510(k) Report

FDA applicant

Exo Imaging

Santa Clara, CA4 decisions2021–20260 recalls

FDA records 4 decisions for Exo Imaging (Santa Clara, CA) from 2021 to 2026: 4 510(k) clearances. Most are in product codes QIH (Automated Radiological Image Processing Software) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Since 2016 its 510(k)s took a median of 103 days from receipt to decision, against 118 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Exo Imaging, Inc.”.

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 Exo Imaging’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

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

Planning a device like Exo Imaging’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • QIHAutomated Radiological Image Processing Software2decisions
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic2decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 103 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 118 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 2 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.

  • K240953AI Platform 2.0 (AIP002)Exo Imaging · 20241cites it
  • K211527Exo IrisExo Imaging, Inc. · 20211cites it

What has FDA decided for it lately?

  • K260217AI Platform 2.2 (AIP002)Exo Imaging · 2026
  • K240953AI Platform 2.0 (AIP002)Exo Imaging · 2024
  • K222198Exo Iris (El2001)Exo Imaging, Inc. · 2022
  • K211527Exo IrisExo Imaging, Inc. · 2021

All 2 as Exo Imaging →All 2 as Exo Imaging, Inc. →