Cleared Traditional

K962699 - RADWORKS MEDICAL IMAGING SOFTWARE

K962699 is an FDA 510(k) clearance for RADWORKS MEDICAL IMAGING SOFTWARE, manufactured by Applicare Medical Imaging, B.V.. The device is a Class 1 Radiology device with product code LMD cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K962699 · Applicare Medical Imaging, B.V. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
39d
Days
Class 1
Risk

K962699 is an FDA 510(k) clearance for the RADWORKS MEDICAL IMAGING SOFTWARE. Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Applicare Medical Imaging, B.V. (Rockville, US). The FDA issued a Cleared decision on August 19, 1996 after a review of 39 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 - K962699

510(k) Number K962699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1996
Decision Date August 19, 1996
Days to Decision 39 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
68d faster than avg
Panel avg: 107d · This submission: 39d
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 138
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K962699.
IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE
K963628 · 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
INFINET
K961689 · Infimed, Inc. · Jul 1996
SHARED VISION(PART NUMBER SV 0015)
K961753 · Imagelabs, Inc. · Jul 1996
NETRA WORKSTATION SYSTEM & NETRA MD SOFTWARE
K960911 · Scimage, Inc. · May 1996
K962699 · RADWORKS MEDICAL IMAGING SOFTWARE
Download PDF FDA Summary Applicare Medical Ima…