FDA 510(k)

TBS iNsight

K-Number: K152299 · 2016-04-29

Decision Date2016-04-29

Product CodeKGI

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TBS iNsight is the device name listed in this FDA 510(k) record. The listed applicant is Medimaps Group SA. It received FDA 510(k) clearance on 2016-04-29 under 510(k) number K152299. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TBS iNsight?

TBS iNsight is a medical device that received FDA 510(k) clearance on 2016-04-29. The listed applicant is Medimaps Group SA. The 510(k) number is K152299.

When did TBS iNsight receive FDA 510(k) clearance?

TBS iNsight received FDA 510(k) clearance on 2016-04-29, under 510(k) number K152299.

Who is the listed applicant for TBS iNsight?

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

What is the FDA product code for TBS iNsight?

The FDA product code for TBS iNsight is KGI.

Other records listing Medimaps Group SA 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.

K243218TBS iNsight (V4)

Related Devices (Code: KGI)

K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC K2510223D-SHAPER3D-Shaper Medical S.L K242295BunkerHill BMDBunkerHill Health K243218TBS iNsight (V4)Medimaps Group SA K220402VirtuOstO.N. Diagnostics K2208223D-SHAPER3D-Shaper Medical S.L

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.