Ingenia Elition S and Ingenia Elition X
FDA 510(k) clearance K173451 · decided 2018-03-20
Clearance details
- K-number
- K173451
- Device name
- Ingenia Elition S and Ingenia Elition X
- Applicant
- Philips Medical Systems Nederland B.V.
- Decision
- Substantially Equivalent
- Date received
- 2017-11-06
- Decision date
- 2018-03-20
- Days to decision
- 134 days
- Clearance type
- Abbreviated
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Best Noord-Brabant, NL
- Third-party review
- No
- Expedited review
- No
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