Identity
- Trade Name
- Reveal 35C EUDAMEDFDA UDI
- Generic Name
- Indirect flat panel x-ray detector FDA UDI
- Device Name
- Reveal 35C Flat Panel Detector EUDAMEDThe flat panel detector, when used with a radiographic imaging system, is intended to generate radiographic images of human anatomy wherever a conventional screen-film, digital radiography (DR) or computed radiography (CR) detector is used for general purposes. FDA UDI
- Model / Reference
- 101 EUDAMEDReveal 35C EUDAMED1 FDA UDI
- Description
- The flat panel detector, when used with a radiographic imaging system, is intended to generate radiographic images of human anatomy wherever a conventional screen-film, digital radiography (DR) or computed radiography (CR) detector is used for general purposes. FDA UDI
Identifiers
- Catalog Number
- 101 FDA UDI
- Primary DI / UDI-DI
- 00628011941015 EUDAMEDFDA UDI
- Basic UDI-DI
- 628011941FPD0100Z7 EUDAMED
- 510(k) Number
- K201591 FDA UDI
- FDA Product Code
- MQB FDA UDI
- EMDN Code
- Z11069099 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Indirect flat panel x-ray detector FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Market of Registration
- Italy 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
No
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
Yes
FDA UDI
Reveal 35C by KA Imaging Inc — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 628011941FPD0100Z7 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- KA Imaging Inc.
- EUDAMED SRN
- CA-MF-000030642
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (2)
- EUDAMED 666627f9-5ddd-4682-827b-28052eaa1101 61 fields · synced May 30, 2026
- FDA UDI a4d5b014-aa61-4406-bdb5-a99c4f3e2dbc 36 fields · synced May 30, 2026