SONOLAYER-L, SAL-77A— 510(k) K852090

Substantially Equivalent

Toshiba Medical Systems

FDA 510(k) clearance K852090 for SONOLAYER-L, SAL-77A, Substantially Equivalent on 1985-12-02. Applicant: Toshiba Medical Systems.

Clearance details

Applicant: Toshiba Medical Systems
Product code: Code ITX
Advisory panel: Radiology
Date received: 1985-05-13
Decision date: 1985-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

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Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.