BodyFIX
The BodyFIX Localizer features three Localizer screens specially designed for stereotactic application. Each of these Localizer screens has three slots with special plastic tubes already…
The BodyFIX Localizer features three Localizer screens specially designed for stereotactic application. Each of these Localizer screens has three slots with special plastic tubes already inserted. As an alternative to the plastic tubes, these BodyFIX® 14 Localizer Fiducial Set Aluminium contrast rods allow improved visualization in CT.
8manufacturers in China registered for this device type
84catalogue numbers in this listing
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 | 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) | K121530 |
| Record published | 2016-08-23 |
| Record revised | 2023-12-15 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Pack of 2, pack of 5 |
| Distribution end date | 2020-12-09 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| P10104-806 | In distribution | ||
| P10102-413 | In distribution | ||
| P10102-102 | In distribution | ||
| P10102-115 | In distribution | ||
| P10104-505 | In distribution | ||
| P10102-119 | In distribution | ||
| P10104-129 | In distribution | ||
| P10104-840 | In distribution | ||
| P10102-203 | In distribution | ||
| P10102-304 | 5 | In distribution | |
| P10102-150 | In distribution | ||
| P10104-847 | In distribution | ||
| P10102-306 | In distribution | ||
| P10104-846 | In distribution | ||
| P10104-838 | In distribution | ||
| P10102-201 | In distribution | ||
| P10104-166 | In distribution | ||
| P10104-132 | In distribution | ||
| P10104-125 | In distribution | ||
| P10104-820 | In distribution | ||
| P10104-130 | In distribution | ||
| P10102-303 | 5 | In distribution | |
| P10104-111 | In distribution | ||
| P10104-500 | In distribution | ||
| P10104-137 | In distribution | ||
| P10104-113 | In distribution | ||
| P10104-156 | In distribution | ||
| P10104-819 | In distribution | ||
| P10102-101 | In distribution | ||
| P10104-118 | In distribution | ||
| P10102-309 | In distribution | ||
| P10102-301 | 5 | In distribution | |
| P10104-837 | In distribution | ||
| P10104-135 | In distribution | ||
| P10104-823 | In distribution | ||
| P10104-147 | In distribution | ||
| P10104-831 | In distribution | ||
| P10102-307 | 3 | In distribution | |
| P10102-200 | In distribution | ||
| P10104-501 | In distribution | ||
| P10104-839 | In distribution | ||
| P10104-114 | In distribution | ||
| P10104-843 | In distribution | ||
| P10102-216 | In distribution | ||
| P10104-143 | In distribution | ||
| P10102-302 | 5 | In distribution | |
| P10104-300 | In distribution | ||
| P10104-139 | In distribution | ||
| P10102-232 | In distribution | ||
| P10102-305 | In distribution | ||
| P10104-122 | In distribution | ||
| P10104-159 | In distribution | ||
| P10102-114 | In distribution | ||
| P10104-836 | In distribution | ||
| P10102-217 | In distribution | ||
| P10104-703 | In distribution | ||
| P10104-821 | In distribution | ||
| P10102-210 | In distribution | ||
| P10102-112 | In distribution | ||
| P10104-511 | In distribution | ||
| P10102-202 | In distribution | ||
| P10102-223 | In distribution | ||
| P10104-822 | In distribution | ||
| P10104-164 | In distribution | ||
| P10102-409 | In distribution | ||
| P10102-212 | In distribution | ||
| P10102-214 | In distribution | ||
| P10102-233 | In distribution | ||
| P10102-213 | In distribution | ||
| P10104-829 | In distribution | ||
| P10104-119 | In distribution | ||
| P10104-824 | In distribution | ||
| P10104-167 | Withdrawn | ||
| P10102-113 | Withdrawn | ||
| P10104-319 | Withdrawn | ||
| P10102-300 | 5 | Withdrawn | |
| P10102-227 | Withdrawn | ||
| P10104-506 | Withdrawn | ||
| P10104-165 | Withdrawn | ||
| P10104-302 | Withdrawn | ||
| P10102-408 | Withdrawn | ||
| P10104-605 | Withdrawn | ||
| P10104-601 | Withdrawn | ||
| P10102-410 | 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 |
| 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 |
| Gold Anchor | Naslund Medical AB | 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.