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FDA 510(k)

CT TrueView

K-Number: K160147 · 2016-08-10

Decision Date2016-08-10
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT TrueView is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2016-08-10 under approval number K160147. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CT TrueView?

CT TrueView is a medical device that received FDA 510(k) clearance on 2016-08-10. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K160147.

When was CT TrueView approved by the FDA?

CT TrueView received FDA 510(k) clearance on 2016-08-10, under approval number K160147.

What company makes CT TrueView?

CT TrueView is manufactured by Philips Medical Systems Nederland B.V..

What is the FDA product code for CT TrueView?

The FDA product code for CT TrueView is OWB.

Other Devices by Philips Medical Systems Nederland B.V.

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Related Devices (Code: OWB)

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.