510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884345Substantially Equivalent

Model Esp-200 Mammographic System

Acoma Medical Imaging, Inc., Wheeling IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884345 is the FDA 510(k) clearance record for MODEL ESP-200 MAMMOGRAPHIC SYSTEM, a class II device, cleared for Acoma Medical Imaging, Inc. on under FDA product code IZH (System, X-Ray, Mammographic). FDA records list 13 510(k) clearances for Acoma Medical Imaging, Inc., from to . As of , FDA records show no recalls naming K884345.

Clearance record

Decision date
Received
(160 days to decision)
Product code
IZH System, X-Ray, Mammographic
Regulation
21 CFR 892.1710
Device class
Class II
Review panel
Radiology
Applicant
Acoma Medical Imaging, Inc. 150 Chaddick Dr., Wheeling IL
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