DIGITAL IMAGE ANALYSIS SYSTEM— 510(k) K962153

Name: FDA 510(k) clearance K962153
Creator: U.S. Food and Drug Administration
Published: 1997-01-17

Substantially Equivalent

University of Washington

FDA 510(k) clearance K962153 for DIGITAL IMAGE ANALYSIS SYSTEM, Substantially Equivalent on 1997-01-17. Applicant: University of Washington. Device class: 2.

Clearance details

Applicant: University of Washington
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 1996-06-04
Decision date: 1997-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.