Cleared Traditional

K961753 - SHARED VISION(PART NUMBER SV 0015)

K961753 is an FDA 510(k) clearance for SHARED VISION(PART NUMBER SV 0015), manufactured by Imagelabs, Inc.. The device is a Class 1 Radiology device with product code LMD cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K961753 · Imagelabs, Inc. · Radiology device
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Jul 1996
Decision
80d
Days
Class 1
Risk

K961753 is an FDA 510(k) clearance for the SHARED VISION(PART NUMBER SV 0015). Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Imagelabs, Inc. (Bedford, US). The FDA issued a Cleared decision on July 25, 1996 after a review of 80 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 Imagelabs, Inc. devices

FDA 510(k) Submission Details - K961753

510(k) Number K961753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1996
Decision Date July 25, 1996
Days to Decision 80 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
27d faster than avg
Panel avg: 107d · This submission: 80d
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 K961753.
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
NETRA WORKSTATION SYSTEM & NETRA MD SOFTWARE
K960911 · Scimage, Inc. · May 1996
KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER
K960382 · Eastman Kodak Company · Apr 1996
RTI MEDICAL
K954567 · Radiology Telenetwork Intl. · Apr 1996