510(k) K231928
- Device
- EFAI RTSUITE CT HCAP-Segmentation System
- Applicant
- Ever Fortune.Ai, Co., Ltd.
- 510(k) number
- K231928
- Product code
- QKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-25
- Date received
- 2023-06-30
- Regulation
- 892.2050
- Classification name
- Radiological Image Processing Software For Radiation Therapy
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Joseph Chang
- Address
- 8 F., # 573, Sec. 2, Taiwan Blvd., W. Dist. Taichung City TW 403020 403020
FDA Registration Numbers#
- 3013410552
- 3021032044
- 3015232217
- 8043933
- 3015169361
- 3021982861
- 3024812789
- 3036758982
- 3025309924
- 3017927156
- 3007545404
- 3007120336
- 3019834893
- 3004526608
- 3031194398
- 3022745617
- 3016686005
- 2126677
- 3022719374
- 3002808157
- 3004363352
Source Documents#
Other 510(k) Records For Product Code QKB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252548 | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | 2026-04-10 |
| K252190 | DeepBT Detector-Plus | Aitewan Biomedical Technology, Inc. | 2026-04-10 |
| K253270 | Contour ProtégéAI+ | Mim Software, Inc. | 2026-03-27 |
| K260509 | AutoContour (RADAC V5) | Radformation, Inc. | 2026-03-19 |
| K251306 | Seg Pro V3 (RT-300) | Ever Fortune.Ai, Co., Ltd. | 2026-01-28 |
| K251351 | AccuContour 4.0 | Manteia Technologies Co., Ltd. | 2026-01-23 |
| K250780 | ARTAssistant | Manteia Technologies Co., Ltd. | 2025-12-05 |
| K250427 | TAIMedImg DeepMets | Taiwan Medical Imaging Co., Ltd. | 2025-05-28 |
| K242925 | MR Contour DL | GE Healthcare | 2025-04-01 |
| K242745 | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | 2025-03-27 |
| K242994 | OncoStudio (OS-01) | Oncosoft. Co., Ltd. | 2025-02-24 |
| K250035 | Contour ProtégéAI+ | Mim Software, Inc. | 2025-02-03 |
| K242729 | AutoContour (Model RADAC V4) | Radformation, Inc. | 2024-12-09 |
| K241490 | Contour+ (MVision AI Segmentation) | Mvision AI OY | 2024-10-18 |
| K241837 | Limbus Contour | Limbus Ai, Inc. | 2024-10-09 |