# K951806: Opgal Intraoperative Vascular Angiography System (Iva-2000)

- Pathway: 510(k) (Traditional)
- Applicant: Opgal Optronic Industries
- Decided: Jul 6, 1995 after 78 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
No predicates in its family tree.
8 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K982327: Inframetrics Infracam-Med (1998), 7 descendants of its own
- 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

Source page: https://510kreport.com/device/K951806
Methodology: https://510kreport.com/methodology