Identity
- Trade Name
- Evolution Upgrade 1.5T EUDAMEDIngenia FDA UDI
- Generic Name
- Full-body MRI system, superconducting magnet FDA UDI
- Device Name
- Magnetic Resonance Imaging Systems EUDAMEDUpgrade to the next generation portfolio for our customers having an Ingenia 1.5T (S) FDA UDI
- Model / Reference
- 782148 EUDAMEDEvolution Upgrade 1.5T FDA UDI
- Description
- Upgrade to the next generation portfolio for our customers having an Ingenia 1.5T (S) FDA UDI
Identifiers
- Catalog Number
- 782148 FDA UDI
- Primary DI / UDI-DI
- 00884838108714 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM697TZ EUDAMED
- Direct Marketing DI
- 00884838108714 EUDAMED
- 510(k) Number
- K213583 FDA UDI
- FDA Product Code
- LNH FDA UDILNI FDA UDI
- EMDN Code
- Z11050104 CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T EUDAMED
- GMDN Term
- Full-body MRI system, superconducting magnet FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Full-body MRI system, superconducting magnet
Evolution Upgrade 1.5T by Philips Medical Systems Nederland B.V. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM697TZ | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems Nederland B.V.
- EUDAMED SRN
- NL-MF-000001489
Sources (2)
- EUDAMED 59682453-7621-4eb6-92b0-9b4137892b4c 61 fields · synced Sep 18, 2026
- FDA UDI 0d98ef86-f957-49a4-bd5c-71588ebecb8e 36 fields · synced May 30, 2026