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FDA 510(k)

Combined High Frequency X-ray Source

K-Number: K222258 · 2022-11-01

ApplicantSuzhou Powersite Electric Co., Ltd.
Decision Date2022-11-01
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Combined High Frequency X-ray Source is a medical device manufactured by Suzhou Powersite Electric Co., Ltd.. It received FDA 510(k) clearance on 2022-11-01 under approval number K222258. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Combined High Frequency X-ray Source?

Combined High Frequency X-ray Source is a medical device that received FDA 510(k) clearance on 2022-11-01. It is manufactured by Suzhou Powersite Electric Co., Ltd.. The 510(k) number is K222258.

When was Combined High Frequency X-ray Source approved by the FDA?

Combined High Frequency X-ray Source received FDA 510(k) clearance on 2022-11-01, under approval number K222258.

What company makes Combined High Frequency X-ray Source?

Combined High Frequency X-ray Source is manufactured by Suzhou Powersite Electric Co., Ltd..

What is the FDA product code for Combined High Frequency X-ray Source?

The FDA product code for Combined High Frequency X-ray Source is IZL.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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