# K231420: Aura 10 PET/CT

- Pathway: 510(k) (Traditional)
- Applicant: Xeos Medical
- Decided: Aug 10, 2023 after 86 days
- Product code: QXL (Cabinet, Emission Computed Tomography System)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K930090 (1993). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210880: Vereos PET/CT, Philips Medical Systems Nederland B.V. (2021) Summary page 4.

## Indications for use
The AURA 10 PET/CT system is a cabinet diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The AURA 10 PET/CT system images harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the surgical procedure. Images can be obtained as CT only, PET only, or a combination of both by surgeon’s discretion. The AURA 10 cabinet PET/CT system provides an image of extent and degree of intensity radiopharmaceutical uptake in the specimen by PET and the anatomical information by CT, which will help the surgeon with further patient management. The AURA 10 PET/CT system is not validated for margin detection.

Source page: https://510kreport.com/device/K231420
Methodology: https://510kreport.com/methodology