Lumify Diagnostic Ultrasound System u00b7 510(k) clearance
The Lumify Diagnostic Ultrasound System from Philips Ultrasound received 510(k) clearance from the FDA on May 8, 2025, classifying it as a Class II medical device.
2025-05
Innolitics (FDA 510(k) Database)
Lumify Diagnostic Ultrasound System (K252558) u2014 FDA 510(k) | Innolitics
This FDA 510(k) clearance on May 5, 2026, details the Lumify Diagnostic Ultrasound System's indications for use, including various imaging modes and applications for healthcare professionals.
2026-05
Innolitics
Q2 2026 AI/ML FDA Clearances and De Novos - Innolitics
The Lumify Diagnostic Ultrasound System is listed among the AI/ML devices cleared by the FDA in Q2 2026, highlighting the growing trend of artificial intelligence integration in medical imaging.
2026-07
Abdominal Radiology (via Springer Nature)
Artificial intelligence in abdominal and pelvic ultrasound imaging: current applications
This peer-reviewed article from November 2024 discusses the current applications of AI in abdominal and pelvic ultrasound imaging, mentioning the Lumify Diagnostic Ultrasound System as an FDA-approved device utilizing AI.
2024-11
Philips
Philips Lumify iOS handheld ultrasound
This Philips page highlights the Lumify system's connectivity features, allowing easy sharing of patient data and images with PACS and EMR systems, and emphasizing data security.
unknown
Philips
Lumify handheld portable ultrasound systems for POC - Philips
This Philips resource emphasizes the Lumify's exceptional image quality, portability, and durability for point-of-care use, including advanced imaging features and AI-powered tools like Auto EF and Auto B-line Quantification.
unknown
unknown
AI in Medical Devices Market Size & Share, Growth Analysis 2035
A market analysis report from April 2026 mentions the Lumify Diagnostic Ultrasound System in the context of AI in medical devices, highlighting Philips Ultrasound, LLC as a key player in the radiology sector.
2026-04
PMC (via npj Digital Medicine)
The landscape of artificial intelligence-enabled medical devices in the EU and the US intended for intensive care units - PMC
This article discusses AI-enabled medical devices in ICUs in the EU and US, listing the Lumify Diagnostic Ultrasound System as a portable diagnostic ultrasound imaging system for point-of-care use, with a 2023 FDA database entry.
unknown

Videos

Product demos, reviews, and walkthroughs for Lumify Diagnostic Ultrasound.

View all on YouTube

Frequently Asked Questions

Philips Lumify integrates AI capabilities primarily in obstetrics for simplifying key measurements and identifying abnormalities during pregnancy, and for cardiac imaging with AI-powered Auto EF Quantification to standardize scanning. Additionally, it offers AI-enhanced algorithms for B-line quantification, which can bolster ultrasound lung imaging. These features aim to reduce training time for non-expert users and streamline workflows.
Lumify is designed to be HIPAA compliant and is compatible with the latest encryption and data security systems. It relies on the security features of the compatible smart device's operating system (iOS/Android) and the healthcare institution's IT security policies, including data encryption and password protection. Philips provides guidelines for securing patient data and recommends consulting local IT Security departments for implementation.
Yes, Philips has received FDA 510(k) clearance for various Lumify components and applications, including AI-based features such as Auto EF Quantification for cardiac imaging and expanded B-lines software for lung assessment. Furthermore, UltraSight, an AI guidance software compatible with Lumify for cardiac imaging, has also received FDA clearance.
While Lumify offers specific AI enhancements, other portable ultrasound systems like Butterfly iQ3, Clarius HD3, GE Vscan Air, and Exo Iris also incorporate advanced AI features for image analysis, guidance, or specific applications. The Butterfly iQ3, for instance, is noted for its versatility and strong AI features, while Clarius and GE Vscan Air also provide AI capabilities in their offerings.
Lumify probes are typically purchased upfront, with prices for transducers around $12,027, and generally do not require a subscription for core imaging features, Doppler, DICOM, or local storage. An optional subscription is available for Lumify Reacts, a secure tele-ultrasound platform. This contrasts with some competitors that utilize mandatory subscription models for their AI features or full functionality.
While AI enhances usability, the fundamental quality of ultrasound imaging remains highly operator-dependent, which can limit AI's effectiveness. AI algorithms may face challenges in generalizability across diverse patient populations or varied clinical settings due to potential biases if the input data used for training is not well-curated. Therefore, the specific AI features on Lumify are focused on particular applications rather than general diagnostic interpretation.
AI integration in Lumify aims to reduce training time for non-expert users, particularly in maternal health, by simplifying measurements and guiding image acquisition. However, the physician's role remains critical for comprehensive diagnosis and interpretation of ultrasound images. Philips provides educational resources and training to help healthcare professionals effectively leverage Lumify's capabilities, including its AI tools.

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Suggest an Edit → | Last Verified: 2026-04-21 | First Added: 2026-04-21
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