FDA 510(k)

Spectral CT on Rails

K-Number: K212875 · 2022-05-13

ApplicantPhilips Medical Systems Nederland B.V.

Decision Date2022-05-13

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Spectral CT on Rails is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2022-05-13 under approval number K212875. 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 on Rails?

Spectral CT on Rails is a medical device that received FDA 510(k) clearance on 2022-05-13. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K212875.

When was Spectral CT on Rails approved by the FDA?

Spectral CT on Rails received FDA 510(k) clearance on 2022-05-13, under approval number K212875.

What company makes Spectral CT on Rails?

Spectral CT on Rails is manufactured by Philips Medical Systems Nederland B.V..

What is the FDA product code for Spectral CT on Rails?

The FDA product code for Spectral CT on Rails 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.