SIGNA Creator, SIGNA Explorer
FDA 510(k) clearance K143251 · decided 2015-02-04
Clearance details
- K-number
- K143251
- Device name
- SIGNA Creator, SIGNA Explorer
- Applicant
- Ge Healthcare (Ge Medical Systems, LLC)
- Decision
- Substantially Equivalent
- Date received
- 2014-11-12
- Decision date
- 2015-02-04
- Days to decision
- 84 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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