# K080575: CORRIDOR4DM

- Pathway: 510(k) (Traditional)
- Applicant: Invia
- Decided: May 13, 2008 after 74 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 K945428 (1995). 5 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001026: 3D-Mspect, The Reagents of the University of Michigan (2000)
- K990426: Calcium Scoring, Siemens Medical Solutions USA, Inc. (1999) Summary page 1.

## Most influential descendants
- K101279: CORRIDOR4DM V2010 Model: V2010 (2010), 12 descendants of its own
- K113754: CFR Quant (2012), 9 descendants of its own
- K143664: HeartSee (2015), 6 descendants of its own
- K171303: Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 (2017), 5 descendants of its own
- K123646: Emory Cardiac Toolbox 4.0 (2013), 3 descendants of its own

## Indications for use
Invia's Corridor4DM application is intended to provide processing, quantification, and multidimensional review of reconstructed cardiac emission tomographic studies (SPECT and PET). Cardiac CT interpretation and calcium quantification are optional features that are integrated into Corridor4DM (SPECT-CT and PET-CT). The calcium-scoring package is a non-invasive diagnostic tool that can be used to evaluate the calcified plaques in the coronary arteries, a risk factor for coronary artery disease. Calcium scoring may be used to monitor the progression or regression overtime of the amount or volume of calcium in the coronary arteries, which may be related to the prognosis of a cardiac attack. Coregistration or fusion of volumetric data (ECT and/or CT) is provided as a quality control for the identification of structures where correlative spatial information is necessary for a diagnostic interpretation.

Source page: https://510kreport.com/device/K080575
Methodology: https://510kreport.com/methodology