Identity
- Trade Name
- Allura Xper FD FDA UDI
- Generic Name
- Stationary angiographic x-ray system, digital FDA UDI
- Device Name
- Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 12-inch flat detector. FDA UDI
- Model / Reference
- Allura Xper R9 7 M12 FDA UDI
- Description
- Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 12-inch flat detector. FDA UDI
Identifiers
- Catalog Number
- 722065 FDA UDI
- Primary DI / UDI-DI
- 00884838083431 FDA UDI
- FDA Product Code
- OWB FDA UDIJAA FDA UDI
- GMDN Term
- Stationary angiographic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1650 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
Allura Xper FD by Philips Medical Systems Nederland B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K163715 also covers:
K172822 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
- Philips Medical Systems Nederland B.V.
Sources (1)
- FDA UDI 6fcd1f55-80a3-47f0-bc27-19896481102a 36 fields · synced Oct 6, 2026