WaterProof Profiler
WaterProof Profiler is a linear detector array for radiotherapy dose measurements, used with the 1230 3D Scanner. Its waterproof enclosure mounts to the scanner's movement mechanisms while…
WaterProof Profiler is a linear detector array for radiotherapy dose measurements, used with the 1230 3D Scanner. Its waterproof enclosure mounts to the scanner’s movement mechanisms while its electronics measure charge generated by ionizing radiation.
The scanner combines dose information with position data and transfers it to SNC Dosimetry software. The software displays dose distributions, analyzes parameters and exports data for treatment planning systems.
Listed Item
Radiation Therapy QA Device. For use with the 1230 3D SCANNER.
Beam Measurement
The array is 504 mm long with detectors spaced 4 mm apart. It supports treatment planning system commissioning and periodic beam quality assurance defined by the responsible medical physicist, including relative-dose measures of beam position, field size, symmetry and flatness.
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) | K142431 |
| Record published | 2019-09-25 |
| 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 |
| Storage | Storage environment temperature 10 to 40 °C; Storage environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 57.2 to 106 KiloPascal; Handling environment temperature -30 to 50 °C; Handling environment humidity 10 to 90 % RH; Handling environment atmospheric pressure 18.7 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1203300Z | In distribution | |
| 12300009Z | 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.