FDA.reportPublic FDA data

RayStation

Primary DI
07350002010570
Brand
RayStation
Company
Raysearch Laboratories AB (Publ)
Model
11B SPT1
Published
2023-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K220141000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220141000RayStation 11BRaySearch Laboratories AB (PUBL)2022-04-15MUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350002010570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350002010570073500020105707350002010570

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
355977901
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350002010464RayCare5A SP12022-05-31
07350002010396RayCare5.02021-09-30
07350002010020RayStation5.0.32017-07-11
07350002010891RayCare2024A SP42025-09-30
07350002010839RayCare2024A SP12025-04-30
07350002010884RayStation2024A SP32025-04-10
07350002010730RayStation12A SP22023-10-18
07350002010556RayStation2023B2023-07-11
07350002010549RayStation12A2023-05-12
07350002010679RayStation12A SP12023-05-12
07350002010280RayCare3.12020-08-24
07350002010426RayStation11B2022-05-03
07350002010440RayStation11A SP22022-05-03
07350002010495RayStation11B SP12022-05-03
07350002010501RayStation11B SP22022-05-03
07350002010532RayCare5B SP12022-05-03
07350002010471RayStation10B SP12022-02-21
07350002010082RayStation6.1.12021-09-30
07350002010136RayStation8.0.12021-09-30
07350002010204RayStation8.1.12021-09-30

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