AlignRT Plus
The InBore imaging assembly is optional camera hardware for AlignRT Plus when used with bore-based linear accelerators. It contributes to a video-based three-dimensional surface imaging…
The InBore imaging assembly is optional camera hardware for AlignRT Plus when used with bore-based linear accelerators. It contributes to a video-based three-dimensional surface imaging system that captures the patient’s skin surface before and during radiotherapy. Imaging does not require body markers or ionizing radiation.
The wider system combines camera units, processing software and a computer workstation. Surface matching during setup and treatment identifies changes in patient position relative to the prescribed treatment isocenter. The optional camera belongs to that surface-tracking system.
Listed Item
InBore Patient Imaging Assembly – Pinned
Treatment Monitoring Role
AlignRT Plus can supply position monitoring and respiratory gating signals, with user-selected surface points tracked in real time. During radiation delivery, the system can withhold the beam if the patient moves outside user-defined tolerances. The InBore camera extends the hardware configuration for a bore-based treatment environment.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Beijing (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Tian Hong Medical Technology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 4 |
| Klarity Medical & Equipment (GZ) Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 3 |
| Elekta Beijing Medical Systems Co., Ltd. | Beijing | Beijing | Contract manufacturer | 1 |
| Manteia Technologies Co., Ltd. | Xiamen | Fujian | Manufacturer | 3 |
| OUR United Corporation | Xian | Shaanxi | Contract manufacturer | 2 |
| Suzhou Linatech Medical Science AND Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Varian Medical Systems China Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Jiangsu Rayer Medical Technology Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Vision RT Limited, United Kingdom |
|---|---|
| FDA product code | IYE |
| Device type | Accelerator, Linear, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Specification developer, Private-label distributor, Complaint-file establishment, Manufacturer |
| 510(k) | K203387 |
| Record published | 2021-09-23 |
| Record revised | 2022-12-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-12-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HD CAM Gen 5 | In distribution | |
| AlignRT InBore | In distribution | |
| Calibration Cube Mk2 | In distribution | |
| InBore Power Repeater | In distribution | |
| Workstation Z4 – IGC TB ART | In distribution | |
| Real Time Coach | In distribution | |
| HP Z2 G9 workstation – AlignRT InBore | In distribution | |
| InBore Patient Imaging Assembly | In distribution | |
| HP Z2 G9 workstation – SimRT | In distribution | |
| Fujitsu M7010X | In distribution | |
| GateRT | In distribution | |
| DoseRT camera-computer interface box | In distribution | |
| HP Z2 G9 workstation – AlignRT Offline | In distribution | |
| Patient Data Workstation | In distribution | |
| Touchless4D | In distribution | |
| Horizon camera | In distribution | |
| ART Remote Control | In distribution | |
| InBore 60mm Calibration Plate Riser | In distribution | |
| Workstation Z2 | In distribution | |
| HP Z2 G9 workstation – AlignRT | In distribution | |
| OSMS 5.0 – TB 115V | In distribution | |
| AlignRT Offline Z2T | In distribution | |
| DoseRT workstation | In distribution | |
| InBore Fibre Hub | In distribution | |
| Real Time Coach | In distribution | |
| Mevion Interface Unit | In distribution | |
| AlignRT 6.3 | In distribution | |
| InBore System Cabinet | In distribution | |
| OSMS 5.0 | In distribution | |
| AlignRT InBore 7.0 | In distribution | |
| Power Distribution Unit | In distribution | |
| DoseRT isolation transformer | In distribution | |
| InBore Patient Imaging Assembly | In distribution | |
| Head Adjuster | In distribution | |
| DoseRT (software) | In distribution | |
| Calibration Plate | In distribution | |
| HD CAM | In distribution | |
| Lenovo P340 workstation | In distribution | |
| Workstation Z4 – OSMS TB | In distribution | |
| OSMS 5.1 115V | In distribution | |
| Varian ProBeam Hold – Switch Box | In distribution | |
| SimRT 7.2 | In distribution | |
| Horizon camera (close range) | In distribution | |
| Power Supply Unit (PSU) | In distribution | |
| GateCT | In distribution | |
| Workstation Z4 – IGC Gen GCT | In distribution | |
| Real Time Coach MK2 | In distribution | |
| HP Z2 G9 workstation – Patient Data Workstation | In distribution | |
| Workstation Z4 – ART | In distribution | |
| Workstation Z4 – IGB GEN ART | In distribution | |
| Real Time Coach (RTC) MK3 | In distribution | |
| Patient Data Workstation Z2T | In distribution | |
| SimRT 7.2 system | In distribution | |
| DoseRT camera (phase 2) | In distribution | |
| Workstation Z4 – OSMS CS | In distribution | |
| AlignRT 7.4 | In distribution | |
| HP Z2 G9 workstation – upgrades | In distribution | |
| Remote Control | In distribution | |
| OSMS 5.1 – TB 115V | In distribution | |
| AlignRT InBore 6.4 | In distribution | |
| OSMS Remote Control | In distribution | |
| Calibration Plate Narrow | In distribution | |
| Workstation Z4 – IGB CS ART | In distribution | |
| MMI 1.0 Breakout Box | In distribution | |
| AlignRT | Withdrawn | |
| AlignRT 6.0 | Withdrawn | |
| AlignRT 6.2 | Withdrawn | |
| AlignRT 6.1 | Withdrawn | |
| AlignRT Offline | Withdrawn | |
| OSMS 6.2 – 115V | Withdrawn | |
| DoseRT (software phase 2) | Withdrawn | |
| AlignRT Plus 6.x – 115V & 230V | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Klarity Medical | Klarity Medical Products, LLC | 891 |
| Orfit Industries | Orfit Industries NV | 680 |
| Aquaplast RT™ | Qfix | 569 |
| Fibreplast® | Qfix | 271 |
| Bionix Radiation Therapy | Bionix Radiation Therapy, LLC | 115 |
| Vac-Lok™ Cushion | Medtec LLC | 100 |
| Visicoil | IZI Medical Products LLC | 86 |
| BodyFIX | 3C-Medical Intelligence GmbH | 84 |
| Fibreplast® Assure™ Open View | Qfix | 72 |
| Accelerator, Linear, Medical | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 71 |
| Thermoplastic Mask | IZI Medical Products LLC | 58 |
| Gold Anchor | Naslund Medical AB | 58 |
Showing 12 of 1,611. All products under Accelerator, Linear, Medical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253012 | 2026-03-18 |
| K243301 | 2025-05-19 |
| K233622 | 2024-03-29 |
| K231185 | 2023-06-23 |
| K212583 | 2021-11-10 |
| K203387 | 2021-03-04 |
| K193431 | 2020-01-03 |
| K181218 | 2018-08-07 |
| K123371 | 2013-01-08 |
| K072171 | 2007-10-01 |
| K052682 | 2006-01-06 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Vision RT Limited | 510(k) number | 2018-08-24 | Class II | Software design | RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB | 690 systens | 2022-07-08 |
| Vision RT Limited | 510(k) number | 2016-06-30 | Class II | Other | Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical Su | 47 | 2017-09-20 |
| Varian Medical Systems, Inc | 510(k) number | 2016-06-23 | Class II | Software design | Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the | 166 OSMS in US, 23 OSMO – International, | 2018-08-24 |
| Varian Medical Systems, Inc | 510(k) number | 2016-06-23 | Class II | Software design | Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the | 21 AlignRT Plus in US, 1 International. | 2018-08-24 |
| Vision RT Limited | 510(k) number | 2014-10-15 | Class II | Software in the Use Environment | Potential failure of AlignRT to assert interlock. | 7 (Six Units distribited in the US and One in OUS.) | 2016-05-10 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-06-30 | Class II | Other | Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical Su | 47 | 2017-09-20 |
| 2014-11-11 | Class II | Under Investigation by firm | Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened. | 55 | 2016-05-11 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.