MODIFIED MAGNETIC RESONANCE IMAGING SYTEM MOD. R28— 510(k) K915657

Substantially Equivalent

Bruker Medical Imaging, Inc.

FDA 510(k) clearance K915657 for MODIFIED MAGNETIC RESONANCE IMAGING SYTEM MOD. R28, Substantially Equivalent on 1992-03-13. Applicant: Bruker Medical Imaging, Inc..

Clearance details

Applicant: Bruker Medical Imaging, Inc.
Product code: Code LNH
Advisory panel: Radiology
Date received: 1991-12-18
Decision date: 1992-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billerica, MA, 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.