Data / Medical devices / United States / Inkspace Imaging, Inc
Inkspace Imaging, Inc: FDA-registered device maker in Pleasanton, CA, United States, 6 510(k) clearances
Inkspace Imaging, Inc is registered with the FDA (registration 3021244844) in Pleasanton, CA, United States. It lists 1 device type. The FDA files 6 510(k) clearances under its listings, the newest dated October 5, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3021244844
- Address
- 5635 West Las Positas Blvd, Suite 403/404, Pleasanton, CA, United States, 94588
- Owner or operator
- Inkspace Imaging, Inc (10083875)
- Roles
- Manufacturer
- First device listed
- December 27, 2021
- Registered through
- 2027
- Brand names listed
- InkSpace Imaging Body Array, InkSpace Imaging Pediatric Body Array, InkSpace Imaging Small Body Array, InkSpace Imaging Snuggle/Silhouette for Philips 1.5T, Silhouette Adult Array, Small Body Array, Snuggle Pediatric Array, Snuggle; Silhouette; Nuzzle
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 5, 2026 | K262813 | InkSpace Imaging Small Body Array (SBA12PH15x) | MOS | Substantially Equivalent | Inkspace Imaging, Inc. | accessdata.fda.gov |
| October 20, 2025 | K253182 | InkSpace Imaging Small Body Array (SBA12PH30x) | MOS | Substantially Equivalent | Inkspace Imaging, Inc. | accessdata.fda.gov |
| December 20, 2024 | K243675 | InkSpace Imaging Small Body Array | MOS | Substantially Equivalent | Inkspace Imaging, Inc. | accessdata.fda.gov |
| January 8, 2024 | K233444 | InkSpace Imaging Small Body Array | MOS | Substantially Equivalent | Inkspace Imaging, Inc. | accessdata.fda.gov |
| December 8, 2022 | K223487 | InkSpace Imaging Body Array | MOS | Substantially Equivalent | Inkspace Imaging, Inc. | accessdata.fda.gov |
| December 17, 2021 | K213397 | InkSpace Imaging Pediatric Body Array | MOS | Substantially Equivalent | Inkspace Imaging, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 5, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.