Orfit Industries
AIO 3.0 Complete Head & Neck, Belly & Pelvic Pelvic Module - with foot support - MR compatible
8manufacturers in China registered for this device type
680catalogue numbers in this listing
10510(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 | Orfit Industries NV, Belgium |
|---|---|
| FDA product code | IYE |
| Device type | Accelerator, Linear, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K131795 |
| Record published | 2022-12-07 |
| Record revised | 2025-03-18 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 10 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 33739/2MA/12MI+N | In distribution | |
| 25101/16MI+N/NH | In distribution | |
| 35754/4 | In distribution | |
| 32122 | In distribution | |
| 35754/6N | In distribution | |
| 39320 | In distribution | |
| 35774/2MA | In distribution | |
| 33683/32MA | In distribution | |
| 35747/6 | In distribution | |
| 35776/2MA | In distribution | |
| 29005-V2 | In distribution | |
| 32301 | In distribution | |
| 32057-V2 | In distribution | |
| 33702/2MA | In distribution | |
| 38002 | In distribution | |
| 29003-V2 | In distribution | |
| 32054-V2 | In distribution | |
| 32169 | In distribution | |
| 35773/16MI/NP | In distribution | |
| 29015-V2 | In distribution | |
| 32015/9 | In distribution | |
| 35754/9 | In distribution | |
| 33740/2MA/12MI+N | In distribution | |
| 32197 | In distribution | |
| 8334Y.3/R | In distribution | |
| 8336.SO1/R/58-1CM | In distribution | |
| 29010-V2 | In distribution | |
| 8333N.SO1/R | In distribution | |
| 29012-V2 | In distribution | |
| 35747 | In distribution | |
| 35794/2MI | In distribution | |
| 60002/EFF32MA | In distribution | |
| 38205 | In distribution | |
| 8336.SO1/R/59 | In distribution | |
| 32133 | In distribution | |
| 33139 | In distribution | |
| 32103/MR | In distribution | |
| 35765 | In distribution | |
| CBS-2 | In distribution | |
| 32124/MR | In distribution | |
| 32015/9/5 | In distribution | |
| 29016-V2 | In distribution | |
| 8353Y.3/R | In distribution | |
| 60002 | In distribution | |
| 33155 | In distribution | |
| 35727/32MA | In distribution | |
| 32317/16 | In distribution | |
| 32317/10 | In distribution | |
| 32301-PED/MR | In distribution | |
| 32172 | In distribution | |
| 32207 | In distribution | |
| 25000/16 | In distribution | |
| 35702/4 | In distribution | |
| 32064 | In distribution | |
| 60095 | In distribution | |
| 32399-MD | In distribution | |
| 38006 | In distribution | |
| 32181 | In distribution | |
| 38209 | In distribution | |
| 35776/2MI | In distribution | |
| 32449 | In distribution | |
| 32204-PED | In distribution | |
| 18206/INDEX | In distribution | |
| 18206 | In distribution | |
| 25116/24MI+N | In distribution | |
| 29027 | In distribution | |
| 32432 | In distribution | |
| 32015/10 | In distribution | |
| 38212 | In distribution | |
| 35764/16MI | In distribution | |
| 33749/2MA/12MI+N/NH | In distribution | |
| 29014-V2 | In distribution | |
| 32838 | In distribution | |
| 32199 | In distribution | |
| 25000/29 | In distribution | |
| 32412 | In distribution | |
| 60097 | In distribution | |
| 32816 | In distribution | |
| 29111-G | In distribution | |
| 29029 | In distribution | |
| 32000 | In distribution | |
| 32030 | In distribution | |
| 8336.SO1/R/59-1CM | In distribution | |
| 29112-V2 | In distribution | |
| 32103/3/MR | In distribution | |
| 35793/32MA | In distribution | |
| 33700/2MA | In distribution | |
| 45204/32MA/EFF | In distribution | |
| 33162 | In distribution | |
| CFB-005/EU | In distribution | |
| 18204 | In distribution | |
| 35791/2MA/G17 | In distribution | |
| 32130/MR | In distribution | |
| 35707 | In distribution | |
| 33159 | In distribution | |
| 33142 | In distribution | |
| 35779/2MA/G | In distribution | |
| 33778/2MA/NP | In distribution | |
| 33124 | In distribution | |
| 33218 | In distribution | |
| 35776/2MI/MO | In distribution | |
| 32157 | In distribution | |
| 25107/2MI+N/NH | In distribution | |
| 35788/32MA | In distribution | |
| 60112/EFF2MI+ | In distribution | |
| 32015/9/2 | In distribution | |
| 35779/16MI | In distribution | |
| 32301/HX | In distribution | |
| 33747/2MA/12MI+N | In distribution | |
| 29026 | In distribution | |
| 32317/15 | In distribution | |
| 32317/14 | In distribution | |
| 32317/19 | In distribution | |
| 35754/3 | In distribution | |
| 35787/32 | In distribution | |
| 45214-BOX10 | In distribution | |
| 38425 | In distribution | |
| 32097 | In distribution | |
| 33789/16MI | In distribution | |
| 35773/2MI/NP | In distribution | |
| 32815 | In distribution | |
| 35768/16MI+N | In distribution | |
| 33730/2MA/12MI+N | In distribution | |
| 33166 | In distribution | |
| CBA-1 | In distribution | |
| 25110/24MI+N | In distribution | |
| 33785/16MI/12MI+N | In distribution | |
| 33755/2MA/12MI+N | In distribution | |
| 35779/2MA | In distribution | |
| 35791/2MI | In distribution | |
| 32179 | In distribution | |
| CFB-003/EU/NG | In distribution | |
| 38107/2 | In distribution | |
| 32001 | In distribution | |
| 32317/1 | In distribution | |
| 32301/HXP | In distribution | |
| 29024-V2 | In distribution | |
| 60120 | In distribution | |
| 38224 | In distribution | |
| 38223 | In distribution | |
| 32070/14 | In distribution | |
| 32317/8 | In distribution | |
| 32406/10 | In distribution | |
| 29036 | In distribution | |
| 29002-V2 | In distribution | |
| 35781-N1/2 | In distribution | |
| 33121 | In distribution | |
| 32070/15 | In distribution | |
| 35704 | In distribution | |
| 60164/5 | In distribution | |
| CFB-003/MR | In distribution | |
| 35776/2MI/NP | In distribution | |
| 18212 | In distribution | |
| 35790/32MA | In distribution | |
| 38215 | In distribution | |
| 25000/1/MR | In distribution | |
| 29054 | In distribution | |
| 25105/2MI+N/NH | In distribution | |
| 38005 | In distribution | |
| 38011 | In distribution | |
| 25105/2MI+N | In distribution | |
| 35773/2MA | In distribution | |
| 32317/11 | In distribution | |
| 32165/6 | In distribution | |
| 32103/1/MR | In distribution | |
| 32427 | In distribution | |
| 32422-MD | In distribution | |
| 35728/32MA | In distribution | |
| 33790/16MI | In distribution | |
| 29115 | In distribution | |
| 29022-V2 | In distribution | |
| 33141 | In distribution | |
| 25000/1 | In distribution | |
| 32447 | In distribution | |
| 18203 | In distribution | |
| 29050 | In distribution | |
| 18200 | In distribution | |
| 32110/8 | In distribution | |
| 35764/2MA/NH | In distribution | |
| 32178 | In distribution | |
| 32166 | In distribution | |
| 32708-MD | In distribution | |
| 60159 | In distribution | |
| 32055-V2 | In distribution | |
| 35706 | In distribution | |
| 35744/6 | In distribution | |
| 60112 | In distribution | |
| 35755 | In distribution | |
| 33177 | In distribution | |
| 33770/2MI+N | In distribution | |
| 25000/26 | In distribution | |
| 33781/16MI/12MI+N | In distribution | |
| 32117MR | In distribution | |
| 32043 | In distribution | |
| 35787/32MA | In distribution | |
| 35758ZF-MD | In distribution | |
| 35745 | In distribution | |
| 32184 | In distribution | |
| 45215-BOX10 | In distribution | |
| 18201 | In distribution | |
| 32700 | In distribution | |
| 33144 | In distribution | |
| 25103/16MI+N/NH | In distribution | |
| 32826 | In distribution | |
| 32130/12 | In distribution | |
| 38203 | In distribution | |
| 35779/2MI | In distribution | |
| 35776/2MA/NP | In distribution | |
| 35754/2 | In distribution | |
| 32317/6 | In distribution | |
| 25000/58/20 | In distribution | |
| 35772/16MI+N | In distribution | |
| 8332Y.2/R | In distribution | |
| 32154 | In distribution | |
| 18099 | In distribution | |
| 33158 | In distribution | |
| 60009 | In distribution | |
| 29009-V2 | In distribution | |
| 33797/16MI/12MI+N | In distribution | |
| 32118 | In distribution | |
| 33783/16MI/12MI+N | In distribution | |
| 35763/16MI/EM | In distribution | |
| 35707/MR | In distribution | |
| 35779/16MI/M | In distribution | |
| INT-3 | In distribution | |
| 32291 | In distribution | |
| 32301-PED/NOLS | In distribution | |
| 32317/1/HX | In distribution | |
| 32414 | In distribution | |
| 32701-MD | In distribution | |
| 35754/8 | In distribution | |
| 32817 | In distribution | |
| 32813 | In distribution | |
| 35773/2MA/NP | In distribution | |
| 32380 | In distribution | |
| 25000/16/MR | In distribution | |
| 32110/7 | In distribution | |
| 60121 | In distribution | |
| 29006-V2 | In distribution | |
| 32810 | In distribution | |
| 35779/32MA | In distribution | |
| 25070/10 | In distribution | |
| 33136 | In distribution | |
| 35795/2MI | In distribution | |
| 32103/3 | In distribution | |
| 35779/16MI+N | In distribution | |
| 32185 | In distribution | |
| 703011 | In distribution | |
| 33750/2MA/12MI+N/NH | In distribution | |
| 32704 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Klarity Medical | Klarity Medical Products, LLC | 891 |
| 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 |
| Gold Anchor | Naslund Medical AB | 58 |
Showing 12 of 1,611. All products under Accelerator, Linear, Medical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202068 | 2020-08-14 |
| K191158 | 2019-08-06 |
| K171734 | 2017-07-25 |
| K162355 | 2016-11-22 |
| K162862 | 2016-11-09 |
| K151946 | 2015-11-09 |
| K151207 | 2015-07-28 |
| K141787 | 2014-08-07 |
| K131795 | 2013-09-26 |
| K991319 | 1999-09-21 |
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.