Product code LLZ: 510(k) clearances and predicates
Product code LLZ covers Syneris PACS v.1.0.1.0. FDA lists 2292 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
2292 clearances on file under product code LLZ. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 65 |
| 2023 | 87 |
| 2024 | 62 |
| 2025 | 58 |
| 2026 so far | 42 |
Recent clearances
Newest LLZ clearances in the FDA index, with applicant and decision date:
- K261874, Syneris PACS v.1.0.1.0, applicant Syneris, decided 2026-09-23. FDA record
- K262442, HipStudio Analysis, applicant Replasia BV, decided 2026-09-22. FDA record
- K261855, Elucid PlaqueIQ, applicant Elucid Bioimaging, Inc., decided 2026-09-18. FDA record
- K254214, OOOPDS, applicant Taiwan Main Orthopaedic Biotechnology Co., Ltd., decided 2026-09-15. FDA record
- K261861, SPINEsim v1.0, applicant Mdsim S.A., decided 2026-09-15. FDA record
- K262060, 3D-RD-S, applicant Radiopharmaceutical Imaging & Dosimetry, LLC, decided 2026-09-04. FDA record
- K261500, KBA3D (v2.4.0), applicant S.M.A.I.O, decided 2026-08-17. FDA record
- K262449, AdvaView, applicant ADVAHEALTH SOLUTIONS, LLC, decided 2026-08-14. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include HipStudio Analysis, Elucid PlaqueIQ. Watch new LLZ clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code LLZ?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent LLZ clearances include Syneris PACS v.1.0.1.0.
How many 510(k) clearances use product code LLZ?
2292 at the time this page was generated, from openFDA records.
How do I find a predicate device under LLZ?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new LLZ clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.