510(k) K201722
K201722 is an FDA 510(k) premarket notification submitted by Hyperfine Research, Inc. for the device "Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System". The FDA issued a decision of Substantially Equivalent on Aug 11, 2020. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Hyperfine Research, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 11, 2020
- Date Received
- Jun 23, 2020
- 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
- 510(k)