LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART— 510(k) K100096

Substantially Equivalent

Integra Radionics, Inc.

FDA 510(k) clearance K100096 for LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART, Substantially Equivalent on 2010-04-22. Applicant: Integra Radionics, Inc..

Clearance details

Applicant: Integra Radionics, Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2010-01-13
Decision date: 2010-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, 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.