FlexTrak OR Ingenia 1.5T

GUDID 00884838082625

The Flextrak OR is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients.

Philips Oy

Full-body MRI system, superconducting magnet

• Primary Device ID: 00884838082625
• NIH Device Record Key: a4704c24-ce46-4427-9dc8-540bda328d13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexTrak OR Ingenia 1.5T
• Version Model Number: 989603051341
• Company DUNS: 539852079
• Company Name: Philips Oy
• 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

• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838082625 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

Devices Manufactured by Philips Oy

• 00884838103528 - MR-RT: 2022-09-08 MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation
• 00884838107311 - MR-RT: 2022-06-22 MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation
• 00884838094093 - MR-RT: 2022-05-04 MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation
• 00884838098206 - MR-RT: 2022-05-04 MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation
• 00884838092112 - RTgo: 2019-06-17 MR-RT RTgo software USB stick
• 00884838068490 - MR-RT CouchTop: 2018-07-06 MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation
• 00884838082618 - FlexTrak OR Ingenia 3.0T: 2018-07-06 The Flextrak OR is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and i
• 00884838082625 - FlexTrak OR Ingenia 1.5T: 2018-07-06The Flextrak OR is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients.
• 00884838082625 - FlexTrak OR Ingenia 1.5T: 2018-07-06 The Flextrak OR is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and i