Accelerator, Linear, Medical
71 catalogue numbers from Soft X-ray chamber 0.2 cm³, listed by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
71catalogue numbers in this listing
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 | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH |
|---|---|
| FDA product code | IYE |
| Device type | Accelerator, Linear, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| 510(k) | K961208 |
| Record published | 2017-04-26 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Soft X-ray chamber 0.2 cm³ | In distribution | |
| Dosimetry Diode PR | In distribution | |
| Markus electron chamber 0.055 cm³ | In distribution | |
| Soft X-ray chamber 0.2 cm³ | In distribution | |
| Dosimetry Diode E | In distribution | |
| Dosimetry Diode E | In distribution | |
| Rigid stem 1.0 cm³ ion chamber | In distribution | |
| Reference chamber PEAKFINDER | In distribution | |
| TANDEM XDR | In distribution | |
| Markus electron chamber 0.055 cm³ | In distribution | |
| MP3-M acrylic water tank | In distribution | |
| TANDEM XDR | In distribution | |
| Rigid stem 0.3 cm³ ion chamber | In distribution | |
| Dosimetry Diode E | In distribution | |
| MP2 acrylic water tank | In distribution | |
| Dosimetry Diode PR | In distribution | |
| MP3 water reservoir, 230V/50-60 Hz | In distribution | |
| MP3-P acrylic tank with moving mechanism | In distribution | |
| DAVID software | In distribution | |
| MP3 positioning device, rotatable | In distribution | |
| MP3 water reservoir, 115V/50-60 Hz | In distribution | |
| Markus electron chamber 0.055 cm³ | In distribution | |
| UNITEST test device | In distribution | |
| Linear Array LA48 | In distribution | |
| Dosimetry Diode P | In distribution | |
| MP3-T acrylic water tank | In distribution | |
| Dosimetry Diode P | In distribution | |
| UniSoft software, Edition 2000 | In distribution | |
| Soft X-ray chamber 0.2 cm³ | In distribution | |
| SLA48 2D-air scanner with head mount | In distribution | |
| MP2 positioning device, rotatable | In distribution | |
| UNITEST test device | In distribution | |
| Soft X-ray chamber 0.02 cm³ | In distribution | |
| MP1 acrylic water tank, extra lines | In distribution | |
| Reference chamber PEAKFINDER | In distribution | |
| Soft X-ray chamber 0.005 cm³ | In distribution | |
| Soft X-ray chamber 0.02 cm³ | In distribution | |
| Reference chamber PEAKFINDER | In distribution | |
| MP1 acrylic water tank | In distribution | |
| Soft X-ray chamber 0.005 cm³ | In distribution | |
| Dosimetry Diode SRS | In distribution | |
| Soft X-ray chamber 0.2 cm³ | In distribution | |
| TANDEM XDR | In distribution | |
| TANDEM | In distribution | |
| Soft X-ray chamber 0.02 cm³ | In distribution | |
| Dosimetry Diode P | In distribution | |
| MP3 lifting carriage | In distribution | |
| MP3-XS water tank | In distribution | |
| Rigid stem 1.0 cm³ ion chamber | In distribution | |
| Markus electron chamber 0.055 cm³ | In distribution | |
| MP3-P-45 acrylic tank w/ moving mechanism | In distribution | |
| MP3 acrylic tank with moving mechanism | In distribution | |
| TANDEM | In distribution | |
| RS232 – Bluetooth Transceiver | In distribution | |
| MP3-M positioning device, rotatable | In distribution | |
| SLA48 2D-air scanner, table-top version | In distribution | |
| Rigid stem 0.3 cm³ ion chamber | In distribution | |
| Rigid stem 1.0 cm³ ion chamber | In distribution | |
| UNITEST test device | In distribution | |
| Soft X-ray chamber 0.005 cm³ | In distribution | |
| Rigid stem 0.3 cm³ ion chamber | In distribution | |
| Soft X-ray chamber 0.005 cm³ | In distribution | |
| Dosimetry Diode SRS | In distribution | |
| MP3-PL acrylic tank with moving mechanism | In distribution | |
| Dosimetry Diode P for up to 6 MV | In distribution | |
| Dosimetry Diode SRS | In distribution | |
| Dosimetry Diode P for up to 6 MV | In distribution | |
| TANDEM | In distribution | |
| Reference chamber PEAKFINDER | In distribution | |
| Dosimetry Diode PR | In distribution | |
| Soft X-ray chamber 0.02 cm³ | 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 |
| 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 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 | Closed |
|---|---|---|---|---|---|---|---|
| PTW Freiburg | 510(k) number | 2015-05-27 | Class II | Software design | In some cases, especially with high dose-per-pulse-rates typical for particle (specifically proton) therapy, measuring errors can result. Individual measurement intervals can be lost that are not visible to the user when there is a high dos | 242 firmwares | 2017-03-31 |
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.