Artis zee/zeego & Artis Q/Q.zen
FDA 510(k) clearance K181407 · decided 2018-08-15
Clearance details
- K-number
- K181407
- Device name
- Artis zee/zeego & Artis Q/Q.zen
- Applicant
- Siemens Medical Solution USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-05-30
- Decision date
- 2018-08-15
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Malvern, PA, US
- Third-party review
- No
- Expedited review
- No
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