The following data is part of a premarket notification filed by Siemens Medical Systems, Inc. with the FDA for Axiom Sireskop Sd.
| Device ID | K051602 |
| 510k Number | K051602 |
| Device Name: | AXIOM SIRESKOP SD |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | SIEMENS MEDICAL SYSTEMS, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 -1406 |
| Contact | Gary Johnson |
| Correspondent | Gary Johnson SIEMENS MEDICAL SYSTEMS, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 -1406 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-16 |
| Decision Date | 2005-07-07 |
| Summary: | summary |