FDA.reportPublic FDA data

iDMS Data Management System

Primary DI
M65810615130
Brand
iDMS Data Management System
Company
ACCURAY INCORPORATED
Model
1061513
Catalog number
NA
Device description
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.
Published
2018-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161144000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161144000iDMS Data Management SystemAccuray Incorporated2016-06-24IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M65810615130PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Patient health record information system application softwareAn application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. It typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. It is supplied for installation into a dedicated information system for patient health records, or existing mainframe or decentralized computers/networks.

Contacts#

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

Regulatory Flags#

DUNS number
785961244
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
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00811376030481TomoHDA® Treatment Delivery System1018286-000NA2022-01-04
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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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