510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K905748Substantially Equivalent

Mamex Dc Ami Sl12/mg15

Soredex, Inc., Sf-00511 Helsinki Finland, FI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905748 is the FDA 510(k) clearance record for MAMEX DC AMI SL12/MG15, a class II device, cleared for Soredex, Inc. on under FDA product code IZH (System, X-Ray, Mammographic). FDA records list one 510(k) clearance for Soredex, Inc. As of , FDA records show no recalls naming K905748.

Clearance record

Decision date
Received
(71 days to decision)
Product code
IZH System, X-Ray, Mammographic
Regulation
21 CFR 892.1710
Device class
Class II
Review panel
Radiology
Applicant
Soredex, Inc. Nilsiankatu 10-14, Sf-00511 Helsinki Finland, FI
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