Identity
- Trade Name
- IntelliSpace Cardiovascular FDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Device Name
- Cardiovascular Image and Information Management Solution (CVIS) FDA UDI
- Model / Reference
- IntelliSpace Cardiovascular 1.2 FDA UDI
- Description
- Cardiovascular Image and Information Management Solution (CVIS) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838076730 FDA UDI
- 510(k) Number
- K061995 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology picture archiving and communication system workstation FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 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
Yes
FDA UDI
Category: Radiology picture archiving and communication system workstation
IntelliSpace Cardiovascular by Philips Medical Systems Nederland B.V. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K061995 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI aff045b9-8eed-44ce-8a93-8dc36c16244f 35 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026