Cleared Traditional

K913418 - SENOGRAPHE DMR/SMR/DM

K913418 is the FDA 510(k) clearance for SENOGRAPHE DMR/SMR/DM by General Electric Co.. It is a Class 2 Radiology device (product code IZH) cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K913418 · General Electric Co. · Radiology device
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Jan 1992
Decision
159d
Days
Class 2
Risk

K913418 is an FDA 510(k) clearance for the SENOGRAPHE DMR/SMR/DM. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on January 6, 1992 after a review of 159 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all General Electric Co. devices

Submission Details

510(k) Number K913418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1991
Decision Date January 06, 1992
Days to Decision 159 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
52d slower than avg
Panel avg: 107d · This submission: 159d
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 K913418.
MOBILE ATHENA HF
K922454 · Fischer Imaging Corp. · Sep 1992
MAMMOSCAN
K923061 · Fischer Imaging Corp. · Sep 1992
AVIVA MAMMOGRAPHIC X-RAY SYSTEM
K915748 · Elscint, Inc. · Feb 1992
PHILIPS MAMMODIAGNOST BC
K913845 · Philips Medical Systems, Inc. · Dec 1991
MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM
K914328 · Siemens Medical Solutions USA, Inc. · Dec 1991
MAM-3RM-A MAMMOGRAPHIC X-RAY SYSTEM
K912974 · Elscint, Inc. · Sep 1991