AlignRT 7.3 (Software)
AlignRT 7.3 Software supports patient positioning and motion monitoring on AlignRT Plus radiotherapy systems. It compares three-dimensional surface images with a reference surface and…
AlignRT 7.3 Software supports patient positioning and motion monitoring on AlignRT Plus radiotherapy systems. It compares three-dimensional surface images with a reference surface and displays positional offsets to trained radiation oncology personnel before and during treatment.
Working with the system’s cameras, the software matches skin surface data to track patient motion. The system can withhold the treatment beam when the patient moves out of position and gate delivery according to respiratory motion. Surface imaging itself does not expose the patient to ionizing radiation.
Listed Item
AlignRT 7.3 (software) used on AlignRT Plus systems
Respiratory Workflows
Respiratory tracking supports simulation for subsequent four-dimensional CT reconstruction and coaching for deep-inspiration breath hold. The software requires compatible AlignRT Plus hardware; additional functions, such as Cherenkov imaging, require their designated camera components.
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) | K233622 |
| Record published | 2024-04-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AlignRT 7.3 (software) | In distribution |
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 |
| AlignRT Plus | Vision RT Limited | 72 |
| 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 |
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
5 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 |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
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.