Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LOGIQ P9; LOGIQ P7

K-Number: K181783 · 2018-09-20

ApplicantGE Healthcare
Decision Date2018-09-20
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LOGIQ P9; LOGIQ P7 is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2018-09-20 under 510(k) number K181783. 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 P9; LOGIQ P7?

LOGIQ P9; LOGIQ P7 is a medical device that received FDA 510(k) clearance on 2018-09-20. The listed applicant is GE Healthcare. The 510(k) number is K181783.

When did LOGIQ P9; LOGIQ P7 receive FDA 510(k) clearance?

LOGIQ P9; LOGIQ P7 received FDA 510(k) clearance on 2018-09-20, under 510(k) number K181783.

Who is the listed applicant for LOGIQ P9; LOGIQ P7?

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

What is the FDA product code for LOGIQ P9; LOGIQ P7?

The FDA product code for LOGIQ P9; LOGIQ P7 is IYN.

Related Clinical Trials

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.

NCT05838482Clinical Feasibility and Evaluation of Silicon Photon Counting CTCOMPLETEDNCT06702917GSI Cardiac on Revolution Apex - USACTIVE_NOT_RECRUITINGNCT07309809Portrait Mobile Monitoring Solution V2.0 External EvaluationNOT_YET_RECRUITINGNCT07394140NMT EasyFit Sensor and CableRECRUITINGNCT07615738SpO2 Infant and Pediatric StudyNOT_YET_RECRUITINGNCT07628296Non-Invasive Blood Pressure Accuracy Study for Adult Subject PopulationsRECRUITING

Other records listing GE Healthcare 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.

K253639ViewPMA P130020Digital breast tomosynthesisK242925MR Contour DLPMA P110006Automated breast ultrasoundK241300ViewPoint 6K232346Digital Expert Access with Remote Scanning

View all 58 devices →

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.

K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLCK262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCK261835LOGIQ 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, LLC

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.

↑