DGH TECHNOLOGY INC.

Address:110 SUMMIT DR., SUITE B,EXTON,PA,19341,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Imaging, Pulsed Echo, Ultrasonic (IYO) (9) Transducer, Ultrasonic, Diagnostic (ITX) (7)

Premarket Exempt

Clear

Pachmate 2 - 00857377006001 Catalog Number :

Device Description : The DGH 55B is a Handheld Ultrasonic Pachymeter. It is a hand-held, battery-powe The DGH 55B is a Handheld Ultrasonic Pachymeter. It is a hand-held, battery-powered electronic medical device that uses ultrasonic pulse technology to measure the thickness of the human cornea.

Device Class : 2

Duns Number: 057188807

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Pachette 4 - 00857377006018 Catalog Number :

Device Description : The DGH 555B is a Desktop Ultrasonic Pachymeter. It is a portable, battery-power The DGH 555B is a Desktop Ultrasonic Pachymeter. It is a portable, battery-powered electronic medical device that uses ultrasonic pulse technology to measure the thickness of the human cornea.

Device Class : 2

Duns Number: 057188807

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Scanmate A - 00857377006094 Catalog Number :

Device Description : The DGH 6000 is a Portable Ultrasonic A-Scan. It is an electronic device that co The DGH 6000 is a Portable Ultrasonic A-Scan. It is an electronic device that connects to the user's PC via USB connection. It is a portable device that uses ultrasonic pulse technology to obtain axial length measurements of the human eye

Device Class : 2

Duns Number: 057188807

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Scanmate B - 00857377006100 Catalog Number :

Device Description : The DGH 8000 is a Portable Ultrasonic B-Scan. It is an electronic device that co The DGH 8000 is a Portable Ultrasonic B-Scan. It is an electronic device that connects to the user's PC via USB connection. The DGH 8000 uses ultrasonic pulse technology to create 2-dimensional, cross-section images of the human eye.

Device Class : 2

Duns Number: 057188807

Premarket Exempt : No

Product Code : ITX, IYO

Prescription Use : Yes

Device Count : 1

Scanmate Flex USB Interface - 00857377006117 Catalog Number :

Device Description : The Scanmate Flex is a multi-purpose computer based ultrasonic diagnostic system The Scanmate Flex is a multi-purpose computer based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power. The system consists of three main components: an interface module with integrated probe holder, one or more ultrasonic probes, and the Scanmate software application.

Device Class : 2

Duns Number: 057188807

Premarket Exempt : No

Product Code : ITX, IYO

Prescription Use : Yes

Device Count : 1

20 MHz B-Scan Probe - 00857377006124 Catalog Number :

Device Description : The DGH1920 is a single-element mechanical sector B-scan probe. This probe conne 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.

Device Class : 2

Duns Number: 057188807

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : Yes

Device Count : 1

12.5 MHz B-Scan Probe - 00857377006131 Catalog Number :

Device Description : The DGH1912 is a single-element mechanical sector B-scan probe. This probe conne The DGH1912 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.

Device Class : 2

Duns Number: 057188807

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : Yes

Device Count : 1

UBM Probe - 00857377006148 Catalog Number :

Device Description : The DGH1500 is a single-element mechanical sector UBM probe. This probe connects The DGH1500 is a single-element mechanical sector UBM 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.

Device Class : 2

Duns Number: 057188807

Premarket Exempt : No

Product Code : ITX, IYO

Prescription Use : Yes

Device Count : 1

UBM 35 MHz Transducer - 00857377006155 Catalog Number :

Device Description : The DGH1500-35 is a 35 MHz ultrasonic element that is for use with the DGH1500 UBM Probe.

Device Class : 2

Duns Number: 057188807

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

UBM 50 MHz Transducer - 00857377006162 Catalog Number :

Device Description : The DGH1500-50 is a 50 MHz ultrasonic element that is for use with the DGH1500 UBM Probe.

Device Class : 2

Duns Number: 057188807

Premarket Exempt : No

Product Code : ITX, IYO

Prescription Use : Yes

Device Count : 1

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