Cleared Traditional

K963592 - IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/SOLARIS] 2000

K963592 is an FDA 510(k) clearance for IMAGESHARE PROTOCOL CONVERTING GATEWAY ..., manufactured by Dejarnette Research Systems. The device is a Class 1 Radiology device with product code LMD cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K963592 · Dejarnette Research Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
59d
Days
Class 1
Risk

K963592 is an FDA 510(k) clearance for the IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/.... Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Dejarnette Research Systems (Towson, US). The FDA issued a Cleared decision on November 7, 1996 after a review of 59 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 Dejarnette Research Systems devices

FDA 510(k) Submission Details - K963592

510(k) Number K963592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1996
Decision Date November 07, 1996
Days to Decision 59 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
48d faster than avg
Panel avg: 107d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

LMD Device Classification - Class 1, General Controls

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 46
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K963592.
FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666
K970293 · Fujifilm Medical System U.S.A., Inc. · Mar 1997
AMICAS WEB/INTRANET IMAGE SERVER
K970064 · Autocyt Group, Inc. · Mar 1997
SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)
K965161 · Sectra-Imtec AB · Mar 1997
KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER
K960382 · Eastman Kodak Company · Apr 1996
PHILIPS SITE VIEW WORKSTATION
K960809 · Philips Medical Systems North America, Inc. · Apr 1996
SIENET SPI SPOOLER
K953552 · Siemens Medical Solutions USA, Inc. · Oct 1995