Autoplaque

Evidence summary

Software verification and validation were conducted on the subject device to demonstrate that the subject device meets specifications and works as intended. In addition, clinical validation studies were undertaken to verify and validate that Autoplaque 3.0 performs as intended. Performance data was collected on a data set of clinically indicated coronary computed tomography angiography (CCTA) images from multiple U.S. sites; the patient population consisted of 201 patients. Performance data was collected on clinically indicated coronary computed tomography angiography (CCTA) images from multiple non-U.S. external sites; the patient population consisted of 175 patients. To establish that the subject device provides clinical performance for total plaque volume, calcified plaque volume, non-calcified plaque volume, and diameter stenosis that is substantially equivalent to the predicate device, a total of 30 lesions (from 27 patients) throughout the coronary artery tree were analyzed using both the subject and predicate devices.

• FDA source
• Exact FDA submission
• Checked 2026-09-19

The exact packet reports software verification and validation plus the U.S., non-U.S., and predicate-comparison performance populations; the prior study-type and reference-standard wording is not retained.

• 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 exact-identifier FDA recall query returned no native recall record for K212758. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.

• Public source
• Exact FDA submission
• Checked 2026-09-08

• Source

• Verify care setting and population: Confirm the intended care setting, patient population, and service line.
• Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
• Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
• Verify pricing and total cost: No public price or quote for the exact K212758 configuration was established in this review.
• Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
• Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

The refreshed discovery snapshot contains 17 PubMed and 2 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 17 PubMed and 2 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, fda device recall, literature index, trial registry, fda decision summary packet, pubmed, clinical trials, openfda device recall