Digi-One

FDA UDI

Class II (US FDA UDI)

by Rimed Ltd.

Identity

Trade Name: Digi-One FDA UDI
Generic Name: General-purpose ultrasound imaging system FDA UDI
Device Name: The Digi-One System is indicated for non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularities in adults and in children.The Rimed Transcarial Doppler Systems are based on a PC platform system. As opposed to the currently approved product Digi-Lite TCD that has the PC component in the device itself, the Digi-One TCD uses a LAN cable to connect and act with any external PC operated with Windows 7 and up FDA UDI
Model / Reference: Digi-One FDA UDI
Description: The Digi-One System is indicated for non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularities in adults and in children.The Rimed Transcarial Doppler Systems are based on a PC platform system. As opposed to the currently approved product Digi-Lite TCD that has the PC component in the device itself, the Digi-One TCD uses a LAN cable to connect and act with any external PC operated with Windows 7 and up FDA UDI

Identifiers

Primary DI / UDI-DI: 07290016734027 FDA UDI
510(k) Number: K143476 FDA UDI
FDA Product Code: IYN FDA UDI
ITX FDA UDI
GMDN Term: General-purpose ultrasound imaging system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1550 FDA UDI
892.1570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

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Lot / Batch Number

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Serial Number

Yes

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Expiration Date

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Manufacturing Date

Yes

FDA UDI

Category: General-purpose ultrasound imaging system

Digi-One by Rimed Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Rimed Ltd.

Sources (1)

FDA UDI 7ccfc9c6-a4a7-4f87-ad07-95d8e17e09a3 34 fields · synced May 30, 2026