FDA Registration
Active
🇮🇱 Israel
Philips Medical Systems Technologies Ltd.
Reg #: 9681475
·
FEI: 3006303679
·
Expires 2026
Products
1
Proprietary Names
9
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Philips Medical Systems Technologies Ltd.
- Registration Number
- 9681475
- FEI Number
- 3006303679
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2 Hapnina Street, P.O. Box 46
- City
- Raanana Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K122523
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 1217116
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
US Agent
- Business Name
- Philips
- Contact Name
- Martin Pedroza
- Address
- 9965 Federal Drive
- City
- Colorado Springs
- State
- CO
- ZIP
- 80921
- Country
- US
- [email protected]
- Phone
- 440 2197243
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2020-05-15 |
Proprietary Names
VUE PACS
Vue Motion
Desktop Diagnostic Viewer
Enterprise Viewer
Web Diagnostic Viewer
Image Management
Vue PACS
Vue PACS (Diagnostic)
Vue PACS, Vue PACS (Diagnostic)
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198