# K051523: Regius Console CS-2000 and Regius Console CS-3000, Medical Image Processing Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Konica Minolta Medical & Graphic, Inc.
- Decided: Jul 20, 2005 after 42 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K041990 (2004). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041990: Fuji Medical CR Console, Model Flash Iip, Fujifilm Medical System U.S.A., Inc. (2004) Summary page 4.

## Most influential descendants
- 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
- K240281: Bone Suppression Software (2024), 0 descendants of its own

## Recalls of this device
- Feb 6, 2006 · Not classified · Z-0862-06: If the patient demographic data is entered into the CS-1 manually, and the user fails to enter any data in one of the demographic data fields labeled as Birthday, Sex, Name or Patient Comments, etc, t

## Indications for use
Receive and process electronic images of patients. The REGIUS CS-2000/CS-3000 is NOT intended for use with digital mammography system.

Source page: https://510kreport.com/device/K051523
Methodology: https://510kreport.com/methodology