Question 1

What types of medical devices does Ultromics, Ltd. manufacture or develop?

Accepted Answer

Ultromics, Ltd. specializes in developing application software for medical imaging and diagnostics. Their primary focus is on software designed for cardiac mapping, ultrasound imaging (specifically echocardiography), and radiology DICOM image processing. Examples include multiple versions of EchoGo, which are tailored for cardiac ultrasound analysis, as well as EchoGo Core and EchoGo Pro, which cater to specific diagnostic workflows in echocardiography.

Question 2

Where is Ultromics, Ltd. based, and where are their devices authorised for use?

Accepted Answer

Ultromics, Ltd. is based in the United States. Their devices are authorised for use in the U.S., where they undergo regulatory processes such as 510(k) submissions and Unique Device Identification (UDI) listings to comply with FDA requirements.

Question 3

Which regulatory registries or databases list Ultromics, Ltd.’s devices?

Accepted Answer

Ultromics, Ltd.’s devices are listed in the FDA’s 510(k) premarket notification registry and the UDI (Unique Device Identification) database. These registries are used to track and authorise medical devices in the United States, ensuring compliance with regulatory standards.

Question 4

How are Ultromics, Ltd.’s devices classified under FDA regulations?

Accepted Answer

Ultromics, Ltd.’s devices fall under Class II classification according to FDA regulations. This classification applies to software applications that modify or enhance the performance of existing medical devices, such as their cardiac mapping and ultrasound imaging software, which require special controls to ensure safety and effectiveness without needing the stringent scrutiny of Class III devices.

Question 5

What is the primary purpose of the software developed by Ultromics, Ltd.?

Accepted Answer

The primary purpose of Ultromics, Ltd.’s software is to enhance diagnostic workflows in cardiology and radiology. Their EchoGo and related applications are designed to streamline ultrasound imaging analysis, particularly in echocardiography, by providing advanced tools for cardiac mapping and DICOM image processing. This helps clinicians improve accuracy, efficiency, and decision-making in patient care.

Device	Model / Reference	Registries	Class	Status
EchoGo	Core	FDA UDI	Class II	Active
EchoGo	Heart Failure 2.0	FDA UDI	Class II	Active
EchoGo	Core 2.0	FDA UDI	Class II	Active
EchoGo	Amyloidosis 1.0	FDA UDI	Class II	Active
EchoGo	Heart Failure 1.0	FDA UDI	Class II	Active
EchoGo	Pro	FDA UDI	Class II	Active
EchoGo Core (2.0)	K213275	FDA 510(k)	Class II	Active
EchoGo Amyloidosis (1.0)	K240860	FDA 510(k)	Class II	Active
EchoGo Heart Failure	K222463	FDA 510(k)	Class II	Active
EchoGo Core	K191171	FDA 510(k)	Class II	Active
EchoGo Heart Failure (2.0)	K240013	FDA 510(k)	Class II	Active
EchoGo Pro	K201555	FDA 510(k)	Class II	Active

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