FDA product code MWP: Cabinet, X-Ray System
MWP is the FDA product code for cabinet, x-ray system. It is a Class II device, regulated under 21 CFR 892.1680 and reviewed by the Radiology panel. FDA has cleared 27 510(k) submissions under MWP, 2 in the last five years, from 12 different applicants. The average 510(k) review took 100 days (median 91).
Classification
| Field | Value |
|---|---|
| Device name | Cabinet, X-Ray System |
| Device class | Class II |
| Regulation | 21 CFR 892.1680 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MWP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 124 |
| 2018 | 1 | 203 |
| 2019 | 5 | 97 |
| 2020 | 2 | 72 |
| 2021 | 4 | 128 |
| 2023 | 2 | 96 |
Compare with all 510(k) review times · Search every MWP clearance
Top MWP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kub Technologies, Inc. | 6 | 2021-09-20 |
| Faxitron Bioptics, LLC | 5 | 2019-03-14 |
| Bioptics, Inc. | 4 | 2010-06-16 |
| Compai Healthcare (Suzhou) Co.,Ltd | 2 | 2023-04-24 |
| Hologic, Inc. | 2 | 2019-01-10 |
7 more applicants have MWP clearances. See the full list in Caduvo.
Most recent MWP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230140 | Compai Healthcare (Suzhou) Co.,Ltd | TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) | 2023-04-24 | 96 |
| K230136 | Compai Healthcare (Suzhou) Co.,Ltd | TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) | 2023-04-24 | 96 |
| K213691 | Cirdan Imaging, Ltd. | Solas OR | 2021-12-22 | 29 |
| K210955 | Kub Technologies, Inc. | Kubtec Mozart Supra (XPERT 84) Radiography System | 2021-09-20 | 174 |
| K210957 | Kub Technologies, Inc. | Kubec Xpert 80 Radiography System | 2021-08-31 | 154 |
Recalls for MWP devices
openFDA lists no recalls for product code MWP.
Frequently asked questions
What is FDA product code MWP?
MWP is the FDA product code for cabinet, x-ray system. It is a Class II device, regulated under 21 CFR 892.1680 and reviewed by the Radiology panel.
What device class is MWP?
Class II, regulation 21 CFR 892.1680. Typical premarket route: 510(k).
How long does a 510(k) take for product code MWP?
Across 27 cleared submissions the average was 100 days from receipt to decision (median 91).
Which companies have the most MWP clearances?
Kub Technologies, Inc. (6); Faxitron Bioptics, LLC (5); Bioptics, Inc. (4); Compai Healthcare (Suzhou) Co.,Ltd (2); Hologic, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code MWP
- Run a recall and safety report across every MWP manufacturer
- Watch product code MWP 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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