Device
ClearCheck is intended to assist radiation therapy professionals in generating and assessing the quality of radiotherapy treatment plans. ClearCheck is also intended to assist radi...
Manufacturer
Radformation, Inc
Radformation, Inc
Model: Version 2.7
DI: 00850072631028
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Description
ClearCheck is intended to assist radiation therapy professionals in generating and assessing the quality of radiotherapy treatment plans. ClearCheck is also intended to assist radiation treatment planners in predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b0efb189-4396-4c89-ad35-3f7340187696
Distribution Status:
In Commercial Distribution
DUNS Number:
080444608
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:
00850072631028
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
IYE
Accelerator, Linear, Medical
Premarket Submissions
Submission Number:
K253962
Supplement Number:
000