X-Mark
1.15mm x 2cm X-MARK Preloaded in 17 g Needle
8manufacturers in China registered for this device type
48catalogue 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 |
| Record published | 2016-09-23 |
| Record revised | 2025-12-31 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 001042 | In distribution | |
| 1003 | In distribution | |
| 001047 | In distribution | |
| 1042 | In distribution | |
| 001002 | In distribution | |
| 1040 | In distribution | |
| 001003 | In distribution | |
| 001007 | In distribution | |
| 001028 | In distribution | |
| 001008 | In distribution | |
| 1001 | In distribution | |
| 001027 | In distribution | |
| 001040 | In distribution | |
| 001023 | In distribution | |
| 1007 | In distribution | |
| 1041 | In distribution | |
| 001009 | In distribution | |
| 1027 | In distribution | |
| 001021 | In distribution | |
| 001001 | In distribution | |
| 1047 | In distribution | |
| 1008 | In distribution | |
| 1029 | In distribution | |
| 001029 | In distribution | |
| 1023 | In distribution | |
| 001022 | In distribution | |
| 1003 | In distribution | |
| 1009 | In distribution | |
| 1021 | In distribution | |
| 001041 | In distribution | |
| 1022 | In distribution | |
| 1028 | In distribution | |
| 1002 | In distribution | |
| 1001 | Withdrawn | |
| 1047 | Withdrawn | |
| 1041 | Withdrawn | |
| 1002 | Withdrawn | |
| 1007 | Withdrawn | |
| 1021 | Withdrawn | |
| 1029 | Withdrawn | |
| 1008 | Withdrawn | |
| 1042 | Withdrawn | |
| 1040 | Withdrawn | |
| 1023 | Withdrawn | |
| 1028 | Withdrawn | |
| 1009 | Withdrawn | |
| 1022 | Withdrawn | |
| 1027 | 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 |
|---|---|
| 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.