SSA-320A JUST VISION 200/ SSA-325A JUST VISION— 510(k) K990490

Substantially Equivalent

Toshiba America Medical Systems, In.C

FDA 510(k) clearance K990490 for SSA-320A JUST VISION 200/ SSA-325A JUST VISION, Substantially Equivalent on 1999-03-02. Applicant: Toshiba America Medical Systems, In.C.

Clearance details

Applicant: Toshiba America Medical Systems, In.C
Product code: Code IYO
Advisory panel: Radiology
Date received: 1999-02-16
Decision date: 1999-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, 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.