FDA product code IZI: System, X-Ray, Angiographic
IZI is the FDA product code for system, x-ray, angiographic. It is a Class II device, regulated under 21 CFR 892.1600 and reviewed by the Radiology panel. FDA has cleared 199 510(k) submissions under IZI, 10 in the last five years, from 90 different applicants. The average 510(k) review took 102 days (median 79); 202 days on average over the last three years. FDA has posted 259 recalls for IZI devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, X-Ray, Angiographic |
| Device class | Class II |
| Regulation | 21 CFR 892.1600 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for IZI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 215 |
| 2018 | 2 | 104 |
| 2019 | 2 | 148 |
| 2020 | 1 | 109 |
| 2021 | 1 | 153 |
| 2022 | 1 | 59 |
| 2023 | 3 | 122 |
| 2024 | 2 | 176 |
| 2025 | 2 | 285 |
| 2026 | 2 | 144 |
Compare with all 510(k) review times · Search every IZI clearance
Top IZI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Medical Solutions USA, Inc. | 13 | 2009-06-18 |
| Xre Corp. | 10 | 1995-02-27 |
| Novadaq Technologies, Inc. | 9 | 2011-02-04 |
| Shimadzu Medical Systems | 8 | 2005-10-17 |
| GE Medical Systems | 8 | 1998-02-13 |
85 more applicants have IZI clearances. See the full list in Caduvo.
Most recent IZI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261037 | Stryker Endoscopy | 780 nm SPY Portable Handheld Imaging (SPY-PHI) System | 2026-05-28 | 59 |
| K253181 | Surgimage Corporation | SURGIMAGE SIM 1000H Fluorescence Imaging Platform | 2026-05-13 | 229 |
| K243645 | Diagnostic Green GmbH | IC-Flow Imaging System 2.0 | 2025-09-22 | 300 |
| K243077 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | Affirm 800 | 2025-06-27 | 270 |
| K231986 | Synaptive Medical, Inc. | Modus IR | 2024-03-25 | 264 |
Recalls for IZI devices
259 product recalls in 109 recall events; 2 initiated in the last five years and 7 still open. Most recent: 2026-05-18.
| Year | Recalls |
|---|---|
| 2017 | 4 |
| 2018 | 22 |
| 2019 | 13 |
| 2020 | 2 |
| 2021 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code IZI?
IZI is the FDA product code for system, x-ray, angiographic. It is a Class II device, regulated under 21 CFR 892.1600 and reviewed by the Radiology panel.
What device class is IZI?
Class II, regulation 21 CFR 892.1600. Typical premarket route: 510(k).
How long does a 510(k) take for product code IZI?
Across 199 cleared submissions the average was 102 days from receipt to decision (median 79).
Which companies have the most IZI clearances?
Siemens Medical Solutions USA, Inc. (13); Xre Corp. (10); Novadaq Technologies, Inc. (9); Shimadzu Medical Systems (8); GE Medical Systems (8).
Have IZI devices been recalled?
Yes: 259 product recalls across 109 recall events; the most recent began 2026-05-18.
Next steps
- Run an FDA pathway report with predicate devices for product code IZI
- Run a recall and safety report across every IZI manufacturer
- Watch product code IZI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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