# K982171: Hamamatsu Pet Scanner, Model SHR-22000

- Pathway: 510(k) (Traditional)
- Applicant: Hamamatsu Photonics K.K.
- Decided: Sep 17, 1998 after 90 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 K962797 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962797: Ecat Exact & Ecat Exact HR+, Cti Pet Systems, Inc. (1996) Summary page 1.

## Indications for use
The Hamamatsu PET Scanner Model SHR-22000 is indicated for the imaging of the distribution of physiological tracer molecules labeled with positron-emitting isotopes. Such images are particularly useful in the assessment of brain function.

Source page: https://510kreport.com/device/K982171
Methodology: https://510kreport.com/methodology