Cleared Traditional

K963628 - IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE

K963628 is an FDA 510(k) clearance for IMAGESHARE COMPUTED RADIOGRAPHY ACQUISI..., 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 57-day FDA review.

K963628 · Dejarnette Research Systems · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
57d
Days
Class 1
Risk

K963628 is an FDA 510(k) clearance for the IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE. 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 57 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.

FDA 510(k) Submission Details - K963628

510(k) Number K963628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1996
Decision Date November 07, 1996
Days to Decision 57 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
50d faster than avg
Panel avg: 107d · This submission: 57d
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 130
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K963628.
LINX NETWORKING SYSTEM
K964250 · Sterling Diagnostic Imaging, Inc. · Dec 1996
IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/SOLARIS] 2000
K963592 · Dejarnette Research Systems · Nov 1996
IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION)
K963594 · Dejarnette Research Systems · Nov 1996
VIEWSEND MEDICAL MODEL 1200
K962225 · Klt Telecom, Inc. · Oct 1996
AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR)
K961023 · Accuimage, Inc. · Sep 1996
RADWORKS MEDICAL IMAGING SOFTWARE
K962699 · Applicare Medical Imaging, B.V. · Aug 1996
K963628 · IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE
Download PDF FDA Summary Dejarnette Research S…