FDA.reportPublic FDA data

VitalBeam

Primary DI
00899475002363
Brand
VitalBeam
Company
VARIAN MEDICAL SYSTEMS, INC.
Model
3.0
Published
2022-06-10
Public version status
Update
Distribution status
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
K213977000
K223839000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213977000TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.2022-06-03IYE
K223839000TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.2023-05-22IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00899475002363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00899475002363008994750023638994750023630899475002363

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
009120817
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008105630206872.4mm V-Probe™ Cryoprobe Right AngleDP35-0902-109CVA2400RA2022-02-18
008105630207861.7 mm RenalCryo™ CryoprobeDP35-0942-203RS-172022-02-18
008105630207931.7 mm RenalCryo™ CryoprobeDP35-0942-208RS-172022-02-18
008105630208091.7 mm Long Shaft RenalCryo™ CryoprobeDP35-0942-204RS-17L2022-02-18
008105630208161.7 mm Long Shaft RenalCryo™ CryoprobeDP35-0942-209RS-17L2022-02-18
008105630208232.4mm RenalCryo™ CryoprobeDP35-0943-203RS-242022-02-18
008105630208472.4mm Long Shaft RenalCryo™ CryoprobeDP35-0943-204RS-24L2022-02-18
008105630208613.8 mm RenalCryo™ CryoprobeDP35-0793-201R3.82022-02-18
008105630208783.8 mm RenalCryo™ CryoprobeDP35-0793-203R3.82022-02-18
008105630208853.8 mm Long Shaft RenalCryo™ CryoprobeDP35-0793-202R3.8L2022-02-18
008105630208923.8 mm Long Shaft RenalCryo™ CryoprobeDP35-0793-204R3.8L2022-02-18
00810563020908TempProbe™ DeviceDP40-0015-213CRYO-55-F2022-02-18
00810563020915Prostate Procedure Probe PackDP35-0965-101CRYO-204-V2022-02-18
00810563020939Prostate Procedure Probe PackDP35-0595-108CRYO-207-V2022-02-18
008105630209608mm CryoprobeDP35-0215-102CRYO-48-F2022-02-18
008163890289062.4mm V-Probe™ CryoprobeDP35-0902-101CVA24002022-02-18
008163890289132.4mm V-Probe™ CryoprobeDP35-0902-102CVA24002022-02-18
00816389027992Interstitial ovoid pair for 30mm spread, with fixation for guide tubesGM11013450GM110134502025-05-21
00816389029538Intrauterine tandem, 30 degrees, 8 cm, CT/ MRGM11012580GM110125802025-05-16
00816389029699Assembly module, CT/ MRGM11012910GM110129102025-05-16

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Primary DI, Brand, Company table
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00841439115336Extremity Riser - JointGlowQfixIYE2026-06-04
00841439115343MultiFix Indexing PostQfixIYE2026-06-04
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