510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832731Substantially Equivalent

Breast & Body Health System 2000

American Thermal Instruments, LLC, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832731 is the FDA 510(k) clearance record for BREAST & BODY HEALTH SYSTEM 2000, a class III device, cleared for American Thermal Instruments, Inc. on under FDA product code KXZ (System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)). FDA records list 2 510(k) clearances for American Thermal Instruments, Inc., from to . As of , FDA records show no recalls naming K832731.

Clearance record

Decision date
Received
(179 days to decision)
Product code
KXZ System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
Regulation
21 CFR 884.2982
Device class
Class III
Review panel
Obstetrics/Gynecology
Applicant
American Thermal Instruments, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KXZ

Trailing 12 months

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

FDA records show no clearances under product code KXZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KXZ, 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