ZURA TEE SYSTEM— 510(k) K080223

Name: FDA 510(k) clearance K080223
Creator: U.S. Food and Drug Administration
Published: 2008-06-24

Substantially Equivalent

Imacor, LLC

FDA 510(k) clearance K080223 for ZURA TEE SYSTEM, Substantially Equivalent on 2008-06-24. Applicant: Imacor, LLC. Device class: 2.

Clearance details

Applicant: Imacor, LLC
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2008-01-29
Decision date: 2008-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philadelphia, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IYO

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K253452 — Accuro 3S2026-07-24
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K252237 — EdgeFlow UW202026-04-17
K254021 — Accuro XV2026-04-09
K253898 — QT Scanner 2000 Model A2026-03-04

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K080223

K-number listed on FDA's recall record

Z-0231-2025 — ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1Class II·Ongoing·ImaCor Inc.·20240916

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080223.

Data sourced from openFDA. This site is unofficial and independent of the FDA.