The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Viewpoint 6.
| Device ID | K103458 |
| 510k Number | K103458 |
| Device Name: | VIEWPOINT 6 |
| Classification | System, Image Processing, Radiological |
| Applicant | GE HEALTHCARE 3000 NORTH GRANDVIEW BLVD #W450 Waukesha, WI 53188 |
| Contact | Nicole Landreville |
| Correspondent | Nicole Landreville GE HEALTHCARE 3000 NORTH GRANDVIEW BLVD #W450 Waukesha, WI 53188 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-23 |
| Decision Date | 2011-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682103640 | K103458 | 000 |