FDR Visionary Suite
FDR Visionary Suite is a stationary X-ray system for general radiographic and tomographic examinations in patients of all ages, including children. It combines a high-voltage generator,…
FDR Visionary Suite is a stationary X-ray system for general radiographic and tomographic examinations in patients of all ages, including children. It combines a high-voltage generator, X-ray tube, support, collimator and digital radiography equipment, with table or stand configurations.
The system acquires images using flat-panel detectors and can also use conventional film-screen or computed-radiography cassettes. Examinations can be performed with patients sitting, standing or lying prone or supine.
Tomosynthesis Option
Optional tomosynthesis reconstructs cross-sectional planes from a series of exposures. Filtered back-projection and shift-and-add modes are available; shift-and-add images are intended to accompany filtered back-projection images. The system is for trained professionals in healthcare facilities and is not intended for mammography.
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) | K152294 |
| Record published | 2020-08-07 |
| 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 |
|---|---|---|
| 566-16130-63 | In distribution | |
| 566-16130-31 | In distribution | |
| 566-16130-82 | In distribution | |
| 566-16130-22 | In distribution | |
| 566-16130-52 | In distribution | |
| 566-16130-33 | In distribution | |
| 566-16130-81 | In distribution | |
| 566-16130-83 | In distribution | |
| 566-16130-23 | In distribution | |
| 566-16130-53 | In distribution | |
| 566-16130-51 | In distribution | |
| 566-16130-61 | In distribution | |
| 566-16130-60 | In distribution | |
| 566-16130-50 | In distribution | |
| 566-16130-62 | In distribution | |
| 566-16130-21 | In distribution | |
| 566-16130-32 | 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 |
| 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
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Fujifilm Healthcare Americas Corporation | 510(k) number | 2026-01-09 | Class II | Process control | It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the dev | 16 units | |
| Fujifilm Healthcare Americas Corporation | 510(k) number | 2025-09-15 | Class II | Device Design | It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while | 16 units | |
| Fujifilm Healthcare Americas Corporation | 510(k) number | 2024-04-11 | Class II | Component design/selection | Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury | 18 units | |
| Fujifilm Healthcare Americas Corporation | 510(k) number | 2017-06-15 | Class II | Device Design | A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography System FDR Visionary Suite. The X-ray tube assembly in these devices is mounted to a tube mounting flange, which is part of the tube holding s | 3 | 2018-05-09 |
| 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.