Cleared Traditional

K973125 - MAMMOLOADER BY C.M.A. SRL

K973125 is an FDA 510(k) clearance for MAMMOLOADER BY C.M.A. SRL, manufactured by C.M.A.. The device is a Class 2 Radiology device with product code IXW cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K973125 · C.M.A. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
49d
Days
Class 2
Risk

K973125 is an FDA 510(k) clearance for the MAMMOLOADER BY C.M.A. SRL. Classified as Processor, Radiographic-film, Automatic (product code IXW), Class II - Special Controls.

Submitted by C.M.A. (Plano, US). The FDA issued a Cleared decision on October 8, 1997 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1900 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K973125

510(k) Number K973125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1997
Decision Date October 08, 1997
Days to Decision 49 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 107d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXW Device Classification - Class 2, Special Controls

Product Code IXW Processor, Radiographic-film, Automatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1900
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IXW Processor, Radiographic-film, Automatic

All 77
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K973125.
KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR
K990969 · Konica Medical Corp. · Jun 1999
AII-PRO 100 PLUS AND ALL-PRO 200
K991435 · All-Pro Imaging Corp. · May 1999
CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS
K981280 · Bayer Corp., Agfa Div. · Apr 1998
KODAK MINILOADER(2000)
K970059 · Eastman Kodak Company · Jan 1997
3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR
K962750 · Imation Corp. · Aug 1996
JPI AUTOMATIC X-RAY FILM PROCESSOR
K955706 · Jpi Healthcare Co, Ltd. · Feb 1996
K973125 · MAMMOLOADER BY C.M.A. SRL
Download PDF FDA Summary C.M.A.