# K091269: Neuropet

- Pathway: 510(k) (Traditional)
- Applicant: Photodetection Systems, Inc.
- Decided: May 8, 2009 after 8 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
No predicates in its family tree.
5 later devices descend from it; 1 cites 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)
- None. The FDA summary names its predicate without a number.
- (no number) Toshiba Medical Systems PCA-8000A, Mark II, PET / CT System: named in the summary without a submission number

## Most influential descendants
- K210450: BBX-PET Scanner (2021), 4 descendants of its own
- 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
This device is a Positron Emission Tomography (PET) system used to detect and display the distribution of positron emitting radionuclides in parts of the human body that will fit in the patient aperture. This device is to be used by trained healthcare professionals. This information can assist in research, diagnosis, therapeutic planning and therapeutic outcome assessment.

Source page: https://510kreport.com/device/K091269
Methodology: https://510kreport.com/methodology