Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Limbus Contour

K-Number: K230575 · 2023-04-07

ApplicantLimbus Ai, Inc.
Decision Date2023-04-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Limbus Contour is a medical device manufactured by Limbus Ai, Inc.. It received FDA 510(k) clearance on 2023-04-07 under approval number K230575. 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 Limbus Contour?

Limbus Contour is a medical device that received FDA 510(k) clearance on 2023-04-07. It is manufactured by Limbus Ai, Inc.. The 510(k) number is K230575.

When was Limbus Contour approved by the FDA?

Limbus Contour received FDA 510(k) clearance on 2023-04-07, under approval number K230575.

What company makes Limbus Contour?

Limbus Contour is manufactured by Limbus Ai, Inc..

What is the FDA product code for Limbus Contour?

The FDA product code for Limbus Contour is LLZ.

Other Devices by Limbus Ai, Inc.

K201232Limbus Contour K241837Limbus Contour

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑