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FDA 510(k)

XPLORER 1000

K-Number: K992955 · 2000-06-02

ApplicantImaging Dynamics Corp.
Decision Date2000-06-02
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XPLORER 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Dynamics Corp.. It received FDA 510(k) clearance on 2000-06-02 under 510(k) number K992955. 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 1000?

XPLORER 1000 is a medical device that received FDA 510(k) clearance on 2000-06-02. The listed applicant is Imaging Dynamics Corp.. The 510(k) number is K992955.

When did XPLORER 1000 receive FDA 510(k) clearance?

XPLORER 1000 received FDA 510(k) clearance on 2000-06-02, under 510(k) number K992955.

Who is the listed applicant for XPLORER 1000?

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

What is the FDA product code for XPLORER 1000?

The FDA product code for XPLORER 1000 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

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

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