AlignRT
AlignRT system
8manufacturers in China registered for this device type
2catalogue numbers in this listing
11510(k) clearances naming this product code
5recalls on this code
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) | K072171 |
| Record published | 2026-04-27 |
| Record revised | 2026-04-20 (version 3) |
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 |
|---|---|---|
| GATECT-RT 1.0 | In distribution | |
| AlignRT 5.x 115V or 230V | 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 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.