X-RAY TV SYSTEM SONIAL VISION G4— 510(k) K131075

Substantially Equivalent

Shimadzu Corp.

FDA 510(k) clearance K131075 for X-RAY TV SYSTEM SONIAL VISION G4, Substantially Equivalent on 2014-03-28. Applicant: Shimadzu Corp..

Clearance details

Applicant: Shimadzu Corp.
Product code: Code JAA
Advisory panel: Radiology
Date received: 2013-04-17
Decision date: 2014-03-28
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Torrance, CA, US

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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.