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FDA 510(k)

Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)

K-Number: K201316 · 2021-02-26

ApplicantSuzhou Peaksonic Medical Technology Co., Ltd.
Decision Date2021-02-26
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) is a medical device manufactured by Suzhou Peaksonic Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-02-26 under approval number K201316. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)?

Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) is a medical device that received FDA 510(k) clearance on 2021-02-26. It is manufactured by Suzhou Peaksonic Medical Technology Co., Ltd.. The 510(k) number is K201316.

When was Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) approved by the FDA?

Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) received FDA 510(k) clearance on 2021-02-26, under approval number K201316.

What company makes Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)?

Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) is manufactured by Suzhou Peaksonic Medical Technology Co., Ltd..

What is the FDA product code for Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)?

The FDA product code for Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) is IYO.

Related Clinical Trials

NCT07179146 A Comparison Of Dental Arch Analysis Using 3d Digital Scanning Versus Conventional Methods In Children COMPLETED NCT07263815 EQUIP - Evaluation of Quality of Imaging on a Next-generation Total Body Pet Scan in Comparison to Conventional PET ACTIVE_NOT_RECRUITING

Other Devices by Suzhou Peaksonic Medical Technology Co., Ltd.

K213488Bladder Scanner, Model Name:M5

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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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