Venue Fit

Evidence summary

The K220848 FDA decision summary describes Venue Fit acquisition modes, labeled examinations and procedural guidance, portability, battery and cart configurations, DICOM or QPath connectivity, and professional-use limitations. The FDA package does not establish a general AI diagnostic sensitivity or specificity claim.

FDA source Exact FDA submission Checked 2026-09-03

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No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Postmarket safety review

1 exact-submission FDA recall record in the 2026-09-02 openFDA snapshot identify K220848. Affected model, version, unit, correction, and current manufacturer instructions still require local confirmation. FDA recall Z-1556-2025 is Open, Classified for Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45335VFS, H45335VFSW), R3 Surgery for China, R3 PeriOP for China, R3 Expert for China, R3 Pro for China, R3 Performance for China, R3 Intervention for China diagnostic ultrasound systems. FDA reason: The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire. FDA action: An URGENT MEDICAL DEVICE CORRECTION notification letter dated 3/6/25 was sent to customers. Actions to be taken by Customer/User: You can continue to use your Venue Go and Venue Fit system after following the actions below: 1) Turn the system Off and unplug the system from the wall socket. 2) Remove the system batteries by following instructions provided in the User Manual Chapter 3. These instructions are also provided in this letter in Appendix A for Venue Go and in Appendix B for Venue Fit. 3) Check the date of manufacture of the system batteries by looking at the label on the bottom of each battery (See Figure 1). The date of manufacture is displayed as YYYY-MM for year and month of manufacture. NOTE: Venue Go has two batteries and Venue Fit has one battery 4) Calculate the age of each of the system batteries. 5) If any of the batteries are more than 2 years old: a. With the system unplugged, re-insert batteries, turn the system On and leave the system On to discharge the batteries. b. Once the battery capacity indicator shows two segments or less (See Figure 2), turn the system Off and remove the batteries per step 2. c. Dispose of batteries according to local regulations. NOTE: After battery removal, you can continue to use the system with use of AC power cord. The system is fully functional without the battery. 6) If the batteries are less than 2 years old, you may continue to use the battery until the battery reaches 2 years old, at which point, repeat instructions in step 5. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your...

FDA source Exact FDA submission Checked 2026-09-04

Each published event was manually matched to the exact FDA submission and affected product or version; a recall does not establish an AI-algorithm defect or current site exposure unless the event states that scope.

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• Verify security and privacy controls: Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
• Verify pricing and total cost: No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA decision materials were reviewed for identity, indication, users, workflow, limitations, and submitted performance. Current vendor material is labeled product-family context where it does not establish the exact release. PubMed and ClinicalTrials.gov results are retained as candidate evidence with version applicability pending; CMS reimbursement context and exact-identifier openFDA postmarket results were also checked. Pricing, final security architecture, contracted services, enabled options, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 0 PubMed and 3 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. 1 FDA recall candidate was manually reviewed: 1 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 1 postmarket candidate record; 1 has been reviewed (1 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, fda decision material, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

• FDA 510(k) decision summary K220848: Venue Fit U.S. Food and Drug Administration · 2026-09-03
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• FDA recall Z-1556-2025: Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45335VFS, H45335VFSW), R3 Surgery for China, R3 PeriOP for China, R3 Expert for China, R3 Pro for China, R3 Performance for China, R3 Intervention for China diagnostic ultrasound systems U.S. Food and Drug Administration · 2026-09-04
• PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
• ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
• Medicare Coverage Database Centers for Medicare & Medicaid Services · 2026-09-01
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
• GE Venue Fit ultrasound system GE HealthCare · 2026-09-03
• Why do People Respond Differently to Resistance Training? U.S. National Library of Medicine · 2026-09-03
• Resistance Training, Detraining, and Retraining Study 2024 (TraDeRe2024) U.S. National Library of Medicine · 2026-09-03
• A Comparative Analysis of Two Hyaluronic Acid Fillers for Nasolabial Fold Correction U.S. National Library of Medicine · 2026-09-03