The Halcyon Couch Positioning Plate is an accessory to the 3D SCANNER system that allows the 3D SCANNER Water Tank to be placed and positioned on a Varian Halcyon delivery system couch. The…
The Halcyon Couch Positioning Plate is an accessory to the 3D SCANNER system that allows the 3D SCANNER Water Tank to be placed and positioned on a Varian Halcyon delivery system couch. The Couch Positioning Plate is indexed to the Halcyon couch and coordinate system; SNC Dosimetry software Autosetup™ has been modified for Halcyon couch measurements using a new, patent-pending leveling technique.
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.
Record
Regulatory record for Halcyon Couch Positioning Plate | Listed by | Sun Nuclear Corporation, United States |
| FDA product code | IYE |
| Device type | Accelerator, Linear, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K101992 |
| Record published | 2019-05-21 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Special storage condition: Ensure that all 3D SCANNER parts and accessories are clean and dry before storing. For cleaning and storage instructions; Handling environment humidity 10 to 90 % RH; Handling environment temperature -30 to 50 °C; Special storage condition: Store the accessory in an indoor, protected environment where it will not be irradiated by the direct beam and where sca; Storage environment humidity 10 to 90 % RH; Storage environment temperature 10 to 40 °C |
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.
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.