The following data is part of a premarket notification filed by Ge Healthcare with the FDA for 4d View.
| Device ID | K131118 |
| 510k Number | K131118 |
| Device Name: | 4D VIEW |
| Classification | System, Image Processing, Radiological |
| Applicant | GE HEALTHCARE 9900 Innovation Drive Wauwatosa, WI 53226 |
| Contact | Bryan Behn |
| Correspondent | Bryan Behn GE HEALTHCARE 9900 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 | 2013-04-22 |
| Decision Date | 2013-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682137621 | K131118 | 000 |
| 00840682122788 | K131118 | 000 |
| 00840682102780 | K131118 | 000 |