# K122241: IMAGEN3D

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Imaging Technologies
- Decided: Oct 24, 2012 after 89 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ecat Lso Pet/CT 16: named in the summary without a submission number
- (no number) ImagenPRO®: named in the summary without a submission number

## Indications for use
The lmagen3D TM System is software application that works in conjunction with ImagenPRO® to correct for photon scatter and prompt gamma contamination present in PET 3D data. The resulting 3D datasets can be reconstructed using lmagenPROO to produce PET and/or PET/CT reconstructed tomo grams.

Source page: https://510kreport.com/device/K122241
Methodology: https://510kreport.com/methodology