Cleared Traditional

K964069 - DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM

K964069 is an FDA 510(k) clearance for DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRA..., manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K964069 · Siemens Medical Solutions USA, Inc. · Radiology device
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May 1997
Decision
210d
Days
Class 2
Risk

K964069 is an FDA 510(k) clearance for the DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY 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 May 8, 1997 after a review of 210 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 Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K964069

510(k) Number K964069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1996
Decision Date May 08, 1997
Days to Decision 210 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
103d slower than avg
Panel avg: 107d · This submission: 210d
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 104
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K964069.
PLANMED CYTOGUIDE
K973493 · Planmed OY · Nov 1997
INFLATABLE POSITIONING CUSHIONS
K973915 · Kci New Technologies, Inc. · Nov 1997
GLORY
K970680 · Elscint, Inc. · Jun 1997
GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM
K953902 · Medical Marketing Intl., Inc. · Mar 1997
PLANNED SOPHIED CLASSIC
K962105 · Planmed OY · Feb 1997
PROFILE MAMMOGRAPHY SYSTEM (M-PRO)
K964576 · Bennett X-Ray Corp. · Jan 1997