510(k) Report

FDA applicant

Inkspace Imaging, Inc.

Pleasanton, CA6 decisions2021–20260 recalls

FDA records 6 decisions for Inkspace Imaging, Inc. (Pleasanton, CA) from 2021 to 2026: 6 510(k) clearances. All are in product code MOS (Coil, Magnetic Resonance, Specialty). Since 2016 its 510(k)s took a median of 42 days from receipt to decision, against 43 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Inkspace Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2021: 12022: 12024: 22025: 12026 (partial year): 1
2021high 2 (2024) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Inkspace Imaging, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MOSCoil, Magnetic Resonance, Specialty6decisions

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 42 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 43 days; 3 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 4 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K233444InkSpace Imaging Small Body ArrayInkspace Imaging, Inc. · 20242cite it
  • K223487InkSpace Imaging Body ArrayInkspace Imaging, Inc. · 20221cites it
  • K213397InkSpace Imaging Pediatric Body ArrayInkspace Imaging, Inc. · 20211cites it

What has FDA decided for it lately?

  • K262813InkSpace Imaging Small Body Array (SBA12PH15x)Inkspace Imaging, Inc. · 2026
  • K253182InkSpace Imaging Small Body Array (SBA12PH30x)Inkspace Imaging, Inc. · 2025
  • K243675InkSpace Imaging Small Body ArrayInkspace Imaging, Inc. · 2024
  • K233444InkSpace Imaging Small Body ArrayInkspace Imaging, Inc. · 2024
  • K223487InkSpace Imaging Body ArrayInkspace Imaging, Inc. · 2022
  • K213397InkSpace Imaging Pediatric Body ArrayInkspace Imaging, Inc. · 2021

All 6 as Inkspace Imaging, Inc. →