Ingenia 1.5T CX and Ingenia 3.0T CX R5.3
FDA 510(k) clearance K162931 · decided 2017-01-06
Clearance details
- K-number
- K162931
- Device name
- Ingenia 1.5T CX and Ingenia 3.0T CX R5.3
- Applicant
- Philips Medical Systems Nederland B.V.
- Decision
- Substantially Equivalent
- Date received
- 2016-10-19
- Decision date
- 2017-01-06
- Days to decision
- 79 days
- Clearance type
- Abbreviated
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Best, NL
- Third-party review
- No
- Expedited review
- No
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