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FDA 510(k)

HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100

K-Number: K945400 · 1995-11-20

ApplicantHitachi Medical Corp. of America
Decision Date1995-11-20
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100 is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Corp. of America. It received FDA 510(k) clearance on 1995-11-20 under 510(k) number K945400. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100?

HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100 is a medical device that received FDA 510(k) clearance on 1995-11-20. The listed applicant is Hitachi Medical Corp. of America. The 510(k) number is K945400.

When did HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100 receive FDA 510(k) clearance?

HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100 received FDA 510(k) clearance on 1995-11-20, under 510(k) number K945400.

Who is the listed applicant for HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100?

The FDA 510(k) record lists Hitachi Medical Corp. of America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100?

The FDA product code for HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100 is IZI.

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Other records listing Hitachi Medical Corp. of America as applicant

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Related Devices (Code: IZI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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