Identity
- Trade Name
- FCRView FDA UDI
- Generic Name
- Diagnostic x-ray digital imaging system workstation FDA UDI
- Device Name
- FCRView (CR-VW 674) is a Workstation intended to associate FCR images with patient and exam information, apply images processing to facilitate diagnosis, display the images, and output the resulting image and exam data for further display, distribution, or archiving. In addition, the FCR View can receive DICOM multi modality images for viewing. The FCR View must not be used for primary diagnosis of mammography images. FDA UDI
- Model / Reference
- CR-VW674 FDA UDI
- Description
- FCRView (CR-VW 674) is a Workstation intended to associate FCR images with patient and exam information, apply images processing to facilitate diagnosis, display the images, and output the resulting image and exam data for further display, distribution, or archiving. In addition, the FCR View can receive DICOM multi modality images for viewing. The FCR View must not be used for primary diagnosis of mammography images. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410316926 FDA UDI
- 510(k) Number
- K081308 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Diagnostic x-ray digital imaging system workstation FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Diagnostic x-ray digital imaging system workstation
FCRView by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- FUJIFILM Corporation
Sources (1)
- FDA UDI ee1a0427-c6ce-470f-afdb-34416fce3dd7 35 fields · synced May 29, 2026