Cleared Traditional

K982535 - INSIGHT DIAGNOSTIC IMAGING WORKSTATION

K982535 is an FDA 510(k) clearance for INSIGHT DIAGNOSTIC IMAGING WORKSTATION, manufactured by Neo Imagery Technologies, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K982535 · Neo Imagery Technologies, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
154d
Days
Class 2
Risk

K982535 is an FDA 510(k) clearance for the INSIGHT DIAGNOSTIC IMAGING 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 Neo Imagery Technologies, Inc. (San Leandro, US). The FDA issued a Cleared decision on December 21, 1998 after a review of 154 days - an extended review 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 - K982535

510(k) Number K982535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1998
Decision Date December 21, 1998
Days to Decision 154 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
47d slower than avg
Panel avg: 107d · This submission: 154d
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 2255
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K982535 · INSIGHT DIAGNOSTIC IMAGING WORKSTATION
Download PDF FDA Summary Neo Imagery Technolog…