510(k) Report

FDA applicant

Elucid Bioimaging, Inc.

Boston, MA6 decisions2017–20260 recalls

FDA records 6 decisions for Elucid Bioimaging, Inc. (Boston, MA) from 2017 to 2026: 6 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and PJA (Coronary Vascular Physiologic Simulation…). Since 2016 its 510(k)s took a median of 106 days from receipt to decision, against 110 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Elucid Bioimaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2017: 12018: 12022: 12024: 12026 (partial year): 2
2017high 2 (2026) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Elucid Bioimaging, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Elucid Bioimaging, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological5decisions
  • PJACoronary Vascular Physiologic Simulation Software1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 106 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 110 days; 4 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K183012vascuCAPElucid Bioimaging, Inc. · 20181cites it
  • K163071vascuCAPElucid Bioimaging, Inc. · 20171cites it
  • K221463ElucidVivo A.3Elucid Bioimaging, Inc. · 20221cites it

What has FDA decided for it lately?

  • K262015Elucid FFR-IQ (B.1)Elucid Bioimaging, Inc. · 2026
  • K261855Elucid PlaqueIQElucid Bioimaging, Inc. · 2026
  • K241524Elucid PlaqueIQElucid Bioimaging, Inc. · 2024
  • K221463ElucidVivo A.3Elucid Bioimaging, Inc. · 2022
  • K183012vascuCAPElucid Bioimaging, Inc. · 2018
  • K163071vascuCAPElucid Bioimaging, Inc. · 2017

All 6 as Elucid Bioimaging, Inc. →