TaiChiA

Primary DI
06973682570144
Brand
TaiChiA
Company
Our United Corporation
Model
TaiChiA
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.
Published
2026-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193207000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193207000TaiChiAOur United Corporation2020-08-07IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973682570144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973682570144069736825701446973682570144

GMDN Terms#

Term, Definition table
TermDefinition
Linear accelerator systemAn assembly of devices designed to produce high-energy electrons to yield high-energy x-rays used for therapeutic applications, primarily to treat cancer. It provides a uniform radiation field of uniform intensity and predictable energy level, in a beam with well defined dimensions. The principle of operation is linear acceleration of electrons by means of electromagnetic (EM) microwaves. The output is used as a treatment beam on the patient, either directly or after passing a suitable target. The system typically includes signal analysis and display devices, patient and device supports, and software.

Regulatory Flags#

DUNS number
560458511
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973682570151CybeRayCybeRay2026-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.IYE2026-04-22
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08720168162779DSPS-Prominent® Cradle-IIIMACROMEDICS B.V.IYE2026-04-22
08720168162786DSPS-Prominent® Cradle-IVMACROMEDICS B.V.IYE2026-04-22