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FDA 510(k)

Venue; Venue Go; Venue Fit; Venue Sprint

K-Number: K251322 · 2025-07-25

ApplicantGE Medical Systems Ultrasound and Primary Care Diagnostics
Decision Date2025-07-25
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Venue; Venue Go; Venue Fit; Venue Sprint 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 2025-07-25 under 510(k) number K251322. 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 Venue; Venue Go; Venue Fit; Venue Sprint?

Venue; Venue Go; Venue Fit; Venue Sprint is a medical device that received FDA 510(k) clearance on 2025-07-25. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K251322.

When did Venue; Venue Go; Venue Fit; Venue Sprint receive FDA 510(k) clearance?

Venue; Venue Go; Venue Fit; Venue Sprint received FDA 510(k) clearance on 2025-07-25, under 510(k) number K251322.

Who is the listed applicant for Venue; Venue Go; Venue Fit; Venue Sprint?

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 Venue; Venue Go; Venue Fit; Venue Sprint?

The FDA product code for Venue; Venue Go; Venue Fit; Venue Sprint 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.

K261668Venue GoK261835LOGIQ 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 Fortis

View all 64 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.

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