IntelliSpace Portal Platform
FDA 510(k) K162025 · Philips Medical Systems Nederlands B.V.
510(k) numberK162025
Submission
- Device name
- IntelliSpace Portal Platform
- Applicant
- Philips Medical Systems Nederlands B.V.
Best, NL - Received
- July 22, 2016
- Decision date
- October 18, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was IntelliSpace Portal Platform cleared by the FDA?
IntelliSpace Portal Platform (K162025) received a 510(k) decision of Substantially Equivalent on October 18, 2016, 88 days after the submission was received.
What is the product code of K162025?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.