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FDA 510(k)

XPLORER 1600 PLUS

K-Number: K062586 · 2006-09-29

ApplicantImaging Dynamics Company , Ltd.
Decision Date2006-09-29
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XPLORER 1600 PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Dynamics Company , Ltd.. It received FDA 510(k) clearance on 2006-09-29 under 510(k) number K062586. 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 PLUS?

XPLORER 1600 PLUS is a medical device that received FDA 510(k) clearance on 2006-09-29. The listed applicant is Imaging Dynamics Company , Ltd.. The 510(k) number is K062586.

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

XPLORER 1600 PLUS received FDA 510(k) clearance on 2006-09-29, under 510(k) number K062586.

Who is the listed applicant for XPLORER 1600 PLUS?

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

What is the FDA product code for XPLORER 1600 PLUS?

The FDA product code for XPLORER 1600 PLUS is MQB.

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Other records listing Imaging Dynamics Company , Ltd. as applicant

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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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