Ingenia 3.0T

GUDID 00884838055339

Magnetic Resonance Equipment

Philips Medical Systems Nederland B.V.

Full-body MRI system, superconducting magnet

• Primary Device ID: 00884838055339
• NIH Device Record Key: bf510fa0-e2b3-4f7e-80a4-fc6c55cd1ca0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ingenia 3.0T
• Version Model Number: 781342
• 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

Customer Support Contacts

• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838055339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110151

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: 4
• Public Version Date: 2019-04-04
• Device Publish Date: 2016-09-23

Devices Manufactured by Philips Medical Systems Nederland B.V.

• 00884838127609 - DUNLEE SENTINELLE: 2025-01-20 ADD-ON ACCESSORIES BREAST SEN MR SET contains - 2 Fiducial Marker Grid Block Assembly and 1 BREAST GRID (USER STERILIZED)
• 00884838119277 - Philips Sentinelle: 2024-12-25 dS 1.5T Interface Box
• 00884838119284 - Philips Sentinelle: 2024-12-25 dS 3.0T Interface Box
• 00884838119291 - Philips Sentinelle: 2024-12-25 dS 1.5T 8CH Medial
• 00884838119307 - Philips Sentinelle: 2024-12-25 dS 3.0T 8CH Medial
• 00884838119314 - Philips Sentinelle: 2024-12-25 dS 1.5T 4CH Lateral Left
• 00884838119321 - Philips Sentinelle: 2024-12-25 dS 3.0T 4CH Lateral Left
• 00884838119338 - Philips Sentinelle: 2024-12-25 dS 1.5T 4CH Lateral Right