Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat Vision RT Limited makes
Vision RT Limited manufactures radiological video camera systems for patient positioning and tracking, as well as software applications for patient administration information and radiation therapy. Their product line includes the SafeRT-ID system, the AlignRT Plus camera system, and the MapRT Web application, which together support real‑time imaging and treatment planning in radiation oncology.
The devices are regulated as Class I and Class II medical devices and are listed in the FDA 510(k) and FDA UDI registries. Vision RT Limited is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Vision RT Limited manufacture?
Vision RT Limited specializes in radiological video camera systems designed for patient positioning and tracking, as well as software applications for radiation therapy and patient administration. Their product line includes systems like the SafeRT-ID for real-time imaging and the AlignRT Plus camera system, which aids in precise patient alignment during treatment. Additionally, they offer the MapRT Web app, which supports treatment planning and data management in radiation oncology.
Where is Vision RT Limited based, and how does that affect its regulatory oversight?
Vision RT Limited is based in the United States, which means its devices fall under FDA regulation. The company’s products are listed in the FDA’s 510(k) and UDI registries, indicating they are subject to premarket notification and unique device identification requirements. The FDA classifies these devices as either Class I or Class II, depending on their risk level and intended use.
Which regulatory registries list Vision RT Limited’s devices?
Vision RT Limited’s devices are included in the FDA’s 510(k) registry, which tracks premarket submissions for medical devices requiring clearance before commercial distribution. They are also listed in the FDA’s UDI (Unique Device Identification) system, ensuring traceability and compliance with identification requirements for medical products in the U.S. market.
How are Vision RT Limited’s devices classified under FDA regulations?
Vision RT Limited’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may be exempt from some premarket controls, while Class II devices require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body system it interacts with, such as radiological imaging or radiation therapy software.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- visionrt.com
- —
- —
- [email protected]
- Phone
- +1 866 594 5443
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 222160801
Catalogue (41)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SafeRT-ID | Application Software | FDA UDI | Class I | Active |
| AlignRT Plus | AlignRT Offline | FDA UDI | Class II | Unknown |
| AlignRT Plus | OSMS 5.1 - TB 115V | FDA UDI | Class II | Active |
| AlignRT Plus | Touchless4D | FDA UDI | Class II | Active |
| AlignRT Plus | HP Z2 G9 workstation - AlignRT Offline | FDA UDI | Class II | Active |
| AlignRT Plus | Workstation Z4 - IGB GEN ART | FDA UDI | Class II | Active |
| AlignRT Plus | Patient Data Workstation Z2T | FDA UDI | Class II | Active |
| MapRT Web app | MapRT Web app | FDA UDI | Class II | Active |
| Respiratory Module | Respiratory Module | FDA UDI | Class II | Unknown |
| AlignRT Plus | Workstation Z4 - IGC Gen GCT | FDA UDI | Class II | Active |
| AlignRT Plus | Workstation Z4 - ART | FDA UDI | Class II | Active |
| AlignRT Plus | HD CAM Gen 5 | FDA UDI | Class II | Active |
| AlignRT Plus | HP Z2 G9 workstation - Patient Data Workstation | FDA UDI | Class II | Active |
| AlignRT Plus | Workstation Z4 - IGC TB ART | FDA UDI | Class II | Active |
| AlignRT Plus | OSMS 5.1 115V | FDA UDI | Class II | Active |
| AlignRT Plus | GateRT | FDA UDI | Class II | Active |
| SafeID | SafeID Server WebAPI | FDA UDI | Class I | Active |
| AlignRT Plus | Workstation Z4 - OSMS TB | FDA UDI | Class II | Active |
| AlignRT Plus | Workstation Z4 - IGB CS ART | FDA UDI | Class II | Active |
| AlignRT Plus | Lenovo P340 workstation | FDA UDI | Class II | Active |
| AlignRT Plus | OSMS 5.0 - TB 115V | FDA UDI | Class II | Active |
| MapRT Web app | MapRT Web app 1.1 | FDA UDI | Class II | Active |
| AlignRT Plus | Workstation Z2 | FDA UDI | Class II | Active |
| SafeID | Pole | FDA UDI | Class I | Unknown |
| AlignRT Plus | HP Z2 G9 workstation - SimRT | FDA UDI | Class II | Active |
| SafeID | SafeID Kiosk Box | FDA UDI | Class I | Unknown |
| AlignRT Plus | ART Remote Control | FDA UDI | Class II | Active |
| Vision RT | AlignRT | FDA UDI | Class II | Unknown |
| AlignRT Plus | Workstation Z4 - OSMS CS | FDA UDI | Class II | Active |
| SafeRT-ID | Server Software | FDA UDI | Class I | Active |
| AlignRT Plus | OSMS 5.0 | FDA UDI | Class II | Active |
| AlignRT Plus | Remote Control | FDA UDI | Class II | Active |
| SafeRT-ID | SafeRT-ID (no interlock) | FDA UDI | Class I | Unknown |
| AlignRT Plus | OSMS Remote Control | FDA UDI | Class II | Active |
| AlignRT Plus | AlignRT | FDA UDI | Class II | Unknown |
| AlignRT Plus | Patient Data Workstation | FDA UDI | Class II | Active |
| AlignRT Plus | OSMS 6.2 - 115V | FDA UDI | Class II | Unknown |
| SafeRT-ID | SafeRT-ID (with interlock) | FDA UDI | Class I | Unknown |
| AlignRT Plus | GateCT | FDA UDI | Class II | Active |
| MapRT acquisition software | MapRT acquisition software | FDA UDI | Class II | Active |
| Gatect-Rt | K072171 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.