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FDA 510(k)

XISCAN MODEL 1000

K-Number: K852346 · 1986-03-10

ApplicantXi Tech
Decision Date1986-03-10
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XISCAN MODEL 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Xi Tech. It received FDA 510(k) clearance on 1986-03-10 under 510(k) number K852346. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XISCAN MODEL 1000?

XISCAN MODEL 1000 is a medical device that received FDA 510(k) clearance on 1986-03-10. The listed applicant is Xi Tech. The 510(k) number is K852346.

When did XISCAN MODEL 1000 receive FDA 510(k) clearance?

XISCAN MODEL 1000 received FDA 510(k) clearance on 1986-03-10, under 510(k) number K852346.

Who is the listed applicant for XISCAN MODEL 1000?

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

What is the FDA product code for XISCAN MODEL 1000?

The FDA product code for XISCAN MODEL 1000 is JAA.

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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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