BRIT Vision

GUDID 00850631008070

BRIT Vision 4.1.0

BRIT SYSTEMS, LLC

Radiology DICOM image processing application software

• Primary Device ID: 00850631008070
• NIH Device Record Key: 21d99ca0-80ee-4d41-a5c7-b76733a2fa97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRIT Vision
• Version Model Number: 4.1.0
• Company DUNS: 941442410
• Company Name: BRIT SYSTEMS, LLC
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850631008070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081168

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-07
• Device Publish Date: 2019-09-11

On-Brand Devices [BRIT Vision]

• 00850631008070: BRIT Vision 4.1.0
• 00850631008490: BRIT Vision 4.1.1