FDA.reportPublic FDA data

Eclipse Treatment Planning System

Primary DI
00855141006011
Brand
Eclipse Treatment Planning System
Company
VARIAN MEDICAL SYSTEMS, INC.
Model
15.0
Published
2016-09-16
Public version status
Update
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
K152393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152393000Eclipse Treatment Planning SystemVarian Medical Systems, Inc.2015-09-18MUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855141006011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855141006011008551410060118551410060110855141006011

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009120817
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00816389029743Retraction Nut CT/MRGM11012960GM110129602025-05-16
00810563022551Needle collector pair for Titanium Fletcher-style applicatorGM11010740GM110107402024-11-19
00850800006074Vitesse5.0Vitesse 5.02024-11-01
00816389020245Crook Prostate Template for 2.0 mm needlesGM11012230GM110122302024-02-19
00816389029286Stainless steel needle 320mm, 18 gauge, trocar pointGM11009580GM110095802023-05-05
00816389029255Stainless steel needle 113mm, 18 gauge, trocar pointGM11009550GM110095502023-04-28
008105630220322.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, EllipsoidalPC-2.1E2023-04-20
008105630220492.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, SphericalPC-2.1S2023-04-20
008105630220562.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, EllipsoidalPC-2.1EL2023-04-20
008105630220632.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, SphericalPC-2.1SL2023-04-20
00816389027756Varian Titanium Applicator probe, 3mm dia x 320mm length, curved 15 degree, 50mmGM11013240GM110132402019-11-06
00816389021242Titanium-Fletcher-Suit-Delclos-style Applicator Set (Flexible Geometry)AL13030001AL130300012016-09-19
00816389021297X-ray marker wire, 160 cm x 0.6, channel 1AL13116000AL131160002016-09-19
00816389021310X-ray marker wire, 160 cm x 0.6, channel 3AL13118000AL131180002016-09-19
00816389021747Central clamping mechanismGM11000860GM110008602016-09-23
00816389021778Intrauterine probe with stop, 30 degrees angle, length 80mmGM11000890GM110008902016-09-23
00816389021792Colpostats for 20mm spread, pairGM11000910GM110009102016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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