Identity
- Trade Name
- SMD Galaxy RTx FDA UDI
- Generic Name
- Teletherapy radionuclide system, conventional FDA UDI
- Device Name
- The device contains 30 Cobalt-60 sources, distributed in a single, compact source carrier or source drawer, which is inside a hemispheric shield. Immediately adjacent to the source unit is the "built-in" primary collimator. An independently rotating secondary collimator hemisphere contains 4 sizes of collimator and a blocking position. The rotating gamma system focuses the thirty beams and combining their individual doses at the target. The design of the system automates the treatment delivery by moving the target to the focal point, while the patient’s head is immobilized in a head frame which has been fitted prior to the commencement of treatment. The entire system consists of a) the gamma ray treatment unit, and b) the stereo-tactic localization system. FDA UDI
- Model / Reference
- 3A FDA UDI
- Description
- The device contains 30 Cobalt-60 sources, distributed in a single, compact source carrier or source drawer, which is inside a hemispheric shield. Immediately adjacent to the source unit is the "built-in" primary collimator. An independently rotating secondary collimator hemisphere contains 4 sizes of collimator and a blocking position. The rotating gamma system focuses the thirty beams and combining their individual doses at the target. The design of the system automates the treatment delivery by moving the target to the focal point, while the patient’s head is immobilized in a head frame which has been fitted prior to the commencement of treatment. The entire system consists of a) the gamma ray treatment unit, and b) the stereo-tactic localization system. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974783050009 FDA UDI
- 510(k) Number
- K200050 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 Galaxy RTx 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 f608531e-3630-4f91-860a-f132917b1365 35 fields · synced May 30, 2026