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EPIQ 7 Diagnostic Ultrasound System Circular Edition
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- EPIQ 7 Diagnostic Ultrasound System Circular Edition FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- VM11.0 update FDA UDI
- Model / Reference
- 795117 FDA UDI
- Description
- VM11.0 update FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838125650 FDA UDI
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX FDA UDIOBJ FDA UDIQIH FDA UDI
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1560 FDA UDI892.1570 FDA UDI870.1200 FDA UDI892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: General-purpose ultrasound imaging system
EPIQ 7 Diagnostic Ultrasound System Circular Edition by Philips Ultrasound LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as General-purpose ultrasound imaging system.
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- Display Module(M5, International, Alone) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- WS80A Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD · Class II
- HS50 / HS60 Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD · Class II
- MEDISONO — Medisono, LLC · Class II
Cleared under the same submission
K233545 also covers:
K233788 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Philips Ultrasound LLC
Sources (2)
- FDA UDI e04d74a2-ebc2-4818-8b29-c50969fbf3b6 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced May 29, 2026