The following data is part of a premarket notification filed by Siemens Medical Corp. with the FDA for 3d-angio.
| Device ID | K984634 |
| 510k Number | K984634 |
| Device Name: | 3D-ANGIO |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS MEDICAL CORP. 186 WOOD AVE. SOUTH Iselin, NJ 08830 |
| Contact | Malgorzata Stanek |
| Correspondent | Malgorzata Stanek SIEMENS MEDICAL 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 | 1998-12-30 |
| Decision Date | 1999-03-12 |
| Summary: | summary |