FDA product code IWB: System, Radiation Therapy, Radionuclide
IWB is the FDA product code for system, radiation therapy, radionuclide. It is a Class II device, regulated under 21 CFR 892.5750 and reviewed by the Radiology panel. FDA has cleared 48 510(k) submissions under IWB, 3 in the last five years, from 27 different applicants. The average 510(k) review took 126 days (median 90); 143 days on average over the last three years. FDA has posted 29 recalls for IWB devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Radiation Therapy, Radionuclide |
| Device class | Class II |
| Regulation | 21 CFR 892.5750 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for IWB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 106 |
| 2018 | 3 | 64 |
| 2019 | 1 | 156 |
| 2020 | 1 | 25 |
| 2021 | 2 | 132 |
| 2022 | 1 | 106 |
| 2024 | 1 | 146 |
| 2025 | 1 | 140 |
Compare with all 510(k) review times · Search every IWB clearance
Top IWB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Elekta Instrument AB | 13 | 2018-03-30 |
| Elekta Solutions AB | 3 | 2025-07-02 |
| Akesis, Inc. | 3 | 2021-03-05 |
| Theratronics, Inc. | 3 | 1998-12-04 |
| Xcision Medical Systems, LLC | 2 | 2018-04-04 |
22 more applicants have IWB clearances. See the full list in Caduvo.
Most recent IWB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250391 | Elekta Solutions AB | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion) | 2025-07-02 | 140 |
| K232854 | Elekta Solutions AB | Leksell GammaPlan (LGP) | 2024-02-08 | 146 |
| K222047 | Elekta Solutions AB | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) | 2022-10-26 | 106 |
| K203250 | Our United Corporation | TaiChiC | 2021-03-12 | 128 |
| K203146 | Akesis, Inc. | Akesis Galaxy RTi | 2021-03-05 | 135 |
Recalls for IWB devices
29 product recalls in 23 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2026-02-18.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2023 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code IWB?
IWB is the FDA product code for system, radiation therapy, radionuclide. It is a Class II device, regulated under 21 CFR 892.5750 and reviewed by the Radiology panel.
What device class is IWB?
Class II, regulation 21 CFR 892.5750. Typical premarket route: 510(k).
How long does a 510(k) take for product code IWB?
Across 48 cleared submissions the average was 126 days from receipt to decision (median 90).
Which companies have the most IWB clearances?
Elekta Instrument AB (13); Elekta Solutions AB (3); Akesis, Inc. (3); Theratronics, Inc. (3); Xcision Medical Systems, LLC (2).
Have IWB devices been recalled?
Yes: 29 product recalls across 23 recall events; the most recent began 2026-02-18.
Next steps
- Run an FDA pathway report with predicate devices for product code IWB
- Run a recall and safety report across every IWB manufacturer
- Watch product code IWB 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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