Cleared Traditional

K961023 - AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR)

K961023 is an FDA 510(k) clearance for AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR), manufactured by Accuimage, Inc.. The device is a Class 1 Radiology device with product code LMD cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K961023 · Accuimage, Inc. · Radiology device
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Sep 1996
Decision
179d
Days
Class 1
Risk

K961023 is an FDA 510(k) clearance for the AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR). Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Accuimage, Inc. (San Leandro, US). The FDA issued a Cleared decision on September 9, 1996 after a review of 179 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Accuimage, Inc. devices

FDA 510(k) Submission Details - K961023

510(k) Number K961023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1996
Decision Date September 09, 1996
Days to Decision 179 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
72d slower than avg
Panel avg: 107d · This submission: 179d
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 79
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K961023.
IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION)
K963594 · Dejarnette Research Systems · Nov 1996
IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE
K963628 · Dejarnette Research Systems · Nov 1996
VIEWSEND MEDICAL MODEL 1200
K962225 · Klt Telecom, Inc. · Oct 1996
RADWORKS MEDICAL IMAGING SOFTWARE
K962699 · Applicare Medical Imaging, B.V. · Aug 1996
INFINET
K961689 · Infimed, Inc. · Jul 1996
SHARED VISION(PART NUMBER SV 0015)
K961753 · Imagelabs, Inc. · Jul 1996