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Epiq Diagnostic Ultrasound System
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 795418510(k) K200304Ref 795231Ref 795232
Identity
- Trade Name
- Epiq Diagnostic Ultrasound System EUDAMEDFDA UDIEPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM FDA UDIEPIQ CVxi DIAGNOSTIC ULTRASOUND SYSTEM FDA UDI
- Generic Name
- MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) EUDAMEDGeneral-purpose ultrasound imaging system FDA UDI
- Device Name
- EPIQ Series Diagnostic Ultrasound System EUDAMEDVM11.0 Update FDA UDIEPIQ CVxi Diagnostic Ultrasound System FDA UDI
- Model / Reference
- 795418 EUDAMED795231 EUDAMEDFDA UDI795232 EUDAMEDFDA UDI
- Description
- VM11.0 Update FDA UDIEPIQ CVxi Diagnostic Ultrasound System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838126305 EUDAMED00884838097933 EUDAMEDFDA UDI00884838123960 EUDAMEDFDA UDI00884838126930 EUDAMEDFDA UDI00884838097940 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM431SR EUDAMED
- FDA Product Code
- ITX FDA UDIIYN FDA UDIIYO FDA UDIOBJ FDA UDIQIH FDA UDI
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Legislation / Framework
- MDR (REGULATION (EU) 2017/745 on medical devices) EUDAMED
- Regulation Number
- 892.1570 FDA UDI892.1550 FDA UDI892.1560 FDA UDI870.1200 FDA UDI892.2050 FDA UDI
- Market of Registration
- Netherlands EUDAMEDGermany EUDAMEDAustria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Epiq Diagnostic Ultrasound System by Philips Ultrasound LLC (multidisciplinary ultrasound scanners (internal and cardiology, etc.)) — Class IIa — FDA_510K…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132304 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K200304 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0884838BM431SR | Class IIa | Active |
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Manufacturer
- Manufacturer
- Philips Ultrasound LLC
- EUDAMED SRN
- US-MF-000002237
- FDA Applicant
- Philips Ultrasound, Inc.
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (10)
- EUDAMED K200304 92 fields · synced Oct 6, 2026
- FDA UDI 651d993e-ac80-445e-8556-69d50cc40bdd 32 fields · synced May 22, 2026
- FDA UDI 9b056261-4af0-46a6-a8e4-54d060443668 34 fields · synced May 30, 2026
- FDA UDI 74225d88-77d7-4388-93f7-a8d0df5cae4a 33 fields · synced May 30, 2026
- FDA UDI 16c47326-a74a-48fe-b68d-bec8f988a020 32 fields · synced May 30, 2026
- EUDAMED ff26127a-7bc2-4e8a-bcea-38295e89446a 61 fields · synced Jun 20, 2026
- EUDAMED 2c85e3a4-039c-4e49-879c-4eb1f9059040 61 fields · synced Jul 14, 2026
- EUDAMED eab9ae5f-3d28-4087-8c23-988081031b53 61 fields · synced Jul 25, 2026
- EUDAMED 7a8194e4-143a-4c13-a54a-a248bfc10998 61 fields · synced Oct 6, 2026
- FDA 510(k) K132304 1 fields · synced May 18, 2026