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FDA 510(k)

THE OBSIDIAN PACS SYSTEM

K-Number: K030635 · 2003-03-28

ApplicantObsidian Medical Technology, Inc.
Decision Date2003-03-28
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THE OBSIDIAN PACS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Obsidian Medical Technology, Inc.. It received FDA 510(k) clearance on 2003-03-28 under 510(k) number K030635. 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 THE OBSIDIAN PACS SYSTEM?

THE OBSIDIAN PACS SYSTEM is a medical device that received FDA 510(k) clearance on 2003-03-28. The listed applicant is Obsidian Medical Technology, Inc.. The 510(k) number is K030635.

When did THE OBSIDIAN PACS SYSTEM receive FDA 510(k) clearance?

THE OBSIDIAN PACS SYSTEM received FDA 510(k) clearance on 2003-03-28, under 510(k) number K030635.

Who is the listed applicant for THE OBSIDIAN PACS SYSTEM?

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

What is the FDA product code for THE OBSIDIAN PACS SYSTEM?

The FDA product code for THE OBSIDIAN PACS SYSTEM is LLZ.

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Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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