Halcyon

Primary DI
00857235006020
Brand
Halcyon
Company
Varian Medical Systems China Co., Ltd.
Model
2.0
Published
2019-05-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K181032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181032000HalcyonVarian Medical Systems, Inc.2018-05-09IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857235006020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857235006020008572350060208572350060200857235006020

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
545295284
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857235006006Halcyon1.02017-09-20

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Primary DI, Brand, Company table
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