510(k) K232981
K232981 is an FDA 510(k) premarket notification submitted by Synaptive Medical, Inc. for the device "Synq Software Version 1.3". The FDA issued a decision of Substantially Equivalent on October 11, 2023. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Synaptive Medical, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 11, 2023
- Date Received
- September 21, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Nuclear Magnetic Resonance Imaging
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type