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FDA 510(k)

ACUSON P200 Diagnostic Ultrasound System

K-Number: K191922 · 2019-08-15

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2019-08-15
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACUSON P200 Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2019-08-15 under 510(k) number K191922. 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 ACUSON P200 Diagnostic Ultrasound System?

ACUSON P200 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2019-08-15. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K191922.

When did ACUSON P200 Diagnostic Ultrasound System receive FDA 510(k) clearance?

ACUSON P200 Diagnostic Ultrasound System received FDA 510(k) clearance on 2019-08-15, under 510(k) number K191922.

Who is the listed applicant for ACUSON P200 Diagnostic Ultrasound System?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUSON P200 Diagnostic Ultrasound System?

The FDA product code for ACUSON P200 Diagnostic Ultrasound System is IYN.

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Related Devices (Code: IYN)

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.

K261617Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic Ultrasound System (Resona I10);Diagnostic Ultrasound System (Resona I10S);Diagnostic Ultrasound System (Resona XI);Diagnostic Ultrasound System (Resona I10 CV);Diagnostic Ultrasound System (Nuewa I10W);Diagnostic Ultrasound System (Nuewa I10 Exp);Diagnostic Ultrasound System (Nuewa I10);Diagnostic Ultrasound System (Nuewa I10S);Diagnostic Ultrasound System (Nuewa XI);Diagnostic UltrasounShenzhen Mindray Bio-Medical Electronics Co., Ltd.K263150V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10 Diagnostic Ultrasound System; XH10 Diagnostic Ultrasound System; V10 ONE Diagnostic Ultrasound System; cV10 ONE Diagnostic Ultrasound System; H10 ONE Diagnostic Ultrasound System; XV10 ONE Diagnostic Ultrasound System; XH10 ONE Diagnostic Ultrasound System; HERA Z10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.K261933Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary care Diagnostics, LLCK262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCK263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics

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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