FDA.reportPublic FDA data

.decimal Astroid Planning App 3.x

Primary DI
00851147007120
Brand
.decimal Astroid Planning App 3.x
Company
DECIMAL, INC.
Model
3.x
Device description
The Astroid Planning App is a cloud based software used for treatment planning of proton radiation therapy treatments.
Published
2022-11-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K173940000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173940000Astroid Planning App.Decimal, LLC2018-05-15MUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851147007120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851147007120008511470071208511470071200851147007120

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

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
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
00851147007069.decimal P.D5.12016-09-24
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
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
00855141006349Eclipse Treatment Planning SystemVARIAN MEDICAL SYSTEMS, INC.MUJ2024-12-20
00856100006370ARIA Radiation Therapy ManagementVARIAN MEDICAL SYSTEMS, INC.MUJ2024-12-20
00859032007170Panther TPSProwess, Inc.MUJ2024-12-19
00859032007194Panther TPSProwess, Inc.MUJ2024-12-19
00859032007200Panther TPSProwess, Inc.MUJ2024-12-19