Cleared Traditional

K914328 - MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SY...

K914328 is the FDA 510(k) clearance for MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SY... by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code IZH) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K914328 · Siemens Medical Solutions USA, Inc. · Radiology device
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Dec 1991
Decision
66d
Days
Class 2
Risk

K914328 is an FDA 510(k) clearance for the MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on December 2, 1991 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1710 - 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.

View all Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K914328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1991
Decision Date December 02, 1991
Days to Decision 66 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 107d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZH System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1710
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 - IZH System, X-ray, Mammographic

All 43
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K914328.
AVIVA MAMMOGRAPHIC X-RAY SYSTEM
K915748 · Elscint, Inc. · Feb 1992
SENOGRAPHE DMR/SMR/DM
K913418 · General Electric Co. · Jan 1992
PHILIPS MAMMODIAGNOST BC
K913845 · Philips Medical Systems, Inc. · Dec 1991
MAM-3RM-A MAMMOGRAPHIC X-RAY SYSTEM
K912974 · Elscint, Inc. · Sep 1991
ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM
K900989 · Fischer Imaging Corp. · Mar 1990
CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC
K896609 · Philips Medical Systems North America, Inc. · Jan 1990