510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850534Substantially Equivalent

Bsi Model Mct 7000-Thermal Imaging System

Bales Scientific, Inc., Lafayette CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850534 is the FDA 510(k) clearance record for BSI MODEL MCT 7000-THERMAL IMAGING SYSTEM, a class I device, cleared for Bales Scientific, Inc. on under FDA product code LHQ (System, Telethermographic (Adjunctive Use)). FDA records list 3 510(k) clearances for Bales Scientific, Inc., from to . As of , FDA records show no recalls naming K850534.

Clearance record

Decision date
Received
(16 days to decision)
Product code
LHQ System, Telethermographic (Adjunctive Use)
Regulation
21 CFR 884.2980
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Bales Scientific, Inc. 10 Middle Rd., Lafayette CA
Third party review
No

Clearances, product code LHQ

Trailing 12 months
1 clearance under product code LHQ in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LHQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260