# K101279: CORRIDOR4DM V2010 Model: V2010

- Pathway: 510(k) (Traditional)
- Applicant: Invia
- Decided: Aug 4, 2010 after 90 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K913770 (1991). 30 ancestors in all.
12 later devices descend from it; 4 cite it directly.
1 of 43 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080575: CORRIDOR4DM, Invia (2008) Summary page 1.
- K083327: Syngocirculation Dynamicpet, Version 1.0, Siemens Medical Solutions USA, Inc. (2009) Summary page 1.
- K063762: Syngo Circulation Software Package with Extended Functionality, Siemens AG Medical Solutions (2007) Summary page 1.
- K023190: E.Cam Computer / E.Soft Workstation, Siemens Medical Solutions USA, Inc. (2002) Summary page 1.
- K003437: Odyssey LX, Model 211320, Philips Medical Systems (Cleveland), Inc. (2001) Summary page 1.

## Most influential descendants
- 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
- K202679: Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 (2021), 2 descendants of its own

## Indications for use
INVIA's Cotridor4DM v201 0Oapplication is intended to provide processing quantification, and multidimensional review of the biodistribution of radionuclides in the body using planar and tomographic images. The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion emission tomographic images. 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. Co-registration or fusion of volumetric data (ECT and/or CT) is providel 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/K101279
Methodology: https://510kreport.com/methodology