Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ICI P AND S SERIES IR CAMERAS

K-Number: K073581 · 2008-07-11

ApplicantTexas Infrared
Decision Date2008-07-11
Product CodeLHQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ICI P AND S SERIES IR CAMERAS is the device name listed in this FDA 510(k) record. The listed applicant is Texas Infrared. It received FDA 510(k) clearance on 2008-07-11 under 510(k) number K073581. 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 ICI P AND S SERIES IR CAMERAS?

ICI P AND S SERIES IR CAMERAS is a medical device that received FDA 510(k) clearance on 2008-07-11. The listed applicant is Texas Infrared. The 510(k) number is K073581.

When did ICI P AND S SERIES IR CAMERAS receive FDA 510(k) clearance?

ICI P AND S SERIES IR CAMERAS received FDA 510(k) clearance on 2008-07-11, under 510(k) number K073581.

Who is the listed applicant for ICI P AND S SERIES IR CAMERAS?

The FDA 510(k) record lists Texas Infrared as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ICI P AND S SERIES IR CAMERAS?

The FDA product code for ICI P AND S SERIES IR CAMERAS is LHQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: LHQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253911Derma-2Neko Health ABK232462ThermPix Thermovisual CameraUsa Therm, Inc.K213650ThermPix Thermovisual CameraUsa Therm, Inc.K212965Smile-100 SystemNiramai Health Analytix Private LimitedK212412IRIS-XPMedicore Co., Ltd.K200999Thermidas IR System (ThIR-A615)Thermidas Americas, Inc.

Official Source

View on FDA Database →

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

↑