EPIDose
EPIDose Model 1214 is software that converts electronic portal imaging device images into a dose distribution for radiation therapy quality assurance. The filing describes comparing that…
EPIDose Model 1214 is software that converts electronic portal imaging device images into a dose distribution for radiation therapy quality assurance.
The filing describes comparing that distribution with a planned dose distribution. It identifies the software for radiotherapy beam quality assurance of treatment plans delivered on devices with an EPID.
Dose Comparison
For the stated comparison, the filing describes conversion to a phantom dose distribution and comparison with a simulated dose distribution in the same phantom geometry, as calculated by the treatment planning system.
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) | K131704 |
| Record published | 2017-01-14 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12140000 | In distribution | |
| 1214 | 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.