LinkQuest Diagnostic Ultrasound System and Transducers

FDA UDI

Class II (US FDA UDI)

by Linkquest, Inc.

Identity

Trade Name: LinkQuest Diagnostic Ultrasound System and Transducers FDA UDI
Generic Name: General-purpose ultrasound imaging system FDA UDI
Device Name: A devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is a mobile assembly which support a wide variety of transducers and related application software packages. FDA UDI
Model / Reference: Model SQ860 FDA UDI
Description: A devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is a mobile assembly which support a wide variety of transducers and related application software packages. FDA UDI

Identifiers

Primary DI / UDI-DI: 00860000784801 FDA UDI
510(k) Number: K172059 FDA UDI
FDA Product Code: IYO FDA UDI
IYN 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
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

FDA UDI

Combination Product

FDA UDI

HCT/P

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Premarket Exempt

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Lot / Batch Number

FDA UDI

Serial Number

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Expiration Date

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Manufacturing Date

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Category: General-purpose ultrasound imaging system

LinkQuest Diagnostic Ultrasound System and Transducers by Linkquest, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K172059 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: Linkquest, Inc.

Sources (1)

FDA UDI d8cd2959-adeb-4a4a-844e-8646b55bb1c6 36 fields · synced May 30, 2026