510(k) K252239
K252239 is an FDA 510(k) premarket notification submitted by Imris Imaging, Inc. for the device "InVision 3T Recharge Operating Suite". The FDA issued a decision of Substantially Equivalent on August 6, 2025. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 2025
- Date Received
- July 17, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Nuclear Magnetic Resonance Imaging
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type