510(k) K192650
K192650 is an FDA 510(k) premarket notification submitted by Mri Division,Beijing Wandong Medical Technology Co., Ltd. for the device "i_Space 1.5T Superconducting Magnetic Resonance Imaging System". The FDA issued a decision of Substantially Equivalent on Jan 29, 2021. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Mri Division,Beijing Wandong Medical Technology Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 29, 2021
- Date Received
- Sep 24, 2019
- 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)