FDA.reportPublic FDA data

Scanmate B

Primary DI
00857377006100
Brand
Scanmate B
Company
DGH TECHNOLOGY INC.
Model
DGH 8000
Device description
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.
Published
2016-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070907000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070907000INTERSON USB ULTRASOUND PROBE SYSTEMRegulatory Management Services2007-04-17IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857377006100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857377006100008573770061008573770061000857377006100

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic ultrasound imaging transducerAn ultrasound imaging transducer that is a hand-held device moved over the intact surface of a patient's eye during imaging applications involving the examination of the lens. It may include single or multiple element transducer assembly configurations that convert electric voltages into an ultrasound beam. Typically used with coupling gels to ensure adequate contact with the patient's eye it steers, focuses and detects the ultrasound beam and resulting echoes mechanically or electronically. This group of devices typically includes ultrasound imaging transducers used with A-mode scanning capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
057188807
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857377006001Pachmate 2DGH 55B2016-10-11
00857377006018Pachette 4DGH 555B2016-10-11
00857377006094Scanmate ADGH 60002016-10-11
00857377006117Scanmate Flex USB InterfaceScanmate Flex2017-09-05
0085737700612420 MHz B-Scan ProbeDGH19202017-09-05
0085737700613112.5 MHz B-Scan ProbeDGH19122017-09-05
00857377006148UBM ProbeDGH15002017-09-05
00857377006155UBM 35 MHz TransducerDGH1500-352017-09-05
00857377006162UBM 50 MHz TransducerDGH1500-502017-09-05
00857377006209DGH 1006 Corded Pachymeter ProbeDGH 10062016-10-11
00857377006216DGH 2006 Corded Pachymeter ProbeDGH 20062016-10-11
00857377006223DGH 3006 Corded A-Scan ProbeDGH 30062016-10-11
00857377006230DGH 6006 Corded A-Scan ProbeDGH 60062016-10-11
00857377006247DET 2006 Detachable Pachymeter ProbeDET 20062016-10-11
00857377006308Single Measurement CalboxSM Calbox2016-10-11
00857377006315Multiple Measurement Calbox MM Calbox2016-10-11
00857377006322Pachmate CalboxDGH 55 Calbox2016-10-11
00857377006339Pachmate 2 CalboxDGH 55B Calbox2016-10-11
00857377006346Pachette 3 CalboxDGH 555 Calbox2016-10-11
00857377006353Pachette 4 CalboxDGH 555B Calbox2016-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850050934233EndoSound® EVS ProbeEndosound, Inc.ITX2026-06-01
00850050934240EndoSound® EVS SideBeam 5103Endosound, Inc.IYO2026-06-01
00850050934257EndoSound® Coax Transducer Extension Connector (TEC)Endosound, Inc.IYO2026-06-01
00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.IYO2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.IYO2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
08056304455826MyLabC25ESAOTE SPAIYO2025-12-10
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
08056304455833MyLabC30ESAOTE SPAIYO2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455017MyLabA50ESAOTE SPAIYO2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455215MyLabE85ESAOTE SPAIYO2025-07-07
08056304455307MyLabA70ESAOTE SPAIYO2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07
08056304455437MyLabA50ESAOTE SPAIYO2025-07-07
08056304455451MyLabA70ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAIYO2025-07-07
08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455635MyLabE80ESAOTE SPAIYO2025-07-07
08056304455642MyLabE85ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAIYO2025-07-07