QVCAD System Installation Kit

GUDID B630QVCSIK1202346

Installation Kit for QVCAD System Release 3.4.6 with Debian 12.2

QVIEW MEDICAL

Ultrasound imaging system application software

• Primary Device ID: B630QVCSIK1202346
• NIH Device Record Key: e241a160-0f22-4473-9ded-23d4aabe1ffa
• Commercial Distribution Discontinuation: 2025-01-22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QVCAD System Installation Kit
• Version Model Number: 12.02-3.4.6
• 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	B630QVCSIK1010344 [Previous]
HIBCC	B630QVCSIK1202346 [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 Installation Kit]

• B630QVCSIK1010343: Installation Kit for QVCAD System Release 3.4.3 with Debian 10.10
• B630QVCSIK1010344: Installation Kit for QVCAD System Release 3.4.3 with Debian 10.10
• B630QVCSIK1202346: Installation Kit for QVCAD System Release 3.4.6 with Debian 12.2