# K041671: Imagenmd

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Imaging Technologies, LLC
- Decided: Jul 22, 2004 after 31 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) AutoQUANT: named in the summary without a submission number
- (no number) SeeMor: named in the summary without a submission number
- (no number) QBS: named in the summary without a submission number

## Indications for use
The ImagenMD TM system is a software and computer system that allows the user to view myocardial perfusion SPEC or PET images from a remote location. The system allows the user to view quantify and process perfusion and gated SPECT images.

Source page: https://510kreport.com/device/K041671
Methodology: https://510kreport.com/methodology