BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX
FDA 510(k) clearance K103476 · decided 2011-06-16
Clearance details
- K-number
- K103476
- Device name
- BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX
- Applicant
- Ge Medical Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-11-24
- Decision date
- 2011-06-16
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- IZL
- Device class
- 2
- Regulation number
- 892.1720
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Waukesha, WI, US
- Third-party review
- No
- Expedited review
- No
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