KOELIS

Address:22 Chemin du Vieux Chene,MEYLAN Isere,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) (7) System, Image Processing, Radiological (LLZ) (3) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (2) System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (1)

Premarket Exempt

Clear

MR DRAW - 03665134000578 Catalog Number :

Device Description : A system based on the PROMAP – 3D Prostate Suite range intended to define prosta A system based on the PROMAP – 3D Prostate Suite range intended to define prostate contour and targets the region of interest on a prostate gland image in anticipation of a fusion with a system compatible with a 3D echography image realized as part of a targeted prostate gland biopsy.

Device Class : 2

Duns Number: 290318455

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Steady Pro - 03665134000592 Catalog Number :

Device Description : Steady Pro (Mechanical probe holder and supports)The steady pro range is intende Steady Pro (Mechanical probe holder and supports)The steady pro range is intended to reliably maintain the position of a transrectal ultrasoung probe during untra-sound-guided intervention.

Device Class : 2

Duns Number: 290318455

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

TRINITY - 03665134000684 Catalog Number :

Device Class :

Duns Number: 290318455

Premarket Exempt : No

Product Code : LLZ, IYO, ITX

Prescription Use : Yes

Device Count : 1

PROMAP – 3D PROSTATE SUITE - 03665134000714 Catalog Number :

Device Class : 2

Duns Number: 290318455

Premarket Exempt : No

Product Code : LLZ, ITX, IYO, IYN

Prescription Use : Yes

Device Count : 1

Steady Pro - 03665134000738 Catalog Number :

Device Description : Steady Pro Probe Holding Arm with I and U extension and rail clamping baseThe St Steady Pro Probe Holding Arm with I and U extension and rail clamping baseThe Steady Pro range is intended to reliably maintain the position of a transrectal ultrasound probe during ultra-sound-guided intervention.

Device Class : 2

Duns Number: 290318455

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Steady Pro - 03665134000745 Catalog Number :

Device Description : Probe holder for transperineal approach.The steady pro range is intended to reli Probe holder for transperineal approach.The steady pro range is intended to reliably maintain the position of a transrectal ultrasound probe during ultra-sound-guided intervention.

Device Class :

Duns Number: 290318455

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Steady Pro - 03665134000776 Catalog Number :

Device Description : Probe holder for transrectal approach

Device Class : 2

Duns Number: 290318455

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Steady Pro - 03665134000806 Catalog Number :

Device Description : Universal clamping baseThe steady pro range is intended to reliably maintain the Universal clamping baseThe steady pro range is intended to reliably maintain the position of a transrectal ultrasound probe during ultra-sound-guided intervention.

Device Class : 2

Duns Number: 290318455

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

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