510(k) K183685
K183685 is an FDA 510(k) premarket notification submitted by Esaote, S.P.A. for the device "O-Scan". The FDA issued a decision of Substantially Equivalent on Jan 22, 2019. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Esaote, S.P.A. has 68 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 22, 2019
- Date Received
- Dec 28, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Nuclear Magnetic Resonance Imaging
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type
- 510(k)