# K063037: Centarisone Ris/Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Centarisone, LLC
- Decided: Oct 18, 2006 after 15 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: 5 generations back to K954678 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051037: Imageqube Pacs, Intuitive Imaging Informatics, LLC (2005) Summary page 1.

## Indications for use
CentarisOneTm RIS/PACS is intended for use by a physicians and other medical staff as a full service DICOM and THE compliant RIS/PACS solution for the storage, distribution and display of medical images from various imaging sources such as CT, MRI, NM, PT, DR, CR, US, XA scanners and secondary capture devices (film digitizers, etc.). This device may be used to archive mammography images (MG) but is not intended for primary diagnostic viewing of mammography images by this device.

Source page: https://510kreport.com/device/K063037
Methodology: https://510kreport.com/methodology