SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH— 510(k) K973327

Substantially Equivalent

Shimadzu Medical Systems

FDA 510(k) clearance K973327 for SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH, Substantially Equivalent on 1997-10-08. Applicant: Shimadzu Medical Systems.

Clearance details

Applicant: Shimadzu Medical Systems
Product code: Code JAK
Advisory panel: Radiology
Date received: 1997-09-04
Decision date: 1997-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrance, CA, 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.