510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935428Substantially Equivalent

Bennett X-Ray Digital Spot Imager

Bennett X-Ray Technologies, Copiague NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935428 is the FDA 510(k) clearance record for BENNETT X-RAY DIGITAL SPOT IMAGER, a class II device, cleared for Bennett X-Ray Technologies on under FDA product code IZH (System, X-Ray, Mammographic). FDA records list 2 510(k) clearances for Bennett X-Ray Technologies, from to . As of , FDA records show no recalls naming K935428.

Clearance record

Decision date
Received
(356 days to decision)
Product code
IZH System, X-Ray, Mammographic
Regulation
21 CFR 892.1710
Device class
Class II
Review panel
Radiology
Applicant
Bennett X-Ray Technologies 445 Oak St., Copiague NY
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