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FDA 510(k)

Med-Hot Thermal Imaging Systems

K-Number: K171928 · 2017-12-08

ApplicantMed-Hot Thermal Imaging, Inc.
Decision Date2017-12-08
Product CodeLHQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Med-Hot Thermal Imaging Systems is a medical device manufactured by Med-Hot Thermal Imaging, Inc.. It received FDA 510(k) clearance on 2017-12-08 under approval number K171928. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Med-Hot Thermal Imaging Systems?

Med-Hot Thermal Imaging Systems is a medical device that received FDA 510(k) clearance on 2017-12-08. It is manufactured by Med-Hot Thermal Imaging, Inc.. The 510(k) number is K171928.

When was Med-Hot Thermal Imaging Systems approved by the FDA?

Med-Hot Thermal Imaging Systems received FDA 510(k) clearance on 2017-12-08, under approval number K171928.

What company makes Med-Hot Thermal Imaging Systems?

Med-Hot Thermal Imaging Systems is manufactured by Med-Hot Thermal Imaging, Inc..

What is the FDA product code for Med-Hot Thermal Imaging Systems?

The FDA product code for Med-Hot Thermal Imaging Systems is LHQ.

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Related PubMed Literature

PMID: 42207283 [Legal responsibility in AI-assisted radiological reporting]. Radiologie (Heidelberg, Germany) (2026) PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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