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FDA 510(k)

ARIETTA Prologue Diagnostic Ultrasound system and Transducers

K-Number: K162902 · 2016-12-15

ApplicantHitachi , Ltd.
Decision Date2016-12-15
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ARIETTA Prologue Diagnostic Ultrasound system and Transducers is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi , Ltd.. It received FDA 510(k) clearance on 2016-12-15 under 510(k) number K162902. 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 ARIETTA Prologue Diagnostic Ultrasound system and Transducers?

ARIETTA Prologue Diagnostic Ultrasound system and Transducers is a medical device that received FDA 510(k) clearance on 2016-12-15. The listed applicant is Hitachi , Ltd.. The 510(k) number is K162902.

When did ARIETTA Prologue Diagnostic Ultrasound system and Transducers receive FDA 510(k) clearance?

ARIETTA Prologue Diagnostic Ultrasound system and Transducers received FDA 510(k) clearance on 2016-12-15, under 510(k) number K162902.

Who is the listed applicant for ARIETTA Prologue Diagnostic Ultrasound system and Transducers?

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

What is the FDA product code for ARIETTA Prologue Diagnostic Ultrasound system and Transducers?

The FDA product code for ARIETTA Prologue Diagnostic Ultrasound system and Transducers is IYN.

Other records listing Hitachi , 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.

K201042PROBEAT-CRK191801PROBEAT-CRK172087SANGRAYK163505ARIETTA PRECISIONK162583ALOKA LISENDO 880K161163PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory

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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.

K261835LOGIQ FocusGE Medical Systems Ultrasound and Primary Care DiagnosticsK261288Handheld Ultrasound ScannerIMGFAX CO., LTD.K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System;Samsung Medison Co., Ltd.K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCK261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound systemEsonic Technology (Wuhan) Co., Ltd.K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd

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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