Mosaiq
6 catalogue numbers from MOSAIQ, listed by Elekta Solutions AB, Sweden, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
6catalogue numbers in this listing
5510(k) clearances naming this product code
2recalls 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 | Elekta Solutions AB, Sweden |
|---|---|
| FDA product code | IYE |
| Device type | Accelerator, Linear, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K183034 |
| Record published | 2019-05-29 |
| Record revised | 2025-06-12 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2025-03-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MOSAIQ | In distribution | |
| MOSAIQ | In distribution | |
| MOSAIQ | In distribution | |
| MOSAIQ | In distribution | |
| 3.2 | In distribution | |
| MOSAIQ | Withdrawn |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 |
|---|---|
| K252188 | 2026-01-15 |
| K223229 | 2023-02-23 |
| K223209 | 2023-02-23 |
| K212114 | 2021-10-01 |
| K203172 | 2020-12-18 |
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Elekta Inc. | 510(k) number | 2026-05-21 | Class II | Software design | Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs. | 12 programs | |
| Elekta Inc. | 510(k) number | 2025-12-10 | Class II | Software change control | Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followe | 1 | |
| Elekta Solutions AB | 510(k) number | 2025-09-17 | Class II | Software design | When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule. | 4 systems that contain the affected software. | |
| Elekta Inc. | 510(k) number | 2025-01-15 | Class II | Software design | Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale. | 64 units | |
| Elekta Inc. | 510(k) number | 2021-09-02 | Class II | Software design | A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value. | 31 | |
| Elekta Inc. | 510(k) number | 2021-04-20 | Class II | Under Investigation by firm | Malware attack | 40 units | 2023-01-17 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2021-09-28 | Class II | Nonconforming Material/Component | There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter. | 2 in the U.S. | 2024-06-14 |
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.