Del Medical, Inc.
The Straight Arm is an economical and space-efficient X-ray system that can perform a comprehensive range of radiographic procedures. Its flexibility permits imaging of patients sitting or…
The Straight Arm is an economical and space-efficient X-ray system that can perform a comprehensive range of radiographic procedures. Its flexibility permits imaging of patients sitting or standing, as well as recumbent when optional mobile table is present.
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 | DEL Medical, Inc., United States |
|---|---|
| FDA product code | KPR |
| Device type | System, X-Ray, Stationary |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1680 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K223550 |
| Record published | 2026-03-05 |
| Record revised | 2026-03-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Distribution end date | 2026-03-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DMX | In distribution | |
| FM-OTC18M | In distribution | |
| DM-FWFC | In distribution | |
| FM-OTC18T | In distribution | |
| FM-FMT18T | In distribution | |
| FM-FMT18M | In distribution | |
| DM-FMT18T | In distribution | |
| CM-OTC18T | In distribution | |
| DM-FMT18M | In distribution | |
| CM-OTC18M | In distribution | |
| DM-FMT | In distribution | |
| DM-OTC18S | In distribution | |
| DM-OTC18M | In distribution | |
| DM-OTC18T | In distribution | |
| DM-SARM | Withdrawn |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 |
| 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 |
|---|---|
| K223550 | 2023-04-10 |
| K152767 | 2015-12-14 |
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.