510(k) K800761— POINT TO POINT LEVEL

Substantially Equivalent

Radiation Products Design, Inc.

Clearance details

Applicant: Radiation Products Design, Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 1980-04-04
Decision date: 1980-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.