RADspeed Fit
RADspeed fit is a stationary X-ray system for routine radiography across the body, including skull, spine, chest, abdomen and extremities. It supports patients of all ages, including…
RADspeed fit is a stationary X-ray system for routine radiography across the body, including skull, spine, chest, abdomen and extremities. It supports patients of all ages, including children, with exposures taken sitting, standing or lying prone or supine. Mammography and tomographic techniques are excluded.
The system combines a high-voltage generator, X-ray tube, tube support and collimator. It can be configured with a radiographic table, stand and digital detector system, or used with conventional film/screen and computed radiography cassettes. Qualified professionals operate it in healthcare facilities.
Digital System Communication
The generator communicates with the digital radiography system to synchronize exposure timing, select an anatomical program and transmit exposure factors and dose information afterward. A calculated dose-area product display provides a reference value. An optional detector rotation tray changes detector orientation without removing it from the tray.
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) | K173517 |
| Record published | 2020-04-03 |
| Record revised | 2025-05-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 566-12700-65 | In distribution | |
| 566-12700-75 | 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 |
| RADspeed Pro | Shimadzu Corp. | 31 |
| 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 |
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 |
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.