Cleared Traditional

K974423 - ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL

K974423 is an FDA 510(k) clearance for ULTRA-VISION MAMMOGRAPHY DETAIL, manufactured by Sterling Diagnostic Imaging, Inc.. The device is a Class 1 Radiology device with product code EAM cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K974423 · Sterling Diagnostic Imaging, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
28d
Days
Class 1
Risk

K974423 is an FDA 510(k) clearance for the ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL. Classified as Screen, Intensifying, Radiographic (product code EAM), Class I - General Controls.

Submitted by Sterling Diagnostic Imaging, Inc. (Greenville, US). The FDA issued a Cleared decision on December 22, 1997 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1960 - 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 Sterling Diagnostic Imaging, Inc. devices

FDA 510(k) Submission Details - K974423

510(k) Number K974423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1997
Decision Date December 22, 1997
Days to Decision 28 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

EAM Device Classification - Class 1, General Controls

Product Code EAM Screen, Intensifying, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1960
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EAM Screen, Intensifying, Radiographic

All 27
Devices cleared under the same product code (EAM) and FDA review panel - the closest regulatory comparables to K974423.
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K942805 · Fujifilm Medical System U.S.A., Inc. · Jul 1994