FDA product code · Radiology · Class 2
IWB: System, Radiation Therapy, Radionuclide
IWB is FDA's product code for "System, Radiation Therapy, Radionuclide": a Class 2 device classified under 21 CFR 892.5750, reviewed by the Radiology panel.
510(k) review time for IWB
Across 10 510(k) clearances under IWB decided from 2018-01-01 to 2026-10-06, the median was 117 days from FDA receipt to decision. Half took between 69 and 139 days, and 80% were decided within 141 days. These are past clearances, not a forecast for a new submission.
| Fastest | 25 |
|---|---|
| 25th percentile | 69 |
| Median | 117 |
| 75th percentile | 139 |
| 80th percentile | 141 |
| 90th percentile | 147 |
| Slowest | 156 |
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.
IWB in the public FDA record
| 510(k) clearances, all years | 48 |
|---|---|
| Device recalls | 29 |
Counts of records, not of devices or events. Adverse event reports for IWB 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 IWB
9 FDA recognized consensus standards cite IWB, 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
- 12-259 IEC 61674 Edition 2.0 2012-11 — Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
- 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
- 12-319 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
- 12-362 IEC 61674 Edition 3.0 2024-07 — Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
- 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.