Identity
- Trade Name
- 2D Perfusion FDA UDI
- Generic Name
- Angiographic x-ray system application software FDA UDI
- Device Name
- Software medical device, used with a Philips Interventional X-Ray System. Provides a color coded representation of a digital subtraction angiography (DSA). FDA UDI
- Model / Reference
- 2D Perfusion - 1 FDA UDI
- Description
- Software medical device, used with a Philips Interventional X-Ray System. Provides a color coded representation of a digital subtraction angiography (DSA). FDA UDI
Identifiers
- Catalog Number
- 001008 FDA UDI
- Primary DI / UDI-DI
- 00884838059276 FDA UDI
- 510(k) Number
- K132147 FDA UDI
- FDA Product Code
- OWB FDA UDILLZ FDA UDI
- GMDN Term
- Angiographic x-ray system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1650 FDA UDI892.2050 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Angiographic x-ray system application software
2D Perfusion by Philips Medical Systems Nederland B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 d0a2d1ed-02d0-40e9-a034-a71e05432202 35 fields · synced Sep 18, 2026