Careverse CoronaryDoc (Careverse CoronaryDoc)

Evidence summary

K251656 FDA evidence is a manufacturer-submitted regulatory agreement package for coronary stenosis and plaque outputs; the stored literature and trial candidate arrays were empty and no independent study was promoted.

FDA source Exact FDA submission Checked 2026-09-07

• Source

Postmarket safety review

The wave22 exact-submission recall query returned no native recall record for K251656. This does not establish absence of family, later-version, or adverse-event information.

Public source Exact FDA submission Checked 2026-09-07

• Source

• Verify security and privacy controls: The reviewed exact FDA packet and Careverse family page do not establish a current scoped security attestation or deployed data-flow controls.
• Verify pricing and total cost: No public list price or contract unit for K251656 was established in the reviewed official sources.

The stored PubMed and ClinicalTrials.gov candidate arrays were screened and were empty. No paper or trial was promoted; empty stored arrays do not establish that no external literature or trials exist. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, acr ai central product, vendor product page, payer policy, fda device recall, literature index, trial registry, stored candidate metadata, pubmed, clinical trials, openfda device recall

• FDA 510(k) K251656: Careverse CoronaryDoc U.S. Food and Drug Administration · 2026-09-07
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• Careverse CoronaryDoc (Careverse CoronaryDoc) model card (K251656) American College of Radiology · 2026-09-01
• 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
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
• Careverse Digital Doctor Platform: Careverse CoronaryDoc Careverse Technology · 2026-09-07
• openFDA exact recall query for K251656 U.S. Food and Drug Administration · 2026-09-07
• CMS LCD L39913 version 7 Centers for Medicare & Medicaid Services · 2026-09-07
• CMS Article A59813 version 6 Centers for Medicare & Medicaid Services · 2026-09-07