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 Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual

• 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