System, Planning, Radiation Therapy Treatment
Oncentra External Beam 4.5.3/Oncentra Brachy v4.6
5manufacturers in China registered for this device type
17catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Jiangsu (2), Fujian (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Manteia Technologies Co., Ltd. | Xiamen | Fujian | Manufacturer | 3 |
| Masep Medical Science & Technology DEVELOPMENT(SHENZHEN)Co. | Shenzhen | Guangdong | Manufacturer | 2 |
| Suzhou Linatech Medical Science AND Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Varian Medical Systems China Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Nucletron B.V., Netherlands |
|---|---|
| FDA product code | MUJ |
| Device type | System, Planning, Radiation Therapy Treatment |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| 510(k) | K121448 |
| Record published | 2018-03-20 |
| Record revised | 2018-07-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2018-04-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 170537-08 | In distribution | |
| 170730 | In distribution | |
| 170607-00 | In distribution | |
| 170003-28 | In distribution | |
| Oncentra External Beam | In distribution | |
| 170018-00 | In distribution | |
| Oncentra Brachy | In distribution | |
| 170538-00 | In distribution | |
| 170537-06 | Withdrawn | |
| 170537-06 | Withdrawn | |
| 170537-05 | Withdrawn | |
| 170003-27 | Withdrawn | |
| 170003-25 | Withdrawn | |
| 170003-23 | Withdrawn | |
| 170537-04 | Withdrawn | |
| 170730 | Withdrawn | |
| 170730 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RayStation | RaySearch Laboratories AB (publ) | 29 |
| Panther TPS | Prowess, Inc. | 14 |
| RayCare | RaySearch Laboratories AB (publ) | 12 |
| Accuray Precision® Treatment Planning System | Accuray Incorporated | 7 |
| Monaco | Elekta Inc. | 7 |
| Eclipse Treatment Planning System for External Beam Radiation Therapy | Varian Medical Systems, Inc | 6 |
| syngo.via RT Image Suite | Siemens Healthcare Limited | 5 |
| Eclipse Treatment Planning System | Varian Medical Systems, Inc | 5 |
| Corvus 09 | Best Nomos | 4 |
| Monaco | Elekta Solutions AB | 4 |
| XKnife® | Integra Lifesciences Corporation | 4 |
| Philips | Philips Medical Systems (Cleveland), Inc. | 4 |
Showing 12 of 98. All products under System, Planning, Radiation Therapy Treatment
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K132816 | 2014-06-13 |
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 | 2022-12-05 | Class II | Software design | A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling | 336 systems | |
| Elekta Inc. | 510(k) number | 2021-10-13 | Class II | Software design | Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels. | 1072 devices | |
| Nucletron B.V. | 510(k) number | 2017-08-10 | Class II | Software design | Incorrect source step size may occur in the software plans | 89 customer sites have the affected software | 2020-11-20 |
| Elekta Inc. | 510(k) number | 2016-12-23 | Class II | Software design | Cross profile for Varian 60 degree wedge shows “horns.” | 433 | 2021-07-16 |
| Elekta Inc. | 510(k) number | 2015-12-18 | Class II | Software design | When using the option “Tumor Overlap Fraction” in VMAT planning it has been observed that in rare cases the system does include an organ at risk as target volume. This could result in open MLC, and open jaws in areas away from the target v | 154 | 2021-09-15 |
| Elekta Inc. | 510(k) number | 2015-05-21 | Class II | Other | Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series. | 351 | 2021-07-16 |
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.