FDA.reportPublic FDA data

.decimal P.D

Primary DI
00851147007069
Brand
.decimal P.D
Company
DECIMAL, INC.
Model
5.1
Device description
p.d software aid's radiation therapy professionals in the design, construction, and testing of radiotherapy beam modifying devices.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K151369000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151369000.decimal p.d.Decimal, LLC2015-08-07MUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851147007069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851147007069008511470070698511470070690851147007069

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
617041967
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851147007144.decimal Blocking TrayN/A2023-07-19
00851147007113Decimal3DN/A2022-12-01
00851147007137decimal Bolus (FlexiBol)N/A2022-12-01
00851147007120.decimal Astroid Planning App 3.x3.x2022-11-23
00851147007007.decimal Proton Aperture2.32016-09-23
00851147007014.decimal Proton Range Compensator2.82016-09-24
00851147007021.decimal Electron Bolus1.02016-09-24
00851147007038.decimal Electron Aperture1.02016-09-24
00851147007045.decimal Photon Block1.32016-09-24
00851147007052.decimal Photon Compensator1.02016-09-24
00851147007076.decimal Astroid Dosimetry App1.02016-09-24
00851147007083.decimal Proton Shell and Lid Assembly2.32016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04056481146030RT Elements Brainlab SEMUJ2025-06-25
07350002010839RayCareRaysearch Laboratories AB (Publ)MUJ2025-04-30
07350002010884RayStationRaysearch Laboratories AB (Publ)MUJ2025-04-10
00040695000008Radiation Planning Assistant (RPA)The University of Texas M. D. Anderson Cancer CenterMUJ2025-01-28