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)

INFRARED SCIENCES BREASTSCAN IR SYSTEM

K-Number: K032350 · 2004-02-20

ApplicantInfrared Sciences Corp.
Decision Date2004-02-20
Product CodeLHQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INFRARED SCIENCES BREASTSCAN IR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Infrared Sciences Corp.. It received FDA 510(k) clearance on 2004-02-20 under 510(k) number K032350. 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 INFRARED SCIENCES BREASTSCAN IR SYSTEM?

INFRARED SCIENCES BREASTSCAN IR SYSTEM is a medical device that received FDA 510(k) clearance on 2004-02-20. The listed applicant is Infrared Sciences Corp.. The 510(k) number is K032350.

When did INFRARED SCIENCES BREASTSCAN IR SYSTEM receive FDA 510(k) clearance?

INFRARED SCIENCES BREASTSCAN IR SYSTEM received FDA 510(k) clearance on 2004-02-20, under 510(k) number K032350.

Who is the listed applicant for INFRARED SCIENCES BREASTSCAN IR SYSTEM?

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

What is the FDA product code for INFRARED SCIENCES BREASTSCAN IR SYSTEM?

The FDA product code for INFRARED SCIENCES BREASTSCAN IR SYSTEM 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.

↑