Device
Radiological Image Processing Software For Radiation Therapy
Manufacturer
OncoSoft. co.,Ltd.
OncoSoft. co.,Ltd.
Model: 2.0.x
DI: 08809839660001
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Description
Radiological Image Processing Software For Radiation Therapy
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
751d1869-c1d3-410a-aaa1-1e6d20f16ad6
Distribution Status:
In Commercial Distribution
DUNS Number:
695660677
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08809839660001
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 40887
Name: Radiation therapy software
Definition:
An 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.
FDA Product Codes
QKB
Radiological Image Processing Software For Radiation Therapy
Premarket Submissions
Submission Number:
K242994
Supplement Number:
000