CARESCAPE Central Station V2
FDA 510(k) clearance K162012 · decided 2016-09-15
Clearance details
- K-number
- K162012
- Device name
- CARESCAPE Central Station V2
- Applicant
- GE Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2016-07-21
- Decision date
- 2016-09-15
- Days to decision
- 56 days
- Clearance type
- Special
- Product code
- DXJ
- Device class
- 2
- Regulation number
- 870.2450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3. recall (Z-0213-2026) | Wipro GE Healthcare Private Ltd. | 2025-10-21 |
| GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3. recall (Z-0214-2026) | Wipro GE Healthcare Private Ltd. | 2025-10-21 |
| CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/1 recall (Z-1265-2022) | GE Healthcare, LLC | 2022-06-13 |
| GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, recall (Z-0808-2022) | GE Healthcare, LLC | 2022-03-16 |
| GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Centra recall (Z-0487-2018) | GE Medical Systems Information Technologies, Inc. | 2018-01-25 |
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 |