ClearCheck V2

GUDID 00860001672770

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.

Radformation, Inc

Radiation therapy software

• Primary Device ID: 00860001672770
• NIH Device Record Key: 91989968-50f1-40e3-8326-b2b45134c890
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearCheck V2
• Version Model Number: RADCC V2
• Company DUNS: 080444608
• Company Name: Radformation, Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (844) 723-3675
• Email: support@radformation.com
• Phone: (844) 723-3675
• Email: support@radformation.com
• Phone: (844) 723-3675
• Email: support@radformation.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001672770 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220583

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-23
• Device Publish Date: 2026-03-13

Devices Manufactured by Radformation, Inc

• 00850072631004 - ClearCalc: 2026-03-23 ClearCalc is intended to assist radiation treatment planners in determining if their treatment planning calculations are accurat
• 00850072631035 - ChartCheck: 2026-03-23 The ChartCheck device is intended for quality assessment of radiotherapy treatment plans and on treatment chart review utilizing
• 00850072631059 - ChartCheck: 2026-03-23 The ChartCheck device is intended for quality assessment of radiotherapy treatment plans and on treatment chart review utilizing
• 00860001672770 - ClearCheck V2: 2026-03-23ClearCheck 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.
• 00860001672770 - ClearCheck V2: 2026-03-23 ClearCheck is intended to assist radiation therapy professionals in generating and assessing the quality of radiotherapy treatme
• 00860001672787 - ClearCalc: 2026-03-23 ClearCalc is intended to assist radiation treatment planners in determining if their treatment planning calculations are accurat
• 00860001672794 - EZFluence: 2026-03-23 EZFluence is intended to assist radiation treatment planning professionals in generating optimal fluences for producing a homoge
• 00860001672725 - ClearCalc: 2021-10-19 ClearCalc is a software intended to assist radiation treatment planners in determining if their treatment planning calculations
• 00860001672732 - AutoContour: 2021-10-19 AutoContour is intended to assist radiation treatment planners in contouring and reviewing structures within medical images in p