ROCS ULTRASEED— 510(k) K984241

Substantially Equivalent

Radiation Oncology Computer Systems

FDA 510(k) clearance K984241 for ROCS ULTRASEED, Substantially Equivalent on 1999-05-12. Applicant: Radiation Oncology Computer Systems.

Clearance details

Applicant: Radiation Oncology Computer Systems
Product code: Code IYE
Advisory panel: Radiology
Date received: 1998-11-27
Decision date: 1999-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, 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.