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510(k) Data Aggregation
K Number
K171301Device Name
Scanmate Flex
Manufacturer
Date Cleared
2017-07-31
(89 days)
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
DGH Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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 Scanmate Flex is intended for the examination of adult patients.
Device Description
The Scanmate Flex is a diagnostic ultrasound system that allows eyecare professionals to visualize and measure internal structures of the eye. The technology is based on ultrasonic pulse echo technology, whereby short bursts of ultrasonic energy are transmitted and the resulting echoes are captured, amplified, filtered and processed. The timing of the echoes is analyzed and converted into distance information (when the A-Scan probe is used) or images (when the B-Scan and UBM probes are used). The distance information and images are displayed on a PC screen. The Scanmate Flex consists of an interface module (which is connected to a standard Windows PC, not included with the Scanmate Flex system) and one or more optional ultrasound probes.
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K Number
K093371Device Name
MODEL DGH 6000 SCANMATE A
Manufacturer
Date Cleared
2010-04-05
(158 days)
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
DGH TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the DGH 6000 is the measurement of AL, ACD, LT of the human eye. The DGH 6000 is also intended to calculate the optical power of an IOL that is to be implanted during cataract surgery. The DGH 6000 is intended to be used solely by qualified medical professionals. Clinical consideration and judgment should be applied when using the DGH 6000.
Device Description
The DGH 6000 A-Scan is a USB plug-in device that uses A-Mode, pulsed echo ultrasound technology to measure the axial length (AL), anterior chamber depth (ACD), and lens thickness (LT) of the human eye. The device includes formulas to calculate the implanted IOL power, using the axial length measurement.
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K Number
K033385Device Name
DGH 55 HANDHELD PACHYMETER (PACHMATE)
Manufacturer
Date Cleared
2003-11-07
(15 days)
Product Code
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
DGH TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Corneal thickness measurements are useful for screening potential laser refractive surgery patients, glaucoma screening, and monitoring corneal swelling.
Device Description
The DGH 55 is a handheld ultrasonic pachymeter that uses echo spike techniques to measure the thickness of the cornea.
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K Number
K965127Device Name
DGH MODEL 9000
Manufacturer
Date Cleared
1997-03-17
(84 days)
Product Code
Regulation Number
886.4670Why did this record match?
Applicant Name (Manufacturer) :
DGH TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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