Cleared Traditional

K901679 - RESUBMITTED ISG 3DMV WORKSTATION

K901679 is an FDA 510(k) clearance for RESUBMITTED ISG 3DMV WORKSTATION, manufactured by I.S.G. Technologies, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K901679 · I.S.G. Technologies, Inc. · Radiology device
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May 1990
Decision
47d
Days
Class 2
Risk

K901679 is an FDA 510(k) clearance for the RESUBMITTED ISG 3DMV WORKSTATION. 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 I.S.G. Technologies, Inc. (Ontario L4v 1s8, CA). The FDA issued a Cleared decision on May 29, 1990 after a review of 47 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.

FDA 510(k) Submission Details - K901679

510(k) Number K901679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1990
Decision Date May 29, 1990
Days to Decision 47 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 107d · This submission: 47d
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 2257
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K901679.
SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF
K901422 · Image Systems, Inc. · Aug 1990
PINNACLE IMAGE PROCESSING SYSTEM
K902648 · Medasys, Inc. · Aug 1990
IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
K903196 · General Electric Co. · Aug 1990
CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS
K900697 · Nuccardiac Software, Inc. · May 1990
DIGITAL IMAGE ENHANCEMENT SYSTEM
K900851 · Atomic Products Corp. · May 1990
LITEBOX DIAGNOSTIC REVIEW WORKSTATION
K901158 · Siemens Gammasonics, Inc. · Apr 1990
K901679 · RESUBMITTED ISG 3DMV WORKSTATION
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