# K133730: CO Pilot/Regius Unitea

- Pathway: 510(k) (Traditional)
- Applicant: Konica Minolta, Inc.
- Decided: Jan 31, 2014 after 56 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
Longest line of descent: 7 generations back to K913770 (1991). 15 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071436: Regius Unitea, Konica Minolta Medical & Graphic, Inc. (2007) Summary page 1.
- K101842: ACIES, Konica Minolta Medical & Graphic, Inc. (2011) Summary page 1.
- K063337: Opal-Rad, Viztek, Inc. (2006) Summary page 1.

## Most influential descendants
- K210066: ImagePilot (2021), 1 descendant of its own
- K240281: Bone Suppression Software (2024), 0 descendants of its own

## Indications for use
The CO pilot is intended for installation on an off-the-shelf PC (REGIUS Unitea /510(K) number: K071436) meeting or exceeding minimum specifications. The CO pilot software primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The CO pilot software can process and display 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 CO pilot must not be used for primary image diagnosis in mammography.

Source page: https://510kreport.com/device/K133730
Methodology: https://510kreport.com/methodology