Cleared Traditional

K962153 - DIGITAL IMAGE ANALYSIS SYSTEM

K962153 is an FDA 510(k) clearance for DIGITAL IMAGE ANALYSIS SYSTEM, manufactured by University of Washington. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K962153 · University of Washington · Radiology device
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Jan 1997
Decision
227d
Days
Class 2
Risk

K962153 is an FDA 510(k) clearance for the DIGITAL IMAGE ANALYSIS SYSTEM. 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 University of Washington (Seattle, US). The FDA issued a Cleared decision on January 17, 1997 after a review of 227 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-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 University of Washington devices

FDA 510(k) Submission Details - K962153

510(k) Number K962153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1996
Decision Date January 17, 1997
Days to Decision 227 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
120d slower than avg
Panel avg: 107d · This submission: 227d
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 1155
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K962153.
CT-MODELLER SYSTEM
K970617 · Materialise NV · Apr 1997
FUJI MEDICAL LASER IMAGER MF PRINT SERVER MF-PS667
K970349 · Fujifilm Medical System U.S.A., Inc. · Mar 1997
EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS
K962010 · Philips Medical Systems (Cleveland), Inc. · Mar 1997
PHILIPS EASYVISION
K963980 · Philips Medical Systems North America, Inc. · Dec 1996
PHILIPS COMPUTED RADIOGRAPHY
K964124 · Philips Medical Systems, Inc. · Dec 1996
FLOUROSPOT T.O.P.
K961871 · Siemens Medical Solutions USA, Inc. · Jul 1996