The following data is part of a premarket notification filed by Ge Medical Systems F.i. Haifa with the FDA for Einstein Processing And Review Workstation.
| Device ID | K000395 |
| 510k Number | K000395 |
| Device Name: | EINSTEIN PROCESSING AND REVIEW WORKSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | GE MEDICAL SYSTEMS F.I. HAIFA P.O. BOX 170 Tirat Hacarmel, IL 30200 |
| Contact | Dan Laor |
| Correspondent | Dan Laor GE MEDICAL SYSTEMS F.I. HAIFA P.O. BOX 170 Tirat Hacarmel, IL 30200 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-07 |
| Decision Date | 2000-05-03 |