510(k) K202414
K202414 is an FDA 510(k) premarket notification submitted by Hyperfine Research, Inc. for the device "BrainInsight". The FDA issued a decision of Substantially Equivalent on Jan 7, 2021. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Hyperfine Research, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 7, 2021
- Date Received
- Aug 24, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
- 510(k)