DOSISOFT

Address:45/47 Avenue Carnot,Cachan Ile-de-France,FR

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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) System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

Clear

EPIgray - B501EPIGRAY020006 Catalog Number : 2.0.6

Device Description : Radiotherapy software quality assurance tool.

Device Class : 2

Duns Number: 264815932

Premarket Exempt : No

Product Code : MUJ

Prescription Use : Yes

Device Count : 1

EPIgray - B501EPIGRAY020007 Catalog Number : 2.0.7

Device Description : Radiotherapy software quality assurance tool

Device Class : 2

Duns Number: 264815932

Premarket Exempt : No

Product Code : MUJ

Prescription Use : Yes

Device Count : 1

MU2net - B501MU2NET020101 Catalog Number : 2.1.1

Device Description : MU2net is a standalone software device designed to perform secondary monitor uni MU2net is a standalone software device designed to perform secondary monitor unit (MU) or dose calculation based on DICOM RT Plan data sets provided by Radiotherapy Treatment Planning Systems.

Device Class : 2

Duns Number: 264815932

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

PLANET, PLANET Onco, PLANET Dose, PLANET Onco Dose - B501PLANET030101 Catalog Number : 3.1.1

Device Description : PLANET Onco Dose is a software platform dedicated to medical diagnosis aid, ther PLANET Onco Dose is a software platform dedicated to medical diagnosis aid, therapy response assessment aid, contouring for radiotherapy and internal dosimetry computation, using molecular imaging modalities.

Device Class : 2

Duns Number: 264815932

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

ThinkQA, EPIbeam - B501THINKQA010002 Catalog Number : 1.0.2

Device Description : Radiation therapy quality assurance and error detection software suite

Device Class : 2

Duns Number: 264815932

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

ThinkQA, EPIbeam - B501THINKQA010004 Catalog Number : 1.0.4

Device Description : Radiation therapy quality assurance and error detection software suite

Device Class : 2

Duns Number: 264815932

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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