AutoContour

GUDID 00860001672732

AutoContour is intended to assist radiation treatment planners in contouring and reviewing structures within medical images in preparation for radiation therapy treatment planning.

Radformation, Inc

Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software

• Primary Device ID: 00860001672732
• NIH Device Record Key: e2bfefe7-e66c-4d68-8061-b7df0f7e639b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AutoContour
• Version Model Number: 2.0
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001672732 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200323

FDA Product Code

• QKB: Radiological Image Processing Software For Radiation Therapy

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: 2021-10-19
• Device Publish Date: 2021-10-11

Devices Manufactured by Radformation, Inc

• 00860001672725 - ClearCalc: 2021-10-19 ClearCalc is a software intended to assist radiation treatment planners in determining if their treatment planning calculations
• 00860001672732 - AutoContour: 2021-10-19AutoContour is intended to assist radiation treatment planners in contouring and reviewing structures within medical images in preparation for radiation therapy treatment planning.
• 00860001672732 - AutoContour: 2021-10-19 AutoContour is intended to assist radiation treatment planners in contouring and reviewing structures within medical images in p
• 00860001672701 - ClearCheck: 2021-10-12 ClearCheck is intended for quality assessment of radiotherapy treatment plans.
• 00860001672718 - EZFluence: 2021-10-12 EZFluence is intended to assist radiation treatment planning professionals in generating optimal fluences for producing a homoge
• 00860001672749 - ChartCheck: 2021-10-12 ChartCheck assists in quality assessment of radiotherapy treatment plans and on treatment chart review utilizing treatment, imag