DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T— 510(k) K132376
Substantially EquivalentGe Healthcare (Ge Medical Systems, LLC)
FDA 510(k) clearance K132376 for DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T, Substantially Equivalent on 2013-11-15. Applicant: Ge Healthcare (Ge Medical Systems, LLC).
Clearance details
- Applicant
- Ge Healthcare (Ge Medical Systems, LLC)
- Product code
- Code LNH
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukesha, WI, US
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, through . 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.