20 MHz B-Scan Probe

FDA UDI

Class II (US FDA UDI)

by DGH Technology, Inc.

Identity

Trade Name: 20 MHz B-Scan Probe FDA UDI
Generic Name: Ophthalmic ultrasound imaging transducer FDA UDI
Device Name: The DGH1920 is a single-element mechanical sector B-scan probe. This probe connects to the Scanmate Flex USB interface module, which is, in turn, connected via a USB cable to a PC running the DGH Scanmate software. FDA UDI
Model / Reference: DGH1920 FDA UDI
Description: The DGH1920 is a single-element mechanical sector B-scan probe. This probe connects to the Scanmate Flex USB interface module, which is, in turn, connected via a USB cable to a PC running the DGH Scanmate software. FDA UDI

Identifiers

Primary DI / UDI-DI: 00857377006124 FDA UDI
510(k) Number: K171301 FDA UDI
FDA Product Code: IYO FDA UDI
ITX FDA UDI
GMDN Term: Ophthalmic ultrasound imaging transducer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1560 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

FDA UDI

Category: Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging transducer

20 MHz B-Scan Probe by DGH Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K171301 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: DGH Technology, Inc.

Sources (1)

FDA UDI e5c8f038-26c8-42d0-b5b6-ae6d8092f25d 34 fields · synced Jun 15, 2026