The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Lca Angiographic Imaging System.
| Device ID | K941946 |
| 510k Number | K941946 |
| Device Name: | LCA ANGIOGRAPHIC IMAGING SYSTEM |
| Classification | System, X-ray, Angiographic |
| Applicant | GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry Kroger |
| Correspondent | Larry Kroger GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-21 |
| Decision Date | 1994-05-20 |