IQon Spectral CT
K-Number: K193454 · 2020-01-24
Decision Date2020-01-24
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
IQon Spectral CT is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2020-01-24 under approval number K193454. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IQon Spectral CT?
IQon Spectral CT is a medical device that received FDA 510(k) clearance on 2020-01-24. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K193454.
When was IQon Spectral CT approved by the FDA?
IQon Spectral CT received FDA 510(k) clearance on 2020-01-24, under approval number K193454.
What company makes IQon Spectral CT?
IQon Spectral CT is manufactured by Philips Medical Systems Nederland B.V..
What is the FDA product code for IQon Spectral CT?
The FDA product code for IQon Spectral CT is JAK.
Other Devices by Philips Medical Systems Nederland B.V.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.