SCENARIA WHOLE-BODY X-RAY CT SYSTEM— 510(k) K101888

Substantially Equivalent

Hitachi Medical Systems America, Inc.

FDA 510(k) clearance K101888 for SCENARIA WHOLE-BODY X-RAY CT SYSTEM, Substantially Equivalent on 2011-04-08. Applicant: Hitachi Medical Systems America, Inc..

Clearance details

Applicant: Hitachi Medical Systems America, Inc.
Product code: Code JAK
Advisory panel: Radiology
Date received: 2010-07-07
Decision date: 2011-04-08
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.