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FDA 510(k)

MODIFICATION TO NORDICICE SOFTWARE

K-Number: K090546 · 2009-06-08

ApplicantNordicimaginglab AS
Decision Date2009-06-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO NORDICICE SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Nordicimaginglab AS. It received FDA 510(k) clearance on 2009-06-08 under 510(k) number K090546. 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 MODIFICATION TO NORDICICE SOFTWARE?

MODIFICATION TO NORDICICE SOFTWARE is a medical device that received FDA 510(k) clearance on 2009-06-08. The listed applicant is Nordicimaginglab AS. The 510(k) number is K090546.

When did MODIFICATION TO NORDICICE SOFTWARE receive FDA 510(k) clearance?

MODIFICATION TO NORDICICE SOFTWARE received FDA 510(k) clearance on 2009-06-08, under 510(k) number K090546.

Who is the listed applicant for MODIFICATION TO NORDICICE SOFTWARE?

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

What is the FDA product code for MODIFICATION TO NORDICICE SOFTWARE?

The FDA product code for MODIFICATION TO NORDICICE SOFTWARE is LLZ.

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Other records listing Nordicimaginglab AS 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.

K092102NORDICBRAINEX SOFTWARE, VERSION 1.0K082441NORDICICE SOFTWARE

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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

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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