PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS— 510(k) K984224

Substantially Equivalent

Siemens Corp.

FDA 510(k) clearance K984224 for PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS, Substantially Equivalent on 1999-02-02. Applicant: Siemens Corp..

Clearance details

Applicant: Siemens Corp.
Product code: Code LNH
Advisory panel: Radiology
Date received: 1998-11-25
Decision date: 1999-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Iselin, NJ, US

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Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.