Duns Number:413819707
Device Description: This innovative magnetic resonance imaging system MR 5300 is powered by Philips exclusive This innovative magnetic resonance imaging system MR 5300 is powered by Philips exclusive BlueSeal magnet for helium-free operations. While its AI-driven technology simplifies and automates the most complex clinical and operational tasks, so you can focus on what matters most: your patients. • Smart Workflow dramatically reduces the number of steps needed to complete an MR exam – with guided patient set-up in under a minute, touchless patient sensing, and single-click initiation of routine exams. And the industry’s lightest Breeze coils help cut patient change-over time by 30% to keep your MR department on schedule. At the same time, they improve patient comfort and staff satisfaction.• Compressed SENSE accelerates MR scans by up to 50% with virtually no loss of image quality to increase diagnostic confidence. And the system’s BlueSeal magnet securely isolates the small amount of liquid helium needed for cooling inside the bore. There’s no helium loss, no refills, and no unexpected costs. • Philips Performance for Life solutions add remote serviceability, AI-enabled predictive maintenance, frequent system updates, and perpetual coil replacement. All helping you to improve uptime and manage your total cost of ownership. Discover the system that transforms MR imaging with fully automated patient-centric workflow, ultra-fast exams, high quality diagnostic outcomes, and performance for life. Make the smart choice – Philips MR 5300.
Catalog Number
782110
Brand Name
MR 5000 Series
Version/Model Number
MR 5300
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K212673
Product Code
LNH
Product Code Name
System, nuclear magnetic resonance imaging
Public Device Record Key
4b1a3835-4081-4a88-ae4d-2ac1a433b10c
Public Version Date
April 11, 2022
Public Version Number
2
DI Record Publish Date
January 28, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 349 |