STANDARD IMAGING INC.

Address:3120 DEMING WAY,MIDDLETON,WI,53562,US

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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) (5) Calibrator, Dose, Radionuclide (KPT) (2)

Premarket Exempt

Clear

Standard Imaging DoseView 3D - 00866562000205 Catalog Number : 92260

Device Description : Standard Imaging DoseView 3D is a medical device intended for performing water p Standard Imaging DoseView 3D is a medical device intended for performing water phantom based commissioning and QA measurements on radiation therapy systems.

Device Class : 2

Duns Number: 788084705

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Standard Imaging HDR 1000 Plus - 00866562000212 Catalog Number : 90008

Device Description : Standard Imaging HDR 1000 Plus is a medical device intended as a transducer for Standard Imaging HDR 1000 Plus is a medical device intended as a transducer for brachytherapy radiation QA measurements.

Device Class : 2

Duns Number: 788084705

Premarket Exempt : No

Product Code : KPT

Prescription Use : Yes

Device Count : 1

Standard Imaging IMSure QA Software - 00866562000229 Catalog Number : 91326

Device Description : Standard Imaging IMSure QA Software is a stand alone software medical device use Standard Imaging IMSure QA Software is a stand alone software medical device used for monitor unit secondary checks and IMRT treatment plan secondary checks of radiation treatment plans from radiation therapy systems.

Device Class : 2

Duns Number: 788084705

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Standard Imaging PIPSpro Software - 00866562000236 Catalog Number : 91309

Device Description : Standard Imaging PIPSpro Software is a stand alone software medical device used Standard Imaging PIPSpro Software is a stand alone software medical device used for QA checks of imaging systems used with radiation therapy systems.

Device Class : 2

Duns Number: 788084705

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Standard Imaging Adaptivo - 00866562000243 Catalog Number : 91350

Device Description : Standard Imaging Adaptivo Software is a stand alone software medical device used Standard Imaging Adaptivo Software is a stand alone software medical device used for QA checks of comparative and cumulative dose received during radiation treatment from radiation therapy systems.

Device Class : 2

Duns Number: 788084705

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Standard Imaging IVB 1000 Well Chamber - 00866562000250 Catalog Number : 90009

Device Description : Standard Imaging IVB 1000 is a medical device intended as a transducer for brach Standard Imaging IVB 1000 is a medical device intended as a transducer for brachytherapy radiation QA measurements.

Device Class : 2

Duns Number: 788084705

Premarket Exempt : No

Product Code : KPT

Prescription Use : Yes

Device Count : 1

Standard Imaging LinacView Software - 00866562000267 Catalog Number : 91330

Device Description : Standard Imaging LinacView Software is a stand alone software medical device use Standard Imaging LinacView Software is a stand alone software medical device used for logfile analysis of radiation therapy systems.

Device Class : 2

Duns Number: 788084705

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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