Allura Xper R9
FDA 510(k) clearance K163715 · decided 2017-01-26
Clearance details
- K-number
- K163715
- Device name
- Allura Xper R9
- Applicant
- Philips Medical Systems Nederland B.V.
- Decision
- Substantially Equivalent
- Date received
- 2016-12-30
- Decision date
- 2017-01-26
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Best Noord-Brabant, NL
- Third-party review
- No
- Expedited review
- No
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