FDA.reportPublic FDA data

Scanmate A

Primary DI
00857377006094
Brand
Scanmate A
Company
DGH TECHNOLOGY INC.
Model
DGH 6000
Device description
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
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
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093371000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093371000MODEL DGH 6000 SCANMATE ADgh Technology, Inc.2010-04-05IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857377006094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857377006094008573770060948573770060940857377006094

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic ultrasound imaging systemAn assembly of mains electricity (AC-powered) devices designed for ophthalmic imaging procedures. It includes software that supports a variety of static and real-time eye and orbital imaging applications including physical measurement and oncology related treatment. It will generate ultrasound pulses, direct them to a target area, detect the resulting ultrasound echoes, and process the resulting information producing and displaying static or dynamic two- or three-dimensional (3-D) images. This GMDN code includes ultrasound imaging systems with, e.g., A-mode, B-mode, Doppler, colour Doppler (CD), M-mode, and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities.

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
00857377006100Scanmate BDGH 80002016-10-11
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
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
00841517112684C5-1FUJIFILM SONOSITE, INC.IYO2026-08-07
00841436125420Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126212Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126229Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126328Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126588Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126595Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGIYO2026-07-24
00841436122672Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125338Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125413Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125819Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436126281Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436126304Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00840432200216BladderScan®VERATHON INCIYO2026-07-22
00841517112011iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112028iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112035iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517112462iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.IYO2026-07-16
00841436126311Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2025-12-31
00195278439352LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00195278439369LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00195278723963NAGE Healthcare Japan CorporationIYO2025-10-15
00195278875860VscanGE Vingmed Ultrasound A/SIYO2025-07-04
00195278910509VolusonGE Ultrasound Korea Ltd.IYO2025-06-04