STATVIEW— 510(k) K913755

Substantially Equivalent

Image Systems, Inc.

FDA 510(k) clearance K913755 for STATVIEW, Substantially Equivalent on 1991-11-19. Applicant: Image Systems, Inc..

Clearance details

Applicant: Image Systems, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1991-08-21
Decision date: 1991-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Leandro, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.