3d Scanner TPR Option
Accessory to the 1230 3D SCANNER.
8manufacturers in China registered for this device type
1catalogue number
19510(k) clearances naming this product code
1recall
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) | K101992 |
| Record published | 2017-01-14 |
| Record revised | 2019-06-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Special storage condition: Do not store the instrument in the treatment room.; Special storage condition: Never leave the instrument on the couch during delivery system warm up.; Special storage condition: Never expose the 3D TPR electronic circuits to the direct radiation beam.; Special storage condition: Store 3D TPR in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where s; Special storage condition: Ensure that all 3D TPR parts, including cable and connector, are clean and dry before placing in storage case. Dry with; Special storage condition: If connector is accidentally immersed in water, allow to dry completely before connecting to 3D SCANNER. |
| Distribution end date | 2019-06-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12300004Z | Withdrawn |
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.