510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K973125Substantially Equivalent

Mammoloader by C.m.a. Srl

C.M.A., Plano TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973125 is the FDA 510(k) clearance record for MAMMOLOADER BY C.M.A. SRL, a class II device, cleared for C.M.A. on under FDA product code IXW (Processor, Radiographic-Film, Automatic). FDA records list one 510(k) clearance for C.M.A. As of , FDA records show no recalls naming K973125.

Clearance record

Decision date
Received
(49 days to decision)
Product code
IXW Processor, Radiographic-Film, Automatic
Regulation
21 CFR 892.1900
Device class
Class II
Review panel
Radiology
Applicant
C.m.a. 7916 Kettlewood Ct., Plano TX
510(k) summary
Summary
Third party review
No

Clearances, product code IXW

Trailing 12 months

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

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