510(k) K172110
K172110 is an FDA 510(k) premarket notification submitted by Hitachi Healthcare Americas Corporation for the device "ECHELON OVAL V6.0A MRI System". The FDA issued a decision of Substantially Equivalent on January 11, 2018. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Hitachi Healthcare Americas Corporation has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 2018
- Date Received
- July 13, 2017
- Clearance Type
- Traditional
- 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