510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K935608Substantially Equivalent

Mamospat

E.V.S. Tool & die Co., Inc., Harrisville RI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935608 is the FDA 510(k) clearance record for MAMOSPAT, a class II device, cleared for E.V.S. Tool & Die Co., Inc. on under FDA product code IZH (System, X-Ray, Mammographic). FDA records list one 510(k) clearance for E.V.S. Tool & Die Co., Inc. As of , FDA records show no recalls naming K935608.

Clearance record

Decision date
Received
(179 days to decision)
Product code
IZH System, X-Ray, Mammographic
Regulation
21 CFR 892.1710
Device class
Class II
Review panel
Radiology
Applicant
E.V.S. Tool & Die Co., Inc. P.O. Box 191, Harrisville RI
510(k) summary
Statement
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