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FDA 510(k)

IQon Spectral CT

K-Number: K163711 · 2017-04-05

Decision Date2017-04-05
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IQon Spectral CT is a medical device manufactured by Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 2017-04-05 under approval number K163711. 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 2017-04-05. It is manufactured by Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K163711.

When was IQon Spectral CT approved by the FDA?

IQon Spectral CT received FDA 510(k) clearance on 2017-04-05, under approval number K163711.

What company makes IQon Spectral CT?

IQon Spectral CT is manufactured by Philips Medical Systems (Cleveland), Inc..

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 (Cleveland), Inc.

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Related Devices (Code: JAK)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.