AccuBrain

GUDID 04897117800007

BrainNow Medical Technology Limited

Radiology DICOM image processing application software

• Primary Device ID: 04897117800007
• NIH Device Record Key: f57acfa9-30fa-41b0-a073-72c03a24edbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuBrain
• Version Model Number: AccuBrain_Intl
• Company DUNS: 664224436
• Company Name: BrainNow Medical Technology Limited
• 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: true
• Manufacturing Date: true
• 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	04897117800007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202847

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2021-08-25
• Device Publish Date: 2021-08-17