MAGNETIC RESON DIAG DEVICE MAGNETOM PROJECT 016— 510(k) K932271

Substantially Equivalent

Siemens Medical Solutions USA, Inc.

FDA 510(k) clearance K932271 for MAGNETIC RESON DIAG DEVICE MAGNETOM PROJECT 016, Substantially Equivalent on 1994-01-07. Applicant: Siemens Medical Solutions USA, Inc..

Clearance details

Applicant: Siemens Medical Solutions USA, Inc.
Product code: Code LNH
Advisory panel: Radiology
Date received: 1993-04-28
Decision date: 1994-01-07
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.