510(k) K240157
K240157 is an FDA 510(k) premarket notification submitted by Deerfield Imaging, Inc. for the device "InVision 1.5 Surgical Theatre". The FDA issued a decision of Substantially Equivalent on February 15, 2024. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Deerfield Imaging, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 15, 2024
- Date Received
- January 19, 2024
- 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