# K090553: Naviscan Pemflex Solo II High Resolution Pet Scanner

- Pathway: 510(k) (Special)
- Applicant: Naviscan, Inc.
- Decided: Mar 31, 2009 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: 2 generations back to K914267 (1992). 4 ancestors in all.
1 later device descends 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)
- K032063: Pem 2400 Pet Scanner, Pem Technologies (2003) Summary page 1.

## Most influential descendants
- K214062: Radialis PET Camera (2022), 0 descendants of its own

## Indications for use
The Naviscan PEMFlex Solo II High Resolution PET Scanner is intended for medical purposes to image and measure the distribution of injected positron emitting radiopharmaceuticals in human beings for the purpose of determining various metabolic and physiologic functions within the human body.

Source page: https://510kreport.com/device/K090553
Methodology: https://510kreport.com/methodology