Digi-Lite IP

FDA UDI

Class II (US FDA UDI)

by Rimed Ltd.

Identity

Trade Name: Digi-Lite IP FDA UDI
Generic Name: General-purpose ultrasound imaging system FDA UDI
Device Name: The Digi-Lite IP color flow imaging system is an ultrasound based system intended for use in non-invasive vascular evaluation for carotid (extracranial diagnosis), peripheral nerves and musculoskeletal in adults and in children. The Digi Lite IP only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the Digi Lite IP via USB 2.0. Minimum requirements are given for the PC. The Linear probe is connected to the Digi Lite IP. FDA UDI
Model / Reference: Digi-Lite IP FDA UDI
Description: The Digi-Lite IP color flow imaging system is an ultrasound based system intended for use in non-invasive vascular evaluation for carotid (extracranial diagnosis), peripheral nerves and musculoskeletal in adults and in children. The Digi Lite IP only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the Digi Lite IP via USB 2.0. Minimum requirements are given for the PC. The Linear probe is connected to the Digi Lite IP. FDA UDI

Identifiers

Catalog Number: 400001 FDA UDI
Primary DI / UDI-DI: 07290016734010 FDA UDI
510(k) Number: K113184 FDA UDI
FDA Product Code: IYO FDA UDI
IYN FDA UDI
ITX FDA UDI
GMDN Term: General-purpose ultrasound imaging system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1560 FDA UDI
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

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

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Cleared under the same submission

K113184 also covers:

Digi-Lite IP Linear Probe — RIMED LTD.

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 887c1756-7f2a-4321-876d-a16bf5667baa 35 fields · synced May 30, 2026