QVCAD System

GUDID B630QVCS346

Computer aided detection system of suspicious lesions in automated breast ultrasound images.

QVIEW MEDICAL

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• Primary Device ID: B630QVCS346
• NIH Device Record Key: dea0f343-9b4a-43a6-ad65-41170bfaf533
• Commercial Distribution Discontinuation: 2025-01-22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QVCAD System
• Version Model Number: 3.4.6
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B630QVCS344 [Previous]
HIBCC	B630QVCS346 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-04
• Device Publish Date: 2024-06-26

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.