The following data is part of a premarket notification filed by Siemens Medical Solutions, Usa Inc. with the FDA for Magnetom Aera And Magnetom Skyra With Software Syngo Mr E11e With Ischemic Heart Disease (ihd) Workflow.
| Device ID | K191050 |
| 510k Number | K191050 |
| Device Name: | MAGNETOM Aera And MAGNETOM Skyra With Software Syngo MR E11E With Ischemic Heart Disease (IHD) Workflow |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Siemens Medical Solutions, USA Inc. 40 Liberty Boulevard Mailcode 65-1A Malvern, PA 19355 |
| Contact | Milind Dhamankar |
| Correspondent | Milind Dhamankar Siemens Medical Solutions, USA Inc. 40 Liberty Boulevard Mailcode 65-1A Malvern, PA 19355 |
| Product Code | LNH |
| Subsequent Product Code | LNI |
| Subsequent Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-19 |
| Decision Date | 2019-07-12 |