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FDA 510(k)

XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM

K-Number: K033066 · 2003-11-12

ApplicantXitec Holdings, LLC
Decision Date2003-11-12
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Xitec Holdings, LLC. It received FDA 510(k) clearance on 2003-11-12 under 510(k) number K033066. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM?

XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2003-11-12. The listed applicant is Xitec Holdings, LLC. The 510(k) number is K033066.

When did XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM receive FDA 510(k) clearance?

XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM received FDA 510(k) clearance on 2003-11-12, under 510(k) number K033066.

Who is the listed applicant for XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM?

The FDA 510(k) record lists Xitec Holdings, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM?

The FDA product code for XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM is OXO.

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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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