Elucid Bioimaging's PlaqueIQ Receives FDA 510(k) Clearance
The diagnostic software, classified as a Class II device, is cleared for aiding in cardiovascular risk assessment, expanding the company's presence in medical imaging analysis.
ProjMed Editorial Desk·Oct 2, 2026·3 min read·Evidence A
Elucid Bioimaging, Inc. announced that its Elucid PlaqueIQ software has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The decision, dated September 18, 2026, deems the device substantially equivalent for its intended use.
Elucid PlaqueIQ is a diagnostic software device, categorized under product code LLZ, an image processing system. This clearance positions the technology to contribute to the analysis of medical images, particularly within the cardiovascular domain, though specific clinical indications and functionalities beyond what is implied by the product code have not been publicly detailed at this time.
Regulatory Pathway and Device Classification
The FDA granted a Traditional 510(k) clearance for Elucid PlaqueIQ. This pathway indicates the device was found substantially equivalent to a predicate device already legally marketed in the U.S. The advisory committee involved in the review was Radiology, consistent with its function as an image processing system.
Elucid PlaqueIQ is classified as a Class II medical device under regulation number 892.2050. Class II devices are those that pose a moderate risk to patients and require special controls in addition to general controls to assure their safety and effectiveness.
The clearance is based on a summary filing, rather than a more extensive premarket approval application, reflecting the substantial equivalence determination.
Market Context and Future Implications
While specific details regarding the software's exact capabilities, clinical validation data, or commercial launch plans have not been publicly disclosed by Elucid Bioimaging, the clearance suggests an ongoing trend toward advanced software solutions in medical diagnostics. These tools aim to augment clinician capabilities in interpreting complex medical imaging, potentially leading to more precise diagnoses and risk stratification in conditions where image-based biomarkers are critical.
Further information regarding the device's integration into clinical workflows, reimbursement strategies, and broader commercial availability is anticipated following this regulatory milestone.
