Digi-Lite

FDA UDI

Class II (US FDA UDI)

by Rimed Ltd.

Identity

Trade Name: Digi-Lite FDA UDI
Generic Name: General-purpose ultrasound imaging system FDA UDI
Device Name: The Digi-Lite System is indicated for non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularities in adults and in children. It is not intended for fetal use. It is not intended for neonatal use. The product includes a Pentium M or equivalent processor, minimum 60 Gbyte hard disc, USB, RS232, LAN 10/100 RJ-45 network connection, a PC keyboard, mouse, touch screen of 15″ TFT color SVGA that provides 1024 × 768 points graphic resolution. FDA UDI
Model / Reference: Digi-Lite FDA UDI
Description: The Digi-Lite System is indicated for non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularities in adults and in children. It is not intended for fetal use. It is not intended for neonatal use. The product includes a Pentium M or equivalent processor, minimum 60 Gbyte hard disc, USB, RS232, LAN 10/100 RJ-45 network connection, a PC keyboard, mouse, touch screen of 15″ TFT color SVGA that provides 1024 × 768 points graphic resolution. FDA UDI

Identifiers

Primary DI / UDI-DI: 07290016734003 FDA UDI
510(k) Number: K062578 FDA UDI
FDA Product Code: ITX FDA UDI
IYN FDA UDI
GMDN Term: General-purpose ultrasound imaging system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
892.1550 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General-purpose ultrasound imaging system

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

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Cleared under the same submission

K062578 also covers:

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 fd84715f-9aa4-4574-890a-4222c944e0a0 34 fields · synced May 31, 2026