Fibreplast™ Variable Perf™
Fibreplast Variable Perf, Head Only CURVE S-Frame, 3.2 mm, Standard
8manufacturers in China registered for this device type
30catalogue numbers in this listing
6510(k) clearances naming this product code
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 | Qfix, United States |
|---|---|
| FDA product code | IYE |
| Device type | Accelerator, Linear, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Record published | 2016-12-22 |
| Record revised | 2026-03-05 (version 6) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Depth 3.2 mm |
| Distribution end date | 2026-03-04 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| RT-1889KYS | Depth 3.2 mm | 5 | In distribution |
| RT-1889KYSD | Depth 3.2 mm | 10 | In distribution |
| RT-1892KYESD | Depth 3.2 mm | 10 | In distribution |
| RT-1892KYSD | Depth 3.2 mm | 10 | In distribution |
| RT-1889KYESD | Depth 3.2 mm | 10 | In distribution |
| RT-1889KYFORF5 | Depth 3.2 mm | 10 | In distribution |
| RT-1889KYFORF3 | Depth 3.2 mm | 10 | In distribution |
| RT-1889KYSD | Depth 3.2 mm | Withdrawn | |
| RT-1889KYS | Depth 3.2 mm | Withdrawn | |
| RT-1889KYS | Depth 3.2 mm | 5 | Withdrawn |
| RT-1889KYFORF3 | Depth 3.2 mm | Withdrawn | |
| RT-1889KYFORF3 | Depth 3.2 mm | 10 | Withdrawn |
| RT-1889KYFORF5 | Depth 3.2 mm | Withdrawn | |
| RT-1889KYFORF3 | Depth 3.2 mm | Withdrawn | |
| RT-1892KYSD | Depth 3.2 mm | Withdrawn | |
| RT-1889KYFORF3 | Depth 3.2 mm | 5 | Withdrawn |
| RT-1892KYESD | Depth 3.2 mm | Withdrawn | |
| RT-1889KYESD | Depth 3.2 mm | Withdrawn | |
| RT-1892KYESD | Depth 3.2 mm | 10 | Withdrawn |
| RT-1889KYFORF5 | Depth 3.2 mm | 5 | Withdrawn |
| RT-1889KYFORF5 | Depth 3.2 mm | 10 | Withdrawn |
| RT-1889KYSD | Depth 3.2 mm | Withdrawn | |
| RT-1889KYSD | Depth 3.2 mm | 10 | Withdrawn |
| RT-1889KYFORF5 | Depth 3.2 mm | Withdrawn | |
| RT-1892KYESD | Depth 3.2 mm | Withdrawn | |
| RT-1889KYESD | Depth 3.2 mm | 10 | Withdrawn |
| RT-1889KYESD | Depth 3.2 mm | Withdrawn | |
| RT-1892KYSD | Depth 3.2 mm | Withdrawn | |
| RT-1892KYSD | Depth 3.2 mm | 10 | Withdrawn |
| RT-1889KYS | Depth 3.2 mm | 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 |
|---|---|
| K230312 | 2023-03-31 |
| K193243 | 2020-02-28 |
| K182189 | 2018-10-04 |
| K171133 | 2017-07-11 |
| K160627 | 2016-06-14 |
| K152321 | 2015-12-04 |
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.