Aquarius 8600 1417WC
FDA 510(k) clearance K171175 · decided 2017-10-05
Clearance details
- K-number
- K171175
- Device name
- Aquarius 8600 1417WC
- Applicant
- Imaging Dynamics Company , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-04-21
- Decision date
- 2017-10-05
- Days to decision
- 167 days
- Clearance type
- Special
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Calgary, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.