Dolphin/IQ, Dolphin/4D and Dolphin/MAX
FDA 510(k) clearance K191023 · decided 2019-05-16
Clearance details
- K-number
- K191023
- Device name
- Dolphin/IQ, Dolphin/4D and Dolphin/MAX
- Applicant
- Viasonix , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-04-17
- Decision date
- 2019-05-16
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Ra'Anana, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.