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FDA 510(k)

ALOKA LISENDO 880

K-Number: K162583 · 2016-11-17

ApplicantHitachi , Ltd.
Decision Date2016-11-17
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ALOKA LISENDO 880 is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi , Ltd.. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K162583. 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 ALOKA LISENDO 880?

ALOKA LISENDO 880 is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Hitachi , Ltd.. The 510(k) number is K162583.

When did ALOKA LISENDO 880 receive FDA 510(k) clearance?

ALOKA LISENDO 880 received FDA 510(k) clearance on 2016-11-17, under 510(k) number K162583.

Who is the listed applicant for ALOKA LISENDO 880?

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 ALOKA LISENDO 880?

The FDA product code for ALOKA LISENDO 880 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.

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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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