QUANTEL MEDICAL

Address:1 rue du bois Joli,COURNON AUVERGNE Puy-de-Dome,FR

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Transducer, Ultrasonic, Diagnostic (ITX) (9) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (5)

Premarket Exempt

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AVISO (S) - 03700542625002 Catalog Number :

Device Description : AVISO (S) Ophthalmic A (A-Std), B Scan and UBM Ultrasound SystemThe QUANTEL MEDI AVISO (S) Ophthalmic A (A-Std), B Scan and UBM Ultrasound SystemThe QUANTEL MEDICAL AVISO modular platform is an ultrasound system intended to be used for:• Axial Length measurement of the eye by ultrasonic means• Implanted IOL power calculation, using the Axial Length measurement• Visualization of the interior of the eye and the orbit by A and B scans(• Advanced diagnostic: standardized echography provides detailed information about the internal reflectivity of tissues and allows optimal tissues differentiation, localization and measurement of structures in the eye and orbit.)

Device Class : 2

Duns Number: 738574953

Premarket Exempt : No

Product Code : ITX, IYO

Prescription Use : No

Device Count : 1

COMPACT TOUCH - 03700542625019 Catalog Number :

Device Description : Ophthalmic Ultrasound System: A/B Scan and PachymetryThe QUANTEL MEDICAL COMPACT Ophthalmic Ultrasound System: A/B Scan and PachymetryThe QUANTEL MEDICAL COMPACT TOUCH Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including:• Visualization of the interior of the eye and the orbit by A and B scans.• Axial Length measurement of the eye by ultrasonic means.• Implanted IOL power calculation, using the Axial Length measurement.• Measurement of corneal thickness by ultrasonic means.

Device Class : 2

Duns Number: 738574953

Premarket Exempt : No

Product Code : ITX, IYO

Prescription Use : No

Device Count : 1

COMPACT TOUCH STS - 03700542625026 Catalog Number :

Device Description : Ophthalmic Ultrasound BiomicroscopeUBM and automatic STS measurement for ICL siz Ophthalmic Ultrasound BiomicroscopeUBM and automatic STS measurement for ICL sizingThe QUANTEL MEDICAL Compact Touch STS UBMTM Ophthalmic Ultrasound System (and its associated Linear 50 MHz probe) is intended to be used for diagnostic imaging and measurement of the eye including:• Visualization of the interior of the eye by B scans.• Make measurements inside the eye (Sulcus to Sulcus, Irido Cornea Angle Left, Irido Cornea Angle Right, Lens curvature and Anterior Chamber depth).

Device Class : 2

Duns Number: 738574953

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : No

Device Count : 1

AXIS NANO - 03700542625033 Catalog Number :

Device Description : Ophthalmic Ultrasound Biometer: Biometry and IOL CalculationThe QUANTEL MEDICAL Ophthalmic Ultrasound Biometer: Biometry and IOL CalculationThe 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 Class : 2

Duns Number: 738574953

Premarket Exempt : No

Product Code : ITX, IYO

Prescription Use : No

Device Count : 1

POCKET - 03700542625040 Catalog Number :

Device Description : Ultrasonic Pachymeter for Glaucoma Screening and Refractive Surgery.

Device Class : 2

Duns Number: 738574953

Premarket Exempt : No

Product Code : IYO

Prescription Use : No

Device Count : 1

B Probe 10MHz AVISO - 03700542625057 Catalog Number :

Device Description : 10 MHz Probe for eye and orbit examination. Automatic biometry readings obtained 10 MHz Probe for eye and orbit examination. Automatic biometry readings obtained from a B mode image allowing axial length measurements for difficult to mesure long eyes or posterior staphyloma.

Device Class : 2

Duns Number: 738574953

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

B Probe 20MHz AVISO - 03700542625064 Catalog Number :

Device Class : 2

Duns Number: 738574953

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

B Probe 10MHz COMPACT TOUCH - 03700542625071 Catalog Number :

Device Class : 2

Duns Number: 738574953

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

LIN 50MHz Probe - 03700542625088 Catalog Number :

Device Description : 50 MHz probe reveals what you can not see with OCT alone, enabling the operator 50 MHz probe reveals what you can not see with OCT alone, enabling the operator to visualize the structures located behind the iris such as ciliary bodies, the processes and lens zonules.Linear scanning offers the greatest signal intensity, providing superior anterior chamber image quality as the probe is always perpendicular with the tissue interface of interest.

Device Class : 2

Duns Number: 738574953

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

Biometry Probe - 03700542625095 Catalog Number :

Device Description : Axial length measurement probe.

Device Class : 2

Duns Number: 738574953

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

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