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FDA 510(k)

CXR16

K-Number: K053148 · 2006-02-17

ApplicantHitachi Medical Systems America, Inc.
Decision Date2006-02-17
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CXR16 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 2006-02-17 under 510(k) number K053148. 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 CXR16?

CXR16 is a medical device that received FDA 510(k) clearance on 2006-02-17. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K053148.

When did CXR16 receive FDA 510(k) clearance?

CXR16 received FDA 510(k) clearance on 2006-02-17, under 510(k) number K053148.

Who is the listed applicant for CXR16?

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 CXR16?

The FDA product code for CXR16 is JAK.

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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