IB Clinic

GUDID B319IBCLINIC20

IMAGING BIOMETRICS, LLC

Radiology DICOM image processing application software

• Primary Device ID: B319IBCLINIC20
• NIH Device Record Key: 9275ad1f-5b19-448f-9ecd-a271df5c363c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IB Clinic
• Version Model Number: 2.0
• Company DUNS: 792265121
• Company Name: IMAGING BIOMETRICS, 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B319IBCLINIC20 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123302

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: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-11-20

On-Brand Devices [IB Clinic]

• B319IBCLINIC20: 2.0
• B319IBCLINIC120: 1.2