BiomarC®
Fiducial Marker System with Enhanced Visibility, kV
8manufacturers in China registered for this device type
15catalogue numbers in this listing
5510(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 | Carbon Medical Technologies, Inc., 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, Complaint-file establishment, Manufacturer |
| 510(k) | K110772 |
| Record published | 2015-11-30 |
| Record revised | 2023-09-18 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Carton of 3, carton of 10, carton of 4 |
| Sizes | Outer diameter 0.9 to 1.7 mm; length 3 to 5 mm; needle gauge 17 to 19 G; length 20 cm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 040121 | Length 3 mm | In distribution |
| 040109 | Length 3 mm | In distribution |
| 040142 | Length 5 mm | In distribution |
| 040133 | Length 3 mm | In distribution |
| 040132 | Length 5 mm | In distribution |
| 040119 | Length 5 mm | In distribution |
| 040167 | Needle Gauge 18 G | In distribution |
| 040147 | Length 4.6 mm | In distribution |
| 040115 | Length 3 mm | In distribution |
| 040126 | Length 3 mm | In distribution |
| 040122 | Length 3 mm | In distribution |
| 040101 | Length 5 mm | In distribution |
| 040123 | Length 3 mm | In distribution |
| 040120 | Outer Diameter 0.9 mm | In distribution |
| 040140 | Length 5 mm | 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 |
| Thermoplastic Mask | IZI Medical Products LLC | 58 |
Showing 12 of 1,611. All products under Accelerator, Linear, Medical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211590 | 2021-06-10 |
| K191797 | 2019-07-29 |
| K132064 | 2014-02-28 |
| K130678 | 2013-04-12 |
| K110772 | 2011-04-28 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Carbon Medical Technologies, Inc. | 510(k) number | 2024-07-26 | Class III | Employee error | This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient. | 25 boxes of 3 devices |
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.