Lumify Diagnostic Ultrasound System iOS
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- Lumify Diagnostic Ultrasound System iOS EUDAMEDFDA UDILumify Diagnostic Ultrasound System EUDAMEDFDA UDILumify FDA UDILumify Ultrasound System iOS FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDIExtracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- Lumify Diagnostic Ultrasound System EUDAMEDLumify Diagnostic Ultrasound System iOS Release 5.1 FDA UDIAndroid 5.0 FDA UDI
- Model / Reference
- 795161 EUDAMEDFDA UDI795216 EUDAMEDFDA UDI795005 EUDAMEDFDA UDI
- Description
- Lumify Diagnostic Ultrasound System iOS Release 5.1 FDA UDIAndroid 5.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838103405 EUDAMEDFDA UDI00884838124141 EUDAMEDFDA UDI00884838122116 EUDAMEDFDA UDI00884838100121 EUDAMEDFDA UDI00884838100138 EUDAMED00884838108462 FDA UDI
- Basic UDI-DI
- 0884838BM433SV EUDAMED
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX FDA UDIQIH FDA UDI
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDIExtracorporeal ultrasound imaging transducer, hand-held FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1560 FDA UDI892.1570 FDA UDI892.2050 FDA UDI
- Market of Registration
- Germany EUDAMEDAustria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
The Lumify Diagnostic Ultrasound System is a medical device designed for diagnostic ultrasound imaging. It provides clinicians with a portable solution for visualizing internal body structures to support clinical assessments.
This system is manufactured by Philips Ultrasound LLC and is classified as a Class IIa device. It is not an implantable device and is not supplied sterile, with regulatory authorization confirmed through FDA 510(k) clearance and MDR compliance.
Frequently asked questions
What is the Lumify Diagnostic Ultrasound System used for?
The Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging, allowing healthcare professionals to perform clinical examinations using ultrasound technology.
Is the Lumify Diagnostic Ultrasound System sterile?
No, the device is not supplied sterile. Users should follow standard clinical protocols for device maintenance and preparation in a medical environment.
What regulatory status does this device hold?
The device has received FDA 510(k) clearance and is compliant with MDR regulations, confirming it meets the necessary standards for its classification as a Class IIa medical device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Lumify handheld ultrasound - Philips, Philips Lumify - Handheld Ultrasound Solution - YouTube, [PDF] December 22, 2025 Philips Ultrasound LLC Gina Quiram ..., Lumify Diagnostic Ultrasound System - Ovid, Philips Lumify Systems - FirstWord HEALTHTECH
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252558 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K252557 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K223771 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K232500 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K242670 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K203406 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K242519 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0884838BM433SV | Class IIa | Active |
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Manufacturer
- Manufacturer
- Philips Ultrasound LLC
- EUDAMED SRN
- US-MF-000002237
- FDA Applicant
- Philips Ultrasound
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (11)
- EUDAMED 1671c795-f912-4038-bdb4-5425dbf7b1ff 85 fields · synced Oct 5, 2026
- FDA UDI 08f8c23b-0457-49b0-b098-1610d8dd2953 33 fields · synced May 27, 2026
- FDA UDI 17f4c536-a97d-495b-aeea-17366e29b028 32 fields · synced May 29, 2026
- FDA UDI 75960e65-e291-4a6c-bf87-8370da58ff0f 34 fields · synced May 30, 2026
- FDA UDI 87a304f9-7989-4c69-8e76-73870f77fea4 32 fields · synced May 30, 2026
- FDA UDI 6315a17a-9ac3-4514-8e18-78471761a380 33 fields · synced May 30, 2026
- EUDAMED 52d7b912-b11c-4623-a924-754f1a62b9bd 61 fields · synced Jul 22, 2026
- EUDAMED 9884f770-9868-48e9-b7a9-2bc8f7858026 61 fields · synced Jul 31, 2026
- EUDAMED 0b700b0e-2349-4e01-9acd-ae0308ac9890 61 fields · synced Aug 2, 2026
- EUDAMED 29903364-dbbc-4950-b0fc-48a49b866486 61 fields · synced Oct 5, 2026
- FDA 510(k) K252558 1 fields · synced May 21, 2026