FDA.reportPublic FDA data

RayStation

Primary DI
07350002010037
Brand
RayStation
Company
Raysearch Laboratories AB (Publ)
Model
6.1
Published
2017-07-13
Public version status
Update
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
K171536000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171536000RayStationRaySearch Laboratories AB (PUBL)2017-06-27MUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350002010037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350002010037073500020100377350002010037

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
07350002010570RayStation11B SPT12023-05-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859032007392Panther TPSProwess, Inc.MUJ2026-10-14
00859032007385Panther OISProwess, Inc.MUJ2026-09-22
00860007402395TrueFit BolusAdaptiiv Medical Technologies IncMUJ2026-06-24
04068151027280syngo.via RT Image Suite VC10Siemens Healthcare GmbHMUJ2026-06-24
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