FDA.reportPublic FDA data

Accuray Precision® Treatment Planning System

Primary DI
00811376030221
Brand
Accuray Precision® Treatment Planning System
Company
Accuray Incorporated
Model
1049210-000
Catalog number
NA
Device description
Accuray Precision® Treatment Planning System
Published
2020-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical
MUJSystem, Planning, Radiation Therapy Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2
MUJSystem, Planning, Radiation Therapy TreatmentRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171086000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171086000Accuray Precision Treatment Planning SystemAccuray Incorporated2017-06-08IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811376030221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811376030221008113760302218113760302210811376030221

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy treatment planning workstationA freestanding image processing device that is a component of radiation therapy treatment planning configuration. It is sometimes considered to be a component of a picture archiving and communication system (PACS) or a local area network (LAN) configuration, e.g., a radiology information system (RIS) or hospital information system (HIS). It does not contain any controls for the direct operation of a radiation therapy system. It can receive and transmit data both on-line and off-line and is configured to provide the capability to remotely process, manipulate and view patient images and information used in treatment planning, record and verification.

Contacts#

Phone, Email table
PhoneEmail
408-716-4600webhelp@accuray.com

Regulatory Flags#

DUNS number
080044624
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00811376030450CyberKnife® M6™ Systems053301-M-000NA2022-01-04
00811376030467CyberKnife® M6™ Systems053401-M-000NA2022-01-04
00811376030474TomoH® Treatment Delivery System1018284-000NA2022-01-04
00811376030481TomoHDA® Treatment Delivery System1018286-000NA2022-01-04
00811376030498CyberKnife® M6™ Systems1047641-000NA2022-01-04
00811376030504TomoTherapy Treatment Delivery System with iDMS1068283NA2022-01-04
00811376030511TomoTherapy Treatment Delivery System with iDMS1068284NA2022-01-04
00811376030528TomoTherapy Treatment Delivery System with iDMS1068286NA2022-01-04
00811376030351reNEW™ Certified Pre-Owned SystemH-0000-0003NA2021-06-24
M65810182860TomoHDA® Treatment Delivery System1018286-000NA2016-09-22
M6580534010CyberKnife® M6™ Systems053401-M-000NA2016-09-22

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