FDA.reportPublic FDA data

Eclipse Treatment Planning System for External Beam Radiation Therapy

Primary DI
00855141006080
Brand
Eclipse Treatment Planning System for External Beam Radiation Therapy
Company
VARIAN MEDICAL SYSTEMS, INC.
Model
16.1
Published
2020-11-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MUJSystem, planning, radiation therapy treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUJSystem, Planning, Radiation Therapy TreatmentRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201607000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201607000Eclipse Treatment Planning System v16.1Varian Medical Systems, Inc.2020-07-10MUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855141006080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855141006080008551410060808551410060800855141006080

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy softwareAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.

Regulatory Flags#

DUNS number
009120817
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854393006084Velocity4.3Velocity 4.32026-07-16
10816389027234Cleaning Cap, dark blue (pack of 25)GM11010770GM110107702016-09-22
00810563021035SynchroWave ST Antenna22-17025-315SWST-14152022-02-18
00810563021042SynchroWave ST Antenna22-17025-320SWST-14202022-02-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860007402395TrueFit BolusAdaptiiv Medical Technologies IncMUJ2026-06-24
04068151027280syngo.via RT Image Suite VC10Siemens Healthcare GmbHMUJ2026-06-24
00859032007361Panther OISProwess, Inc.MUJ2026-06-09
00859032007378Panther TPSProwess, Inc.MUJ2026-06-09
00884838123786Multimodality Simulation Workspace (MM Sim)1.0Philips Medical Systems Nederland B.V.MUJ2026-06-07
00884838123793Multimodality Simulation Workspace (MM Sim)1.0 UpgradePhilips Medical Systems Nederland B.V.MUJ2026-06-07
00859032007316Panther TPSProwess, Inc.MUJ2026-06-01
00859032007323Panther TPSProwess, Inc.MUJ2026-06-01
00859032007330Panther OISProwess, Inc.MUJ2026-06-01
00859032007347Panther TPSProwess, Inc.MUJ2026-06-01
00859032007354Panther OISProwess, Inc.MUJ2026-06-01
00860015780805INTContourCarina Medical LLCMUJ2026-04-27
08436567540024RadianceGMV SOLUCIONES GLOBALES INTERNET SAMUJ2026-04-08
07340201500118MonacoElekta Solutions ABMUJ2026-03-20
00850072631004ClearCalcRadformation, IncMUJ2026-03-13
00860001672787ClearCalcRadformation, IncMUJ2026-03-13
00860001672794EZFluenceRadformation, IncMUJ2026-03-13
07340201503898Leksell GammaPlanElekta Solutions ABMUJ2026-02-04
05060494200091XBeam XSTRAHL LIMITEDMUJ2026-01-19
03770019940013ART-PlanTHERAPANACEAMUJ2025-12-10
03770019940020ART-PlanTHERAPANACEAMUJ2025-12-10
04056869959009syngo.via RT Image SuiteSiemens Healthcare GmbHMUJ2025-11-18
04068151011388syngo.via RT Image SuiteSiemens Healthcare GmbHMUJ2025-11-18
00860014658303PinZ Patient ImmobilizerZAP SURGICAL SYSTEMS, INC.MUJ2025-11-17
00860183001542Kit, Container, Head ImmobilizerZAP SURGICAL SYSTEMS, INC.MUJ2025-11-17
00860183001573ZAP-Axon Treatment Planning SystemZAP SURGICAL SYSTEMS, INC.MUJ2025-11-17
00860183001580DoseGuardZAP SURGICAL SYSTEMS, INC.MUJ2025-11-17
00860183001597Kit, Container, Fixation Pins, ImmobilizerZAP SURGICAL SYSTEMS, INC.MUJ2025-11-17
08717213058118NANucletron B.V.MUJ2025-11-13
05060608881574Plan AISUN NUCLEAR CORP.MUJ2025-11-07