# K241280: Constellation (CON-001)

- Pathway: 510(k) (Traditional)
- Applicant: Q Bio, Inc.
- Decided: Sep 12, 2024 after 128 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 3 generations back to K061855 (2006). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192051: THINQ, Corticometrics, LLC (2020) Summary page 5.
- K211983: AMRA Profiler, Amra Medical AB (2021) Summary page 5.

## Indications for use
Constellation is intended for non-invasive labeling and calculation of quantitative measurements for anatomical regions. Constellation utilizes DICOM MR images gathered on a GE MR450W that encompass the whole-body. It is intended to be used for healthy adult patients. Clinicians may use Constellation as a clinical decision support tool, but it is not to be used in triage events, emergency medicine, or critical care. A clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices.

Source page: https://510kreport.com/device/K241280
Methodology: https://510kreport.com/methodology