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FDA 510(k)

XPLORER 1600

K-Number: K042041 · 2004-09-17

ApplicantImaging Dynamics Company Limited
Decision Date2004-09-17
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XPLORER 1600 is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Dynamics Company Limited. It received FDA 510(k) clearance on 2004-09-17 under 510(k) number K042041. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XPLORER 1600?

XPLORER 1600 is a medical device that received FDA 510(k) clearance on 2004-09-17. The listed applicant is Imaging Dynamics Company Limited. The 510(k) number is K042041.

When did XPLORER 1600 receive FDA 510(k) clearance?

XPLORER 1600 received FDA 510(k) clearance on 2004-09-17, under 510(k) number K042041.

Who is the listed applicant for XPLORER 1600?

The FDA 510(k) record lists Imaging Dynamics Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XPLORER 1600?

The FDA product code for XPLORER 1600 is MQB.

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Related Devices (Code: MQB)

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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