MR Contour DL
FDA 510(k) clearance K242925 · decided 2025-04-01
Clearance details
- K-number
- K242925
- Device name
- MR Contour DL
- Applicant
- GE Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2024-09-24
- Decision date
- 2025-04-01
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- QKB
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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| AutoContour (RADAC V5) (K260509) | Radformation, Inc. | 2026-03-19 |
| Seg Pro V3 (RT-300) (K251306) | Ever Fortune.Ai, Co., Ltd. | 2026-01-28 |
| AccuContour 4.0 (K251351) | Manteia Technologies Co., Ltd. | 2026-01-23 |
| ARTAssistant (K250780) | Manteia Technologies Co., Ltd. | 2025-12-05 |
| TAIMedImg DeepMets (K250427) | Taiwan Medical Imaging Co., Ltd. | 2025-05-28 |
| AI-Rad Companion Organs RT (K242745) | Siemens Healthcare GmbH | 2025-03-27 |
| OncoStudio (OS-01) (K242994) | Oncosoft. Co., Ltd. | 2025-02-24 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Senographe Pristina 3D (P130020/S005) | GE Healthcare | 2025-11-21 |
| Invenia ABUS Premium, Invenia ABUS Prime (P110006/S011) | GE Healthcare | 2025-02-04 |
| Senographe Pristina 3D and SenoClaire (P130020/S004) | GE Healthcare | 2021-03-23 |
| Invenia ABUS (Automated Breast Ultrasound System) 2.0 (P110006/S010) | GE Healthcare | 2018-08-24 |
| Invenia ABUS 2.0 Automated Breast Ultrasound System (P110006/S009) | GE Healthcare | 2018-05-11 |
| Senographe Pristina 3D (P130020/S003) | GE Healthcare | 2017-12-28 |
| Invenia ABUS Autoated Breast Ultrasound System (P110006/S008) | GE Healthcare | 2017-09-07 |
| Invenia ABUS - Automated Breast Ultrasound System (P110006/S007) | GE Healthcare | 2017-05-01 |