Fraxion™
"The FRAXION™ Stereotactic Frame is for target localization in stereotactic radiation therapy and radiosurgery. The purpose of the stereotactic frame is to impose fiducials on images of the…
“The FRAXION™ Stereotactic Frame is for target localization in stereotactic radiation therapy and radiosurgery. The purpose of the stereotactic frame is to impose fiducials on images of the patient acquired during CT scanning. The fiducials are used for determining target coordinates and for slice alignment by treatment planning software.”
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 | 3C-Medical Intelligence GmbH, Germany |
|---|---|
| FDA product code | IYE |
| Device type | Accelerator, Linear, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K112210 |
| Record published | 2018-10-29 |
| Record revised | 2023-12-15 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 10 to 30 °C; Storage environment humidity up to 70 % RH; Handling environment temperature 10 to 30 °C; Handling environment humidity up to 70 % RH |
| Packaging | Pack of 10 |
| Distribution end date | 2021-10-12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| P10106-300 | 10 | In distribution | |
| P10106-132 | In distribution | ||
| P10106-323 | In distribution | ||
| P10106-402 | In distribution | ||
| P10106-103 | In distribution | ||
| P10106-101 | In distribution | ||
| P10106-104 | In distribution | ||
| P10106-210 | In distribution | ||
| P10106-321 | In distribution | ||
| P10106-110 | In distribution | ||
| P10106-602 | In distribution | ||
| P10106-102 | In distribution | ||
| P10106-212 | In distribution | ||
| P10106-114 | In distribution | ||
| P10106-106 | In distribution | ||
| P10106-115 | In distribution | ||
| P10106-213 | In distribution | ||
| P10106-320 | In distribution | ||
| P10106-324 | In distribution | ||
| P10106-113 | In distribution | ||
| P10106-200 | 5 | In distribution | |
| P10106-130 | In distribution | ||
| P10106-123 | In distribution | ||
| P10106-322 | In distribution | ||
| P10106-214 | In distribution | ||
| P10106-120 | In distribution | ||
| P10106-302 | 10 | In distribution | |
| P10106-211 | In distribution | ||
| P10106-111 | In distribution | ||
| P10106-301 | 10 | In distribution | |
| P10106-603 | In distribution | ||
| P10106-122 | Withdrawn | ||
| P10106-131 | 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
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 |
|---|---|---|---|---|---|
| 2019-07-18 | Class II | Software design | Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (CCC) can be too sensitive and iGUIDE may incorrectly demand a verification scan. | 496 units | 2023-08-11 |
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.