# K982327: Inframetrics Infracam-Med

- Pathway: 510(k) (Traditional)
- Applicant: Inframetrics, Inc.
- Decided: Aug 18, 1998 after 47 days
- Product code: LHQ (System, Telethermographic (Adjunctive Use))
- Device class: 1
- Regulation: 21 CFR 884.2980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951806 (1995). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951806: Opgal Intraoperative Vascular Angiography System (Iva-2000), Opgal Optronic Industries (1995) Summary page 1.

## Cited in the summary but kept off the family tree
- K822729: Inframetrics Model 535 Infrared Medical Thermography System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K990416: Omnicorder Bioscan System (1999), 3 descendants of its own
- K033967: Telethermographic Camera, Series a, E, S and P (2004), 2 descendants of its own
- K032350: Infrared Sciences Breastscan IR System (2004), 2 descendants of its own
- K162767: Sentinel BreastScan II System (2017), 0 descendants of its own
- K160573: FirstSense Breast Exam (2016), 0 descendants of its own

## Indications for use
The InfraCAM-MED is a non-contact, non-invasive, non-radiating, thermal (infrared) imaging video camera intended for viewing heat patterns generated by the relative surface temperature of human heart tissue and vessels during coronary artery bypass surgery. Images of the exposed heart may be captured as black/white video images using VHS/SVHS videotape, or black/white still images using a thermal image printer. The InfraCAM-MED may be used to perform the following: * Viewing and documenting temperature differences between myocardium, graft and vessels distal to the anastomotic site generated by the injection of cold or warm fluid into the proximal end of a vein graft. * Viewing and documenting temperature differences between myocardium, graft and vessels distal to the anastomotic site generated by blood flow after release of the cross clamp(s) on an arterial graft. * Viewing and documenting temperature changes to the myocardium during the retrograde or antegrade perfusion of warm or cold cardioplegia.

Source page: https://510kreport.com/device/K982327
Methodology: https://510kreport.com/methodology