510(k) K262813
K262813 is an FDA 510(k) premarket notification submitted by Inkspace Imaging, Inc. for the device "InkSpace Imaging Small Body Array (SBA12PH15x)". The FDA issued a decision of Substantially Equivalent on Oct 5, 2026. 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 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 5, 2026
- Date Received
- Aug 7, 2026
- 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
- 510(k)