FDA 510(k)

ERAD PACS

K-Number: K061421 · 2006-07-25

Decision Date2006-07-25

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ERAD PACS is the device name listed in this FDA 510(k) record. The listed applicant is Erad, Inc.. It received FDA 510(k) clearance on 2006-07-25 under 510(k) number K061421. 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 ERAD PACS?

ERAD PACS is a medical device that received FDA 510(k) clearance on 2006-07-25. The listed applicant is Erad, Inc.. The 510(k) number is K061421.

When did ERAD PACS receive FDA 510(k) clearance?

ERAD PACS received FDA 510(k) clearance on 2006-07-25, under 510(k) number K061421.

Who is the listed applicant for ERAD PACS?

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

What is the FDA product code for ERAD PACS?

The FDA product code for ERAD PACS is LLZ.

Other records listing Erad, Inc. as applicant

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.

K241223eRAD PACS K120995ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCT

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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.