Cleared Traditional

K994270 - INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000

K994270 is an FDA 510(k) clearance for INSTATRAK 3000 SYSTEM WITH FLUOROTRAK M..., manufactured by Visualization Technology, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K994270 · Visualization Technology, Inc. · Radiology device
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Mar 2000
Decision
80d
Days
Class 2
Risk

K994270 is an FDA 510(k) clearance for the INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000. 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 Visualization Technology, Inc. (Wilmington, US). The FDA issued a Cleared decision on March 9, 2000 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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 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 Visualization Technology, Inc. devices

FDA 510(k) Submission Details - K994270

510(k) Number K994270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1999
Decision Date March 09, 2000
Days to Decision 80 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
27d faster than avg
Panel avg: 107d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

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 1330
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K994270.
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