Home / 510(k) Clearances / K003130

510(k) K003130

REGUTHERM 952 THERMOGRAPHIC SYSTEM by Sie-Med, Inc. — Product Code LHQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2001
Date Received
October 6, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Telethermographic (Adjunctive Use)
Device Class
Class I
Regulation Number
884.2980
Review Panel
RA
Submission Type

Other clearances by Sie-Med, Inc.

  • K964083 — ULTRATHERM (908) (April 3, 1997)

Other clearances for product code LHQ

  • K232462 — ThermPix Thermovisual Camera (September 14, 2023)
  • K213650 — ThermPix Thermovisual Camera (April 12, 2022)
  • K212965 — Smile-100 System (March 10, 2022)
  • K212412 — IRIS-XP (September 13, 2021)
  • K200999 — Thermidas IR System (ThIR-A615) (January 6, 2021)
  • K181716 — InTouch Thermal Camera (March 25, 2019)
  • K171928 — Med-Hot Thermal Imaging Systems (December 8, 2017)
  • K162767 — Sentinel BreastScan II System (January 9, 2017)
  • K160573 — FirstSense Breast Exam (June 1, 2016)
  • K150457 — AlfaSight 9000 Thermographic System (April 10, 2015)