Identity
- Trade Name
- Philips Medical Systems DMC FDA UDI
- Generic Name
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
- Model / Reference
- Juno DRF FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08057737120411 FDA UDI
- 510(k) Number
- K050190 FDA UDI
- FDA Product Code
- KPW FDA UDIIXL FDA UDIKXJ FDA UDI
- GMDN Term
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1610 FDA UDI892.1670 FDA UDI892.1980 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Philips Medical Systems DMC by Villa Sistemi Medicali Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K050190 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Villa Sistemi Medicali Spa
Sources (1)
- FDA UDI c804d27f-45ca-4ed4-99d7-3e20d51b186c 34 fields · synced May 30, 2026