FDA 510(k) clearance · back to tracker

Leltek Ultrasound Imaging System (Model: LU700 Series)

Leltek, Inc. cleared K222365 on 2022-10-25, decision: substantially equivalent

K-number

K222365

Sponsor

Leltek, Inc.

Device

Leltek Ultrasound Imaging System (Model: LU700 Series)

Class

Class II

Decision

Substantially Equivalent

Decision date

2022-10-25

Product code

IYN

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1550

Official FDA record

Open K222365on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.