FDA 510(k)

BREAST-SCAN(TM)

K-Number: K872962 · 1987-10-20

Decision Date1987-10-20

Product CodeLHM

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

BREAST-SCAN(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Thermascan, Inc.. It received FDA 510(k) clearance on 1987-10-20 under 510(k) number K872962. The device is classified under product code LHM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREAST-SCAN(TM)?

BREAST-SCAN(TM) is a medical device that received FDA 510(k) clearance on 1987-10-20. The listed applicant is Thermascan, Inc.. The 510(k) number is K872962.

When did BREAST-SCAN(TM) receive FDA 510(k) clearance?

BREAST-SCAN(TM) received FDA 510(k) clearance on 1987-10-20, under 510(k) number K872962.

Who is the listed applicant for BREAST-SCAN(TM)?

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

What is the FDA product code for BREAST-SCAN(TM)?

The FDA product code for BREAST-SCAN(TM) is LHM.

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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.