Identity
- Trade Name
- Exprimer FDA UDI
- Generic Name
- Indirect flat panel x-ray detector FDA UDI
- Device Name
- The EVS 2430GW Digital X-ray detector is designed as a digital imaging solution, for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. FDA UDI
- Model / Reference
- EVS 2430GW FDA UDI
- Description
- The EVS 2430GW Digital X-ray detector is designed as a digital imaging solution, for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800018404508 FDA UDI
- 510(k) Number
- K171137 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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Cleared under the same submission
K171137 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 f6314a04-7b32-4f58-8974-4df699a466c3 34 fields · synced Jun 1, 2026