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Sign in to claim this brandImacor, Inc.
US
Last updated May 31, 2026
What Imacor, Inc. makes
Imacor, Inc. manufactures handheld ultrasound imaging systems designed for body-surface applications, including transesophageal and handheld probes for portable diagnostic imaging. Their portfolio includes systems like the ZURA EVO and ZURA TEE, as well as the ClariTEE probe for transesophageal echocardiography (TEE). These devices are intended for real-time imaging in clinical settings where mobility and ease of use are critical.
The company’s devices fall under FDA Class II regulation and are listed under the 510(k) and Unique Device Identifier (UDI) programs. Their products are intended for use in the United States, where they comply with applicable FDA requirements for medical imaging systems.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Imacor, Inc. manufacture?
Imacor, Inc. specializes in handheld ultrasound imaging systems designed for body-surface applications. Their devices include systems like the ZURA EVO and ZURA TEE, as well as transesophageal probes such as the ClariTEE. These products are engineered for portable, real-time imaging, particularly in clinical environments where mobility and ease of use are essential.
Where is Imacor, Inc. based, and where are their devices primarily used?
Imacor, Inc. is based in the United States. Their devices are designed and intended for use in the U.S. market, where they comply with applicable FDA requirements for medical imaging systems. The company’s focus on handheld and transesophageal ultrasound systems aligns with clinical needs in the U.S. healthcare system.
Which regulatory registries or programs list Imacor, Inc.’s devices?
Imacor, Inc.’s devices are listed under the FDA’s 510(k) premarket notification program and the Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with U.S. medical device regulations, particularly for Class II devices like their handheld ultrasound systems and transesophageal probes.
How are Imacor, Inc.’s devices classified under FDA regulations?
Imacor, Inc.’s devices fall under FDA Class II classification. This classification applies to medical devices that generally pose moderate risk and require special controls to ensure safety and effectiveness. The company’s handheld ultrasound systems and transesophageal probes, such as the ZURA EVO and ClariTEE, are subject to these regulatory requirements.
What distinguishes Imacor, Inc.’s devices from other ultrasound systems?
Imacor, Inc.’s devices are distinguished by their handheld and portable design, specifically tailored for body-surface and transesophageal imaging. Unlike traditional ultrasound systems that require stationary setups, their products like the ZURA TEE with ClariTEE probe are optimized for real-time, on-the-go diagnostics. This portability is critical for applications like bedside imaging or procedures where mobility is essential.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- imacorinc.com
- —
- —
- [email protected]
- Phone
- 516 393 0970
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 604116553
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ImaCor | ZHH | FDA UDI | Class II | Active |
| ClariTEE | ClariTEE | FDA UDI | Class II | Active |
| ImaCor Inc. | EVO 1 | FDA UDI | Class II | Active |
| Imacor Zura Evo Imaging System | K142054 | FDA 510(k) | Class II | Active |
| Zura Tee System With Claritee Probe | K100989 | FDA 510(k) | Class II | Active |
| Zura Tee System | K080223 | FDA 510(k) | Class II | Active |
| ImaCor Zura Handheld ZHH-010 | K220490 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Imacor, Inc. has two FDA recall records initiated between September 16, 2024, and August 29, 2025. One record remains open, while the other is classified. The first involves variability in epoxy used to seal the transducer, which may affect ultrasound signal quality. The second cites a production assembly error that could result in reversed articulation of the probe lever.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Aug 29, 2025 | Z-0038-2026 | — | open, classified | 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. |
| Sep 16, 2024 | Z-0231-2025 | — | open, classified | 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. |