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FDA 510(k)

PATIENTGALLERY IMAGING SOFTWARE

K-Number: K070954 · 2007-04-20

ApplicantRaster Builders, Inc.
Decision Date2007-04-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PATIENTGALLERY IMAGING SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Raster Builders, Inc.. It received FDA 510(k) clearance on 2007-04-20 under 510(k) number K070954. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATIENTGALLERY IMAGING SOFTWARE?

PATIENTGALLERY IMAGING SOFTWARE is a medical device that received FDA 510(k) clearance on 2007-04-20. The listed applicant is Raster Builders, Inc.. The 510(k) number is K070954.

When did PATIENTGALLERY IMAGING SOFTWARE receive FDA 510(k) clearance?

PATIENTGALLERY IMAGING SOFTWARE received FDA 510(k) clearance on 2007-04-20, under 510(k) number K070954.

Who is the listed applicant for PATIENTGALLERY IMAGING SOFTWARE?

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

What is the FDA product code for PATIENTGALLERY IMAGING SOFTWARE?

The FDA product code for PATIENTGALLERY IMAGING SOFTWARE is LLZ.

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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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