ACCURAY INCORPORATED

Address:1310 CHESAPEAKE TERRACE,Sunnyvale,CA,94089,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) (10) System,Planning,Radiation Therapy Treatment (MUJ) (3) System, Planning, Radiation Therapy Treatment (MUJ) (1)

Premarket Exempt

Clear

iDMS™ Data Management System - M65810572080 Catalog Number : NA

Device Description : Software, Version 1.1, iDMS™ Data Management SystemThe iDMS™ Data Management Sys Software, Version 1.1, iDMS™ Data Management SystemThe iDMS™ Data Management System is indicated for the storage, retrieval, and processing of data utilized in the practice of radiotherapy, stereotactic radiotherapy and stereotactic radiosurgery.

Device Class : 2

Duns Number: 785961244

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Delivery Analysis TM - M65810573750 Catalog Number : NA

Device Description : Software, Delivery Analysis, Version 1.2

Device Class : 2

Duns Number: 785961244

Premarket Exempt : No

Product Code : IYE, MUJ

Prescription Use : Yes

Device Count : 1

Radixact®, Treatment Delivery Console (TDC) - M65810577270 Catalog Number : NA

Device Description : Software, Version 1.0.0.4, Treatment Delivery Console, Radixact(Operating Softwa Software, Version 1.0.0.4, Treatment Delivery Console, Radixact(Operating Software for Radixact Treatment Delivery System)

Device Class : 2

Duns Number: 785961244

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Accuray Precision® Treatment Planning System - M65810598110 Catalog Number : NA

Device Description : Software, Version 1.1.1, Accuray Precision Treatment Planning SystemThe Accuray Software, Version 1.1.1, Accuray Precision Treatment Planning SystemThe Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.

Device Class : 2

Duns Number: 785961244

Premarket Exempt : No

Product Code : IYE, MUJ

Prescription Use : Yes

Device Count : 1

Radixact® Treatment Delivery System - M65810600000 Catalog Number : NA

Device Description : The Radixact Treatment Delivery System is a radiation therapy delivery system th The Radixact Treatment Delivery System is a radiation therapy delivery system that provides Image Guided Radiation Therapy (IGRT) using integral megavoltage CTimaging capabilities and delivers helical (rotational) and fixed-angle (non-rotational) radiation therapy to tumors and other targeted tissues.The Radixact Treatment Delivery System is a prescription device that delivers radiation in accordance with a physician approved plan. The Radixact Treatment Delivery System does not diagnose disease, recommend treatment regimens or quantify treatment effectiveness. It is not intended for diagnostic use.

Device Class : 2

Duns Number: 785961244

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Radixact™ Treatment Delivery System - M65810602530 Catalog Number : N/A

Device Description : Radixact Delivery System Software (Version 1.1)

Device Class : 2

Duns Number: 785961244

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

NA - M65810604640 Catalog Number : NA

Device Description : Software, TomoApps, Version 5.1.2Operating Software for TomoTherapy systems (inc Software, TomoApps, Version 5.1.2Operating Software for TomoTherapy systems (including TomoH®, TomoHD®, TomoHDA) and Onrad Treatment System™

Device Class : 2

Duns Number: 785961244

Premarket Exempt : No

Product Code : IYE, MUJ

Prescription Use : Yes

Device Count : 1

iDMS Data Management System - M65810615130 Catalog Number : NA

Device Description : Software, Version 2.0, iDMS Data Management SystemThe iDMS Data Management Syste Software, Version 2.0, iDMS Data Management SystemThe iDMS Data Management System is indicated for the storage, retrieval, and processing of data utilized in the practice of radiotherapy, stereotactic radiotherapy and stereotactic radiosurgery.

Device Class : 2

Duns Number: 785961244

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

Accuray Precision® Treatment Planning System - M65810617990 Catalog Number : NA

Device Description : Software, Accuray Precision Treatment Planning System, (Version 1.1.1.1)The Accu Software, Accuray Precision Treatment Planning System, (Version 1.1.1.1)The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.

Device Class : 2

Duns Number: 785961244

Premarket Exempt : No

Product Code : MUJ, IYE

Prescription Use : Yes

Device Count : 1

TomoTherapy Treatment Delivery System with iDMS - M65810620710 Catalog Number : NA

Device Description : TomoTherapy Treatment Delivery System with iDMS, Version 1.1

Device Class : 2

Duns Number: 785961244

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

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