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

Cover, Mattress (Medical Purposes) (FMW) (6) Cradle, Patient, Radiologic (KXH) (4)

Premarket Exempt

Yes

Clear

PearlFit Cushion 90x60x5 Vac - 07640178060425 Catalog Number : 1144

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 27x6x1 - 07640178060432 Catalog Number : 1145

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

CT Table Cover 2090 - 07640178060449 Catalog Number : 1164

Device Description : Universal patient positioning aid for CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : FMW

Prescription Use : Yes

Device Count : 1

CT Table Cover 1790 - 07640178060456 Catalog Number : 1165

Device Description : Universal patient positioning aid for CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : FMW

Prescription Use : Yes

Device Count : 1

CT Table Cover 2360 - 07640178060463 Catalog Number : 1166

Device Description : Universal patient positioning aid for CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : FMW

Prescription Use : Yes

Device Count : 1

CT Table Cover 1860 - 07640178060470 Catalog Number : 1167

Device Description : Universal patient positioning aid for CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : FMW

Prescription Use : Yes

Device Count : 1

CT Table Cover 2070 - 07640178060487 Catalog Number : 1168

Device Description : Universal patient positioning aid for CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : FMW

Prescription Use : Yes

Device Count : 1

CT Table Cover 400 - 07640178060494 Catalog Number : 1169

Device Description : Universal patient positioning aid for CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : FMW

Prescription Use : Yes

Device Count : 1

PearlFit Cushion MAQSIE Vac - 07640178060517 Catalog Number : 1146

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 Tilt15 - 07640178060524 Catalog Number : 1148

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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