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FDA 510(k)

IQQA-LIVER MULTIMODALITY SOFTWARE

K-Number: K131498 · 2013-07-25

ApplicantEdda Technology, Inc.
Decision Date2013-07-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IQQA-LIVER MULTIMODALITY SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Edda Technology, Inc.. It received FDA 510(k) clearance on 2013-07-25 under 510(k) number K131498. 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 IQQA-LIVER MULTIMODALITY SOFTWARE?

IQQA-LIVER MULTIMODALITY SOFTWARE is a medical device that received FDA 510(k) clearance on 2013-07-25. The listed applicant is Edda Technology, Inc.. The 510(k) number is K131498.

When did IQQA-LIVER MULTIMODALITY SOFTWARE receive FDA 510(k) clearance?

IQQA-LIVER MULTIMODALITY SOFTWARE received FDA 510(k) clearance on 2013-07-25, under 510(k) number K131498.

Who is the listed applicant for IQQA-LIVER MULTIMODALITY SOFTWARE?

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

What is the FDA product code for IQQA-LIVER MULTIMODALITY SOFTWARE?

The FDA product code for IQQA-LIVER MULTIMODALITY SOFTWARE is LLZ.

Related Clinical Trials

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Other records listing Edda Technology, 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.

K061696IQQA-LIVER SOFTWAREK042408IQQA-CHEST SOFTWARE PACKAGE

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

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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