FDA product code · Radiology · Class 2
IYE: Accelerator, Linear, Medical
IYE is FDA's product code for "Accelerator, Linear, Medical": a Class 2 device classified under 21 CFR 892.5050, reviewed by the Radiology panel.
510(k) review time for IYE
Across 144 510(k) clearances under IYE decided from 2018-01-01 to 2026-10-06, the median was 109 days from FDA receipt to decision. Half took between 52 and 206 days, and 80% were decided within 231 days. These are past clearances, not a forecast for a new submission.
| Fastest | 17 |
|---|---|
| 25th percentile | 52 |
| Median | 109 |
| 75th percentile | 206 |
| 80th percentile | 231 |
| 90th percentile | 259 |
| Slowest | 454 |
| Year | Median days | n |
|---|---|---|
| 2018 | 58 | 21 |
| 2019 | 83 | 19 |
| 2020 | 67 | 20 |
| 2021 | 86 | 19 |
| 2022 | 172 | 12 |
| 2023 | 129 | 18 |
| 2024 | 239 | 9 |
| 2025 | 170 | 12 |
| 2026 (to 10-06, partial) | 120 | 14 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
IYE in the public FDA record
| 510(k) clearances, all years | 737 |
|---|---|
| Device recalls | 562 |
| Establishment listings | 479 |
| GUDID device identifiers | 6,484 |
Counts of records, not of devices or events. Adverse event reports for IYE are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite IYE
10 FDA recognized consensus standards cite IYE, among them IEC 62083 Edition 2.0 2009-09; IEC 62274 First Edition 2005-05; IEC 60976 Edition 2.0 2007-10. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-217 IEC 62083 Edition 2.0 2009-09 — Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
- 12-241 IEC 62274 First Edition 2005-05 — Medical electrical equipment - Safety of radiotherapy record and verify systems
- 12-253 IEC 60976 Edition 2.0 2007-10 — Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
- 12-255 IEC 60601-2-11 Edition 3.0 2013-01 — Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
- 12-267 IEC 61217 Edition 2.0 2011-12 — Radiotherapy equipment - Coordinates movements and scales
- 12-304 IEC 60731 Edition 3.1 2016-04 — Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
- 12-307 AAMI RT2:2017 — Radiation therapy readiness check
- 12-319 IEC 60601-2-68 Edition 1.0 2014-09 — Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators light ion beam therapy equipment and radionuclide beam therapy equipment
- 12-338 IEC 60601-2-1 Edition 4.0 2020-10 — Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
- 12-381 IEC 60601-2-68 Edition 2.0 2025-02 — Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators light ion beam therapy equipment and radionuclide beam therapy equipment
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.