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FDA 510(k)

NORDICBRAINEX SOFTWARE, VERSION 1.0

K-Number: K092102 · 2009-08-25

ApplicantNordicimaginglab AS
Decision Date2009-08-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NORDICBRAINEX SOFTWARE, VERSION 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Nordicimaginglab AS. It received FDA 510(k) clearance on 2009-08-25 under 510(k) number K092102. 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 NORDICBRAINEX SOFTWARE, VERSION 1.0?

NORDICBRAINEX SOFTWARE, VERSION 1.0 is a medical device that received FDA 510(k) clearance on 2009-08-25. The listed applicant is Nordicimaginglab AS. The 510(k) number is K092102.

When did NORDICBRAINEX SOFTWARE, VERSION 1.0 receive FDA 510(k) clearance?

NORDICBRAINEX SOFTWARE, VERSION 1.0 received FDA 510(k) clearance on 2009-08-25, under 510(k) number K092102.

Who is the listed applicant for NORDICBRAINEX SOFTWARE, VERSION 1.0?

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 NORDICBRAINEX SOFTWARE, VERSION 1.0?

The FDA product code for NORDICBRAINEX SOFTWARE, VERSION 1.0 is LLZ.

Related Clinical Trials

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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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.

K090546MODIFICATION TO NORDICICE SOFTWAREK082441NORDICICE 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.

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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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