DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS— 510(k) K063494

Substantially Equivalent

Pro-Med Instruments GmbH

FDA 510(k) clearance K063494 for DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS, Substantially Equivalent on 2007-05-21. Applicant: Pro-Med Instruments GmbH.

Clearance details

Applicant: Pro-Med Instruments GmbH
Product code: Code HBL
Advisory panel: Neurology
Date received: 2006-11-20
Decision date: 2007-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lehigh Acres, FL, US

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Adverse events under product code HBL

product code HBL

Death: 3
Injury: 753
Malfunction: 1,421
Total: 2,177

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.