LINUS— 510(k) K812398

Substantially Equivalent

Fischer Imaging Corp.

FDA 510(k) clearance K812398 for LINUS, Substantially Equivalent on 1981-11-10. Applicant: Fischer Imaging Corp..

Clearance details

Applicant: Fischer Imaging Corp.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1981-08-20
Decision date: 1981-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.