Spectral CT
K-Number: K244008 · 2025-05-16
Decision Date2025-05-16
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Spectral CT is a medical device manufactured by Philips Medical Systems Technologies , Ltd.. It received FDA 510(k) clearance on 2025-05-16 under approval number K244008. 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 2025-05-16. It is manufactured by Philips Medical Systems Technologies , Ltd.. The 510(k) number is K244008.
When was Spectral CT approved by the FDA?
Spectral CT received FDA 510(k) clearance on 2025-05-16, under approval number K244008.
What company makes Spectral CT?
Spectral CT is manufactured by Philips Medical Systems Technologies , Ltd..
What is the FDA product code for Spectral CT?
The FDA product code for Spectral CT is JAK.
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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.