Cleared Traditional

K960326 - FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM

K960326 is an FDA 510(k) clearance for FCR DMS OPTICAL DISK IMAGE FILING UNIT ..., manufactured by Fujifilm Medical System U.S.A., Inc.. The device is a Class 1 Radiology device with 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

FDA 510(k) Submission Details - K960326

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.

LMB Device Classification - Class 1, General Controls

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

All 33
Devices cleared under the same product code (LMB) and FDA review panel - the closest regulatory comparables to K960326.
UPACS
K960941 · Base Ten Systems, Inc. · Jun 1996
LAST IMAGE HOLD
K951942 · Insight Systems · Apr 1996
TIGERSCAN/TIGERVIEW
K955237 · Tau Corp. · Apr 1996
VIDCAS (VIDEO CAPTURE AND ARCHIVING SOFTWARE)
K952238 · Imaging Concepts, Inc. · Feb 1996
ACCULUPE
K955184 · E For M Imaging Systems Div., Marquette Electronic · Jan 1996
NT SERIES DIGITAL IMAGE MANAGER
K955232 · Camtronics, Ltd. · Dec 1995