Identity
- Trade Name
- DigitalDiagnost C90 EUDAMEDFDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- Fixed Rad-System EUDAMEDThe DigitalDiagnost C90 is a high-end digital radiography system, that inlcudes - Adjustable Straps for Patient Support; - Battery for SkyPlate E; - Compression Belt (singles. pull); - Hand grips (Pair of); - Infusion bottle holder; - Lateral cassette holder; - Mobile Detector Holder; - Paper roll holder; - Parking frame for accessories; - Patient Support for Stitching; - Remote control holder; - Side Bar; - Stretch Grip for VS/VM Stand; - Table top support FDA UDI
- Model / Reference
- 712034 EUDAMEDFDA UDI
- Description
- The DigitalDiagnost C90 is a high-end digital radiography system, that inlcudes - Adjustable Straps for Patient Support; - Battery for SkyPlate E; - Compression Belt (singles. pull); - Hand grips (Pair of); - Infusion bottle holder; - Lateral cassette holder; - Mobile Detector Holder; - Paper roll holder; - Parking frame for accessories; - Patient Support for Stitching; - Remote control holder; - Side Bar; - Stretch Grip for VS/VM Stand; - Table top support FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838090699 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM440SS EUDAMED
- FDA Product Code
- MQB FDA UDIKPR FDA UDILLZ FDA UDI
- EMDN Code
- Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Stationary basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 FDA UDI892.2050 FDA UDI
- Market of Registration
- Netherlands 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
Yes
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Electromagnetic surgical navigation device tracking system
DigitalDiagnost C90 by Philips Medical Systems DMC GmbH — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202564 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K182973 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 0884838BM440SS | Class IIb | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems DMC GmbH
- EUDAMED SRN
- DE-MF-000005362
Sources (3)
- EUDAMED 4baada71-08d6-4bb5-9abf-f46216518789 61 fields · synced Jul 19, 2026
- FDA UDI 015226af-dcde-4fe2-9ca5-2ff99d5b9c34 33 fields · synced May 30, 2026
- FDA 510(k) K202564 1 fields · synced May 18, 2026