FDA product code OWB: Interventional Fluoroscopic X-Ray System
OWB is the FDA product code for interventional fluoroscopic x-ray system. It is a Class II device, regulated under 21 CFR 892.1650 and reviewed by the Radiology panel. FDA has cleared 325 510(k) submissions under OWB, 83 in the last five years, from 115 different applicants. The average 510(k) review took 113 days (median 89); 170 days on average over the last three years. FDA has posted 624 recalls for OWB devices, 336 initiated in the last five years.
Definition
Interventional fluoroscopy
Classification
| Field | Value |
|---|---|
| Device name | Interventional Fluoroscopic X-Ray System |
| Device class | Class II |
| Regulation | 21 CFR 892.1650 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OWB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 20 | 84 |
| 2018 | 23 | 85 |
| 2019 | 9 | 192 |
| 2020 | 16 | 71 |
| 2021 | 24 | 89 |
| 2022 | 21 | 126 |
| 2023 | 12 | 154 |
| 2024 | 13 | 150 |
| 2025 | 22 | 168 |
| 2026 | 15 | 192 |
Compare with all 510(k) review times · Search every OWB clearance
Top OWB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Medical Solutions USA, Inc. | 37 | 2026-04-24 |
| Philips Medical Systems Nederland B.V. | 29 | 2026-08-07 |
| Ziehm Imaging GmbH | 16 | 2025-03-17 |
| Toshibamedical Systems Corporation | 13 | 2017-12-14 |
| Canon Medical Systems Corporation | 12 | 2026-03-10 |
110 more applicants have OWB clearances. See the full list in Caduvo.
Most recent OWB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253726 | Shanghai United Imaging Healthcare Co., Ltd. | uAngio AVIVA CX | 2026-08-21 | 270 |
| K261413 | DRTECH Corporation | EXTRON 3;EXTRON 6 | 2026-08-19 | 111 |
| K254205 | Philips Medical Systems Nederland B.V. | Zenition 30 | 2026-08-07 | 221 |
| K260607 | Radiaction , Ltd. | Shield System (Siemens 30x40) | 2026-07-31 | 157 |
| K253670 | Philips Medical Systems B.V. | SmartCT (R3.0 (L10)) | 2026-07-10 | 231 |
Recalls for OWB devices
624 product recalls in 272 recall events; 336 initiated in the last five years and 334 still open. Most recent: 2026-08-04.
| Year | Recalls |
|---|---|
| 2017 | 22 |
| 2018 | 41 |
| 2019 | 57 |
| 2020 | 37 |
| 2021 | 45 |
| 2022 | 42 |
| 2023 | 47 |
| 2024 | 46 |
| 2025 | 114 |
| 2026 | 61 |
Frequently asked questions
What is FDA product code OWB?
OWB is the FDA product code for interventional fluoroscopic x-ray system. It is a Class II device, regulated under 21 CFR 892.1650 and reviewed by the Radiology panel.
What device class is OWB?
Class II, regulation 21 CFR 892.1650. Typical premarket route: 510(k).
How long does a 510(k) take for product code OWB?
Across 325 cleared submissions the average was 113 days from receipt to decision (median 89).
Which companies have the most OWB clearances?
Siemens Medical Solutions USA, Inc. (37); Philips Medical Systems Nederland B.V. (29); Ziehm Imaging GmbH (16); Toshibamedical Systems Corporation (13); Canon Medical Systems Corporation (12).
Have OWB devices been recalled?
Yes: 624 product recalls across 272 recall events; the most recent began 2026-08-04.
Next steps
- Run an FDA pathway report with predicate devices for product code OWB
- Run a recall and safety report across every OWB manufacturer
- Watch product code OWB 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