Identity
- Trade Name
- SHNC DRIVERBOX 1.0T EUDAMEDPhilips FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- SHNC DRIVERBOX 1.0T EUDAMEDFDA UDI
- Model / Reference
- SHNC DRIVERBOX 1.0T EUDAMED4598-000-51831 FDA UDI
- Description
- SHNC DRIVERBOX 1.0T FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970564410826 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06970564410826 EUDAMED
- 510(k) Number
- K031815 FDA UDI
- FDA Product Code
- MOS FDA UDI
- EMDN Code
- Z1105018001 MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS EUDAMED
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: MRI system coil, radio-frequency
Philips by Shanghai Chenguang Medical Technologies Co., Ltd — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shanghai Chenguang Medical Technologies Co., Ltd
Sources (2)
- FDA UDI a153bf34-741e-4e99-8b80-504fa596dcc8 34 fields · synced Jun 18, 2026
- EUDAMED 8be5dfed-7c08-45af-9d16-acb0b3baabec 61 fields · synced Jun 18, 2026