The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Leonardo Syngo Cardiology Workstation.
| Device ID | K042203 |
| 510k Number | K042203 |
| Device Name: | LEONARDO SYNGO CARDIOLOGY WORKSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Contact | Ana Ladino |
| Correspondent | Ana Ladino SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-16 |
| Decision Date | 2004-09-24 |
| Summary: | summary |