FDA.reportPublic FDA data

MRIdian LINAC

Primary DI
10868029000305
Brand
MRIdian LINAC
Company
VIEWRAY INCORPORATED
Model
20000
Published
2017-03-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K162393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162393000The ViewRay (MRIdian) Linac SystemViewray, Incorporated2017-02-24IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10868029000305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1086802900030510868029000305

GMDN Terms#

Term, Definition table
TermDefinition
Linear accelerator systemAn assembly of devices designed to produce high-energy electrons to yield high-energy x-rays used for therapeutic applications, primarily to treat cancer. It provides a uniform radiation field of uniform intensity and predictable energy level, in a beam with well defined dimensions. The principle of operation is linear acceleration of electrons by means of electromagnetic (EM) microwaves. The output is used as a treatment beam on the patient, either directly or after passing a suitable target. The system typically includes signal analysis and display devices, patient and device supports, and software.

Regulatory Flags#

DUNS number
015705677
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00868029000308Head Neck Coil (Receive Only) – Bottom117652022-05-06
00868029000315Medium Torso Coil (Receive Only) – Bottom129812022-05-06
00868029000346MRIdian Linac System20000-012022-05-06
00868029000353Head Neck Coil (Receive Only) – Top147752022-05-06
00868029000360Medium Torso Coil (Receive Only) – Top147742022-05-06
00868029000391Head Coil (Receive Only)238202022-05-06
00850036816027MRIdian A3i SoftwareA3i2022-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850065937113eMotusEMPNIA INC.IYE2026-09-21
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00850065937212eMotusEMPNIA INC.IYE2026-09-21
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00850065937243eMotusEMPNIA INC.IYE2026-09-21
00850065937250eMotusEMPNIA INC.IYE2026-09-21
00850065937267eMotusEMPNIA INC.IYE2026-09-21
00850065937274eMotusEMPNIA INC.IYE2026-09-21
00850065937298eMotusEMPNIA INC.IYE2026-09-21
00850065937304eMotusEMPNIA INC.IYE2026-09-21