Sonocubic 3D Ultrasound Software

GUDID B118314160

Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional i

MEDGE PLATFORMS INC

Ultrasound imaging system application software

• Primary Device ID: B118314160
• NIH Device Record Key: 1ec57650-9772-424e-b0f7-da8b9c5ee28e
• Commercial Distribution Discontinuation: 2016-05-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Sonocubic 3D Ultrasound Software
• Version Model Number: Classic
• Company DUNS: 122782324
• Company Name: MEDGE PLATFORMS 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: true
• 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

Customer Support Contacts

• Phone: 646-233-1356
• Email: rgayoso@medgeplatforms.com
• Phone: 646-233-1356
• Email: rgayoso@medgeplatforms.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B118314160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003672

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-03

On-Brand Devices [Sonocubic 3D Ultrasound Software]

• B118314170: Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store
• B118314160: Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store