QVCAD System

GUDID B630QVCS33

QVIEW MEDICAL

Ultrasound imaging system application software

• Primary Device ID: B630QVCS33
• NIH Device Record Key: 6472c3d1-5b6e-4428-ae1c-09d1d6b158d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QVCAD System
• Version Model Number: 3.3
• Company DUNS: 063962130
• Company Name: QVIEW MEDICAL
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B630QVCS33 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150043

FDA Product Code

• MYN: Analyzer,Medical Image

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: 2018-02-09

On-Brand Devices [QVCAD System]

• B630QVCS33: 3.3
• B630QVCS34: 3.4
• B630QVCS342: 3.4.2
• B630QVCS343: 3.4.3
• B630QVCS344: Computer aided detection system of suspicious lesions in automated breast ultrasound images.
• B630QVCS346: Computer aided detection system of suspicious lesions in automated breast ultrasound images.