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FDA 510(k), K173079, Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4
FDA 510(k), K173079, Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4
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510(K) Number: K173079
Device Name: Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4
Manufacturer: Jan van de Kerkhot
Device Classification Name: System, Nuclear Magnetic Resonance Imaging
Regulation Number: LNH
Classification Product Code: 09/29/2017
Date Received: 04/04/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4
Manufacturer: Jan van de Kerkhot
Device Classification Name: System, Nuclear Magnetic Resonance Imaging
Regulation Number: LNH
Classification Product Code: 09/29/2017
Date Received: 04/04/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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