Cleared Traditional

KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER (K960382) - FDA 510(k) Clearance

Class I Radiology device.

K960382 · Eastman Kodak Company · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
83d
Days
Class 1
Risk

K960382 is an FDA 510(k) clearance for the KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER. Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Eastman Kodak Company (Dallas, US). The FDA issued a Cleared decision on April 17, 1996 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2020 - 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 Eastman Kodak Company devices

Submission Details

510(k) Number K960382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1996
Decision Date April 17, 1996
Days to Decision 83 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
24d faster than avg
Panel avg: 107d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LMD System, Digital Image Communications, Radiological
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.2020
Definition A Medical Image Communications Device Provides Electronic Transfer Of Medical Image Data Between Medical Devices. It May Include A Physical Communications Medium, Modems, Interfaces, And A Communications Protocol. It May Provide Simple Image Review Software Functionality For Medical Image Processing And Manipulation, Such As Grayscale Window And Level, Zoom And Pan, User Delineated Geometric Measurements, Compression, Or User Added Image Annotations. The Device Does Not Perform Advanced Image Processing Or Complex Quantitative Functions.
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 - LMD System, Digital Image Communications, Radiological

All 13
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K960382.
JPACS
K980918 · Philips Medical Systems (Cleveland), Inc. · Jun 1998
KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW)
K974107 · Eastman Kodak Company · Jan 1998
SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY)
K973131 · Siemens Medical Solutions USA, Inc. · Nov 1997
SIENET SPI SPOOLER
K953552 · Siemens Medical Solutions USA, Inc. · Oct 1995
KODAK EKTASCAN NETWORK INTERFACE/FOR OTHER MANUFACTURERS
K936116 · Eastman Kodak Company · Apr 1994
KODAK EKTASCAN IMAGELINK SYSTEM (KEIS)
K931551 · Eastman Kodak Company · Jun 1993