IBA Dosimetry GmbH

Address:Bahnhofstrasse 5,SCHWARZENBRUCK Bavaria,DE

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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

Accelerator, Linear, Medical (IYE) (10)

Premarket Exempt

No Yes

Clear

Detector Holder - EIBAM90063300 Catalog Number : DA07-800

Device Description : Detector holder for use of Exradin chamber, diameter 6-10 mm with WP1D

Device Class : 2

Duns Number: 332599307

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Detector Holder - EIBAM90063400 Catalog Number : DA07-900

Device Description : Detector holder for use of Exradin chamber, diameter 10-13 mm with WP1D

Device Class : 2

Duns Number: 332599307

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

IMRT - Bodyphantom - EIBAM98000000 Catalog Number :

Device Description : IMRT - Bodyphantom

Device Class : 2

Duns Number: 332599307

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Chamber Holder - EIBAMC0000000 Catalog Number :

Device Description : Small reference chamber holder for attachment to a Siemens Oncor Linac head

Device Class : 2

Duns Number: 332599307

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Chamber Holder - EIBAMC0004000 Catalog Number :

Device Description : Small reference chamber holder for attachment to a Varian Linac head

Device Class : 2

Duns Number: 332599307

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Chamber Holder - EIBAMC0005000 Catalog Number :

Device Description : Small reference chamber holder for attachment to an Elekta Linac head

Device Class : 2

Duns Number: 332599307

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

myQA FastTrack - EIBAMQ002000 Catalog Number :

Device Class : 2

Duns Number: 332599307

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

myQA FastTrack PT - EIBAMQ002700 Catalog Number :

Device Description : myQA FastTrack PT plugin

Device Class : 2

Duns Number: 332599307

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

myQA Cockpit - EIBAMQ010000 Catalog Number :

Device Class : 2

Duns Number: 332599307

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

myQA Patients - EIBAMQ020000 Catalog Number :

Device Class : 2

Duns Number: 332599307

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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