| Primary Device ID | 06974783050023 |
| NIH Device Record Key | 0587e971-f585-44d6-8583-3570b9e7c172 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SMD-XGD/AR Galaxy |
| Version Model Number | 1A |
| Company DUNS | 530271160 |
| Company Name | Our Smd Medical (Wuhan) Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 4000650088 |
| jingyao.xu@ourunited.com | |
| Phone | 4000650088 |
| jingyao.xu@ourunited.com | |
| Phone | 4000650088 |
| jingyao.xu@ourunited.com | |
| Phone | 4000650088 |
| jingyao.xu@ourunited.com | |
| Phone | 4000650088 |
| jingyao.xu@ourunited.com | |
| Phone | 4000650088 |
| jingyao.xu@ourunited.com | |
| Phone | 4000650088 |
| jingyao.xu@ourunited.com | |
| Phone | 4000650088 |
| jingyao.xu@ourunited.com | |
| Phone | 4000650088 |
| jingyao.xu@ourunited.com | |
| Phone | 4000650088 |
| jingyao.xu@ourunited.com | |
| Phone | 4000650088 |
| jingyao.xu@ourunited.com | |
| Phone | 4000650088 |
| jingyao.xu@ourunited.com | |
| Phone | 4000650088 |
| jingyao.xu@ourunited.com | |
| Phone | 4000650088 |
| jingyao.xu@ourunited.com | |
| Phone | 4000650088 |
| jingyao.xu@ourunited.com | |
| Phone | 4000650088 |
| jingyao.xu@ourunited.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06974783050023 [Primary] |
| IWB | System, Radiation Therapy, Radionuclide |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-09 |
| Device Publish Date | 2025-05-30 |
| 06974783050023 - SMD-XGD/AR Galaxy | 2025-06-09The SMD-XGD/AR Galaxy Rotating Gamma System is a teletherapy device which contains 30 cobalt - 60 sources distributed on a hemispheric source carrier, which is inside a hemispheric shield. Inside the source unit is the "built-in" secondary collimator, which has 4 sizes of collimators and 1 block position. When not treating a patient, all sources are aligned with the block position of the secondary collimator, which in this case acts as a radiation shutter Treatment starts by aligning the sources to the desired collimator size, then both the source unit and the secondary collimator rotates as one unit. By rotating the cobalt -60 y-ray beams during treatment, 30 non-overlapping full 360° arcs are formed, resulting in high focal dose uniformity and small focal spot penumbra. The entire system consists of a) The y-ray treatment unit, and b) the stereotactic localization system. |
| 06974783050023 - SMD-XGD/AR Galaxy | 2025-06-09 The SMD-XGD/AR Galaxy Rotating Gamma System is a teletherapy device which contains 30 cobalt - 60 sources distributed on a hemis |
| 06974783050009 - SMD Galaxy RTx | 2025-06-03 The device contains 30 Cobalt-60 sources, distributed in a single, compact source carrier or source drawer, which is inside a he |