FDA 510(k)

MD-6000S Bladder Scanner

K-Number: K260313 · 2026-09-24

Decision Date2026-09-24

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MD-6000S Bladder Scanner is the device name listed in this FDA 510(k) record. The listed applicant is MEDA Co., Ltd.. It received FDA 510(k) clearance on 2026-09-24 under 510(k) number K260313. 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 MD-6000S Bladder Scanner?

MD-6000S Bladder Scanner is a medical device that received FDA 510(k) clearance on 2026-09-24. The listed applicant is MEDA Co., Ltd.. The 510(k) number is K260313.

When did MD-6000S Bladder Scanner receive FDA 510(k) clearance?

MD-6000S Bladder Scanner received FDA 510(k) clearance on 2026-09-24, under 510(k) number K260313.

Who is the listed applicant for MD-6000S Bladder Scanner?

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

What is the FDA product code for MD-6000S Bladder Scanner?

The FDA product code for MD-6000S Bladder Scanner is IYO.

Other records listing MEDA Co., Ltd. as applicant

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.

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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.