Spectral CT
K-Number: K203020 · 2021-02-26
Decision Date2021-02-26
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Spectral CT is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2021-02-26 under approval number K203020. 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 Spectral CT?
Spectral CT is a medical device that received FDA 510(k) clearance on 2021-02-26. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K203020.
When was Spectral CT approved by the FDA?
Spectral CT received FDA 510(k) clearance on 2021-02-26, under approval number K203020.
What company makes Spectral CT?
Spectral CT is manufactured by Philips Medical Systems Nederland B.V..
What is the FDA product code for Spectral CT?
The FDA product code for 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.