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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 the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2022-05-13 under 510(k) 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. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K212875.

When did Spectral CT on Rails receive FDA 510(k) clearance?

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

Who is the listed applicant for Spectral CT on Rails?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

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.

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