FDA 510(k)

Revolution Ascend

K-Number: K213938 · 2022-02-04

ApplicantGe Healthcare Japan Corporation

Decision Date2022-02-04

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Revolution Ascend is a medical device manufactured by Ge Healthcare Japan Corporation. It received FDA 510(k) clearance on 2022-02-04 under approval number K213938. 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 Revolution Ascend?

Revolution Ascend is a medical device that received FDA 510(k) clearance on 2022-02-04. It is manufactured by Ge Healthcare Japan Corporation. The 510(k) number is K213938.

When was Revolution Ascend approved by the FDA?

Revolution Ascend received FDA 510(k) clearance on 2022-02-04, under approval number K213938.

What company makes Revolution Ascend?

Revolution Ascend is manufactured by Ge Healthcare Japan Corporation.

What is the FDA product code for Revolution Ascend?

The FDA product code for Revolution Ascend is JAK.

Other Devices by Ge Healthcare Japan Corporation

K193170Deep Learning Image Reconstruction K203169Revolution Ascend K212067Deep Learning Image Reconstruction K220961Deep Learning Image Reconstruction K230807Deep Learning Image Reconstruction K233698True Enhance DL

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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.