Nrt - Nordisk Røntgen Teknik A/S

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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

Interventional Fluoroscopic X-Ray System (OWB) (10) System, X-Ray, Fluoroscopic, Image-Intensified (JAA) (10)

Premarket Exempt

Clear

Intelli-C Left Side Suspended Table - 05713464000121 Catalog Number :

Device Description : The Intelli-C X-ray device is a multi-purpose - also sometimes known as a univer The Intelli-C X-ray device is a multi-purpose - also sometimes known as a universal C-arm fluoroscopy system, designed for diagnostic medical imaging examinations, from barium studies to interventional and angiography studies.

Device Class : 2

Duns Number: 307332705

Premarket Exempt : No

Product Code : JAA, OWB

Prescription Use : No

Device Count : 1

Intelli-C Accessory - 05713464000305 Catalog Number :

Device Description : A set of four triangular foam pads for the Intelli-C X-ray system to be used tog A set of four triangular foam pads for the Intelli-C X-ray system to be used together with the Patient Support Strap, to support the patient during lateral table tilting movements.

Device Class : 2

Duns Number: 307332705

Premarket Exempt : No

Product Code : OWB, JAA

Prescription Use : No

Device Count : 1

Intelli-C Accessory - 05713464000312 Catalog Number :

Device Description : Mattress, 3 cm for the Intelli-C X-ray system, for optimizing patient comfort wh Mattress, 3 cm for the Intelli-C X-ray system, for optimizing patient comfort when lying on table.

Device Class : 2

Duns Number: 307332705

Premarket Exempt : No

Product Code : OWB, JAA

Prescription Use : No

Device Count : 1

Intelli-C Accessory - 05713464000329 Catalog Number :

Device Description : Table Top support, CPR for the Intelli-C X-ray system. A height adjustable devic Table Top support, CPR for the Intelli-C X-ray system. A height adjustable device intended to give support to the patient table in case of emergency CPR on the table.

Device Class : 2

Duns Number: 307332705

Premarket Exempt : No

Product Code : OWB, JAA

Prescription Use : No

Device Count : 1

Intelli-C Accessory - 05713464000336 Catalog Number :

Device Description : Footrest for the Intelli-C X-ray system to support the patient during table top Footrest for the Intelli-C X-ray system to support the patient during table top angulation.

Device Class : 2

Duns Number: 307332705

Premarket Exempt : No

Product Code : OWB, JAA

Prescription Use : No

Device Count : 1

Intelli-C Accessory - 05713464000343 Catalog Number :

Device Description : A pair of Hand Grips for the Intelli-C X-ray system to be fixed freely along bot A pair of Hand Grips for the Intelli-C X-ray system to be fixed freely along both sides of the table for increased patient comfort.

Device Class : 2

Duns Number: 307332705

Premarket Exempt : No

Product Code : OWB, JAA

Prescription Use : No

Device Count : 1

Intelli-C Accessory - 05713464000350 Catalog Number :

Device Description : A long mattress for the Intelli-C X-ray system with a strap, for fixating the ma A long mattress for the Intelli-C X-ray system with a strap, for fixating the mattress when the table is tilted.

Device Class : 2

Duns Number: 307332705

Premarket Exempt : No

Product Code : OWB, JAA

Prescription Use : No

Device Count : 1

Intelli-C Accessory - 05713464000374 Catalog Number :

Device Description : A set of leg supports for the Intelli-C X-ray system for gynecological and urol A set of leg supports for the Intelli-C X-ray system for gynecological and urological examinations. The leg supports can be placed freely along the table top.

Device Class : 2

Duns Number: 307332705

Premarket Exempt : No

Product Code : JAA, OWB

Prescription Use : No

Device Count : 1

Intelli-C Accessory - 05713464000381 Catalog Number :

Device Description : Shoulder support for the Intelli-C X-ray system. The Shoulder support guides the Shoulder support for the Intelli-C X-ray system. The Shoulder support guides the positioning/support of the patient during angulation towards the Trendelenburg position.

Device Class : 2

Duns Number: 307332705

Premarket Exempt : No

Product Code : OWB, JAA

Prescription Use : No

Device Count : 1

Intelli-C Accessory - 05713464000398 Catalog Number :

Device Description : Arm support for the Intelli-C X-ray system. An adjustable arm support intended m Arm support for the Intelli-C X-ray system. An adjustable arm support intended mainly for use during intravenous injections of contrast media.

Device Class : 2

Duns Number: 307332705

Premarket Exempt : No

Product Code : OWB, JAA

Prescription Use : No

Device Count : 1

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