Identity
- Trade Name
- Omega Medical Imaging FDA UDI
- Generic Name
- Stationary angiographic x-ray system, digital FDA UDI
- Device Name
- CS50 is a Complete System 50 eVIEW Fluoroscopic Imaging system. The Patient table, Positioner, X-Ray tube, Image Receptor and Image processor are configurable with interchangeable components that are customer specific resulting in a unit configuration i.e. CS50-P2-G2-T3-I4-A4. FDA UDI
- Model / Reference
- CS50 FDA UDI
- Description
- CS50 is a Complete System 50 eVIEW Fluoroscopic Imaging system. The Patient table, Positioner, X-Ray tube, Image Receptor and Image processor are configurable with interchangeable components that are customer specific resulting in a unit configuration i.e. CS50-P2-G2-T3-I4-A4. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853901007001 FDA UDI
- 510(k) Number
- K100102 FDA UDI
- FDA Product Code
- MQB FDA UDI
- GMDN Term
- Stationary angiographic x-ray system, digital 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: Stationary angiographic x-ray system, digital
Omega Medical Imaging by Omega Medical Imaging, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K100102 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
- Omega Medical Imaging, LLC
Sources (1)
- FDA UDI 934517b8-a1aa-45a1-95d6-3d38d2a1f609 34 fields · synced Jun 9, 2026