Philips Incisive CT
FDA 510(k) clearance K180015 · decided 2018-03-20
Clearance details
- K-number
- K180015
- Device name
- Philips Incisive CT
- Applicant
- Philips Healthcare (Suzhou) Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-01-02
- Decision date
- 2018-03-20
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Suzhou, CN
- Third-party review
- No
- Expedited review
- No
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