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) (6) Holder, Head, Radiographic (IWY) (3) Bedding, Disposable, Medical (KME) (1)

Premarket Exempt

Yes

Clear

Crania Adult - 07640178060012 Catalog Number : 1001

Device Description : Head positioning aid for MR imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : IWY

Prescription Use : Yes

Device Count : 1

Crania Child - 07640178060029 Catalog Number : 1004

Device Description : Head positioning aid for MR imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : IWY

Prescription Use : Yes

Device Count : 1

Multipad Standard - 07640178060036 Catalog Number : 1012

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

Multipad Plus - 07640178060043 Catalog Number : 1022

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

Multipad Slim - 07640178060050 Catalog Number : 1071

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

Cover Multipad - 07640178060067 Catalog Number : 1101

Device Description : Sanitary Cover to use with short-term patient positioning and stabilization devi Sanitary Cover to use with short-term patient positioning and stabilization device for MR and CT imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KME

Prescription Use : Yes

Device Count : 100

Multipad Ear - 07640178060074 Catalog Number : 1104

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 HeadFix - 07640178060081 Catalog Number : 1105

Device Description : Positioning aid for head fixation in the CT head holder.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : IWY

Prescription Use : Yes

Device Count : 1

BabyFix Cocoon - 07640178060104 Catalog Number : 1107

Device Description : Positioning aid for the immobilization of new - borns (2 to 5 kg) during MR imaging.

Device Class : 1

Duns Number: 480151859

Premarket Exempt : Yes

Product Code : KXH

Prescription Use : Yes

Device Count : 1

Multipad Bendy - 07640178060111 Catalog Number : 1108

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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