Identity
- Trade Name
- Philips Radiology Smart Assistant FDA UDI
- Generic Name
- Diagnostic x-ray digital imaging system workstation application software FDA UDI
- Model / Reference
- 1.0 FDA UDI
Identifiers
- Catalog Number
- 30000581513X FDA UDI
- Primary DI / UDI-DI
- 00884838104013 FDA UDI
- 510(k) Number
- K212186 FDA UDI
- FDA Product Code
- KPR FDA UDIJAA FDA UDI
- GMDN Term
- Diagnostic x-ray digital imaging system workstation application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1680 FDA UDI892.1650 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 Radiology Smart Assistant by Philips Medical Systems GmbH, Dmc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Philips Medical Systems GmbH, Dmc
Sources (1)
- FDA UDI 30585b7b-bebd-498d-af92-afe79fd98ffc 35 fields · synced May 30, 2026