Cleared Traditional

K933161 - ULTRA-VISION SUPER RAPID INTENSIFYING S...

K933161 is an FDA 510(k) clearance for ULTRA-VISION SUPER RAPID INTENSIFYING S..., manufactured by Dupont Medical Products. The device is a Class 1 Radiology device with product code EAM cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K933161 · Dupont Medical Products · Radiology device
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Oct 1993
Decision
100d
Days
Class 1
Risk

K933161 is an FDA 510(k) clearance for the ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN. Classified as Screen, Intensifying, Radiographic (product code EAM), Class I - General Controls.

Submitted by Dupont Medical Products (Wilmington, US). The FDA issued a Cleared decision on October 7, 1993 after a review of 100 days - within the typical 510(k) review window.

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: 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 Dupont Medical Products devices

FDA 510(k) Submission Details - K933161

510(k) Number K933161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1993
Decision Date October 07, 1993
Days to Decision 100 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
7d faster than avg
Panel avg: 107d · This submission: 100d
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 26
Devices cleared under the same product code (EAM) and FDA review panel - the closest regulatory comparables to K933161.
KYOKKO BLUE SERIES INTENSIFYING SCREENS
K942805 · Fujifilm Medical System U.S.A., Inc. · Jul 1994
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K942909 · Eastman Kodak Company · Jul 1994
KYOKKO UM SERIES INTENSIFYING SCREEN
K942399 · Fujifilm Medical System U.S.A., Inc. · Jun 1994
MICROVISION FAST DETAIL INTENSIFYING SCREEN
K931283 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1993
ULTRA-VISION RAPID INTENSIFYING SCREEN
K920190 · E.I. Dupont DE Nemours & Co., Inc. · May 1992
ULTRA-VISION DETAIL INTENSIFYING SCREEN
K920200 · E.I. Dupont DE Nemours & Co., Inc. · May 1992