Identity
- Trade Name
- 1717SCV FDA UDI
- Generic Name
- Indirect flat panel x-ray detector FDA UDI
- Device Name
- Flat Panel Detector is indicated for digital imaging solution designed for general radio graphic system for human anatomy. It is intended to replace film or screen based radio graphic systems in all general purpose diagnostic procedures. Not to be used for mammography. FDA UDI
- Model / Reference
- 1717SCV FDA UDI
- Description
- Flat Panel Detector is indicated for digital imaging solution designed for general radio graphic system for human anatomy. It is intended to replace film or screen based radio graphic systems in all general purpose diagnostic procedures. Not to be used for mammography. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800018600627 FDA UDI
- 510(k) Number
- K201796 FDA UDI
- FDA Product Code
- MQB FDA UDI
- GMDN Term
- Indirect flat panel x-ray detector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Indirect flat panel x-ray detector
1717scv by Rayence Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K201796 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Rayence Co., Ltd.
Sources (1)
- FDA UDI 27b28bd6-494e-49e5-8363-4831e2cf8ad8 35 fields · synced May 31, 2026