SHARPVIEW IMAGE ENHANCEMENT SYSTEM— 510(k) K993802

Substantially Equivalent

Context Vision AB

FDA 510(k) clearance K993802 for SHARPVIEW IMAGE ENHANCEMENT SYSTEM, Substantially Equivalent on 2000-01-18. Applicant: Context Vision AB.

Clearance details

Applicant: Context Vision AB
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1999-11-09
Decision date: 2000-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Findley, MN, US

Download summary PDF View on FDA.gov ↗

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.