Cleared Traditional

K960326 - FCR DMS OPTICAL DISK IMAGE FILING UNIT ...

K960326 is the FDA 510(k) clearance for FCR DMS OPTICAL DISK IMAGE FILING UNIT ... by Fujifilm Medical System U.S.A., Inc.. It is a Class 1 Radiology device (product code LMB) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K960326 · Fujifilm Medical System U.S.A., Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
43d
Days
Class 1
Risk

K960326 is an FDA 510(k) clearance for the FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM. Classified as Device, Digital Image Storage, Radiological (product code LMB), Class I - General Controls.

Submitted by Fujifilm Medical System U.S.A., Inc. (Stamford, US). The FDA issued a Cleared decision on March 7, 1996 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2010 - 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 Fujifilm Medical System U.S.A., Inc. devices

Submission Details

510(k) Number K960326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1996
Decision Date March 07, 1996
Days to Decision 43 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
64d faster than avg
Panel avg: 107d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LMB Device, Digital Image Storage, Radiological
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.2010
Definition Medical Image Storage Hardware Is A Device That Provides Electronic Maintenance And Access Functions For Medical Images.
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 - LMB Device, Digital Image Storage, Radiological

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