FDA product code · Radiology · Class 2
OWB: Interventional Fluoroscopic X-Ray System
OWB is FDA's product code for "Interventional Fluoroscopic X-Ray System": a Class 2 device classified under 21 CFR 892.1650, reviewed by the Radiology panel.
510(k) review time for OWB
Across 155 510(k) clearances under OWB decided from 2018-01-01 to 2026-10-06, the median was 115 days from FDA receipt to decision. Half took between 34 and 193 days, and 80% were decided within 219 days. These are past clearances, not a forecast for a new submission.
| Fastest | 9 |
|---|---|
| 25th percentile | 34 |
| Median | 115 |
| 75th percentile | 193 |
| 80th percentile | 219 |
| 90th percentile | 261 |
| Slowest | 462 |
| Year | Median days | n |
|---|---|---|
| 2018 | 54 | 23 |
| 2019 | 174 | 9 |
| 2020 | 53 | 16 |
| 2021 | 60 | 24 |
| 2022 | 90 | 21 |
| 2023 | 152 | 12 |
| 2024 | 126 | 13 |
| 2025 | 148 | 22 |
| 2026 (to 10-06, partial) | 221 | 15 |
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.
OWB in the public FDA record
| 510(k) clearances, all years | 325 |
|---|---|
| Device recalls | 624 |
| Establishment listings | 557 |
| GUDID device identifiers | 702 |
Counts of records, not of devices or events. Adverse event reports for OWB 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 OWB
5 FDA recognized consensus standards cite OWB, 1 of them recognized only in part, among them NEMA XR 27 Amendment 1-2013; IEC 61910-1 Edition 1.0 2014-09; IEC 60601-2-54 Edition 2.0 2022-09. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-286 NEMA XR 27 Amendment 1-2013 — X-ray equipment for interventional procedures - User Quality Control Mode
- 12-290 IEC 61910-1 Edition 1.0 2014-09 — Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
- 12-348 IEC 60601-2-54 Edition 2.0 2022-09 (partial recognition) — Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- 12-351 IEC 60601-2-43 Edition 3.0 2022-12 — Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
- 12-364 IEC 61223-3-8 Edition 1.0 2024-03 — Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.