ChartCheck

GUDID 00850072631035

The ChartCheck device is intended for quality assessment of radiotherapy treatment plans and on treatment chart review utilizing treatment, treatment imaging, and documentation data.

Radformation, Inc

Radiation therapy software

• Primary Device ID: 00850072631035
• NIH Device Record Key: f21ac929-d114-405f-94fe-da5d5e2ba99f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ChartCheck
• Version Model Number: RADCH V1.6
• 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	00850072631035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252988

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

On-Brand Devices [ChartCheck]

• 00860001672749: ChartCheck assists in quality assessment of radiotherapy treatment plans and on treatment chart
• 00850072631059: The ChartCheck device is intended for quality assessment of radiotherapy treatment plans and on
• 00850072631035: The ChartCheck device is intended for quality assessment of radiotherapy treatment plans and on