Identity
- Trade Name
- SMD-XGD/AR Galaxy FDA UDI
- Generic Name
- Teletherapy radionuclide system, conventional FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 1A FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974783050023 FDA UDI
- 510(k) Number
- K190844 FDA UDI
- FDA Product Code
- IWB FDA UDI
- GMDN Term
- Teletherapy radionuclide system, conventional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Teletherapy radionuclide system, conventional
SMD-XGD/AR Galaxy by Our Smd Medical (Wuhan) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Our Smd Medical (Wuhan) Co., Ltd.
Sources (1)
- FDA UDI 0587e971-f585-44d6-8583-3570b9e7c172 35 fields · synced May 30, 2026