The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound And Primary Care Diagnostics, with the FDA for 4d View.
| Device ID | K182750 |
| 510k Number | K182750 |
| Device Name: | 4D View |
| Classification | System, Image Processing, Radiological |
| Applicant | GE Medical Systems Ultrasound And Primary Care Diagnostics, 9900 W Innovation Drive Wauwatosa, WI 53226 |
| Contact | Tracey Ortiz |
| Correspondent | Tracey Ortiz GE Medical Systems Ultrasound And Primary Care Diagnostics, 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 | 2018-09-28 |
| Decision Date | 2018-12-21 |
| Summary: | summary |