OPERATING ARM SYSTEM (OAS)— 510(k) K951262

Substantially Equivalent

Radionics Software Applications, Inc.

FDA 510(k) clearance K951262 for OPERATING ARM SYSTEM (OAS), Substantially Equivalent on 1995-11-13. Applicant: Radionics Software Applications, Inc..

Clearance details

Applicant: Radionics Software Applications, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1995-03-21
Decision date: 1995-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.