FDA.reportPublic FDA data

Best TPS

Primary DI
00852656007052
Brand
Best TPS
Company
Best Nomos
Model
209867
Device description
The Best TPS system is a computer based software system developed the use of assisting in the placement of anatomical localization and low dose rate isotope implants Best TPS uses multiple two-dimensional images including ultrasound and DICOM images which are outlined by a qualified medical staff member, then reconstructed to create three dimensional structures and matrices.
Published
2016-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K981678000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981678000STRATA, MODEL V.O.95Rosses Medical Systems1998-12-11MUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852656007052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852656007052008526560070528526560070520852656007052

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

Contacts#

Phone, Email table
PhoneEmail
(412) 312-6700info@nomos.com

Regulatory Flags#

DUNS number
146920025
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852656007229Disposable Template, 18 Gauge, Non-Siemens, 5 Pack60462016-10-31
00852656007236Disposable Template, 18 Gauge, Siemens, 5 Pack60472016-10-31
00852656007243Disposable Template, 17 Gauge, Non-Siemens, 5 Pack60482016-10-31
00852656007250Disposable Template, 17 Gauge, Siemens, 5 Pack60492016-10-31
00852656007335Disposable Template, 18 Gauge, Non-Siemens, Single61042016-10-31
00852656007342Disposable Template, 18 Gauge, Siemens, Single61052016-10-31
00852656007359Disposable Template, 17 Gauge, Non-Siemens, Single61062016-10-31
00852656007366Disposable Template, 17 Gauge, Siemens, Single61072016-10-31
00852656007519Cradle, SonoScape2107812022-11-17
00852656007175Reusable Frame, Best Precision Stepper60502016-10-31
00852656007182Reusable Frame, Bard SurePoint Stepper60512016-10-31
00852656007199Reusable Frame, Civco/BW Stepper (Non-Siemens Grid)60522016-10-31
00852656007205Reusable Frame, Civco/BW Stepper (Siemens Grid)60532016-10-31
00852656007212Reusable Frame, CMS AccuSeed60622016-10-31
00852656007267High Dose Rate Frame, Best Precision Stepper (Siemens Grid)60122016-10-31
00852656007274High Dose Rate Frame, Best Precision Stepper (BK Grid)60362016-10-31
00852656007281High Dose Rate Frame, Civco/BW Stepper60632016-10-31
00852656007298High Dose Rate Frame, Tayman Stepper60642016-10-31
00852656007304High Dose Rate Frame, SurePoint Stepper60652016-10-31
00852656007311High Dose Rate Sandwich, 15 Gauge60132016-10-31

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