510(k) clearance
InkSpace Imaging Small Body Array (SBA12PH15x)
- 510(k) number
- K262813
- Applicant
- Inkspace Imaging, Inc.
- Decision date
- Oct 5, 2026
- Date received
- Aug 7, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- MOS
- Device type
- Coil, Magnetic Resonance, Specialty
- Device class
- Class II
- Regulation
- 21 CFR 892.1000
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Pleasanton, CA, US