# K041990: Fuji Medical CR Console, Model Flash Iip

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Aug 6, 2004 after 14 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 6 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Fuji CR DIMS CRT Image Console HI-C654: named in the summary without a submission number

## Most influential descendants
- K051523: Regius Console CS-2000 and Regius Console CS-3000, Medical Image Processing Workstation (2005), 5 descendants of its own
- K071436: Regius Unitea (2007), 4 descendants of its own
- K101842: ACIES (2011), 3 descendants of its own
- K133730: CO Pilot/Regius Unitea (2014), 2 descendants of its own
- K210066: ImagePilot (2021), 1 descendant of its own

## Indications for use
The Fuji CR Console is a CR modality workstation intended to associate FCR images (except mammography images) with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving.

Source page: https://510kreport.com/device/K041990
Methodology: https://510kreport.com/methodology