# K070589: C!

- Pathway: 510(k) (Traditional)
- Applicant: Transphoton Corporation
- Decided: Apr 24, 2007 after 54 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: 3 generations back to K013353 (2002). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033874: Myolight, Ge Medical Systems F.I. Haifa (2003) Summary page 1.
- K053062: Cardiarc Spect Imaging Device, Model CQ103-RV2, Cardiarc, Ltd. (2006) Summary page 1.
- K033001: Apex Detector Electronics & Acquisition Interface, Model XL-4, Transphoton Corporation (2003) Summary page 1.

## Indications for use
The C! is indicated for use in the acquisition of Single Photon Emission Computed Tomography (SPECT) and Planar gamma camera images.

Source page: https://510kreport.com/device/K070589
Methodology: https://510kreport.com/methodology