The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Somatom Project 059.
| Device ID | K941546 |
| 510k Number | K941546 |
| Device Name: | SOMATOM PROJECT 059 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS CORP. 186 WOOD AVE., SOUTH Iselin, NJ 08830 |
| Contact | Cathy A Pinto |
| Correspondent | Cathy A Pinto SIEMENS CORP. 186 WOOD AVE., SOUTH Iselin, NJ 08830 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-31 |
| Decision Date | 1994-09-20 |