PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER— 510(k) K103616

Substantially Equivalent

Aktina Medical Physics Corp.

FDA 510(k) clearance K103616 for PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER, Substantially Equivalent on 2011-01-25. Applicant: Aktina Medical Physics Corp..

Clearance details

Applicant: Aktina Medical Physics Corp.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2010-12-10
Decision date: 2011-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Congers, NY, 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.