Ingenia Ambition X

GUDID 00884838090040

Magnetic Resonance Equipment

Philips Medical Systems Nederland B.V.

Full-body MRI system, superconducting magnet

• Primary Device ID: 00884838090040
• NIH Device Record Key: ef6a9388-3f81-4f04-889c-2004788ee4e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ingenia Ambition X
• Version Model Number: 781356
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838090040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181479
• Premarket Notification: K193215

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: 2019-05-09
• Device Publish Date: 2018-08-30

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