510(k) K203280
K203280 is an FDA 510(k) premarket notification submitted by Perspectum, Ltd. for the device "Hepatica v1 (Hepatica v1.0.0)". The FDA issued a decision of Substantially Equivalent on January 12, 2021. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Perspectum, Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 2021
- Date Received
- November 6, 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