FDA.reportPublic FDA data

RayCare

Primary DI
07350002010532
Brand
RayCare
Company
Raysearch Laboratories AB (Publ)
Model
5B SP1
Published
2022-05-03
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
K200487000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200487000RayCare 3.1RaySearch Laboratories AB (PUBL)2020-06-10MUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350002010532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350002010532073500020105327350002010532

GMDN Terms#

Term, Definition table
TermDefinition
Radiology information system application softwareAn application software program, routines, and/or algorithms used as or in a radiology information system (RIS) to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within/between facilites, to support the administrative and clinical activities associated with the provision and utilization of radiology services and facilities. It may be used for patient scheduling and work-list generation for specific radiological systems; it may be used in conjunction with PACS and include various technology imaging modalities. It is installed into a dedicated radiology information system or existing mainframe or decentralized computers/network.

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
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
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