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Ultrasight, Inc.

Israel Last updated 22 Oct 2026

Devices
5
Registries
EUDAMEDGUDIDFDA 510(k)FDA
FDA recalls
0

Catalogue5

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Ultrasight Ness Ziona Central · IL FEI 3029923647

What Ultrasight, Inc. makes

Ultrasight, Inc. develops AI-powered ultrasound guidance systems designed to assist in real-time imaging for procedural interventions, enhancing visualization and precision during medical procedures.

The company’s products are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) clearance pathway. The portfolio is listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

How many devices does Ultrasight, Inc. have in the registry?

The registry currently lists 5 devices for Ultrasight, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ultrasight, Inc.'s devices?

Among its 5 most recently registered devices, Ultrasight, Inc. has devices listed in EUDAMED (1 device), FDA 510(k) (1 device) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Ultrasight, Inc.'s devices fall under?

Among its 5 most recently registered devices, the classes recorded for Ultrasight, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Ultrasight, Inc. in the registry?

The most recently registered devices listed for Ultrasight, Inc. include UltraSight Guidance V2, PVAD IQ V1, UltraSight Guidance V1 and UltraSight AI Guidance.

Which FDA establishments are linked to Ultrasight, Inc.?

1 FDA establishment is linked to Ultrasight, Inc. in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.

Information

Address
8, Sapir Pinchas, Ness Ziona, Israel
PRRC contact
Rani Shoham
EUDAMED SRN
IL-MF-000035620