# K071436: Regius Unitea

- Pathway: 510(k) (Traditional)
- Applicant: Konica Minolta Medical & Graphic, Inc.
- Decided: Jun 27, 2007 after 35 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: 2 generations back to K041990 (2004). 2 ancestors in all.
4 later devices descend from it; 3 cite 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)
- K051523: Regius Console CS-2000 and Regius Console CS-3000, Medical Image Processing Workstation, Konica Minolta Medical & Graphic, Inc. (2005) Summary page 1.

## Most influential descendants
- 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
- May 9, 2018 · Class II · Z-2282-2018: Panasonic has issued a Mandatory Product Safety Notice, indicating a possibility of battery ignition (fire) in CF-C2 "Toughbook" laptops. Since Konica Minolta uses this laptop in some of its product c

## Indications for use
The REGIUS Unitea software is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications. The REGIUS Unitea software primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The REGIUS Unitea software can process and display medical images from the following modality types: Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and other DICOM compliant modalities. The REGIUS Unitea must not be used for primary image diagnosis in mammography.

Source page: https://510kreport.com/device/K071436
Methodology: https://510kreport.com/methodology