EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)
K-Number: K241923 · 2024-12-06
ApplicantEver Fortune.Ai, Co., Ltd.
Decision Date2024-12-06
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) is a medical device manufactured by Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2024-12-06 under approval number K241923. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)?
EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) is a medical device that received FDA 510(k) clearance on 2024-12-06. It is manufactured by Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K241923.
When was EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) approved by the FDA?
EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) received FDA 510(k) clearance on 2024-12-06, under approval number K241923.
What company makes EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)?
EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) is manufactured by Ever Fortune.Ai, Co., Ltd..
What is the FDA product code for EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)?
The FDA product code for EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) is QAS.
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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.