FDA 510(k)

RS85 Diagnostic Ultrasound System

K-Number: K240516 · 2024-06-12

Decision Date2024-06-12

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

RS85 Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Medison Co., Ltd.. It received FDA 510(k) clearance on 2024-06-12 under 510(k) number K240516. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RS85 Diagnostic Ultrasound System?

RS85 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2024-06-12. The listed applicant is Samsung Medison Co., Ltd.. The 510(k) number is K240516.

When did RS85 Diagnostic Ultrasound System receive FDA 510(k) clearance?

RS85 Diagnostic Ultrasound System received FDA 510(k) clearance on 2024-06-12, under 510(k) number K240516.

Who is the listed applicant for RS85 Diagnostic Ultrasound System?

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

What is the FDA product code for RS85 Diagnostic Ultrasound System?

The FDA product code for RS85 Diagnostic Ultrasound System is IYN.

Other records listing Samsung Medison 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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Related Devices (Code: IYN)

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.