Product code IZI: 510(k) clearances and predicates
Product code IZI covers 780 nm SPY Portable Handheld Imaging (SPY-PHI) System. FDA lists 199 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
199 clearances on file under product code IZI. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2023 | 3 |
| 2024 | 2 |
| 2025 | 2 |
| 2026 so far | 2 |
Recent clearances
Newest IZI clearances in the FDA index, with applicant and decision date:
- K261037, 780 nm SPY Portable Handheld Imaging (SPY-PHI) System, applicant Stryker Endoscopy, decided 2026-05-28. FDA record
- K253181, SURGIMAGE SIM 1000H Fluorescence Imaging Platform, applicant Surgimage Corporation, decided 2026-05-13. FDA record
- K243645, IC-Flow Imaging System 2.0, applicant Diagnostic Green GmbH, decided 2025-09-22. FDA record
- K243077, Affirm 800, applicant Digital Surgery Systems, Inc. (D.B.A True Digital Surgery), decided 2025-06-27. FDA record
- K231986, Modus IR, applicant Synaptive Medical, Inc., decided 2024-03-25. FDA record
- K234090, EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004), applicant Surgvision GmbH, decided 2024-03-20. FDA record
- K231075, Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option), applicant Carl Zeiss Meditec, Inc., decided 2023-06-20. FDA record
- K230727, SPY Portable Handheld Imaging (SPY-PHI) System, applicant Novadaq Technologies Ulc (A Part of Stryker), decided 2023-06-05. 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 SURGIMAGE SIM 1000H Fluorescence Imaging Platform, IC-Flow Imaging System 2.0. Watch new IZI 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 IZI?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent IZI clearances include 780 nm SPY Portable Handheld Imaging (SPY-PHI) System.
How many 510(k) clearances use product code IZI?
199 at the time this page was generated, from openFDA records.
How do I find a predicate device under IZI?
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 IZI clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.