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FDA 510(k)

NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1

K-Number: K063539 · 2007-01-17

ApplicantNordicicemedical AS
Decision Date2007-01-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1 is the device name listed in this FDA 510(k) record. The listed applicant is Nordicicemedical AS. It received FDA 510(k) clearance on 2007-01-17 under 510(k) number K063539. 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 NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1?

NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1 is a medical device that received FDA 510(k) clearance on 2007-01-17. The listed applicant is Nordicicemedical AS. The 510(k) number is K063539.

When did NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1 receive FDA 510(k) clearance?

NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1 received FDA 510(k) clearance on 2007-01-17, under 510(k) number K063539.

Who is the listed applicant for NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1?

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

What is the FDA product code for NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1?

The FDA product code for NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1 is LLZ.

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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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