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FDA 510(k)

XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM

K-Number: K984406 · 1999-02-02

ApplicantXitec, Inc.
Decision Date1999-02-02
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Xitec, Inc.. It received FDA 510(k) clearance on 1999-02-02 under 510(k) number K984406. 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 OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM?

XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1999-02-02. The listed applicant is Xitec, Inc.. The 510(k) number is K984406.

When did XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM receive FDA 510(k) clearance?

XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM received FDA 510(k) clearance on 1999-02-02, under 510(k) number K984406.

Who is the listed applicant for XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM?

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

What is the FDA product code for XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM?

The FDA product code for XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM is OXO.

Related Clinical Trials

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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Other records listing Xitec, Inc. as applicant

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.

K003568XISCAN 6000 IMAGING SYSTEM

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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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