TaiChiC Radiation Therapy Radionuclide System
by Our United Corporation 510(k)
Active
510(k) K203250
Overview
The TaiChiC is a Radiation Therapy Radionuclide System (product code IWB), designed for targeted internal radiotherapy. It delivers controlled doses of radionuclides to treat specific pathological tissues, such as those in oncology applications. The device operates under Class II regulatory controls, incorporating special design and manufacturing requirements to ensure safety and efficacy in clinical settings. Its classification aligns with the FDA’s Radiation Therapy category, where precise dosing and shielding are critical.
This system is intended for use in radiology departments within hospitals or specialized treatment centers. It is supplied as a reusable medical device, requiring adherence to sterile preparation protocols and maintenance procedures as outlined in the manufacturer’s instructions. The device is MRI-unsafe due to its radionuclide components and must be stored in designated radiation-controlled areas with appropriate shielding. Authorized for use in the United States under FDA 510(k) clearance (K203250), it complies with regulatory requirements for Class II devices under the Radiation Therapy Radionuclide product code (IWB)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK203250 | Date12 Mar 2021 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- TaiChiC
- 510(k) Number
- FDA Product Code
- IWB
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5750
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Our United Corporation
Questions
What is the TaiChiC Radionuclide System used for?
The TaiChiC is designed for targeted internal radiotherapy, delivering controlled doses of radionuclides to treat specific pathological tissues, primarily in oncology applications. It is intended for use in radiology departments within hospitals or specialized treatment centers where precise dosing and shielding are critical.
Is the TaiChiC a single-use or reusable device?
The TaiChiC is supplied as a reusable medical device. It requires adherence to sterile preparation protocols and maintenance procedures as outlined in the manufacturer’s instructions to ensure safety and efficacy during repeated use.
Where must the TaiChiC be stored?
Due to its radionuclide components, the TaiChiC must be stored in designated radiation-controlled areas with appropriate shielding. This ensures safety for personnel and compliance with regulatory requirements for handling radioactive materials.
Can the TaiChiC be used in an MRI environment?
No, the TaiChiC is MRI-unsafe because of its radionuclide components. It should never be placed in or near an MRI scanner, as this could pose significant safety risks to patients and staff.
What regulatory approval does the TaiChiC hold?
The TaiChiC is authorized for use in the United States under FDA 510(k) clearance (K203250). It complies with regulatory requirements for Class II devices under the Radiation Therapy Radionuclide product code (IWB), ensuring it meets special design and manufacturing standards for safety and efficacy.