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InfiMed Digital Imaging System, Precision MPi, RF, CCD Camera
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- InfiMed Digital Imaging System, Precision MPi, RF, CCD Camera FDA UDI
- Generic Name
- X-ray system computer, diagnostic, general-purpose FDA UDI
- Model / Reference
- Precision MPi RF FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854344007108 FDA UDI
- 510(k) Number
- K012490 FDA UDI
- FDA Product Code
- OWB FDA UDIJAA FDA UDI
- GMDN Term
- X-ray system computer, diagnostic, general-purpose FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1650 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: X-ray system computer, diagnostic, general-purpose
InfiMed Digital Imaging System, Precision MPi, RF, CCD Camera by Varex Imaging Corporation — Class II — FDA UDI — listed in FDA GUDID
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Also classified as X-ray system computer, diagnostic, general-purpose.
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Cleared under the same submission
K012490 also covers:
- InfiMed Digital Imaging System, Platinum One, DSA, CCD Camera — Varex Imaging Corporation
- InfiMed Digital Imaging System, Platinum One, RF, CCD Camera — Varex Imaging Corporation
- InfiMed Digital Imaging System, Precision MPi, DSA, CCD Camera — Varex Imaging Corporation
- InfiMed Digital Imaging System, Precision RXi, RF/DSA, CCD Camera — Varex Imaging Corporation
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Varex Imaging Corporation
Sources (1)
- FDA UDI bb77429c-a173-4251-a6e8-ed6d42a56ca7 33 fields · synced Jun 9, 2026