510(k) K223487
K223487 is an FDA 510(k) premarket notification submitted by Inkspace Imaging, Inc. for the device "InkSpace Imaging Body Array". The FDA issued a decision of Substantially Equivalent on December 8, 2022. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Inkspace Imaging, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 2022
- Date Received
- November 21, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coil, Magnetic Resonance, Specialty
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type