Hitachi Dynamic 3D Imaging System SF-VA100

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K945400 ↗

FDA Product Code

IZI

Device Class

Class II

Regulation

21 CFR Part 892.1600

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Hitachi Medical Corp. of America →

• What is the Hitachi Dynamic 3D Imaging System SF-VA100 used for?

  The Hitachi Dynamic 3D Imaging System SF-VA100 is an X-ray angiographic system used in radiology for imaging blood vessels and supporting diagnostic procedures, as indicated by its classification and intended use in radiological settings.

• Is the Hitachi Dynamic 3D Imaging System SF-VA100 sterile or single-use?

  The device is not described as sterile, single-use, or reusable in the provided data; no information is given about its sterility status or reprocessing requirements, so users should consult the manufacturer’s labeling for specific handling instructions.

• What regulatory pathway was used for the Hitachi Dynamic 3D Imaging System SF-VA100?

  The device received FDA 510(k) clearance under K945400 on November 20, 1995, through a traditional submission process, and was determined to be substantially equivalent to a predicate device in the radiology specialty.