510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K872962Substantially Equivalent

Breast-Scan(tm)

Thermascan, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872962 is the FDA 510(k) clearance record for BREAST-SCAN(TM), a class I device, cleared for Thermascan, Inc. on under FDA product code LHM (System, Thermographic, Liquid Crystal). FDA records list one 510(k) clearance for Thermascan, Inc. As of , FDA records show no recalls naming K872962.

Clearance record

Decision date
Received
(83 days to decision)
Product code
LHM System, Thermographic, Liquid Crystal
Regulation
21 CFR 884.2982
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Thermascan, Inc. 500 Fifth Ave., New York NY
Third party review
No

Clearances, product code LHM

Trailing 12 months

FDA records hold no clearances under product code LHM in the trailing twelve months.

FDA records show no clearances under product code LHM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LHM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260