FDA product code IYN: System, Imaging, Pulsed Doppler, Ultrasonic
IYN is the FDA product code for system, imaging, pulsed doppler, ultrasonic. It is a Class II device, regulated under 21 CFR 892.1550 and reviewed by the Radiology panel. FDA has cleared 1,183 510(k) submissions under IYN, 242 in the last five years, from 253 different applicants. The average 510(k) review took 94 days (median 70); 132 days on average over the last three years. 1 PMA application cites this product code. FDA has posted 299 recalls for IYN devices, 121 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Imaging, Pulsed Doppler, Ultrasonic |
| Device class | Class II |
| Regulation | 21 CFR 892.1550 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for IYN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 64 | 91 |
| 2018 | 59 | 89 |
| 2019 | 47 | 82 |
| 2020 | 57 | 93 |
| 2021 | 46 | 123 |
| 2022 | 53 | 136 |
| 2023 | 44 | 113 |
| 2024 | 50 | 136 |
| 2025 | 57 | 137 |
| 2026 | 38 | 122 |
Compare with all 510(k) review times · Search every IYN clearance
Top IYN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 83 | 2026-05-11 |
| Siemens Medical Solutions USA, Inc. | 75 | 2026-06-16 |
| Samsung Medison Co., Ltd. | 68 | 2026-07-28 |
| GE Medical Systems Ultrasound and Primary Care Diagnostics | 60 | 2026-09-02 |
| GE Healthcare | 52 | 2022-02-17 |
248 more applicants have IYN clearances. See the full list in Caduvo.
Most recent IYN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261313 | GE Medical Systems Ultrasound and Primary Care Diagnostics | Vivid Explorer/Vivid Advanced/Vivid Focus | 2026-09-02 | 134 |
| K254027 | Sonoscape Medical Corp. | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90) | 2026-08-24 | 251 |
| K261668 | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | Venue Go | 2026-08-07 | 79 |
| K262311 | Philips Ultrasound, LLC | Alturion Series Diagnostic Ultrasound System | 2026-08-04 | 27 |
| K261288 | IMGFAX CO., LTD. | Handheld Ultrasound Scanner | 2026-07-30 | 101 |
Recalls for IYN devices
299 product recalls in 161 recall events; 121 initiated in the last five years and 125 still open. Most recent: 2026-08-07.
| Year | Recalls |
|---|---|
| 2017 | 14 |
| 2018 | 18 |
| 2019 | 10 |
| 2020 | 9 |
| 2021 | 13 |
| 2022 | 10 |
| 2023 | 10 |
| 2024 | 14 |
| 2025 | 81 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code IYN?
IYN is the FDA product code for system, imaging, pulsed doppler, ultrasonic. It is a Class II device, regulated under 21 CFR 892.1550 and reviewed by the Radiology panel.
What device class is IYN?
Class II, regulation 21 CFR 892.1550. Typical premarket route: 510(k).
How long does a 510(k) take for product code IYN?
Across 1,183 cleared submissions the average was 94 days from receipt to decision (median 70).
Which companies have the most IYN clearances?
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (83); Siemens Medical Solutions USA, Inc. (75); Samsung Medison Co., Ltd. (68); GE Medical Systems Ultrasound and Primary Care Diagnostics (60); GE Healthcare (52).
Have IYN devices been recalled?
Yes: 299 product recalls across 161 recall events; the most recent began 2026-08-07.
Next steps
- Run an FDA pathway report with predicate devices for product code IYN
- Run a recall and safety report across every IYN manufacturer
- Watch product code IYN 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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