CINESCAN S— 510(k) K021683

Substantially Equivalent

Quantel Medical

FDA 510(k) clearance K021683 for CINESCAN S, Substantially Equivalent on 2002-06-21. Applicant: Quantel Medical.

Clearance details

Applicant: Quantel Medical
Product code: Code IYO
Advisory panel: Radiology
Date received: 2002-05-22
Decision date: 2002-06-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Hasbrouck Heights, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.