SONOLAYER-L, SAL-77B— 510(k) K863947

Name: FDA 510(k) clearance K863947
Creator: U.S. Food and Drug Administration
Published: 1987-01-09

Substantially Equivalent

Toshiba Medical Systems

FDA 510(k) clearance K863947 for SONOLAYER-L, SAL-77B, Substantially Equivalent on 1987-01-09. Applicant: Toshiba Medical Systems. Device class: 2.

Clearance details

Applicant: Toshiba Medical Systems
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 1986-10-10
Decision date: 1987-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

Download summary PDF View on FDA.gov ↗

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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.