Clarius Ultrasound System
FDA 510(k) clearance K163138 · decided 2016-11-30
Clearance details
- K-number
- K163138
- Device name
- Clarius Ultrasound System
- Applicant
- Clarius Mobile Health Corp.
- Decision
- Substantially Equivalent
- Date received
- 2016-11-09
- Decision date
- 2016-11-30
- Days to decision
- 21 days
- Clearance type
- Abbreviated
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Burnaby, CA
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.