The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Osteo Ct For The Somatom Ar Family And Plus 4 Ct Systems.
| Device ID | K971054 |
| 510k Number | K971054 |
| Device Name: | OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Contact | Jing Zhang |
| Correspondent | Jing Zhang SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE 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 | 1997-03-24 |
| Decision Date | 1997-06-13 |
| Summary: | summary |