510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042679Substantially Equivalent

Ir Viewer

Infrared Imaging Systems, Inc., Columbus OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042679 is the FDA 510(k) clearance record for IR VIEWER, a class I device, cleared for Infrared Imaging Systems, Inc. on under FDA product code KZA (Device, Vein Location, Liquid Crystal). FDA records list one 510(k) clearance for Infrared Imaging Systems, Inc. As of , FDA records show no recalls naming K042679.

Clearance record

Decision date
Received
(72 days to decision)
Product code
KZA Device, Vein Location, Liquid Crystal
Regulation
21 CFR 880.6970
Device class
Class I
Review panel
General Hospital
Applicant
Infrared Imaging Systems, Inc. 1275 Kinnear Rd., Columbus OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KZA

Trailing 12 months

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

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