Monarch™ Thermoplastic Frame
For use with Monarch™ Overhead Arm Positioner
8manufacturers in China registered for this device type
1catalogue number
20510(k) clearances naming this product code
5recalls on this 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 | Medtec LLC, United States |
|---|---|
| FDA product code | IYE |
| Device type | Accelerator, Linear, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K974703 |
| Record published | 2017-08-02 |
| Record revised | 2019-05-31 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OAP120 | 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 |
|---|---|
| K132908 | 2014-03-04 |
| K974703 | 1998-03-10 |
| K974700 | 1998-03-04 |
| K954705 | 1996-01-05 |
| K952729 | 1995-09-15 |
| K952189 | 1995-08-09 |
| K950075 | 1995-07-13 |
| K951947 | 1995-07-12 |
| K951679 | 1995-07-12 |
| K951808 | 1995-07-06 |
| K951717 | 1995-06-28 |
| K950866 | 1995-05-30 |
| K943199 | 1994-12-07 |
| K944315 | 1994-11-22 |
| K935411 | 1994-07-18 |
| K935412 | 1994-07-18 |
| K942282 | 1994-07-18 |
| K935300 | 1994-07-18 |
| K933227 | 1994-07-18 |
| K935021 | 1994-04-07 |
Recalls
2 of these are 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 |
|---|---|---|---|---|---|
| 2020-05-12 | Class II | Component design/selection | Potential for disengagement of the Varian Style Type-S Extension during patient repositioning. The risk associated with the disengagement of the extension could be a patient fall if the patient is not supported by clinical staff. | 171 units | 2021-03-25 |
| 2019-04-15 | Class II | Device Design | There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment. | 28 units | 2020-10-05 |
| 2009-08-31 | Not classified | Process control | Some of the packages contain the incorrect mask style. | 12 boxes | 2012-03-07 |
| 2008-02-28 | Not classified | Labeling mix-ups | Mislabeled: Fiducial markers were incorrectly labeled. They are marked (0.9x3mm cylindrical) Soft tissue gold markers, but contain (2mm spheres) Bone gold markers. | 33/3-marker pouches | 2008-07-02 |
| 2008-02-28 | Not classified | Labeling mix-ups | Mislabeled: Fiducial markers were incorrectly labeled. They are marked (2mm spheres) Bone gold markers, but contain (0.9x3mm cylindrical) Soft tissue gold markers. | 36/3-marker pouches | 2008-07-02 |
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.