Ingenia 781270

GUDID 00884838095083

Philips Medical Systems Nederland B.V.

Full-body MRI system, superconducting magnet

• Primary Device ID: 00884838095083
• NIH Device Record Key: 1d744488-05a7-4a85-97e7-b91afff13bba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ingenia
• Version Model Number: Smartpath to dStream for 3.0T
• Catalog Number: 781270
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838095083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162931

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-01
• Device Publish Date: 2019-09-23

On-Brand Devices [Ingenia]

• 00884838095083: Smartpath to dStream for 3.0T
• 00884838095076: MRDD Equipment
• 00884838009820: MRDD Equipment
• 00884838009813: MRDD Equipment
• 00884838099715: Ingenia 1.5T
• 00884838099043: Ingenia 1.5T
• 00884838098350: Ingenia Ambition X
• 00884838098343: Ingenia Ambition S
• 00884838098336: Ingenia Elition X
• 00884838098329: Ingenia Elition S
• 00884838098312: Ingenia 3.0T CX
• 00884838098299: Ingenia 3.0T
• 00884838098275: Ingenia 1.5T
• 00884838104129: The Ingenia Elition X with the gradient and RF designs, as well as Compressed SENSE delivers on
• 00884838099500: The HA FlexTrak II is Height-adjustable to facilitate easy patient transfer and allows patient p
• 00884838099494: A moveable tabletop which combined with the standard table top enables a maximum field of view o
• 00884838099487: The Patient Trolley Frame is a stainless steel frame with four wheels for easy transportation of
• 00884838099470: The HA FlexTrak is Height-adjustable to facilitate easy patient transfer and allows patient prep
• 00884838099463: The FlexTrak allows patient preparation for an examination while the previous patient is being s
• 00884838099456: "The Achieva acoustic hood is designed to be used with the SENSE Pediatric Head Spine coil and t
• 00884838099449: "The Achieva acoustic hood is designed to be used with the SENSE Pediatric Head Spine coil and t
• 00884838108646: Enables trained physicians to obtain cross-sectional and spectroscopic images of internal struct
• 00884838108639: Enables trained physicians to obtain cross-sectional and spectroscopic images of internal struct
• 00884838108622: Enables trained physicians to obtain cross-sectional and spectroscopic images of internal struct
• 00884838108615: Enables trained physicians to obtain cross-sectional and spectroscopic images of internal struct
• 00884838108608: Enables trained physicians to obtain cross-sectional and spectroscopic images of internal struct