SmartTarget

Evidence summary

The K170250 FDA decision summary documents nonclinical phantom testing with a 2.0 mm image-alignment error and a 2.9 mm needle-tip placement error for the exact SmartTarget configuration. These bench results do not establish clinical outcomes or performance for unlabeled anatomy, instruments, or workflows.

• FDA source
• Exact FDA submission
• Checked 2026-09-04

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Postmarket safety review

1 exact-submission FDA recall record matched K170250 in the 2026-09-02 openFDA snapshot. Confirm affected model, version, units, correction, and current manufacturer instructions locally. FDA recall Z-1243-2026 is Open, Classified for Focalyx Fusion. FDA reason: Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment/therapy delays, so firm is recommending stop use until device is verified/validated with Windows 11. FDA action: On 12/23/2025, correction notices started being emailed to customers informing them of the following: You will be contacted to schedule installation of the new version. An IFU will be provided at time of installation. Complete and return the response form via email to corporate@focalyx.com If there are any questions, contact the firm at: focalyxtechnologies.com/contact, support@focalyxtechnologies.com, (888) 636 2259, (Sel. 3 Technical Support)

• 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 license or hardware basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.
• Verify local validation and lifecycle monitoring: The exact FDA decision and checked recall snapshot do not establish a complete local postmarket monitoring protocol. Track version, population, anatomy, protocol, input quality, edits, failures, repeats, downstream effects, downtime, incidents, recalls, and updates locally.

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact-name and exact-submission searches in the checked 2026-09-01 indexes returned 3 PubMed candidate records and 4 ClinicalTrials.gov candidate records for K170250; review status is candidate_review_pending. Any candidate literature or registry record remains quarantined as product-family evidence unless exact submission and version linkage is established. The checked openFDA snapshot has 1 exact native-submission recall record. Pricing, complete security architecture, contracted deployment, exact reimbursement, and local interoperability remain unverified. Automated exact-name discovery found 3 PubMed and 4 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, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall