Clearance Summary
MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow received FDA 510(k) clearance under submission number K191050, sponsored by Siemens Medical Solutions USA, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2019-07-12.
- Submission: K191050
- Applicant / Sponsor: Siemens Medical Solutions USA, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2019-07-12
Classification & Regulation
This clearance is catalogued under FDA product code LNH and 21 CFR 892.1000, within the Radiology review panel as a Class II device.