510(k) · Cleared
ClearedInframetrics Infracam-Med
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inframetrics, Inc. · LHQ System, Telethermographic (Adjunctive Use)
Cleared on Aug 18, 1998 as substantially equivalent to K951806 (Opgal Optronic Industries, 1995) after a 47-day review. Its family tree reaches back 1 generation to 1995. 7 later devices descend from it.
- Decided
- Aug 18, 1998
- Review
- 47 days
- Class
- Class I
- Product code
- LHQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K951806 (1995). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK951806 Opgal Intraoperative Vascular Angiography System (Iva-2000)Opgal Optronic Industries · 1995
- This deviceK982327 Inframetrics Infracam-MedInframetrics, Inc. · 1998
- Descendant · cites it directly · 3 of its ownK990416 Omnicorder Bioscan SystemOmnicorder Technologies, Inc. · 1999
- Descendant · cites it directly · 2 of its ownK033967 Telethermographic Camera, Series a, E, S and PFlir Systems · 2004
- Descendant · 2 generations on · 2 of its ownK032350 Infrared Sciences Breastscan IR SystemInfrared Sciences Corp. · 2004
- Descendant · 3 generations on · 0 of its ownK162767 Sentinel BreastScan II SystemFirst Sense Medical, LLC · 2017
- Descendant · 3 generations on · 0 of its ownK160573 FirstSense Breast ExamFirst Sense Medical, LLC · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K990416Omnicorder Bioscan SystemOmnicorder Technologies, Inc. · 1999 · cites it directly3descendants
- K033967Telethermographic Camera, Series a, E, S and PFlir Systems · 2004 · cites it directly2descendants
- K032350Infrared Sciences Breastscan IR SystemInfrared Sciences Corp. · 2004 · 2 generations on2descendants
- K162767Sentinel BreastScan II SystemFirst Sense Medical, LLC · 2017 · 3 generations on0descendants
- K160573FirstSense Breast ExamFirst Sense Medical, LLC · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951806 | Opgal Intraoperative Vascular Angiography System (Iva-2000) | Opgal Optronic Industries | 1995 | — |
| 0 (this device) | K982327 | Inframetrics Infracam-Med | Inframetrics, Inc. | 1998 | — |
| +1 | K990416 | Omnicorder Bioscan System | Omnicorder Technologies, Inc. | 1999 | — |
| +1 | K033967 | Telethermographic Camera, Series a, E, S and P | Flir Systems | 2004 | — |
| +2 | K032350 | Infrared Sciences Breastscan IR System | Infrared Sciences Corp. | 2004 | — |
| +3 | K162767 | Sentinel BreastScan II System | First Sense Medical, LLC | 2017 | — |
| +3 | K160573 | FirstSense Breast Exam | First Sense Medical, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), the FDA summary (predicates and indications), 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951806 | Opgal Intraoperative Vascular Angiography System (Iva-2000)Summary page 1…ED The Inframetrics InfraCAM-MED is substantially equivalent to several legally marketed infrared thermography systems, such as the Opgal IVA-2000 distributed by OPGAL (K951806), and the Inframetrics Model 535 Infrared Medical Thermography System (K822729). Inframetrics, Inc. 510(k) 7/1/98 Inframetrics… | 1995 |
| 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…marketed infrared thermography systems, such as the Opgal IVA-2000 distributed by OPGAL (K951806), and the Inframetrics Model 535 Infrared Medical Thermography System (K822729). Inframetrics, Inc. 510(k) 7/1/98 Inframetrics InfraCAM-MED Page E-1 4, DEVICE DESCRIPTION The InfraCAM-MED is… |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K990416 (Omnicorder Technologies, Inc., 1999) has gone furthest, with 3 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 | — |
What is it indicated for?
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…
Read the full statement (150 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982327 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982327: Inframetrics Infracam-Med.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982327
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026