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) (9) Cover, Mattress (Medical Purposes) (FMW) (1)

Premarket Exempt

Yes

Clear

ProFoam Wedge 26x25x7 DS - 07640178060630 Catalog Number : 1160

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

ProFoam Wedge 18x11x5 DS - 07640178060647 Catalog Number : 1161

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

ProFoam Wedge 36x25x12 DS - 07640178060654 Catalog Number : 1162

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

ProFoam Wedge60x25x12 DS - 07640178060661 Catalog Number : 1163

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

ProBelt 200 R2 - 07640178060678 Catalog Number : 1170

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

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

ProBelt 200 R3 - 07640178060685 Catalog Number : 1171

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

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

ProBelt 200 T5 - 07640178060692 Catalog Number : 1172

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

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

ProBelt 200 Thorax PFC - 07640178060708 Catalog Number : 1173

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

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

ProBelt 200 Thorax PFW - 07640178060715 Catalog Number : 1174

Device Description : Universal patient positioning belt 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 310 - 07640178060722 Catalog Number : 1175

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

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