Pearl Technology AG

Address:Wiesenstrasse 33,Schlieren Zurich,CH

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Filters

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

Cradle, Patient, Radiologic (KXH) (10)

Premarket Exempt

Yes

Clear

PearlFit Forehead - 07640178060227 Catalog Number : 1122

Device Description : Patient positioning aid for MR and CT imaging. Head support used in the forehead Patient positioning aid for MR and CT imaging. Head support used in the forehead area in prone position.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

PearlFit Inlay Head - 07640178060234 Catalog Number : 1123

Device Description : Universal patient positioning aid for MR and CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

PearlFit Cushion 50x20x4 - 07640178060241 Catalog Number : 1124

Device Description : Universal patient positioning aid for MR and CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

PearlFit Cushion 30x20x4 Vac - 07640178060258 Catalog Number : 1125

Device Description : Universal patient positioning aid for MR and CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

PearlFit Cushion 50x30x7 Vac - 07640178060265 Catalog Number : 1126

Device Description : Universal patient positioning aid for MR and CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

PearlFit Cushion 50x30x10 Vac - 07640178060272 Catalog Number : 1127

Device Description : Universal patient positioning aid for MR and CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

PearlFit Wedge 26x25x7 Vac - 07640178060289 Catalog Number : 1128

Device Description : Universal patient positioning aid for MR and CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

PearlFit Cushion 130x50x10 Vac - 07640178060296 Catalog Number : 1129

Device Description : Universal patient positioning aid for MR and CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

PearlFit Head/Neck Vac - 07640178060302 Catalog Number : 1130

Device Description : Universal patient positioning aid for MR and CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

PearlFit Cushion 50x20x4 Vac - 07640178060319 Catalog Number : 1131

Device Description : Universal patient positioning aid for MR and CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

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