Cleared Traditional

K945743 - PREFERENCE MAMMOGRAPHY SYSTEM

K945743 is the FDA 510(k) clearance for PREFERENCE MAMMOGRAPHY SYSTEM by Philips Medical Systems (Cleveland), Inc.. It is a Class 2 Radiology device (product code IZH) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K945743 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Mar 1995
Decision
128d
Days
Class 2
Risk

K945743 is an FDA 510(k) clearance for the PREFERENCE MAMMOGRAPHY SYSTEM. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Cleveland, US). The FDA issued a Cleared decision on March 31, 1995 after a review of 128 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 Philips Medical Systems (Cleveland), Inc. devices

Submission Details

510(k) Number K945743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1994
Decision Date March 31, 1995
Days to Decision 128 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
21d slower than avg
Panel avg: 107d · This submission: 128d
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 K945743.
SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE
K953250 · GE Medical Systems · Jan 1996
REAL TIME STEREOTIX
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MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM
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ATHENA HFX
K945619 · Fischer Imaging Corp. · Mar 1995
SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096)
K944816 · Philips Medical Systems (Cleveland), Inc. · Feb 1995
MAMMOMAT 300 AND MAMMOMAT 3000
K932672 · Siemens Medical Solutions USA, Inc. · Sep 1994