FDA.reportPublic FDA data

Head Neck Coil (Receive Only) – Bottom

Primary DI
00868029000308
Brand
Head Neck Coil (Receive Only) – Bottom
Company
VIEWRAY INCORPORATED
Model
11765
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
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
00868029000308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868029000308008680290003088680290003080868029000308

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.

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
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
10868029000305MRIdian LINAC200002017-03-20

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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00850065937250eMotusEMPNIA INC.IYE2026-09-21
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00850065937304eMotusEMPNIA INC.IYE2026-09-21