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 Roll 40 - 07640178060128 Catalog Number : 1112

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 Roll 50 - 07640178060135 Catalog Number : 1113

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 - 07640178060142 Catalog Number : 1114

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 - 07640178060159 Catalog Number : 1115

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 - 07640178060166 Catalog Number : 1116

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 - 07640178060173 Catalog Number : 1117

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 Flex 6 - 07640178060180 Catalog Number : 1118

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 Flex 3 - 07640178060197 Catalog Number : 1119

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 130x60x10 - 07640178060203 Catalog Number : 1120

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 - 07640178060210 Catalog Number : 1121

Device Description : Patient positioning aid for MR and CT imaging. The PearlFit Head/Neck is used as Patient positioning aid for MR and CT imaging. The PearlFit Head/Neck is used as a head support when patients are lying supine on the patient table.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

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