The following data is part of a premarket notification filed by Ge Healthcare with the FDA for 4d-view 9.1 (4d View Pc Software) Model: H48651sz.
| Device ID | K101166 |
| 510k Number | K101166 |
| Device Name: | 4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-26 |
| Decision Date | 2010-10-07 |
| Summary: | summary |