FDA.reportPublic FDA data

MRIdian Linac System

Primary DI
00868029000346
Brand
MRIdian Linac System
Company
VIEWRAY INCORPORATED
Model
20000-01
Published
2022-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212958000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212958000MRIdian Linac SystemViewray, Incorporated2021-12-14IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868029000346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868029000346008680290003468680290003460868029000346

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic teletherapy radionuclide system, MRI-imagingA stationary assembly of computer-based devices designed to simultaneously create magnetic resonance imaging (MRI) images and deliver gamma radiation from a radionuclide source (typically cobalt) for stereotactic-radiosurgical therapy, typically to treat malignant tumours; the MRI images can be used to monitor treatment in real-time. It consists of radiation-emitting heads and collimators in a rotating gantry assembly; a magnet MRI system for soft-tissue imaging; patient couch and integrated positioning system; control consoles for image acquisition, planning and treatment administration; and integrated software.

Sterilization Methods#

Method table
Method

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
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
10868029000305MRIdian LINAC200002017-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850065937304eMotusEMPNIA INC.IYE2026-09-21