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FDA 510(k)

RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM

K-Number: K030544 · 2003-05-21

ApplicantSigma Vision, Inc.
Decision Date2003-05-21
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Vision, Inc.. It received FDA 510(k) clearance on 2003-05-21 under 510(k) number K030544. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM?

RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2003-05-21. The listed applicant is Sigma Vision, Inc.. The 510(k) number is K030544.

When did RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM receive FDA 510(k) clearance?

RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM received FDA 510(k) clearance on 2003-05-21, under 510(k) number K030544.

Who is the listed applicant for RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM?

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

What is the FDA product code for RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM?

The FDA product code for RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM is OWB.

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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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