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FDA 510(k)

SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM

K-Number: K983283 · 1998-11-06

ApplicantSignet Radiology, Inc.
Decision Date1998-11-06
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Signet Radiology, Inc.. It received FDA 510(k) clearance on 1998-11-06 under 510(k) number K983283. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM?

SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1998-11-06. The listed applicant is Signet Radiology, Inc.. The 510(k) number is K983283.

When did SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM receive FDA 510(k) clearance?

SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM received FDA 510(k) clearance on 1998-11-06, under 510(k) number K983283.

Who is the listed applicant for SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM?

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

What is the FDA product code for SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM?

The FDA product code for SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM is MUH.

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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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