SOMATOM PLUS 4WITH VOLUME ZOOM CT SCANNERS— 510(k) K982349

Substantially Equivalent

Siemens Medical Solutions USA, Inc.

FDA 510(k) clearance K982349 for SOMATOM PLUS 4WITH VOLUME ZOOM CT SCANNERS, Substantially Equivalent on 1998-09-30. Applicant: Siemens Medical Solutions USA, Inc..

Clearance details

Applicant: Siemens Medical Solutions USA, Inc.
Product code: Code JAK
Advisory panel: Radiology
Date received: 1998-07-06
Decision date: 1998-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Iselin, NJ, 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.