The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Top Acom Station.
| Device ID | K945293 |
| 510k Number | K945293 |
| Device Name: | TOP ACOM STATION |
| Classification | System, X-ray, Angiographic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. ROENTGEN ANGIOGRAPHY CHICAGO 2501 N. BARRINGTON ROAD Hoffman Estates, IL 60195 -7372 |
| Contact | Paul H Oris |
| Correspondent | Paul H Oris SIEMENS MEDICAL SOLUTIONS USA, INC. ROENTGEN ANGIOGRAPHY CHICAGO 2501 N. BARRINGTON ROAD Hoffman Estates, IL 60195 -7372 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-31 |
| Decision Date | 1995-01-05 |