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510(k) Data Aggregation
K Number
K102027Device Name
AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM
Manufacturer
Date Cleared
2010-12-22
(156 days)
Product Code
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
QUANTEL MEDICAL S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The QUANTEL MEDICAL AXIS NANO Ophthalmic Ultrasound System and the probes that are used with it are indicated for the biometric measurement of the eye including:
- Axial Length measurement of the eye by ultrasonic means.
- Implanted IOL power calculation, using the Axial Length measurement. .
Device Description
The AXIS NANO is an ultrasonic system designed for ophthalmic use. It uses A type scaris for biometric measurements of the eye. The system is composed of a laptop computer connected an acquisition module. The A-scan probe (either TP-01-b or TP-02-las) connects to the acquisition module.
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K Number
K102198Device Name
COMPACT TOUCH STS
Manufacturer
Date Cleared
2010-11-05
(93 days)
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
QUANTEL MEDICAL S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Quantel Medical COMPACT TOUCH STS is intended to be used for diagnostic imaging and measurement of the eye including:
◆ Visualization of the interior of the eye by B scan
◆ Make measurements inside the eye (Sulcus to Sulcus, Irido Cornea Angle Left, Irido Cornea Angle Right, Lens curvature and Anterior Chamber Depth).
Device Description
The COMPACT TOUCH STS is an ultrasonic system designed for ophthalmic use. It performs B type scans for diagnostic imaging of the eye. It is not intended to be used for determining the power of implanted lenses, but rather is capable of making intra-ocular measurements. The system is composed of a main console controlled by a touch screen. It uses a B-scan probe (LIN50) which is a motor driven 50 MHz transducer.
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