Radiochromic.com

GUDID B9876X00

Radiochromic film dosimetry and radiation therapy QA software

RADIOCHROMIC SL.

Radiation therapy software

• Primary Device ID: B9876X00
• NIH Device Record Key: 86927ee7-bb71-4b93-9d8d-d02ffffccbb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radiochromic.com
• Version Model Number: 6.0
• Company DUNS: 468141103
• Company Name: RADIOCHROMIC SL.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B9876X00 [Primary]

FDA Product Code

• MWW: Accessory - Film Dosimetry System

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: 2025-12-17
• Device Publish Date: 2025-12-09

On-Brand Devices [Radiochromic.com]

• B9873X30: Radiochromic film dosimetry and radiation therapy QA software
• B9873X40: Radiochromic film dosimetry and radiation therapy QA software
• B9874X00: Radiochromic film dosimetry and radiation therapy QA software
• B9875X00: Radiochromic film dosimetry and radiation therapy QA software
• B9875X10: Radiochromic film dosimetry and radiation therapy QA software
• B9876X00: Radiochromic film dosimetry and radiation therapy QA software