Thermoplastic Mask
58 catalogue numbers from MK8039, listed by IZI Medical Products LLC, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
58catalogue numbers in this listing
1510(k) clearance
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 | IZI Medical Products LLC, United States |
|---|---|
| FDA product code | IYE |
| Device type | Accelerator, Linear, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K022708 |
| Record published | 2017-01-25 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MK8039 | In distribution | |
| MK8062 | In distribution | |
| MK8024 | In distribution | |
| MK8046 | In distribution | |
| MK8020 | In distribution | |
| MK8069 | In distribution | |
| MK8013 | In distribution | |
| MK8023 | In distribution | |
| MK8037 | In distribution | |
| MK8030 | In distribution | |
| MK8048 | In distribution | |
| MK8038 | In distribution | |
| MK8041 | In distribution | |
| MK8009 | In distribution | |
| MK8006 | In distribution | |
| MK8032 | In distribution | |
| MK8100 | In distribution | |
| MK8002 | In distribution | |
| MK8005 | In distribution | |
| MK8025 | In distribution | |
| MK8016 | In distribution | |
| MK8047 | In distribution | |
| MK8060 | In distribution | |
| MK8201 | In distribution | |
| MK8200 | In distribution | |
| MK8004 | In distribution | |
| MK8044 | In distribution | |
| MK8021 | In distribution | |
| MK8015 | In distribution | |
| MK8001 | In distribution | |
| MK8003 | In distribution | |
| MK8007 | In distribution | |
| MK8042 | In distribution | |
| MK8068 | In distribution | |
| MK8031 | In distribution | |
| MK8018 | In distribution | |
| MK8061 | In distribution | |
| MK8012 | In distribution | |
| MK8034 | In distribution | |
| MK8043 | In distribution | |
| MK8067 | In distribution | |
| MK8063 | In distribution | |
| MK8036 | In distribution | |
| MK8026 | In distribution | |
| MK8045 | In distribution | |
| MK8008 | In distribution | |
| MK8064 | In distribution | |
| MK8035 | In distribution | |
| MK8101 | In distribution | |
| MK8040 | In distribution | |
| MK8014 | In distribution | |
| MK8066 | In distribution | |
| MK8019 | In distribution | |
| MK8027 | In distribution | |
| MK8028 | In distribution | |
| MK8011 | In distribution | |
| MK8017 | In distribution | |
| MK8029 | 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 |
| Gold Anchor | Naslund Medical AB | 58 |
Showing 12 of 1,611. All products under Accelerator, Linear, Medical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162265 | 2016-11-15 |
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.