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

Instrument, Quality-Assurance, Radiologic (LHO) (7) Accelerator, Linear, Medical (IYE) (3)

Premarket Exempt

No Yes

Clear

Dosimeter Dosimax plus A - EIBAVD02017470 Catalog Number : VD0201747

Device Description : Single channel dosimeter according to IEC 61674, designed for acceptance tests a Single channel dosimeter according to IEC 61674, designed for acceptance tests and for quality checks at radiographic, fluoroscopic, dental and mammographic X-ray units.

Device Class : 1

Duns Number: 332599307

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Dosimeter Dosimax plus I - EIBAVD02017480 Catalog Number : VD0201748

Device Description : Single channel dosimeter according to IEC 61674, designed for quality checks at Single channel dosimeter according to IEC 61674, designed for quality checks at radiographic, fluoroscopic, dental and mammographic X-ray units.

Device Class : 1

Duns Number: 332599307

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Dosimeter Dosimax plus A HV - EIBAVD02017900 Catalog Number : VD0201790

Device Description : Dosimeter with internal high voltage supply according to IEC 61674 for use with Dosimeter with internal high voltage supply according to IEC 61674 for use with ionization chamber DCT10-RS. Designed for measurements at all types of X-ray units.

Device Class : 1

Duns Number: 332599307

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Multimeter MagicMax - rad/flu/dent - EIBAVD02019400 Catalog Number : VD0201940

Device Description : Multimeter with fixed XR Multidetector, for kV and HVL measurements of radiograp Multimeter with fixed XR Multidetector, for kV and HVL measurements of radiography X-ray Units, incl. kV-waveform.

Device Class : 1

Duns Number: 332599307

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Dosimeter MagixMaX - rad/flu/dent - EIBAVD02019450 Catalog Number : VD0201945

Device Description : Dosimeter with RQA Detector. For dose, dose rate and time measurements, incl. waveform.

Device Class : 1

Duns Number: 332599307

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

KV-Meter MagicMax mam - EIBAVD02019580 Catalog Number : VD0201958

Device Description : KV-Meter with fixed XM Multidetector, for kV and HVL measurements of mammography KV-Meter with fixed XM Multidetector, for kV and HVL measurements of mammography X-ray units, incl. kV-waveform.

Device Class : 1

Duns Number: 332599307

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Multimeter MagicMaX-Universal - EIBAVD02020100 Catalog Number : VD0202010

Device Description : Multimeter MagicMaX developed in accordance with IEC 61674. Flexible solution fo Multimeter MagicMaX developed in accordance with IEC 61674. Flexible solution for exact dose- and kV-measurements at all X-ray units incl. CT.

Device Class : 1

Duns Number: 332599307

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

DC300 Diagnostic chamber - EIBAVD07021040 Catalog Number :

Device Description : DC300 Diagnostic Chamber, 2,8 ccm, TNC Triax

Device Class : 2

Duns Number: 332599307

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

DC300 Diagnostic chamber - EIBAVD07021090 Catalog Number :

Device Description : DC300 Diagnostic Chamber, 2,8 ccm, BNC Triax

Device Class : 2

Duns Number: 332599307

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

DC300 Diagnostic chamber - EIBAVD07021100 Catalog Number :

Device Description : DC300 Diagnostic Chamber, 2,8 ccm, Lemosa Triax

Device Class : 2

Duns Number: 332599307

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

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