Suwon-Si, KR · 14 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| IZL | System, X-Ray, Mobile | Class II | Radiology | 3 | 2024-10-01 |
| QDA | Electrocardiograph Software For Over-The-Counter Use | Class II | Cardiovascular | 3 | 2024-08-02 |
| KPR | System, X-Ray, Stationary | Class II | Radiology | 2 | 2026-08-27 |
| QZW | Over-The-Counter Device To Assess Risk Of Sleep Apnea | Class II | Anesthesiology | 2 | 2026-07-20 |
| SCR | Air-Conduction Hearing Aid Software | Class II | Ear, Nose, Throat | 1 | 2026-07-31 |
| PHL | Powered Exoskeleton | Class II | Physical Medicine | 1 | 2022-04-21 |
| FRA | Purifier, Air, Ultraviolet, Medical | Class II | General Hospital | 1 | 2021-11-26 |
| MYN | Analyzer, Medical Image | Class II | Radiology | 1 | 2021-08-31 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-08-27 | K260481 | GC85A | KPR | Class II | Radiology |
| 2026-07-31 | K261187 | Hearing Aid Feature | SCR | Class II | Ear, Nose, Throat |
| 2026-07-20 | K261011 | Sleep Apnea Feature (v2.0) | QZW | Class II | Anesthesiology |
| 2024-10-01 | K242651 | GM85 | IZL | Class II | Radiology |
| 2024-09-19 | K242478 | GF85 (models GF85-3P, GF85-SP) | KPR | Class II | Radiology |
| 2024-08-02 | K240909 | Samsung ECG App v 1.3 (ECG) | QDA | Class II | Cardiovascular |
| 2024-02-06 | DEN230041 | Sleep Apnea Feature | QZW | Class II | Anesthesiology |
| 2023-05-02 | K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | QDA | Class II | Cardiovascular |
| 2022-09-29 | K222353 | GM85 | IZL | Class II | Radiology |
| 2022-04-21 | K220175 | GM85 | IZL | Class II | Radiology |
| 2022-04-21 | K213452 | GEMS-H | PHL | Class II | Physical Medicine |
| 2021-11-26 | K211139 | CUBE Air Purifier | FRA | Class II | General Hospital |
| 2021-08-31 | K201560 | Auto Lung Nodule Detection | MYN | Class II | Radiology |
| 2020-08-04 | K201168 | ECG Monitor App | QDA | Class II | Cardiovascular |