Device
Image-guided radionuclide radiation therapy system for external beam radiotherapy treatment.
Manufacturer
Akesis Inc.
Akesis Inc.
Model: Galaxy RTi
DI: 00860014221910
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
Image-guided radionuclide radiation therapy system for external beam radiotherapy treatment.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
15899c50-a6ff-49d1-b3d1-dfe34bcd3013
Distribution Status:
In Commercial Distribution
DUNS Number:
081307120
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860014221910
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 62931
Name: Teletherapy radionuclide system, CT-imaging
Definition:
A 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.
FDA Product Codes
IWB
System, Radiation Therapy, Radionuclide
Premarket Submissions
Submission Number:
K203146
Supplement Number:
000