# K140206: Scintillation Gamma Camera

- Pathway: 510(k) (Traditional)
- Applicant: Ddd-Diagnostic A/S
- Decided: May 8, 2014 after 101 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 K001888 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001888: Unicorn Model SYS0630, Danish Diagnostic Development A/S (2000) Summary page 1.

## Most influential descendants
- K161674: QuantumCam (2016), 0 descendants of its own

## Indications for use
The QuantumCam is a gamma camera system designed to acquire data for whole body static, gated or dynamic and multi-slice images. The system is intended for use as diagnostic imaging device. When used with appropriate radio pharmaceuticals, images are produced representing the internal distribution of radioactivity in head or body. The system allows you to acquire data for high resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using Tc- 99m, TI-201, 1-123, In-ill1, Ga-67, Co-57.

Source page: https://510kreport.com/device/K140206
Methodology: https://510kreport.com/methodology