FDA.reportPublic FDA data

510(k) K233444

Device
InkSpace Imaging Small Body Array
Applicant
Inkspace Imaging, Inc.
510(k) number
K233444
Product code
MOS
Decision
Substantially Equivalent (SESE)
Decision date
2024-01-08
Date received
2023-10-19
Regulation
892.1000
Classification name
Coil, Magnetic Resonance, Specialty
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Peter Fischer
Address
5635 W. Las Positas Blvd., Suite 403/404 Pleasanton CA US 94588 94588

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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