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EPIQ 5 Diagnostic Ultrasound System
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 795204510(k) K160807Ref 795206Ref 795205Ref 795231
Identity
- Trade Name
- EPIQ 5 Diagnostic Ultrasound System EUDAMEDEPIQ Diagnostic Ultrasound System EUDAMEDEPIQ 5W DIAGNOSTIC ULTRASOUND SYSTEM FDA UDIEPIQ 5C DIAGNOSTIC ULTRASOUND SYSTEM FDA UDIEPIQ CVx Diagnostic Ultrasound System FDA UDIEPIQ 5G DIAGNOSTIC ULTRASOUND SYSTEM FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- EPIQ Series Diagnostic Ultrasound System EUDAMEDSoftware version 10.0.X FDA UDI
- Model / Reference
- 795204 EUDAMEDFDA UDI795206 EUDAMEDFDA UDI795205 EUDAMEDFDA UDI795231 EUDAMEDFDA UDI
- Description
- Software version 10.0.X FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838097896 EUDAMEDFDA UDI00884838097919 EUDAMEDFDA UDI00884838097902 EUDAMEDFDA UDI00884838114135 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM431SR EUDAMED
- FDA Product Code
- IYO FDA UDIIYN FDA UDIITX 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
- Regulation Number
- 892.1560 FDA UDI892.1550 FDA UDI892.1570 FDA UDI870.1200 FDA UDI892.2050 FDA UDI
- Market of Registration
- Germany 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 5 Diagnostic Ultrasound System by Philips Ultrasound LLC — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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 | K160807 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K182857 | 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 (9)
- EUDAMED c43162f0-18ca-4170-b00c-83990173eff2 85 fields · synced Oct 7, 2026
- FDA UDI bd9a23de-db38-4b93-94d2-2f838cce7903 32 fields · synced May 30, 2026
- FDA UDI e640b204-b15b-4408-8d99-a01adf4cde0c 32 fields · synced May 30, 2026
- FDA UDI 85167407-b469-4753-b421-a7128dbad9a1 33 fields · synced May 30, 2026
- FDA UDI 08b70091-8350-47d2-8b60-1f96be1f0488 32 fields · synced May 30, 2026
- EUDAMED 5175ae4a-b911-41d2-803d-93381025b738 61 fields · synced Jul 8, 2026
- EUDAMED d5597a18-79e8-4a39-bbe0-7eb5ff2db20d 61 fields · synced Jul 9, 2026
- EUDAMED 5a31f955-64d4-4b0d-ba70-6f7eaea1106c 61 fields · synced Jul 29, 2026
- FDA 510(k) K160807 1 fields · synced May 18, 2026