DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T
FDA 510(k) clearance K132376 · decided 2013-11-15
Clearance details
- K-number
- K132376
- Device name
- DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T
- Applicant
- Ge Healthcare (Ge Medical Systems, LLC)
- Decision
- Substantially Equivalent
- Date received
- 2013-07-30
- Decision date
- 2013-11-15
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Waukesha, WI, US
- Third-party review
- No
- Expedited review
- No
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