# K101391: Scandia-45 Gamma Camera System

- Pathway: 510(k) (Traditional)
- Applicant: Scandia Corporation
- Decided: Aug 4, 2010 after 78 days
- Product code: IYX (Camera, Scintillation (Gamma))
- Device class: 1
- Regulation: 21 CFR 892.1100
- 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 K052473 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073456: T-Quest System, Medx, Inc. (2007) Summary page 1.

## Indications for use
The Scandia-45 is indicated for use in the acquisition, processing, display, and analysis of planar images of the thyroid and other small organs

Source page: https://510kreport.com/device/K101391
Methodology: https://510kreport.com/methodology