SMD Galaxy RTx

GUDID 06974783050009

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.

Our Smd Medical (Wuhan) Co., Ltd.

Teletherapy radionuclide system, conventional

• Primary Device ID: 06974783050009
• NIH Device Record Key: f608531e-3630-4f91-860a-f132917b1365
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMD Galaxy RTx
• Version Model Number: 3A
• 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

Customer Support Contacts

• Phone: 4000650088
• Email: jingyao.xu@ourunited.com
• Phone: 4000650088
• Email: jingyao.xu@ourunited.com
• Phone: 4000650088
• Email: jingyao.xu@ourunited.com
• Phone: 4000650088
• Email: jingyao.xu@ourunited.com
• Phone: 4000650088
• Email: jingyao.xu@ourunited.com
• Phone: 4000650088
• Email: jingyao.xu@ourunited.com
• Phone: 4000650088
• Email: jingyao.xu@ourunited.com
• Phone: 4000650088
• Email: jingyao.xu@ourunited.com
• Phone: 4000650088
• Email: jingyao.xu@ourunited.com
• Phone: 4000650088
• Email: jingyao.xu@ourunited.com
• Phone: 4000650088
• Email: jingyao.xu@ourunited.com
• Phone: 4000650088
• Email: jingyao.xu@ourunited.com
• Phone: 4000650088
• Email: jingyao.xu@ourunited.com
• Phone: 4000650088
• Email: jingyao.xu@ourunited.com
• Phone: 4000650088
• Email: jingyao.xu@ourunited.com
• Phone: 4000650088
• Email: jingyao.xu@ourunited.com
• Phone: 4000650088
• Email: jingyao.xu@ourunited.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974783050009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200050

FDA Product Code

• IWB: System, Radiation Therapy, Radionuclide

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-03
• Device Publish Date: 2025-05-26

Devices Manufactured by Our Smd Medical (Wuhan) Co., Ltd.

• 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: 2025-06-03The 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.
• 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