GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS— 510(k) K091103

Substantially Equivalent

Hitachi Medical Systems America, Inc.

FDA 510(k) clearance K091103 for GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS, Substantially Equivalent on 2009-06-15. Applicant: Hitachi Medical Systems America, Inc..

Clearance details

Applicant: Hitachi Medical Systems America, Inc.
Product code: Code JAK
Advisory panel: Radiology
Date received: 2009-04-16
Decision date: 2009-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Twinsburg, OH, US

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Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.