FDA product code LHN: System, Radiation Therapy, Charged-Particle, Medical
LHN is the FDA product code for system, radiation therapy, charged-particle, medical. It is a Class II device, regulated under 21 CFR 892.5050 and reviewed by the Radiology panel. FDA has cleared 92 510(k) submissions under LHN, 11 in the last five years, from 48 different applicants. The average 510(k) review took 142 days (median 95); 193 days on average over the last three years. FDA has posted 58 recalls for LHN devices, 15 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Radiation Therapy, Charged-Particle, 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 LHN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 159 |
| 2018 | 3 | 105 |
| 2019 | 2 | 92 |
| 2020 | 4 | 91 |
| 2022 | 2 | 214 |
| 2023 | 2 | 181 |
| 2024 | 1 | 189 |
| 2025 | 3 | 208 |
| 2026 | 3 | 183 |
Compare with all 510(k) review times · Search every LHN clearance
Top LHN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ion Beam Applications S.A. | 13 | 2017-08-17 |
| Varian Medical Systems, Inc. | 5 | 2026-04-23 |
| Hitachi , Ltd. | 4 | 2020-07-13 |
| Hitachi, Ltd., Health Care Company | 4 | 2016-04-21 |
| Medcom GmbH | 3 | 2018-09-21 |
43 more applicants have LHN clearances. See the full list in Caduvo.
Most recent LHN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260174 | Hitachi High-Tech Corp. | PROBEAT-CR | 2026-06-11 | 141 |
| K252815 | Varian Medical Systems, Inc. | ProBeam 360 Proton Therapy System v3.0 | 2026-04-23 | 231 |
| K253406 | Mevion Medical Systems, Inc. | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | 2026-03-25 | 176 |
| K250986 | Mevion Medical Systems, Inc. | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | 2025-09-12 | 165 |
| K243900 | Empnia, Inc. | eMotus Respiratory Motion Management System | 2025-06-27 | 190 |
Recalls for LHN devices
58 product recalls in 53 recall events; 15 initiated in the last five years and 16 still open. Most recent: 2026-02-06.
| Year | Recalls |
|---|---|
| 2017 | 10 |
| 2018 | 6 |
| 2019 | 1 |
| 2020 | 4 |
| 2021 | 3 |
| 2022 | 3 |
| 2023 | 1 |
| 2024 | 7 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code LHN?
LHN is the FDA product code for system, radiation therapy, charged-particle, medical. It is a Class II device, regulated under 21 CFR 892.5050 and reviewed by the Radiology panel.
What device class is LHN?
Class II, regulation 21 CFR 892.5050. Typical premarket route: 510(k).
How long does a 510(k) take for product code LHN?
Across 92 cleared submissions the average was 142 days from receipt to decision (median 95).
Which companies have the most LHN clearances?
Ion Beam Applications S.A. (13); Varian Medical Systems, Inc. (5); Hitachi , Ltd. (4); Hitachi, Ltd., Health Care Company (4); Medcom GmbH (3).
Have LHN devices been recalled?
Yes: 58 product recalls across 53 recall events; the most recent began 2026-02-06.
Next steps
- Run an FDA pathway report with predicate devices for product code LHN
- Run a recall and safety report across every LHN manufacturer
- Watch product code LHN 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