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FDA 510(k)

IMAGEQUBE

K-Number: K124048 · 2013-01-29

ApplicantIntuitive Imaging Informatics, LLC
Decision Date2013-01-29
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGEQUBE is the device name listed in this FDA 510(k) record. The listed applicant is Intuitive Imaging Informatics, LLC. It received FDA 510(k) clearance on 2013-01-29 under 510(k) number K124048. 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 IMAGEQUBE?

IMAGEQUBE is a medical device that received FDA 510(k) clearance on 2013-01-29. The listed applicant is Intuitive Imaging Informatics, LLC. The 510(k) number is K124048.

When did IMAGEQUBE receive FDA 510(k) clearance?

IMAGEQUBE received FDA 510(k) clearance on 2013-01-29, under 510(k) number K124048.

Who is the listed applicant for IMAGEQUBE?

The FDA 510(k) record lists Intuitive Imaging Informatics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMAGEQUBE?

The FDA product code for IMAGEQUBE is LLZ.

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Other records listing Intuitive Imaging Informatics, LLC 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.

K051037IMAGEQUBE PACSK031473RATIONAL IMAGING PACS

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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