FDA.reportPublic FDA data

Galaxy RTi

Primary DI
00860014221910
Brand
Galaxy RTi
Company
Akesis Inc.
Model
Galaxy RTi
Device description
Image-guided radionuclide radiation therapy system for external beam radiotherapy treatment.
Published
2026-05-11
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
IWBSystem, Radiation Therapy, Radionuclide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWBSystem, Radiation Therapy, RadionuclideRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203146000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203146000Akesis Galaxy RTiAkesis, Inc.2021-03-05IWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014221910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014221910008600142219108600142219100860014221910

GMDN Terms#

Term, Definition table
TermDefinition
Teletherapy radionuclide system, CT-imagingA stationary assembly of computer-based devices designed to deliver a therapeutic radiation dose to an anatomical region, typically to treat malignant tumours, and which uses CT-based image-guided radiation therapy (IGRT) [e.g., CBCT, fluoroscopy] and intensity-modulated radiation therapy (IMRT) functionalities to provide automatic adjustment of the radiation dose and delivery settings according to the location, 3-D shape, and motion of the tumour during a treatment session. It typically consists of a rotating gantry, a treatment head with a radioactive source (typically cobalt), CT imaging unit, multi-leaf collimator, robotic patient table, and an operator's console.

Regulatory Flags#

DUNS number
081307120
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860014221903Gemini360RTGemini360RT2025-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973682570151CybeRayOur United CorporationIWB2026-04-24
07340201503898Leksell GammaPlanElekta Solutions ABIWB2026-02-04
06974783050023SMD-XGD/AR GalaxyOur Smd Medical (Wuhan) Co., Ltd.IWB2025-05-30
06974783050009SMD Galaxy RTxOur Smd Medical (Wuhan) Co., Ltd.IWB2025-05-26
07340201502136Leksell GammaPlanElekta Solutions ABIWB2024-02-14
07340201501139Leksell Gamma Knife EspritElekta Solutions ABIWB2023-03-27
07340048311786Leksell Gamma Knife IconElekta Instrument ABIWB2021-03-28
07340048311700Leksell Gamma Knife Perfexion/IconElekta Solutions ABIWB2021-03-28
07340048311731Leksell Gamma Knife Perfexion/IconElekta Solutions ABIWB2021-03-28
07340048311755Leksell Gamma Knife Perfexion/IconElekta Solutions ABIWB2021-03-28
07340048311762Leksell Gamma Knife Perfexion/IconElekta Solutions ABIWB2021-03-28
07340048311779Leksell Gamma Knife IconElekta Instrument ABIWB2021-03-28
07540180000238Clarity®Elekta Solutions ABIWB2020-06-19
07340048311878Leksell GammaPlanElekta Instrument ABIWB2020-06-13
07540180000221Clarity®Elekta Solutions ABIWB2020-05-22
05060608880522ISORAD Detector, 1-4MV (-) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880539ISORAD Detector, 1-4MV (+) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880546ISORAD Detector, 6-12MV (-) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880553ISORAD Detector, 6-12MV (+) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880560ISORAD Detector, 6-12MV (-) 1.5mSUN NUCLEAR CORP.IWB2019-05-21
05060608880577ISORAD Detector, 15-25MV (-) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880584ISORAD Detector, 15-25MV (+) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880591ISORAD Detector, 15-25MV (-) 1.5mSUN NUCLEAR CORP.IWB2019-05-21
07340048306447Leksell Gamma Knife Perfexion/IconElekta Instrument ABIWB2019-04-17
07540180000214Clarity®Elekta Solutions ABIWB2019-03-27
10850002615361GammaPod™ Breast Immobilization and Localization System XCISION MEDICAL SYSTEMS, LLCIWB2019-03-22
10850002615378GammaPod™ Breast Immobilization and Localization System XCISION MEDICAL SYSTEMS, LLCIWB2019-03-22
10850002615385GammaPod™ Breast Immobilization and Localization System XCISION MEDICAL SYSTEMS, LLCIWB2019-03-22
10850002615392GammaPod™ Breast Immobilization and Localization System XCISION MEDICAL SYSTEMS, LLCIWB2019-03-22
10850002615408GammaPod™ Breast Immobilization and Localization System XCISION MEDICAL SYSTEMS, LLCIWB2019-03-22