IMACOR, Inc
Jericho, NY, US
IMACOR, Inc appears in FDA device records in Jericho, NY. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for IMACOR, Inc between 2008 and 2022. The busiest year on record is 2008, with 1. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2010 | 1 |
| 2014 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220490 | ImaCor Zura Handheld ZHH-010 | IYN | Substantially Equivalent | |
| K142054 | IMACOR ZURA EVO IMAGING SYSTEM | IYO | Substantially Equivalent | |
| K100989 | ZURA TEE SYSTEM WITH CLARITEE PROBE | IYN | Substantially Equivalent | |
| K080223 | ZURA TEE SYSTEM | IYO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006382185 | 3006382185 | IMACOR, Inc | 50 Jericho Turnpike, Jericho, NY 11753 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0038-2026 | ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH. | Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa. | Class II | Open, Classified | |
| Z-0231-2025 | ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1 | Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could attenuate the ultrasound signal with a potential impact on the quality of images obtained from the probes. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain