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FDA 510(k)

ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM

K-Number: K071806 · 2007-08-28

ApplicantHitachi Medical Systems America, Inc.
Decision Date2007-08-28
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2007-08-28 under 510(k) number K071806. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM?

ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 2007-08-28. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K071806.

When did ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM receive FDA 510(k) clearance?

ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM received FDA 510(k) clearance on 2007-08-28, under 510(k) number K071806.

Who is the listed applicant for ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM?

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

What is the FDA product code for ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM?

The FDA product code for ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM is JAK.

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Other records listing Hitachi Medical Systems America, Inc. as applicant

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Related Devices (Code: JAK)

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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