FDA product code IYO: System, Imaging, Pulsed Echo, Ultrasonic
IYO is the FDA product code for system, imaging, pulsed echo, ultrasonic. It is a Class II device, regulated under 21 CFR 892.1560 and reviewed by the Radiology panel. FDA has cleared 894 510(k) submissions under IYO, 40 in the last five years, from 376 different applicants. The average 510(k) review took 129 days (median 88); 175 days on average over the last three years. FDA has posted 83 recalls for IYO devices, 21 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Imaging, Pulsed Echo, Ultrasonic |
| Device class | Class II |
| Regulation | 21 CFR 892.1560 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for IYO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 19 | 125 |
| 2018 | 14 | 117 |
| 2019 | 13 | 106 |
| 2020 | 11 | 78 |
| 2021 | 15 | 98 |
| 2022 | 5 | 219 |
| 2023 | 11 | 184 |
| 2024 | 10 | 190 |
| 2025 | 7 | 172 |
| 2026 | 7 | 162 |
Compare with all 510(k) review times · Search every IYO clearance
Top IYO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Medical Solutions USA, Inc. | 31 | 2024-06-12 |
| General Electric Co. | 21 | 2007-10-17 |
| Advanced Technology Laboratories, Inc. | 20 | 1999-08-23 |
| Volcano Corporation | 19 | 2021-01-19 |
| Hewlett-Packard Co. | 14 | 1998-07-14 |
371 more applicants have IYO clearances. See the full list in Caduvo.
Most recent IYO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253452 | Rivanna Medical, Inc. | Accuro 3S | 2026-07-24 | 291 |
| K260190 | ROPCA ApS | ARTHUR | 2026-06-18 | 147 |
| K252237 | Edgecare, Inc. | EdgeFlow UW20 | 2026-04-17 | 274 |
| K254021 | Rivanna Medical, Inc. | Accuro XV | 2026-04-09 | 114 |
| K253898 | QT Imaging Holdings, Inc. | QT Scanner 2000 Model A | 2026-03-04 | 89 |
Recalls for IYO devices
83 product recalls in 51 recall events; 21 initiated in the last five years and 17 still open. Most recent: 2026-08-06.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 3 |
| 2019 | 1 |
| 2021 | 13 |
| 2022 | 1 |
| 2026 | 9 |
Frequently asked questions
What is FDA product code IYO?
IYO is the FDA product code for system, imaging, pulsed echo, ultrasonic. It is a Class II device, regulated under 21 CFR 892.1560 and reviewed by the Radiology panel.
What device class is IYO?
Class II, regulation 21 CFR 892.1560. Typical premarket route: 510(k).
How long does a 510(k) take for product code IYO?
Across 894 cleared submissions the average was 129 days from receipt to decision (median 88).
Which companies have the most IYO clearances?
Siemens Medical Solutions USA, Inc. (31); General Electric Co. (21); Advanced Technology Laboratories, Inc. (20); Volcano Corporation (19); Hewlett-Packard Co. (14).
Have IYO devices been recalled?
Yes: 83 product recalls across 51 recall events; the most recent began 2026-08-06.
Next steps
- Run an FDA pathway report with predicate devices for product code IYO
- Run a recall and safety report across every IYO manufacturer
- Watch product code IYO 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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