X-RAY TV SYSTEM SONIALVISION G4— 510(k) K142341

Substantially Equivalent

Shimadzu Corp.

FDA 510(k) clearance K142341 for X-RAY TV SYSTEM SONIALVISION G4, Substantially Equivalent on 2015-03-06. Applicant: Shimadzu Corp..

Clearance details

Applicant: Shimadzu Corp.
Product code: Code JAA
Advisory panel: Radiology
Date received: 2014-08-21
Decision date: 2015-03-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Kyoto, JP

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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.