MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow
FDA 510(k) K191050 · Siemens Medical Solutions USA, Inc.
510(k) numberK191050
Submission
- Device name
- MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow
- Applicant
- Siemens Medical Solutions USA, Inc.
Malvern, PA, US - Received
- April 19, 2019
- Decision date
- July 12, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow cleared by the FDA?
MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow (K191050) received a 510(k) decision of Substantially Equivalent on July 12, 2019, 84 days after the submission was received.
What is the product code of K191050?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.