DEVICE: MR 5000 Series (00884838099364)

Device Identifier (DI) Information

MR 5000 Series
MR 5300
In Commercial Distribution
782110
Philips Medical Systems Nederland B.V.
00884838099364
GS1

1
413819707 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
37654 Full-body MRI system, superconducting magnet
A diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly and can be fixed-location, mobile, or transportable. Some systems can perform MR spectroscopy or various real-time imaging procedures for MRI guided interventional, therapeutic, or surgical applications. The system is available in a variety of system gantry configurations including closed bore, open bore, and open-sided or other kinds of patient accessible designs.
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FDA Product Code

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Product Code Product Code Name
LNH System, nuclear magnetic resonance imaging
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K212673 000
K223442 000
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Humidity: between 20 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 50 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

4b1a3835-4081-4a88-ae4d-2ac1a433b10c
November 09, 2023
4
January 28, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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