FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
IntelliSpace Portal Platform
K Number: K162025
·
Decision Oct 18, 2016
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
8
Review Days
88
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Basic Information
- Device Name
- IntelliSpace Portal Platform
- K Number
- K162025
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Medical Systems Nederlands B.V.
- Date Received
- July 22, 2016
- Decision Date
- October 18, 2016
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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