FDA Device Entity Profile: Hitachi Medical Systems America, Inc.

Known Identifiers & Locations

FEI Numbers 1528028

Owner Operator Numbers N/A

Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (2)

Submission #	Device Name	Decision Date	Decision Description	Action
K102889	HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON	2010-12-20	Substantially Equivalent	View Details
K151015	ECHELON Oval V 5.0 MRI System	2015-07-29	Substantially Equivalent	View Details

FDA Recall History (1)

Recall #	Product Description	Initiation Date	Status	Action
Z-0029-2007	MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J. Reason: Image orientation error. When a 3D Maximum Intensity Projection (MIP) image data set is transferred from the MRI system to a computer workstation via the DICOM protocol, the anatomical markers do not change between the images as they rotate.	2006-08-16	Terminated	View Details

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