Brightonix
PHAROS is a specialized high-sensitivity and high-resolution PET system designed for imaging specific organs, such as the brain, breast, arms and legs. Input voltage: 200-240V~ /…
PHAROS is a specialized high-sensitivity and high-resolution PET system designed for imaging specific organs, such as the brain, breast, arms and legs. Input voltage: 200-240V~ / Specification: 4 Detector modules
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 | Brightonix Imaging Inc., South Korea |
|---|---|
| FDA product code | KPS |
| Device type | System, Tomography, Computed, Emission |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1200 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K250170 |
| Record published | 2025-09-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PHAROS | In distribution | |
| PHAROS | In distribution | |
| PHAROS | In distribution | |
| PHAROS | In distribution | |
| PHAROS | In distribution | |
| PHAROS | In distribution |
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| Affinity | Hermes Medical Solutions, AB | 3 |
Showing 12 of 172. All products under System, Tomography, Computed, Emission
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250170 | 2025-08-15 |
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.