CORNEOMAP 4500— 510(k) K844299

Substantially Equivalent

Radionics Medical, Inc.

FDA 510(k) clearance K844299 for CORNEOMAP 4500, Substantially Equivalent on 1985-04-18. Applicant: Radionics Medical, Inc..

Clearance details

Applicant: Radionics Medical, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1984-11-07
Decision date: 1985-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scarborough, Ontario, Can, CA

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.