SMD-XGD/AR Galaxy
Basic Information
- Brand Name
- SMD-XGD/AR Galaxy
- Primary DI
- 06974783050023
- Version / Model
- 1A
- Company Name
- Our Smd Medical (Wuhan) Co., Ltd.
- Labeler DUNS
- 530271160
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-30
- Public Version
- 1
- Public Version Date
- 2025-06-09
- Public Version Status
- New
- Public Device Record Key
- 0587e971-f585-44d6-8583-3570b9e7c172
Device Description
The 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IWB | System, Radiation Therapy, Radionuclide | Radiology | 892.5750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38297 | Teletherapy radionuclide system, conventional | A stationary assembly of computer-based devices designed to deliver a therapeutic radiation dose to an anatomical region from a single external radiation beam produced by a radionuclide source, typically to treat malignant tumours; it does not provide image-guided radiation therapy (IGRT) functionality during treatment delivery. A typical system is: 1) the treatment head (a shielded source vault containing a single radioactive source); 2) a rotating or fixed gantry with the treatment head; 3) a collimator mechanism attached to the gantry to align the treatment beam; 4) a moveable patient table; and 5) an operator's console with controls. It is commonly known as a cobalt therapy machine. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06974783050023 | GS1 |
Customer Contacts
- Phone
- 4000650088
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190844 | 000 |