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FDA 510(k)

RemedyLogic AI MRI Lumbar Spine Reader

K-Number: K241108 · 2024-10-30

ApplicantRemedy Logic, Inc.
Decision Date2024-10-30
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RemedyLogic AI MRI Lumbar Spine Reader is a medical device manufactured by Remedy Logic, Inc.. It received FDA 510(k) clearance on 2024-10-30 under approval number K241108. 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 RemedyLogic AI MRI Lumbar Spine Reader?

RemedyLogic AI MRI Lumbar Spine Reader is a medical device that received FDA 510(k) clearance on 2024-10-30. It is manufactured by Remedy Logic, Inc.. The 510(k) number is K241108.

When was RemedyLogic AI MRI Lumbar Spine Reader approved by the FDA?

RemedyLogic AI MRI Lumbar Spine Reader received FDA 510(k) clearance on 2024-10-30, under approval number K241108.

What company makes RemedyLogic AI MRI Lumbar Spine Reader?

RemedyLogic AI MRI Lumbar Spine Reader is manufactured by Remedy Logic, Inc..

What is the FDA product code for RemedyLogic AI MRI Lumbar Spine Reader?

The FDA product code for RemedyLogic AI MRI Lumbar Spine Reader is QIH.

Related Clinical Trials

NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT07328165 The Impact of Core Stability Versus Respiratory Muscle Strengthening Exercises on Bone Mineral Density in Children With Down Syndrome ACTIVE_NOT_RECRUITING NCT06545812 Immune Response During the Conservative and Minimal Invasive Treatment of Pain Caused by Lumbar Disc Herniation COMPLETED NCT07545733 Comparison of 5 vs 8 cmH₂O PEEP on Respiratory Mechanics in Prone Lumbar Surgery NOT_YET_RECRUITING NCT06971835 INDUCE: A Prospective 2-Year Spine Registry ENROLLING_BY_INVITATION NCT06720948 The ION Facet Screw System Ambispective Evaluation ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026)

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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.

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