Synq Software Version 1.3
FDA 510(k) clearance K232981 · decided 2023-10-11
Clearance details
- K-number
- K232981
- Device name
- Synq Software Version 1.3
- Applicant
- Synaptive Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-21
- Decision date
- 2023-10-11
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Toronto, CA
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.