ACCESSORIES TO THE STEREOTACTIC BODY FRAM— 510(k) K970291

Substantially Equivalent

Elekta Instrument AB

FDA 510(k) clearance K970291 for ACCESSORIES TO THE STEREOTACTIC BODY FRAM, Substantially Equivalent on 1997-04-24. Applicant: Elekta Instrument AB.

Clearance details

Applicant: Elekta Instrument AB
Product code: Code IYE
Advisory panel: Radiology
Date received: 1997-01-24
Decision date: 1997-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Linkoping, SE

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.