510(k) Report

FDA applicant

Echopixel, Inc.

Mountain View, CA4 decisions2015–20202 recalls

FDA records 4 decisions for Echopixel, Inc. (Mountain View, CA) from 2015 to 2020: 4 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 44 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 2 predicates, 1 of them its own earlier devices. 2 recalls are 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 Echopixel, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2015: 12017: 12019: 12020: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2018

2016: 12018: 1
2015high 1 (2016) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Echopixel, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological4decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 44 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 107 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K142107Echo True 3D ViewerEchopixel, Inc. · 20153cite it
  • K170167True 3D Viewer SoftwareEchopixel, Inc. · 20171cites it
  • K193149True 3D Viewer SoftwareEchopixel, Inc. · 20191cites it

What has FDA decided for it lately?

  • K201365True 3D ViewerEchopixel, Inc. · 2020
  • K193149True 3D Viewer SoftwareEchopixel, Inc. · 2019
  • K170167True 3D Viewer SoftwareEchopixel, Inc. · 20171 recall
  • K142107Echo True 3D ViewerEchopixel, Inc. · 20151 recall

All 4 as Echopixel, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K170167True 3D Viewer, Model: EP-00003Feb 21, 2018Class II
  • K142107TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The…Apr 11, 2016Class II