Radformation, Inc

Address:335 Madison Avenue, 4th Floor,New York,NY,10017,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) (3) System, Planning, Radiation Therapy Treatment (MUJ) (2) Radiological Image Processing Software For Radiation Therapy (QKB) (1)

Premarket Exempt

Clear

ClearCheck - 00860001672701 Catalog Number :

Device Description : ClearCheck is intended for quality assessment of radiotherapy treatment plans.

Device Class : 2

Duns Number: 080444608

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

EZFluence - 00860001672718 Catalog Number :

Device Description : EZFluence is intended to assist radiation treatment planning professionals in ge EZFluence is intended to assist radiation treatment planning professionals in generating optimal fluences for producing a homogeneous dose distribution in external beam radiation therapy treatment plans consisting of photo treatment fields.

Device Class : 2

Duns Number: 080444608

Premarket Exempt : No

Product Code : IYE, MUJ

Prescription Use : No

Device Count : 1

ClearCalc - 00860001672725 Catalog Number :

Device Description : ClearCalc is a software intended to assist radiation treatment planners in deter ClearCalc is a software intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.

Device Class : 2

Duns Number: 080444608

Premarket Exempt : No

Product Code : MUJ

Prescription Use : No

Device Count : 1

AutoContour - 00860001672732 Catalog Number :

Device Description : AutoContour is intended to assist radiation treatment planners in contouring and AutoContour is intended to assist radiation treatment planners in contouring and reviewing structures within medical images in preparation for radiation therapy treatment planning.

Device Class : 2

Duns Number: 080444608

Premarket Exempt : No

Product Code : QKB

Prescription Use : Yes

Device Count : 1

ChartCheck - 00860001672749 Catalog Number :

Device Description : ChartCheck assists in quality assessment of radiotherapy treatment plans and on ChartCheck assists in quality assessment of radiotherapy treatment plans and on treatment chart review utilizing treatment, imaging, and documentation data in a simple, web-based interface.

Device Class : 2

Duns Number: 080444608

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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