RADspeed Pro
RADspeed Pro is a stationary X-ray system for routine radiographic and tomographic imaging of the body. It supports digital detectors, conventional film/screen and computed radiography…
RADspeed Pro is a stationary X-ray system for routine radiographic and tomographic imaging of the body. It supports digital detectors, conventional film/screen and computed radiography cassettes. Qualified professionals use it in hospitals, clinics or imaging centers for patients of all ages, including children.
The system includes a high-voltage generator, tube, tube support and collimator, with optional table, stand and digital imaging configurations. Patients may be imaged sitting, standing or lying prone or supine. Mammographic applications are excluded.
Optional Tomosynthesis
The tomosynthesis option reconstructs a selected cross-sectional plane from acquired projections. Available modes include filtered back-projection, shift addition and iterative reconstruction. The iterative mode addresses metal artifacts, while shift addition can address artifacts observed at joints and similar locations.
Who Else Makes It
Concentrated in Shanghai (3), Beijing (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Orich Medical Equipment (Tianjin) Co., Ltd. | Tianjin | Tianjin | Manufacturer | 5 |
Record
| Listed by | Shimadzu Corp., United States |
|---|---|
| FDA product code | KPR |
| Device type | System, X-Ray, Stationary |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1680 |
| 510(k) | K152244 |
| Record published | 2016-09-16 |
| Record revised | 2025-05-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 503-79460-41 | In distribution | |
| 503-79460-63 | In distribution | |
| 566-26000-30 | In distribution | |
| 503-79460-26 | In distribution | |
| 503-79460-53 | In distribution | |
| 503-79460-64 | In distribution | |
| 566-26000-43 | In distribution | |
| 566-26000-31 | In distribution | |
| 503-79460-61 | In distribution | |
| 503-79460-23 | In distribution | |
| 503-79460-06 | In distribution | |
| 566-26007-32 | In distribution | |
| 566-26000-41 | In distribution | |
| 503-79460-42 | In distribution | |
| 503-79460-01 | In distribution | |
| 503-79460-52 | In distribution | |
| 503-79460-02 | In distribution | |
| 503-79460-43 | In distribution | |
| 503-77550-09 | In distribution | |
| 503-79460-22 | In distribution | |
| 503-79460-21 | In distribution | |
| 566-26000-40 | In distribution | |
| 566-26000-21 | In distribution | |
| 566-26000-42 | In distribution | |
| 503-79460-62 | In distribution | |
| 503-79460-03 | In distribution | |
| 503-77550-11 | In distribution | |
| 566-26007-01 | In distribution | |
| 503-79460-51 | In distribution | |
| 566-26000-33 | In distribution | |
| 503-77550-10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drgem | Drgem Corporation | 171 |
| Q-RAD System | Carestream Health, Inc. | 159 |
| DRX – Ascend System | Carestream Health, Inc. | 121 |
| FDR Clinica | Drgem Corporation | 41 |
| FDR Visionary Suite | Shimadzu Corp. | 17 |
| Exsys DEXi | Drtech Corporation | 15 |
| Del Medical, Inc. | DEL Medical, Inc. | 15 |
| GXR-Es,ecs Diagnostic X-ray System | Drgem Corporation | 14 |
| X-CEL X-RAY Corporation | Arquilla, Inc. | 14 |
| DRX-Evolution Plus System | Carestream Health, Inc. | 12 |
| Carestream DRX-Evolution | Carestream Health, Inc. | 10 |
| System, X-Ray, Stationary | Samsung Electronics Co., Ltd. | 8 |
Showing 12 of 138. All products under System, X-Ray, Stationary
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233719 | 2024-03-28 |
| K233722 | 2024-02-23 |
| K173517 | 2018-03-30 |
| K152294 | 2016-07-15 |
| K152244 | 2016-06-20 |
| K990715 | 1999-04-16 |
| K942792 | 1994-07-29 |
| K934005 | 1993-11-24 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Shimadzu Medical Systems Usa Com | 510(k) number | 2017-05-23 | Class II | Device Design | Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. | 1673 units total | 2019-10-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.