FDA.reportPublic FDA data

Eclipse Treatment Planning System for External Beam Radiation Therapy

Primary DI
00855141006073
Brand
Eclipse Treatment Planning System for External Beam Radiation Therapy
Company
VARIAN MEDICAL SYSTEMS, INC.
Model
16.0
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
K200608000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200608000Eclipse Treatment Planning System v16.0Varian Medical Systems, Inc.2020-04-03MUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855141006073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855141006073008551410060738551410060730855141006073

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
00810563022025Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrinGM11014700GM110147002024-02-16
00810563022322Temperature Sensor Probe, 18G x 20cmABL-18TP202024-08-09
00816389029460Intrauterine tandem, 15 degrees, 2 cm, CT/ MRGM11012510GM110125102025-05-16
00816389029637Ovoid, 40 mm, pair, CT/ MRGM11012750GM110127502025-05-16
00816389029712Retractor, 30 mm, CT/ MRGM11012930GM110129302025-05-16
00816389020276Crook Prostate Template for 17 gauge (1.47 mm) needlesGM11012260GM110122602024-02-19
008105630209538mm CryoprobeDP35-0215-101CRYO-48-F2022-02-18
00810563020984MicroThermX Microwave Ablation System20-17222-001MTX-1802022-02-18
00810563020991MicroThermX Microwave Ablation System20-17222-101MTX180-T22022-02-18
008163890289062.4mm V-Probe™ CryoprobeDP35-0900-101CVA24002022-02-18
008163890289202.4mm V-Probe™ Cryoprobe Right AngleDP35-0902-108CVA2400RA2022-02-18
00816389028869VariSource VS2000 HDR Ir 192 Brachytherapy Sealed SourceAL09400000AL094000002022-01-09
00856104006000Varian Treatment13.02016-09-16
00856545006027VariSource iX1.2AL19004-0002016-09-16
00856545006034VariSource iX(t)1.2AL19004-0012016-09-16
00816389020986TANDEM ROTATE & SLIDE BLOCK (CT/MR FSD)AL10715008AL107150082016-09-19
00816389021686Intrauterine probe with stopper, angle 30 degrees, length 50 mmGM11000790GM110007902016-09-23
00816389021785Mini-colpostats, pairGM11000900GM110009002016-09-19
00816389022164Applicator probe 6/3 mm diameter, curved 15 degrees, length 320 mmGM110022302016-09-22
00816389022386Implant needle, 120 mm, 1.7 mm diameter, curvedGM11002930GM110029302016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06429830064237Dose+Mvision AI OyMUJ2025-10-03
07350002010891RayCareRaysearch Laboratories AB (Publ)MUJ2025-09-30