510(k) K220490 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ImaCor Zura Handheld ZHH-010
| Applicant | Imacor, Inc., Jericho NY, US |
| Decision | Substantially Equivalent, Apr 8, 2022 |
| Received | Feb 22, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220490
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 3, 2025 | ImaCor Inc. ClariTEE Miniaturized TEE probe. Model Number: CLT-010.
Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH. Open, Classified |
ITX | None listed |
| Oct 25, 2024 | ImaCor Inc. ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms.
Model/Catalog Number: CLT-010, CLT-010-1 Open, Classified |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.