FDA 510(k)

Bladder Scanner

K-Number: K153581 · 2016-04-08

Decision Date2016-04-08

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Bladder Scanner is the device name listed in this FDA 510(k) record. The listed applicant is Caresono Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-04-08 under 510(k) number K153581. 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?

Bladder Scanner is a medical device that received FDA 510(k) clearance on 2016-04-08. The listed applicant is Caresono Technology Co., Ltd.. The 510(k) number is K153581.

When did Bladder Scanner receive FDA 510(k) clearance?

Bladder Scanner received FDA 510(k) clearance on 2016-04-08, under 510(k) number K153581.

Who is the listed applicant for Bladder Scanner?

The FDA 510(k) record lists Caresono Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bladder Scanner?

The FDA product code for Bladder Scanner is IYO.

Related Devices (Code: IYO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApS K252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.K253714IntraSight PlusPhilips Image Guided Therapy Corporation

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.