Encompass™ SRS Fibreplast™ System
Encompass Fibreplast Variable Perf Open View Mask System
4manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Beijing (1), Shanghai (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Neusoft Positron Medical Systems Co., Ltd. | Shen Yang | Liaoning | Manufacturer | 1 |
Record
| Listed by | Qfix, United States |
|---|---|
| FDA product code | KPS |
| Device type | System, Tomography, Computed, Emission |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1200 |
| Record published | 2016-09-14 |
| Record revised | 2026-03-05 (version 6) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Pack of 5 |
| Distribution end date | 2026-03-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RT-B889KYCF | In distribution | |
| RT-B889KYCF2 | In distribution | |
| RT-B889KYCF | Withdrawn | |
| RT-B889KYCF2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NeuroQ | Syntermed, Inc. | 11 |
| Emory Cardiac Toolbox | Syntermed, Inc. | 10 |
| Discovery | GE Medical Systems, L.L.C. | 7 |
| uMI | Shanghai United Imaging Healthcare Co., Ltd. | 7 |
| Brightonix | Brightonix Imaging Inc. | 6 |
| UltraSPECT | Ultraspect USA, LLC | 5 |
| Discovery | G E Medical Systems Israel Ltd. | 5 |
| Veriton CT | Spectrum Dynamics Medical Ltd. | 5 |
| Cardius 2 | Digirad Corp. | 4 |
| Veriton NM | Spectrum Dynamics Medical Ltd. | 3 |
| Cedars-Sinai Cardiac Suite | Cedars Sinai Medical Center | 3 |
| Affinity | Hermes Medical Solutions, AB | 3 |
Showing 12 of 172. All products under System, Tomography, Computed, Emission
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.