MR 5000 Series
Basic Information
- Brand Name
- MR 5000 Series
- Primary DI
- 00884838099364
- Version / Model
- MR 5300
- Catalog Number
- 782110
- Company Name
- Philips Medical Systems Nederland B.V.
- Labeler DUNS
- 413819707
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-28
- Public Version
- 4
- Public Version Date
- 2023-11-09
- Public Version Status
- Update
- Public Device Record Key
- 4b1a3835-4081-4a88-ae4d-2ac1a433b10c
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LNH | System, nuclear magnetic resonance imaging | Radiology | 892.1000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838099364 | GS1 |
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal