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510(k) Data Aggregation
K Number
K210921Device Name
TaiChiB
Manufacturer
Our United Corporation
Date Cleared
2021-11-02
(218 days)
Product Code
IYE, IWB
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
Our United Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TaiChiB Digital Radiotherapy System is a teletherapy device equipped with two radiation beam delivery units within an enclosed gantry.
(1) The electron linear accelerator producing 6MV photon beam is indicated to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
(2) The rotating focused gamma beam emitting unit with multiple Cobalt-60 sources is indicated to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions in the brain and head where radiation treatment is indicated.
Device Description
TaiChiB Digital Radiotherapy System integrates medical linear accelerator technology and rotating gamma technology for precision radiotherapy and stereotactic radiosurgery.
TaiChiB contains a gantry with a slip ring, 6 MV X-ray Beam Generation Module (BGM), Beam Shaping Module (BSM), Rotating Gamma Subsystem (RGS), Image Guidance System (IGS), Patient Support System (PSS), Treatment Control System (TCS).
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K Number
K203250Device Name
TaiChiC
Manufacturer
Our United Corporation
Date Cleared
2021-03-12
(128 days)
Product Code
IWB
Regulation Number
892.5750Why did this record match?
Applicant Name (Manufacturer) :
Our United Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The system is a teletherapy device intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions in the brain and head where radiation treatment is indicated.
Device Description
TaiChiC Rotating Gamma System has been designed to deliver radiation treatments in accordance with a prescribed plan. This system is a stereotactic radiotherapy equipment developed by applying the principle and mature technology of Cobalt-60 rotary focusing. It is suitable for brain and head lesions and tumors requiring radiotherapy, and provides image guided stereotactic radiosurgery and precision radiotherapy.
TaiChiC consists of a gantry with a slip ring, a focusing gamma ray treatment head, image guidance subsystem, couch, power supply and electrical cabinet, main cover and treatment bore etc. TaiChiC combines gamma beam stereotactic radiation therapy technology with contemporary advanced image guidance technology (IGRT) to provide image guided stereiotactic radiotherapy and precision radiotherapy.
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K Number
K193207Device Name
TaiChiA
Manufacturer
Our United Corporation
Date Cleared
2020-08-07
(261 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
Our United Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TaiChiA, is a Medical Linear Accelerator intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Device Description
TaiChiA Medical Linear Accelerator, has been designed to deliver radiation treatment in accordance with a prescribed plan. This system utilizes kV image guidance technology (IGRT) to deliver photon based radiation therapy treatments, using an integrated rotating linear accelerator system. TaiChiA is a single energy medical linear accelerator designed to deliver Image Guided Radiation Therapy and Radiosurgery, using 3DCRT, IMRT and VMAT techniques. It consists of the accelerator and patient support within a radiation shielded treatment room and a control console in the control room.
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