ViewPoint 6
FDA 510(k) clearance K162743 · decided 2016-11-22
Clearance details
- K-number
- K162743
- Device name
- ViewPoint 6
- Applicant
- GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2016-09-30
- Decision date
- 2016-11-22
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Wauwatosa, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591P recall (Z-3146-2024) | GE Healthcare GmbH | 2024-09-13 |