FDA product code · Radiology · Class 2
LHN: System, Radiation Therapy, Charged-Particle, Medical
LHN is FDA's product code for "System, Radiation Therapy, Charged-Particle, Medical": a Class 2 device classified under 21 CFR 892.5050, reviewed by the Radiology panel.
510(k) review time for LHN
Across 21 510(k) clearances under LHN decided from 2018-01-01 to 2026-10-06, the median was 165 days from FDA receipt to decision. Half took between 84 and 199 days, and 80% were decided within 211 days. These are past clearances, not a forecast for a new submission.
| Fastest | 17 |
|---|---|
| 25th percentile | 84 |
| Median | 165 |
| 75th percentile | 199 |
| 80th percentile | 211 |
| 90th percentile | 257 |
| Slowest | 270 |
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.
LHN in the public FDA record
| 510(k) clearances, all years | 92 |
|---|---|
| Device recalls | 58 |
Counts of records, not of devices or events. Adverse event reports for LHN 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 LHN
11 FDA recognized consensus standards cite LHN, among them IEC 62083 Edition 2.0 2009-09; IEC 62274 First Edition 2005-05; IEC 60601-2-11 Edition 3.0 2013-01. 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
- 12-255 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
- 12-318 IEC 60601-2-64 Edition 1.0 2014-09 — Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
- 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
- 12-320 IEC 62667 Edition 1.0 2017-08 — Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
- 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.