510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K003130Substantially Equivalent

Regutherm 952 Thermographic System

Sie-Med, Inc., Clarksville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003130 is the FDA 510(k) clearance record for REGUTHERM 952 THERMOGRAPHIC SYSTEM, a class I device, cleared for Sie-Med, Inc. on under FDA product code LHQ (System, Telethermographic (Adjunctive Use)). FDA records list 2 510(k) clearances for Sie-Med, Inc., from to . As of , FDA records show no recalls naming K003130.

Clearance record

Decision date
Received
(133 days to decision)
Product code
LHQ System, Telethermographic (Adjunctive Use)
Regulation
21 CFR 884.2980
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Sie-Med, Inc. 11902 Simpson Rd., Clarksville MD
510(k) summary
Summary
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