510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001171Substantially Equivalent

Delta 16 Tact

Instrumentarium Imaging, Inc., Milwaukee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001171 is the FDA 510(k) clearance record for DELTA 16 TACT, a class II device, cleared for Instrumentarium Imaging, Inc. on under FDA product code IZH (System, X-Ray, Mammographic). FDA records list 24 510(k) clearances for Instrumentarium Imaging, Inc., from to . As of , FDA records show no recalls naming K001171.

Clearance record

Decision date
Received
(31 days to decision)
Product code
IZH System, X-Ray, Mammographic
Regulation
21 CFR 892.1710
Device class
Class II
Review panel
Radiology
Applicant
Instrumentarium Imaging, Inc. 300 W. Edgerton Ave., Milwaukee WI
510(k) summary
Summary
Third party review
No

Clearances, product code IZH

Trailing 12 months

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

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