The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Ge Advantage Digitizer Workstation.
| Device ID | K970628 |
| 510k Number | K970628 |
| Device Name: | GE ADVANTAGE DIGITIZER WORKSTATION |
| Classification | System, Digital Image Communications, Radiological |
| Applicant | GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger, Ph.d. |
| Correspondent | Larry A Kroger, Ph.d. GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | LMD |
| CFR Regulation Number | 892.2020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-19 |
| Decision Date | 1997-05-12 |
| Summary: | summary |