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FDA 510(k)

FastStroke, CT Perfusion 4D

K-Number: K193289 · 2020-11-12

ApplicantGE Medical Systems SCS
Decision Date2020-11-12
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FastStroke, CT Perfusion 4D is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems SCS. It received FDA 510(k) clearance on 2020-11-12 under 510(k) number K193289. 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 FastStroke, CT Perfusion 4D?

FastStroke, CT Perfusion 4D is a medical device that received FDA 510(k) clearance on 2020-11-12. The listed applicant is GE Medical Systems SCS. The 510(k) number is K193289.

When did FastStroke, CT Perfusion 4D receive FDA 510(k) clearance?

FastStroke, CT Perfusion 4D received FDA 510(k) clearance on 2020-11-12, under 510(k) number K193289.

Who is the listed applicant for FastStroke, CT Perfusion 4D?

The FDA 510(k) record lists GE Medical Systems SCS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FastStroke, CT Perfusion 4D?

The FDA product code for FastStroke, CT Perfusion 4D 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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