MR 7700 782155

GUDID 00884838115668

MR 7700 extends the gradient and RF designs with extreme gradient performance to deliver superb image quality in diffusion and neuro-science, improve patient handling setup time, combined with accelerations in 2D- and 3D scanning.

Philips Medical Systems Nederland B.V.

Full-body MRI system, superconducting magnet

• Primary Device ID: 00884838115668
• NIH Device Record Key: 7b826e15-8d2d-45ef-8251-f73348494147
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR 7700
• Version Model Number: MR 7700
• Catalog Number: 782155
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• 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: true
• 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

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838115668 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223458

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-09-26
• Device Publish Date: 2024-06-19

Devices Manufactured by Philips Medical Systems Nederland B.V.

• 00884838115668 - MR 7700: 2025-09-26MR 7700 extends the gradient and RF designs with extreme gradient performance to deliver superb image quality in diffusion and neuro-science, improve patient handling setup time, combined with accelerations in 2D- and 3D scanning.
• 00884838115668 - MR 7700: 2025-09-26 MR 7700 extends the gradient and RF designs with extreme gradient performance to deliver superb image quality in diffusion and n
• 00884838115682 - Ingenia: 2025-09-26 Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extrem
• 00884838124325 - Philips IntelliSite Pathology Solution: 2025-09-09 Whole Slide Imaging System. The device is an automated digital slide creation, viewing, and management system.
• 00884838124349 - Philips IntelliSite Pathology Solution: 2025-09-09 Whole Slide Imaging System. The device is an automated digital slide creation, viewing and management system
• 00884838123168 - Advanced Visualization Workspace: 2025-07-01 AVW15.1 configuration
• 00884838119253 - Spectral CT System Upgrades: 2025-06-02
• 00884838126381 - eCareManager: 2025-03-25 Telehealth Center Product License
• 00884838127746 - Radiology Operations Command Center Console: 2025-03-24