Cleared Traditional

K962225 - VIEWSEND MEDICAL MODEL 1200

K962225 is an FDA 510(k) clearance for VIEWSEND MEDICAL MODEL 1200, manufactured by Klt Telecom, Inc.. The device is a Class 1 Radiology device with product code LMD cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K962225 · Klt Telecom, Inc. · Radiology device
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Oct 1996
Decision
137d
Days
Class 1
Risk

K962225 is an FDA 510(k) clearance for the VIEWSEND MEDICAL MODEL 1200. Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Klt Telecom, Inc. (Chantilly, US). The FDA issued a Cleared decision on October 25, 1996 after a review of 137 days - within the typical 510(k) review window.

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 Klt Telecom, Inc. devices

FDA 510(k) Submission Details - K962225

510(k) Number K962225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1996
Decision Date October 25, 1996
Days to Decision 137 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 107d · This submission: 137d
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 K962225.
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
IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE
K963628 · Dejarnette Research Systems · Nov 1996
AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR)
K961023 · Accuimage, Inc. · Sep 1996
RADWORKS MEDICAL IMAGING SOFTWARE
K962699 · Applicare Medical Imaging, B.V. · Aug 1996
INFINET
K961689 · Infimed, Inc. · Jul 1996