Cleared Traditional

K964576 - PROFILE MAMMOGRAPHY SYSTEM (M-PRO)

K964576 is an FDA 510(k) clearance for PROFILE MAMMOGRAPHY SYSTEM (M-PRO), manufactured by Bennett X-Ray Corp.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K964576 · Bennett X-Ray Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
57d
Days
Class 2
Risk

K964576 is an FDA 510(k) clearance for the PROFILE MAMMOGRAPHY SYSTEM (M-PRO). Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Bennett X-Ray Corp. (Copiague, US). The FDA issued a Cleared decision on January 10, 1997 after a review of 57 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 Bennett X-Ray Corp. devices

FDA 510(k) Submission Details - K964576

510(k) Number K964576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1996
Decision Date January 10, 1997
Days to Decision 57 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
50d faster than avg
Panel avg: 107d · This submission: 57d
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 60
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K964576.
MAMMOTEST ADAPTER DRIVER
K973400 · Fischer Imaging Corp. · Nov 1997
GLORY
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DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM
K964069 · Siemens Medical Solutions USA, Inc. · May 1997
MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION
K960381 · Elscint, Inc. · Apr 1996
DELTA 16
K955411 · Instrumentarium Imaging, Inc. · Mar 1996
SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE
K953250 · GE Medical Systems · Jan 1996