Vscan Extend
FDA 510(k) clearance K180995 · decided 2018-06-25
Clearance details
- K-number
- K180995
- Device name
- Vscan Extend
- Applicant
- GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2018-04-16
- Decision date
- 2018-06-25
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Wauwatosa, WI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch GE Medical Systems Ultrasound and Primary Care Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Vscan Extend, being sold as "Vscan Extend Console" recall (Z-0518-2022) | GE Healthcare, LLC | 2022-01-24 |
| GE Vscan Extend, being sold as "Vscan Extend Dual DICOM" recall (Z-0519-2022) | GE Healthcare, LLC | 2022-01-24 |
| GE Vscan Extend, being sold as "Vscan Extend Dual USB" recall (Z-0520-2022) | GE Healthcare, LLC | 2022-01-24 |
| GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi" recall (Z-0521-2022) | GE Healthcare, LLC | 2022-01-24 |
| GE Vscan Extend, being sold as "Vscan Extend Sector DICOM" recall (Z-0522-2022) | GE Healthcare, LLC | 2022-01-24 |
| GE Vscan Extend, being sold as "Vscan Extend Sector USB" recall (Z-0523-2022) | GE Healthcare, LLC | 2022-01-24 |
| GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi" recall (Z-0524-2022) | GE Healthcare, LLC | 2022-01-24 |