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FDA 510(k)

LVivo Seamless

K-Number: K202546 · 2020-09-29

Decision Date2020-09-29
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LVivo Seamless is the device name listed in this FDA 510(k) record. The listed applicant is Dia Imaging Analysis, Ltd.. It received FDA 510(k) clearance on 2020-09-29 under 510(k) number K202546. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LVivo Seamless?

LVivo Seamless is a medical device that received FDA 510(k) clearance on 2020-09-29. The listed applicant is Dia Imaging Analysis, Ltd.. The 510(k) number is K202546.

When did LVivo Seamless receive FDA 510(k) clearance?

LVivo Seamless received FDA 510(k) clearance on 2020-09-29, under 510(k) number K202546.

Who is the listed applicant for LVivo Seamless?

The FDA 510(k) record lists Dia Imaging Analysis, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LVivo Seamless?

The FDA product code for LVivo Seamless is QIH.

Other records listing Dia Imaging Analysis, Ltd. 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.

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Related Devices (Code: QIH)

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.

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.