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FDA 510(k)

PORTALVISION ADVANCED IMAGING

K-Number: K091209 · 2009-06-23

ApplicantVarian Medical Systems, Inc.
Decision Date2009-06-23
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PORTALVISION ADVANCED IMAGING is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2009-06-23 under 510(k) number K091209. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTALVISION ADVANCED IMAGING?

PORTALVISION ADVANCED IMAGING is a medical device that received FDA 510(k) clearance on 2009-06-23. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K091209.

When did PORTALVISION ADVANCED IMAGING receive FDA 510(k) clearance?

PORTALVISION ADVANCED IMAGING received FDA 510(k) clearance on 2009-06-23, under 510(k) number K091209.

Who is the listed applicant for PORTALVISION ADVANCED IMAGING?

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

What is the FDA product code for PORTALVISION ADVANCED IMAGING?

The FDA product code for PORTALVISION ADVANCED IMAGING is IYE.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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