InkSpace Imaging Small Body Array (SBA12PH15x)— 510(k) K262813
Substantially EquivalentInkspace Imaging, Inc.
FDA 510(k) clearance K262813 for InkSpace Imaging Small Body Array (SBA12PH15x), Substantially Equivalent on 2026-10-05. Applicant: Inkspace Imaging, Inc.. Device class: 2.
Summary
The InkSpace Imaging Small Body Array (SBA12PH15x) is filed under MOS, specialty magnetic resonance coils. The record doesn't name the MR systems it's compatible with.
Class II, 21 CFR 892.1000. The Radiology panel reviewed it as a Special 510(k).
Inkspace Imaging filed from Pleasanton, California. Review took 59 days (August 7 to October 5, 2026).
Clearance details
- Applicant
- Inkspace Imaging, Inc.
- Product code
- Product code MOS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Pleasanton, CA, US
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More clearances from Inkspace Imaging, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.