IQon Spectral CT
FDA 510(k) K193454 · Philips Medical Systems Nederland B.V.
510(k) numberK193454
Submission
- Device name
- IQon Spectral CT
- Applicant
- Philips Medical Systems Nederland B.V.
Best Noord-Brabant, NL - Received
- December 13, 2019
- Decision date
- January 24, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was IQon Spectral CT cleared by the FDA?
IQon Spectral CT (K193454) received a 510(k) decision of Substantially Equivalent on January 24, 2020, 42 days after the submission was received.
What is the product code of K193454?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.