QUANTUM SURGICAL

Address:1000 rue du mas de verchant,montpellier Herault,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

System, X-Ray, Tomography, Computed (JAK) (5)

Premarket Exempt

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Patient Reference - 03760305400024 Catalog Number : 02-0026

Device Description : The Patient Reference is an instrument of the EPIONE device used to track the pa The Patient Reference is an instrument of the EPIONE device used to track the patientposition and motions including breathing.

Device Class : 2

Duns Number: 268397609

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

Navigation probe - 03760305400055 Catalog Number : 02-0031

Device Description : The Navigation Probe is an instrument of the EPIONE device. It enables visualizi The Navigation Probe is an instrument of the EPIONE device. It enables visualizing reference points or anatomical landmarks in the medical images. It allows the verificationof patient registration accuracy, using external anatomical landmarks or skin markers.

Device Class : 2

Duns Number: 268397609

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

Needle Guide - 03760305400062 Catalog Number : 02-0027-19G

Device Description : The Needle Guide is an instrument of the EPIONE device. It provides mechanical g The Needle Guide is an instrument of the EPIONE device. It provides mechanical guidance for rigid straight instruments of a range of external diameter specified in the Technical Specifications.

Device Class : 2

Duns Number: 268397609

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

Short Navigation Probe - 03760305400079 Catalog Number : 02-0044

Device Description : The Navigation Probe is an instrument of the EPIONE device. It enables visualizi The Navigation Probe is an instrument of the EPIONE device. It enables visualizingreference points or anatomical landmarks in the medical images. It allows the verificationof patient registration accuracy, using external anatomical landmarks or skin markers.

Device Class : 2

Duns Number: 268397609

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

EPIONE - 03760305400086 Catalog Number : 30-0001-01-USA

Device Description : The EPIONE device is a user controlled, stereotactic accessory intended to assis The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures

Device Class : 2

Duns Number: 268397609

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

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