WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home

The Tracker / September 2026 / K261855

510(k) cleared

Elucid PlaqueIQ

Elucid Bioimaging, Inc. · Sep 18, 2026 · K261855 · In the directory

FDA cleared the Elucid PlaqueIQ from Elucid Bioimaging, Inc. on Sep 18, 2026 under K261855, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 3, 2026. The decision came 107 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Elucid Bioimaging, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261855?

K261855 is the FDA 510(k) for Elucid PlaqueIQ, submitted by Elucid Bioimaging, Inc.. FDA's decision date was Sep 18, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the Elucid PlaqueIQ?

Elucid Bioimaging, Inc., based in Boston, MA, is the applicant of record for K261855. The company is listed in the MedDevice Startups directory.

How long did the K261855 review take?

FDA received the submission on Jun 3, 2026 and issued its decision on Sep 18, 2026, 107 days later.

← All decisions in September 2026

Sources

In the startup directory

Elucid

Imaging & Radiology · Boston, MA