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DigitalDiagnost C50
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
510(k) K163410Ref 712204Model DigitalDiagnost C50
Identity
- Trade Name
- DigitalDiagnost C50 EUDAMEDFDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- Stationary Digital Radiographic System EUDAMEDStationary x-ray system FDA UDI
- Model / Reference
- DigitalDiagnost C50 EUDAMEDFDA UDI712204 EUDAMED
- Description
- Stationary x-ray system FDA UDI
Identifiers
- Catalog Number
- 712204 FDA UDI
- Primary DI / UDI-DI
- 00884838095199 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM299TH EUDAMED
- Direct Marketing DI
- 00884838095199 EUDAMED
- FDA Product Code
- KPR FDA 510(k)FDA UDI
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
- GMDN Term
- Stationary basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)FDA UDI
- Market of Registration
- France EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- Not 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
DigitalDiagnost C50 by Philips Healthcare (Suzhou) Co., Ltd. — Class II — MDR, FDA_510K — listed in FDA 510(k), FDA GUDID, EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDR
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K163410 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Healthcare (Suzhou) Co., Ltd.
Sources (3)
- FDA 510(k) K163410 24 fields · synced Jul 9, 2026
- FDA UDI 91ed4d9e-2b28-4a43-a3c8-830c260ebe99 38 fields · synced May 29, 2026
- EUDAMED f3e00918-ea28-4880-8bf3-d647daf7dd56 61 fields · synced Jul 9, 2026