FDA.reportPublic FDA data

iDMS Data Management System

Primary DI
00811376030085
Brand
iDMS Data Management System
Company
ACCURAY INCORPORATED
Model
1061514
Catalog number
NA
Device description
IDMS Data Management System (Version 3.0)
Published
2019-05-31
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
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
00811376030085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811376030085008113760300858113760300850811376030085

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.

Sterilization Methods#

Method table
Method

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
Primary DIBrandModelCatalogPublished
00811376030863Adapt LTE powered by Accuray Cenos1097715-0002025-12-19
00811376030795SW, Legal Labelling Install Disk, 5.1.910930132023-12-21
00811376030009Radixact™ Treatment Delivery System1060000N/A2018-01-26
M65810492110Onrad Treatment System1049211NA2018-06-22
00811376030344TomoHD® Treatment Delivery System1018283-000NA2022-01-04
00811376030368CyberKnife® VSI™ Robotic Radiosurgery System033000-000NA2022-01-04
00811376030429CyberKnife® VSI™ Robotic Radiosurgery System Japan032500-M-000NA2022-01-04
00811376030436CyberKnife® M6™ Systems053101-M-000NA2022-01-04
00811376030443CyberKnife® M6™ Systems053201-M-000NA2022-01-04
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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