Carestream DRX-Evolution
Assm-Universal Grid Holder, DRX-Evolutio
7manufacturers in China registered for this device type
10catalogue numbers in this listing
11510(k) clearances naming this product code
11recalls on this code
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 | Carestream Health, Inc., United States |
|---|---|
| FDA product code | KPR |
| Device type | System, X-Ray, Stationary |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1680 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K091889 |
| Record published | 2016-09-16 |
| Record revised | 2025-12-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2025-12-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CARESTREAM DRX-EVOLUTION | In distribution | |
| CARESTREAM DRX-EVOLUTION | In distribution | |
| CARESTREAM DRX-EVOLUTION | In distribution | |
| CARESTREAM DRX-EVOLUTION | In distribution | |
| CARESTREAM DRX-EVOLUTION | In distribution | |
| CARESTREAM DRX-EVOLUTION | In distribution | |
| CARESTREAM DRX-EVOLUTION | In distribution | |
| CARESTREAM DRX-EVOLUTION | Withdrawn | |
| CARESTREAM DRX-EVOLUTION | Withdrawn | |
| CARESTREAM DRX-EVOLUTION | Withdrawn |
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 |
| 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 |
|---|---|
| K250954 | 2026-01-20 |
| K233381 | 2024-03-12 |
| K223842 | 2023-01-20 |
| K201373 | 2020-06-26 |
| K193574 | 2020-01-22 |
| K191879 | 2019-12-20 |
| K190330 | 2019-11-04 |
| K163203 | 2016-12-13 |
| K141837 | 2015-03-11 |
| K091889 | 2009-07-20 |
| K081836 | 2008-07-30 |
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 |
|---|---|---|---|---|---|---|---|
| Carestream Health, Inc. | 510(k) number | 2013-06-03 | Class II | Radiation Control for Health and Safety Act | Due to potential for an x-ray exposure technique change. | US: 49 units; Foreign: 183 units (revised) | 2014-01-29 |
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-01-30 | Class II | Software design | After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (OTC) could potentially continue the movement unexpectedly to a certain distance which could potentially result in a injury | 72 units | |
| 2020-01-06 | Class II | Component change control | Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm. | 79 | 2020-05-29 |
| 2015-08-07 | Class II | Software design | Software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph. | Domestic: 76 units, Foreign: 160 units | 2016-07-06 |
| 2014-07-09 | Class II | Device Design | An on-site evaluation of the equipment parts that attach the Beta Assembly (x-ray tube and collimator) to the Over Head Tube Crane (OTC) Telescope was completed by Carestream Health (CSH) Service Engineering. Inspection of these parts rev | 589 systems | 2017-05-12 |
| 2014-05-30 | Class II | Nonconforming Material/Component | A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Technologist is positioning the equipment using the “Up” or “Down” control buttons. Downward movement occurs at three times the normal rate of spe | Domestic: 100 units; Foreign: 46 units | 2014-12-17 |
| 2013-12-26 | Class II | Software Manufacturing/Software Deployment | Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error. | 164 units Total (42 domestically & 122 internationally) | 2017-03-10 |
| 2013-08-20 | Class II | Radiation Control for Health and Safety Act | Carestream received a report of an exposure being initiated without a patient image captured. The patient was imaged 2 times before an image was captured. The field engineer who visited the site reported the system allowed an exposure witho | 4 units | 2016-06-28 |
| 2007-12-21 | Not classified | Software design | Unintended Positioner Movement – The U-Arm Positioner starts to move 1) without command from the operator and/or 2) can unexpectedly start movement if the system is powered down and re-energized after a collision has occurred with the Quant | Domestic – 19 units | 2008-04-10 |
| 2007-03-06 | Not classified | Other | The x-ray systems do not indicate the field size when the system’s detector is turned off and the collimator is in manual mode. This results in the systems being noncompliant with the field indication performance standards of section 1020.3 | Domestic: 7 units, Canada: 2 units | 2007-07-02 |
| 2007-03-06 | Not classified | Other | The x-ray systems do not indicate the field size when the system’s detector is turned off and the collimator is in manual mode. This results in the systems being noncompliant with the field indication performance standards of section 1020.3 | Domestic: 28 units | 2007-06-29 |
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.