OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]— 510(k) K961844
Substantially EquivalentRadionics Software Applications, Inc.
FDA 510(k) clearance K961844 for OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES], Substantially Equivalent on 1996-10-23. Applicant: Radionics Software Applications, Inc..
Clearance details
- Applicant
- Radionics Software Applications, Inc.
- Product code
- Code HAW
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burlington, MA, US
Adverse events under product code HAW
product code HAW- Death
- 52
- Injury
- 1,083
- Malfunction
- 17,300
- Total
- 18,435
Source: openFDA MAUDE database, through . 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.