# K161674: QuantumCam

- Pathway: 510(k) (Abbreviated)
- Applicant: Ddd-Diagnostic A/S
- Decided: Oct 20, 2016 after 126 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 K001888 (2000). 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)
- K140206: Scintillation Gamma Camera, Ddd-Diagnostic A/S (2014) Summary page 4.

## 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 T¢c-99m, TI-201, 1-123, 1-131, In-111, Ga-67, Co-57.

Source page: https://510kreport.com/device/K161674
Methodology: https://510kreport.com/methodology