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FDA 510(k)

LOGIQ E9, LOGIQ E9 XDClear 2.0

K-Number: K163077 · 2016-11-17

ApplicantGE Medical Systems Ultrasound and Primary Care Diagnostics
Decision Date2016-11-17
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LOGIQ E9, LOGIQ E9 XDClear 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K163077. 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 LOGIQ E9, LOGIQ E9 XDClear 2.0?

LOGIQ E9, LOGIQ E9 XDClear 2.0 is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K163077.

When did LOGIQ E9, LOGIQ E9 XDClear 2.0 receive FDA 510(k) clearance?

LOGIQ E9, LOGIQ E9 XDClear 2.0 received FDA 510(k) clearance on 2016-11-17, under 510(k) number K163077.

Who is the listed applicant for LOGIQ E9, LOGIQ E9 XDClear 2.0?

The FDA 510(k) record lists GE Medical Systems Ultrasound and Primary Care Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOGIQ E9, LOGIQ E9 XDClear 2.0?

The FDA product code for LOGIQ E9, LOGIQ E9 XDClear 2.0 is IYN.

Other records listing GE Medical Systems Ultrasound and Primary Care Diagnostics 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.

K261835LOGIQ FocusK260398LOGIQ eK260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 PowerK253370LOGIQ TotusK253366LOGIQ FortisK252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

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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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