K203677 is an FDA 510(k) clearance for the ViewPoint 6. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (Wauwatosa, US). The FDA issued a Cleared decision on January 15, 2021, 29 days after receiving the submission on December 17, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K203677 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2020 |
| Decision Date | January 15, 2021 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ - System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |