Identity
- Trade Name
- Exprimer FDA UDI
- Generic Name
- Indirect flat panel x-ray detector FDA UDI
- Device Name
- The EVS 4343 Detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light. FDA UDI
- Model / Reference
- EVS 4343 FDA UDI
- Description
- The EVS 4343 Detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800018403501 FDA UDI
- 510(k) Number
- K162555 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
No
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
Exprimer by Drtech Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- PEDRA — Radisen Co., Ltd. · Class II
Cleared under the same submission
K162555 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
- Drtech Corp.
Sources (1)
- FDA UDI 895bd7f1-4836-4cf2-8355-17b3df9ba936 34 fields · synced Jun 1, 2026