Cleared Traditional

3M MEDICAL DIAGNOSTIC VIDEOCASSETTE (K931604) - FDA 510(k) Clearance

Class I Radiology device.

K931604 · 3M Health Care, Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
111d
Days
Class 1
Risk

K931604 is an FDA 510(k) clearance for the 3M MEDICAL DIAGNOSTIC VIDEOCASSETTE. Classified as Film, Radiographic (product code IWZ), Class I - General Controls.

Submitted by 3M Health Care, Ltd. (St. Paul, US). The FDA issued a Cleared decision on July 21, 1993 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1840 - 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 3M Health Care, Ltd. devices

Submission Details

510(k) Number K931604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1993
Decision Date July 21, 1993
Days to Decision 111 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
4d slower than avg
Panel avg: 107d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IWZ Film, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1840
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 - IWZ Film, Radiographic

All 19
Devices cleared under the same product code (IWZ) and FDA review panel - the closest regulatory comparables to K931604.
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K832504 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1983
KODAK CINEFLUOROGRAPHIC FILM SO-274
K813005 · Eastman Kodak Company · Nov 1981