Revolution CT
FDA 510(k) clearance K163213 · decided 2016-12-16
Clearance details
- K-number
- K163213
- Device name
- Revolution CT
- Applicant
- Ge Medical Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-11-16
- Decision date
- 2016-12-16
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Waukesha, WI, US
- Third-party review
- No
- Expedited review
- No
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