Cleared Traditional

K040125 - SENOGRAPHIC STEREO

K040125 is an FDA 510(k) clearance for SENOGRAPHIC STEREO, manufactured by Ge Medical Systems, Inc.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K040125 · Ge Medical Systems, Inc. · Radiology device
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Apr 2004
Decision
90d
Days
Class 2
Risk

K040125 is an FDA 510(k) clearance for the SENOGRAPHIC STEREO. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Ge Medical Systems, Inc. (Waukesha, US). The FDA issued a Cleared decision on April 19, 2004 after a review of 90 days - within the typical 510(k) review window.

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 Ge Medical Systems, Inc. devices

FDA 510(k) Submission Details - K040125

510(k) Number K040125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2004
Decision Date April 19, 2004
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZH Device Classification - Class 2, Special Controls

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 62
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K040125.
DIGITAL SPOT MAMMOGRAPHY SYSTEM
K100692 · Hologic, Inc. · Apr 2010
MAMMOTEST
K042095 · Fischer Imaging Corp. · Oct 2004
LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM
K040884 · Hologic, Inc. · Apr 2004
OPDIMA
K003945 · Siemens Medical Solutions USA, Inc. · Feb 2001
DELTA 32 AND DELTA 32 TACT
K002472 · Instrumentarium Imaging, Inc. · Nov 2000
DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)
K000976 · Instrumentarium Imaging, Inc. · Jun 2000