SonialVision G4— 510(k) K190373

Substantially Equivalent

Shimadzu Corporation

FDA 510(k) clearance K190373 for SonialVision G4, Substantially Equivalent on 2019-03-15. Applicant: Shimadzu Corporation.

Clearance details

Applicant: Shimadzu Corporation
Product code: Code JAA
Advisory panel: Radiology
Date received: 2019-02-19
Decision date: 2019-03-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Kyoto, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

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.