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FDA 510(k)

IMORGON ULTRASOUND PACS SOLUTIONS

K-Number: K050736 · 2005-05-05

ApplicantSea Ridge Software, Inc.
Decision Date2005-05-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMORGON ULTRASOUND PACS SOLUTIONS is the device name listed in this FDA 510(k) record. The listed applicant is Sea Ridge Software, Inc.. It received FDA 510(k) clearance on 2005-05-05 under 510(k) number K050736. 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 IMORGON ULTRASOUND PACS SOLUTIONS?

IMORGON ULTRASOUND PACS SOLUTIONS is a medical device that received FDA 510(k) clearance on 2005-05-05. The listed applicant is Sea Ridge Software, Inc.. The 510(k) number is K050736.

When did IMORGON ULTRASOUND PACS SOLUTIONS receive FDA 510(k) clearance?

IMORGON ULTRASOUND PACS SOLUTIONS received FDA 510(k) clearance on 2005-05-05, under 510(k) number K050736.

Who is the listed applicant for IMORGON ULTRASOUND PACS SOLUTIONS?

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

What is the FDA product code for IMORGON ULTRASOUND PACS SOLUTIONS?

The FDA product code for IMORGON ULTRASOUND PACS SOLUTIONS 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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