FDA product code IYE: Accelerator, Linear, Medical
IYE is the FDA product code for accelerator, linear, medical. It is a Class II device, regulated under 21 CFR 892.5050 and reviewed by the Radiology panel. FDA has cleared 738 510(k) submissions under IYE, 65 in the last five years, from 244 different applicants. The average 510(k) review took 130 days (median 90); 184 days on average over the last three years. FDA has posted 563 recalls for IYE devices, 72 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Accelerator, Linear, Medical |
| Device class | Class II |
| Regulation | 21 CFR 892.5050 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for IYE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 23 | 150 |
| 2018 | 21 | 111 |
| 2019 | 19 | 88 |
| 2020 | 20 | 115 |
| 2021 | 19 | 94 |
| 2022 | 12 | 158 |
| 2023 | 18 | 130 |
| 2024 | 9 | 248 |
| 2025 | 12 | 158 |
| 2026 | 14 | 145 |
Compare with all 510(k) review times · Search every IYE clearance
Top IYE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Varian Medical Systems, Inc. | 70 | 2026-08-03 |
| Varian Assoc., Inc. | 27 | 1999-02-08 |
| Brainlab AG | 21 | 2025-06-23 |
| Medtec, Inc. | 20 | 2014-03-04 |
| Siemens Medical Solutions USA, Inc. | 18 | 2018-10-03 |
239 more applicants have IYE clearances. See the full list in Caduvo.
Most recent IYE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261865 | Stabilix, LLC | AerFrame Alignment Laser Box (LBV2) | 2026-09-16 | 104 |
| K261718 | Radformation, Inc. | EZFluence (RADEZ V2) | 2026-08-31 | 97 |
| K260733 | Manteia Technologies Co., Ltd. | MRIA Radiation Therapy Information System (MRIA) | 2026-08-26 | 173 |
| K261856 | Varian Medical Systems, Inc. | Halcyon, Ethos Radiotherapy System (5.0) | 2026-08-03 | 60 |
| K252937 | Dosisoft SA | ThinkQA 3 | 2026-06-12 | 270 |
Recalls for IYE devices
563 product recalls in 357 recall events; 72 initiated in the last five years and 31 still open. Most recent: 2026-08-04.
| Year | Recalls |
|---|---|
| 2017 | 26 |
| 2018 | 17 |
| 2019 | 17 |
| 2020 | 14 |
| 2021 | 10 |
| 2022 | 5 |
| 2023 | 50 |
| 2024 | 3 |
| 2025 | 8 |
| 2026 | 4 |
Frequently asked questions
What is FDA product code IYE?
IYE is the FDA product code for accelerator, linear, medical. It is a Class II device, regulated under 21 CFR 892.5050 and reviewed by the Radiology panel.
What device class is IYE?
Class II, regulation 21 CFR 892.5050. Typical premarket route: 510(k).
How long does a 510(k) take for product code IYE?
Across 738 cleared submissions the average was 130 days from receipt to decision (median 90).
Which companies have the most IYE clearances?
Varian Medical Systems, Inc. (70); Varian Assoc., Inc. (27); Brainlab AG (21); Medtec, Inc. (20); Siemens Medical Solutions USA, Inc. (18).
Have IYE devices been recalled?
Yes: 563 product recalls across 357 recall events; the most recent began 2026-08-04.
Next steps
- Run an FDA pathway report with predicate devices for product code IYE
- Run a recall and safety report across every IYE manufacturer
- Watch product code IYE 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.
All Radiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times