Fuji Medical CR Console Flash IIP
by Fujifilm Medical System U.S.A., Inc. 510(k)
Active
510(k) K041990
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041990 | Date6 Aug 2004 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Fuji Medical Cr Console, Model Flash Iip
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Fuji Medical CR Console Flash IIP is a computed radiography (CR) modality workstation, designed to process and display digital x-ray images (excluding mammography) for diagnostic purposes. It integrates patient and exam data, applies image processing algorithms, and facilitates image output for archiving, distribution, or further review. Classified under the Radiology advisory committee, this device supports workflow efficiency in radiology departments by enhancing image clarity and accessibility.
This workstation is intended for use in clinical radiology settings and is supplied as a standalone console. It is not single-use and requires proper maintenance per manufacturer guidelines. The device is not MRI-safe and must be stored in a controlled environment to preserve functionality. Authorized under FDA 510(k) clearance (K041990), it adheres to regulatory standards for medical imaging equipment, ensuring compliance with radiology workflow requirements.
Other devices from Fujifilm Medical System U.S.A., Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of x-ray images can the Fuji Medical CR Console Flash IIP process and display, and does it include mammography support?
The Fuji Medical CR Console Flash IIP is designed specifically for processing and displaying digital x-ray images, excluding mammography. It integrates patient and exam data, applies image processing algorithms, and enhances clarity for diagnostic review. Since mammography is explicitly excluded in the description, this console is not intended for breast imaging.
Is the Fuji Medical CR Console Flash IIP meant for single-use or repeated use in a clinical setting, and how should it be maintained?
The Fuji Medical CR Console Flash IIP is a standalone console intended for repeated use in clinical radiology settings. It is not single-use and requires proper maintenance as outlined by the manufacturer to ensure optimal performance and longevity. Regular upkeep is essential to preserve functionality and compliance with radiology workflow standards.
What kind of environment is recommended for storing the Fuji Medical CR Console Flash IIP, and is it safe to use near MRI equipment?
The device must be stored in a controlled environment to maintain its functionality and performance. Importantly, the Fuji Medical CR Console Flash IIP is not MRI-safe, meaning it should never be placed in or near an MRI scanner or area where MRI procedures are conducted, as this could pose risks to both the device and patients.
How does the Fuji Medical CR Console Flash IIP support workflow efficiency in radiology departments, and what specific features does it offer?
The console enhances workflow efficiency by integrating patient and exam data, applying advanced image processing algorithms to improve clarity, and enabling seamless output for archiving, distribution, or further review. This integration streamlines diagnostic processes, making it easier for radiologists to access and analyze images quickly while maintaining high-quality standards.