Cleared Traditional

K925964 - IMAGE TRANSPORT SERIES III (FDA 510(k) Clearance)

Class I Radiology device.

K925964 · Dataview Imaging Intl., Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Feb 1995
Decision
800d
Days
Class 1
Risk

K925964 is an FDA 510(k) clearance for the IMAGE TRANSPORT SERIES III. Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Dataview Imaging Intl., Inc. (Washington, US). The FDA issued a Cleared decision on February 3, 1995 after a review of 800 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Dataview Imaging Intl., Inc. devices

Submission Details

510(k) Number K925964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1992
Decision Date February 03, 1995
Days to Decision 800 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
693d slower than avg
Panel avg: 107d · This submission: 800d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.