True Definition DL

Evidence summary

The exact FDA decision material describes a three-strength deep-learning reconstruction function implemented on compatible Revolution CT and Apex family systems, with design-control and MTF spatial-resolution evaluation. No universal diagnostic sensitivity or specificity claim is established.

FDA source Exact FDA submission Checked 2026-09-04

• Source

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

Postmarket safety review

The 2026-09-02 openFDA device-recall snapshot contained no record matched to K253686 by exact native submission identifier. This does not exclude product-family, later, or adverse-event information.

Public source Exact FDA submission Checked 2026-09-04

Exact-identifier review does not prove absence of all product-family safety signals.

• Source

• Verify DICOM, HL7/FHIR, PACS/RIS/EHR integration: The public exact-submission material does not establish a complete integration contract. Confirm DICOM, worklist, identity, interfaces, exports, routing, audit behavior, and downtime locally.
• Verify deployment and data flow: The public exact-submission material does not establish the complete deployment topology, hosting responsibility, availability, upgrade path, or service contract.
• 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.

This submission was added after the prior exact-submission extraction and remains queued for source review. Exact-name and exact-submission searches in the checked 2026-09-01 indexes returned no PubMed records and no ClinicalTrials.gov records for K253686; 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. Current vendor material is product-family context. Pricing, complete security architecture, contracted deployment, exact reimbursement, and local interoperability remain unverified. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 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 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 material K253686: True Definition DL U.S. Food and Drug Administration · 2026-09-04
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• 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 HealthCare CT family context GE HealthCare · 2026-09-04