Cleared Traditional

IMAGE TRANSPORT SERIES II (K925963) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K925963 · Dataview Imaging Intl., Inc. · Radiology device
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Feb 1995
Decision
800d
Days
Class 2
Risk

K925963 is an FDA 510(k) clearance for the IMAGE TRANSPORT SERIES II. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special 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 892.2050 - 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: Incremental AI imaging tool. Moderate-to-high equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Dataview Imaging Intl., Inc. devices

Submission Details

510(k) Number K925963 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. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 770
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K925963.
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K953164 · Toshiba America Medical Systems, In.C · Aug 1995
SIENET DIAGNOSTIC REPORTING CONSOLE VA02 UPGRADE
K935694 · Siemens Medical Solutions USA, Inc. · Mar 1994
PRESTILIX 1694 D IMAGE INTENSIFIED FLUOROSCCOPIC
K924310 · GE Medical Systems · Jan 1993
DU PONT LINX HD-25 LASR IMAGER
K923042 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1992