SunCHECK
The listed Model 1299028 is SunCHECK, a server-based web application accessible from a networked computer. The FDA filing describes a platform for radiation therapy patient quality…
The listed Model 1299028 is SunCHECK, a server-based web application accessible from a networked computer. The FDA filing describes a platform for radiation therapy patient quality assurance, machine quality assurance and data-management workflows.
Its stated purpose is to collect, detect, compare, calculate, analyze, display and store radiotherapy quality-assurance and dosimetry data.
Listed Item
SunCHECK is a software platform intended to collect, detect, compare, calculate, analyze, display, and store radiotherapy quality assurance and dosimetry data. SunCHECK is a server-based Web application which is accessible from any networked PC. It is intended to provide radiation therapy professionals with a platform that integrates patient QA, machine QA and data management workflows. This platform consists of a single GUI and database that is intended to provide a centralized view of a radiation therapy department’s QA efforts.
Quality Workflows
The filing describes a single interface and database intended to give a centralized view of a radiation therapy department’s quality-assurance work. The named functions also include treatment-device and imaging-system quality assurance.
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 | Sun Nuclear Corporation, United States |
|---|---|
| FDA product code | IYE |
| Device type | Accelerator, Linear, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K170307 |
| Record published | 2020-04-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1299028 | 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 |
|---|---|
| K170307 | 2017-10-25 |
| K161946 | 2016-09-16 |
| K160057 | 2016-05-13 |
| K142617 | 2015-11-20 |
| K150848 | 2015-05-20 |
| K142431 | 2014-12-05 |
| K142142 | 2014-12-05 |
| K141800 | 2014-09-26 |
| K131862 | 2013-08-21 |
| K131466 | 2013-08-20 |
| K131704 | 2013-08-05 |
| K101992 | 2010-10-01 |
| K092019 | 2009-09-15 |
| K063021 | 2006-11-22 |
| K051921 | 2005-07-27 |
| K021463 | 2002-06-06 |
| K011332 | 2001-07-26 |
| K010449 | 2001-05-04 |
| K002444 | 2000-10-18 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2014-08-08 | Class II | Use error | Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment. | 6 Units. | 2015-03-23 |
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.