FDA 510(k) clearance · back to tracker

Portable DR Imaging System

Shantou Institute of Ultrasonic Instruments Co., Ltd. cleared K253058 on 2026-06-18, decision: substantially equivalent

K-number

K253058

Sponsor

Shantou Institute of Ultrasonic Instruments Co., Ltd.

Device

Portable DR Imaging System

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-06-18

Product code

IZL

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1720

Official FDA record

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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.