# K210450: BBX-PET Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Prescient Imaging, LLC
- Decided: Mar 17, 2021 after 29 days
- Product code: KPS (System, Tomography, Computed, Emission)
- 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: 1 generation back to K091269 (2009). 1 ancestor in all.
4 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091269: Neuropet, Photodetection Systems, Inc. (2009) Summary page 4.

## Most influential descendants
- K250170: Pharos (2025), 0 descendants of its own
- K241751: NeuroLF  (Basic); NeuroLF  (Pro); NeuroLF  (Advanced); NeuroLF Seat (2024), 0 descendants of its own
- K240827: SET-5002 (2024), 0 descendants of its own
- K232569: Caremibrain (2023), 0 descendants of its own

## Indications for use
BBXT™-PET scanner is intended to obtain positron emission tomography (PET) images of parts of the human body that fit in the patient aperture (e.g., head) to detect abnormal pattern of distribution of radioactivity after injection of a positron emitting radiopharmaceutical. This information can assist in research, diagnosis, therapeutic planning and therapeutic outcome assessment.

Source page: https://510kreport.com/device/K210450
Methodology: https://510kreport.com/methodology