Skip to content

MSKai

by Mskai

510(k) K240793

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK240793 Date16 Dec 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
QIH
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

MSKai is a device classified under the product code QIH, which corresponds to a radiology-related device type as indicated by the advisory committee assignment. It was determined to be substantially equivalent to a legally marketed predicate device through a traditional 510(k) clearance process.

The device was manufactured by Mskai in Memphis, Tennessee, and received FDA 510(k) clearance under K240793 on December 16, 2024. It is authorized for distribution in the United States and is not a third-party submission.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the MSKai device used for?

    The MSKai device is classified under product code QIH, which corresponds to a radiology-related device type as determined by the advisory committee assignment, indicating its intended use falls within radiology applications.

  • How was the MSKai device cleared for market release?

    The MSKai device received FDA 510(k) clearance through a traditional submission process, demonstrating substantial equivalence to a legally marketed predicate device under K240793.

  • When did the MSKai device receive FDA clearance?

    The MSKai device was granted FDA 510(k) clearance on December 16, 2024, under submission number K240793, following its initial receipt on March 22, 2024.

  • Who manufactures the MSKai device and where is it produced?

    The MSKai device is manufactured by Mskai at their facility located at 6075 Poplar, Suite 221, Memphis, Tennessee, 38119, United States.