RPM RESPIRATORY GATING SYSTEM— 510(k) K102024

Substantially Equivalent

Varian Medical Systems

FDA 510(k) clearance K102024 for RPM RESPIRATORY GATING SYSTEM, Substantially Equivalent on 2010-10-15. Applicant: Varian Medical Systems.

Clearance details

Applicant: Varian Medical Systems
Product code: Code IYE
Advisory panel: Radiology
Date received: 2010-07-19
Decision date: 2010-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

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.