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 ID06974783050009
NIH Device Record Keyf608531e-3630-4f91-860a-f132917b1365
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMD Galaxy RTx
Version Model Number3A
Company DUNS530271160
Company NameOur Smd Medical (Wuhan) Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone4000650088
Emailjingyao.xu@ourunited.com
Phone4000650088
Emailjingyao.xu@ourunited.com
Phone4000650088
Emailjingyao.xu@ourunited.com
Phone4000650088
Emailjingyao.xu@ourunited.com
Phone4000650088
Emailjingyao.xu@ourunited.com
Phone4000650088
Emailjingyao.xu@ourunited.com
Phone4000650088
Emailjingyao.xu@ourunited.com
Phone4000650088
Emailjingyao.xu@ourunited.com
Phone4000650088
Emailjingyao.xu@ourunited.com
Phone4000650088
Emailjingyao.xu@ourunited.com
Phone4000650088
Emailjingyao.xu@ourunited.com
Phone4000650088
Emailjingyao.xu@ourunited.com
Phone4000650088
Emailjingyao.xu@ourunited.com
Phone4000650088
Emailjingyao.xu@ourunited.com
Phone4000650088
Emailjingyao.xu@ourunited.com
Phone4000650088
Emailjingyao.xu@ourunited.com
Phone4000650088
Emailjingyao.xu@ourunited.com

Device Identifiers

Device Issuing AgencyDevice ID
GS106974783050009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IWBSystem, Radiation Therapy, Radionuclide

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-03
Device Publish Date2025-05-26

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