510(k) · Cleared
ClearedOpgal Intraoperative Vascular Angiography System (Iva-2000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Opgal Optronic Industries · LHQ System, Telethermographic (Adjunctive Use)
Cleared on Jul 6, 1995 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Jul 6, 1995
- Review
- 78 days
- Class
- Class I
- Product code
- LHQ
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK951806 Opgal Intraoperative Vascular Angiography System (Iva-2000)Opgal Optronic Industries · 1995
- Descendant · cites it directly · 7 of its ownK982327 Inframetrics Infracam-MedInframetrics, Inc. · 1998
- Descendant · 2 generations on · 3 of its ownK990416 Omnicorder Bioscan SystemOmnicorder Technologies, Inc. · 1999
- Descendant · 2 generations on · 2 of its ownK033967 Telethermographic Camera, Series a, E, S and PFlir Systems · 2004
- Descendant · 3 generations on · 2 of its ownK032350 Infrared Sciences Breastscan IR SystemInfrared Sciences Corp. · 2004
- Descendant · 4 generations on · 0 of its ownK162767 Sentinel BreastScan II SystemFirst Sense Medical, LLC · 2017
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K982327Inframetrics Infracam-MedInframetrics, Inc. · 1998 · cites it directly7descendants
- K990416Omnicorder Bioscan SystemOmnicorder Technologies, Inc. · 1999 · 2 generations on3descendants
- K033967Telethermographic Camera, Series a, E, S and PFlir Systems · 2004 · 2 generations on2descendants
- K032350Infrared Sciences Breastscan IR SystemInfrared Sciences Corp. · 2004 · 3 generations on2descendants
- K162767Sentinel BreastScan II SystemFirst Sense Medical, LLC · 2017 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951806 | Opgal Intraoperative Vascular Angiography System (Iva-2000) | Opgal Optronic Industries | 1995 | — |
| +1 | K982327 | Inframetrics Infracam-Med | Inframetrics, Inc. | 1998 | — |
| +2 | K990416 | Omnicorder Bioscan System | Omnicorder Technologies, Inc. | 1999 | — |
| +2 | K033967 | Telethermographic Camera, Series a, E, S and P | Flir Systems | 2004 | — |
| +3 | K032350 | Infrared Sciences Breastscan IR System | Infrared Sciences Corp. | 2004 | — |
| +4 | K162767 | Sentinel BreastScan II System | First Sense Medical, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LHQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LHQ device
- #1 K253911 Derma-2score 12.0 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982327 | Inframetrics Infracam-Med | 1998 | 7 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K982327 (Inframetrics, Inc., 1998) has gone furthest, with 7 descendants of its own.
How does its category compare?
All LHQ devicesLHQ System, Telethermographic (Adjunctive Use): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LHQ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LHQ
Too few LHQ 510(k)s in any year since 2007 to give a median.
Recalls per year · LHQ
No recall names LHQ since 2007.
Adverse event reports per year · LHQ
1in 2025
MAUDE reports naming product code LHQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K951806 · printed Nov 4, 2026
Cite this page
510(k) Report. “K951806: Opgal Intraoperative Vascular Angiography System (Iva-2000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951806
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026