The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound And Primary with the FDA for Viewpoint 6.
| Device ID | K173456 |
| 510k Number | K173456 |
| Device Name: | ViewPoint 6 |
| Classification | System, Image Processing, Radiological |
| Applicant | GE Medical Systems Ultrasound And Primary Care Diagnostics, LLC 9900 W Innovation Drive Wauwatosa, WI 53226 |
| Contact | Tracey Ortiz |
| Correspondent | Tracey Ortiz GE Medical Systems Ultrasound And Primary Care Diagnostics, LLC 9900 W Innovation Drive Wauwatosa, WI 53226 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-07 |
| Decision Date | 2018-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682145718 | K173456 | 000 |
| 00840682140744 | K173456 | 000 |