The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound & Primary Care Diagnostics,llc with the FDA for Viewpoint 6.
| Device ID | K203677 |
| 510k Number | K203677 |
| Device Name: | ViewPoint 6 |
| Classification | System, Image Processing, Radiological |
| Applicant | GE Medical Systems Ultrasound & Primary Care Diagnostics,LLC 9900 W. Innovation Drive Wauwatosa, WI 53226 |
| Contact | Tracey Ortiz |
| Correspondent | Tracey Ortiz GE Medical Systems Ultrasound & Primary Care Diagnostics,LLC 9900 W. Innovation Drive Wauwatosa, WI 53226 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-17 |
| Decision Date | 2021-01-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278517340 | K203677 | 000 |