COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIED— 510(k) K911750

Substantially Equivalent

Medical Instrumentation & Diagnostics Corp.(Midco)

FDA 510(k) clearance K911750 for COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIED, Substantially Equivalent on 1991-10-15. Applicant: Medical Instrumentation & Diagnostics Corp.(Midco).

Clearance details

Applicant: Medical Instrumentation & Diagnostics Corp.(Midco)
Product code: Code IYE
Advisory panel: Radiology
Date received: 1991-04-18
Decision date: 1991-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Albuquerque, NM, 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.