Scanmate Flex
DGH Technology, Inc.
DGH TECHNOLOGY, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2522950 | 2522950 | DGH TECHNOLOGY, INC. | 1 | Y | 2026-01-01 | 110 SUMMIT DR., SUITE B EXTON PA US 19341 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 38352 | 1423928270 | K920906 | DGH-500 PACHYMETER | IYO | 1992-11-02 |
| 38352 | 1958731469 | K913067 | DGH-4000 A-SCAN/PACHYMETER | IYO | 1992-01-31 |
| 38352 | 1555207360 | K872726 | DGH-3000A A-SCAN | IYO | 1987-12-04 |
| 38352 | 1991304190 | K171301 | Scanmate Flex | IYO | 2017-07-31 |
| 38352 | 1999478448 | K093371 | MODEL DGH 6000 SCANMATE A | IYO | 2010-04-05 |
| 38352 | 1729719498 | K070907 | INTERSON USB ULTRASOUND PROBE SYSTEM | IYO | 2007-04-17 |
| 38352 | 1283545019 | K033385 | DGH 55 HANDHELD PACHYMETER (PACHMATE) | IYO | 2003-11-07 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| IYO | 7 | 2017-07-31 |
PMN#
MODEL DGH 6000 SCANMATE A
DGH TECHNOLOGY, INC.
DGH 55 HANDHELD PACHYMETER (PACHMATE)
DGH TECHNOLOGY, INC.
DGH MODEL 9000
DGH TECHNOLOGY, INC.
DGH-500 PACHYMETER
DGH TECHNOLOGY, INC.
DGH-4000 A-SCAN/PACHYMETER
DGH TECHNOLOGY, INC.
DGH-3000A A-SCAN
DGH TECHNOLOGY, INC.
GUDID#
Pachette 4 Calbox - The pachymeter calbox is an accessory that connects to a pachymeter and creates a series of precise, predetermined electronic pulses. The pachymeter measures the pulses, and the operator verifies that the measurement values are within an acceptable range.
2016-10-11
Pachette 3 Calbox - The pachymeter calbox is an accessory that connects to a pachymeter and creates a series of precise, predetermined electronic pulses. The pachymeter measures the pulses, and the operator verifies that the measurement values are within an acceptable range.
2016-10-11
Pachmate 2 Calbox - The pachymeter calbox is an accessory that connects to a pachymeter and creates a series of precise, predetermined electronic pulses. The pachymeter measures the pulses, and the operator verifies that the measurement values are within an acceptable range.
2016-10-11
Pachmate Calbox - The pachymeter calbox is an accessory that connects to a pachymeter and creates a series of precise, predetermined electronic pulses. The pachymeter measures the pulses, and the operator verifies that the measurement values are within an acceptable range.
2016-10-11
Multiple Measurement Calbox - The pachymeter calbox is an accessory that connects to a pachymeter and creates a series of precise, predetermined electronic pulses. The pachymeter measures the pulses, and the operator verifies that the measurement values are within an acceptable range.
2016-10-11
Single Measurement Calbox - The pachymeter calbox is an accessory that connects to a pachymeter and creates a single precise, predetermined electronic pulse. The pachymeter measures the pulse, and the operator verifies that the measurement value is within an acceptable range.
2016-10-11
DET 2006 Detachable Pachymeter Probe - The DET2006 is a small, removable probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic pachymeter devices.
2016-10-11
DGH 6006 Corded A-Scan Probe - The DGH6006 is a corded probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic A-Scan devices.
2016-10-11
DGH 3006 Corded A-Scan Probe - The DGH3006 is a corded probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic A-Scan devices.
2016-10-11
DGH 2006 Corded Pachymeter Probe - The DGH2006 is an angled corded probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic pachymeter devices.
2016-10-11
DGH 1006 Corded Pachymeter Probe - The DGH1006 is a straight corded probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic pachymeter devices.
2016-10-11
UBM 50 MHz Transducer - The DGH1500-50 is a 50 MHz ultrasonic element that is for use with the DGH1500 UBM Probe.
2017-09-05
UBM 35 MHz Transducer - The DGH1500-35 is a 35 MHz ultrasonic element that is for use with the DGH1500 UBM Probe.
2017-09-05
UBM Probe - 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.
2017-09-05
12.5 MHz B-Scan Probe - 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.
2017-09-05
20 MHz B-Scan Probe - 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.
2017-09-05
Scanmate Flex USB Interface - 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.
2017-09-05
Scanmate B - 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.
2016-10-11
Scanmate A - 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
2016-10-11
Pachette 4 - 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.
2016-10-11
Pachmate 2 - 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.
2016-10-11