Identity
- Trade Name
- FCR XL-2 FDA UDI
- Generic Name
- Computed radiography digital imaging scanner FDA UDI
- Device Name
- The FCR XL-2/FCR Aspire CRm (CR-IR 359) is equipment designed to read X-ray image information recorded on an imaging plate (IP). FDA UDI
- Model / Reference
- CR-IR 359 FDA UDI
- Description
- The FCR XL-2/FCR Aspire CRm (CR-IR 359) is equipment designed to read X-ray image information recorded on an imaging plate (IP). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410250459 FDA UDI
- 510(k) Number
- K111646 FDA UDI
- FDA Product Code
- MUE FDA UDI
- GMDN Term
- Computed radiography digital imaging scanner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1715 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: Computed radiography digital imaging scanner
Fcr Xl-2 by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Computed radiography digital imaging scanner.
- CANON INC. — CANON INC. · Class II
- DX-M — Agfa Corp. · Class II
- Vita XE CR System — CARESTREAM HEALTH, INC. · Class II
- CANON INC. — CANON INC. · Class II
- Radlink CR Pro 2200 — RADLINK, INC. · Class II
- GMR40 Retrofit Kit — Neurologica Corporation · Class II
- CANON INC. — CANON INC. · Class II
- Vita Flex CR System — CARESTREAM HEALTH, INC. · Class II
Cleared under the same submission
K111646 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- FUJIFILM Corporation
Sources (1)
- FDA UDI 75b13ef0-0d64-42c2-ad3d-7e33c652e99d 36 fields · synced Jun 1, 2026