The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Ge View Applications (consisting Of Ge Viewing Station And Ge Extended Viewing Station) Version 1.2c.
| Device ID | K991629 |
| 510k Number | K991629 |
| Device Name: | GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EXTENDED VIEWING STATION) VERSION 1.2C |
| Classification | System, Image Processing, Radiological |
| Applicant | GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry Kroger |
| Correspondent | Larry Kroger GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-11 |
| Decision Date | 1999-08-02 |
| Summary: | summary |