Ingenia 1.5T CX

GUDID 00884838068445

Magnetic Resonance Equipment

Philips Medical Systems Nederland B.V.

Full-body MRI system, superconducting magnet

• Primary Device ID: 00884838068445
• NIH Device Record Key: 4b3725f3-22f8-429c-a367-97bf86993ffa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ingenia 1.5T CX
• Version Model Number: 781262
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838068445 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063559

FDA Product Code

• LNI: System, nuclear magnetic resonance spectroscopic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-02
• Device Publish Date: 2016-09-23

Devices Manufactured by Philips Medical Systems Nederland B.V.

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