SHARP VIEW IMAGE ENHANCEMENT SYSTEM— 510(k) K024028

Name: FDA 510(k) clearance K024028
Creator: U.S. Food and Drug Administration
Published: 2003-01-24

Substantially Equivalent

Context Vision AB

FDA 510(k) clearance K024028 for SHARP VIEW IMAGE ENHANCEMENT SYSTEM, Substantially Equivalent on 2003-01-24. Applicant: Context Vision AB. Device class: 2.

Clearance details

Applicant: Context Vision AB
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2002-12-06
Decision date: 2003-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Linkoping, SE

Download summary PDF View on FDA.gov ↗

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K993802 — SHARPVIEW IMAGE ENHANCEMENT SYSTEM2000-01-18

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.