510(k) Report

FDA applicant

Imacor, Inc.

Garden City, NY4 decisions2008–20222 recalls

FDA records 4 decisions for Imacor, Inc. (Garden City, NY) from 2008 to 2022: 4 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 10 predicates, 3 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Imacor, LLC”.

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 Imacor, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2008: 12010: 12014: 12022: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2025

2024: 12025: 1
2008high 1 (2024) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Imacor, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic2decisions
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic2decisions

Whose devices does it build on?

Its devices cite 10 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 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.

  • K080223Zura Tee SystemImacor, LLC · 20084cite it
  • K100989Zura Tee System with Claritee ProbeImacor, Inc. · 20101cites it

What has FDA decided for it lately?

  • K220490ImaCor Zura Handheld ZHH-010Imacor, Inc. · 20222 recalls
  • K142054Imacor Zura Evo Imaging SystemImacor, Inc. · 20141 recall
  • K100989Zura Tee System with Claritee ProbeImacor, Inc. · 20101 recall
  • K080223Zura Tee SystemImacor, LLC · 20081 recall

All 3 as Imacor, Inc. →The one decision as Imacor, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K220490ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE…Aug 29, 2025Class II
  • K220490ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor…Sep 16, 2024Class II