# K173547: ImagenUniversal

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Imaging Technologies
- Decided: Jan 12, 2018 after 57 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: 13 generations back to K002715 (2000). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060631: Biograph 64 and Biograph 40, Siemens Medical Solutions USA, Inc. (2006) Summary page 4.
- K151486: Biograph mCT and mCT Flow PET/CT Scanners, Siemens Medical Solutions USA, Inc. (2015) Summary page 4.
- K050366: Imagenpro, Cardiovascular Imaging Technologies, LLC (2005) Summary page 4.

## Indications for use
The ImagenUniversaJTM system is a software. application that allows the user to visualize raw PET and/or PET/CT data, to correct for transmission and emission misregislration, and to correct PET 3D data for photon scatter and prompt gamma photons. The resulting corrected tomograms can be exported to cardiac interpretive software for interpretation. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear med icine physicians) trained in the use of nuclear medicine imaging devices.

Source page: https://510kreport.com/device/K173547
Methodology: https://510kreport.com/methodology