STEREOTACTIC BODY FRAME— 510(k) K960338
Substantially EquivalentElekta Instrument AB
FDA 510(k) clearance K960338 for STEREOTACTIC BODY FRAME, Substantially Equivalent on 1996-04-23. Applicant: Elekta Instrument AB. Device class: 2.
Clearance details
- Applicant
- Elekta Instrument AB
- Product code
- Code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code IYE
view allMore clearances from Elekta Instrument AB
view allAdverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
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.