FDA 510(k) clearance · back to tracker

Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6)

Shantou Institute of Ultrasonic Instruments Co., Ltd. cleared K243132 on 2024-12-10, decision: substantially equivalent

K-number

K243132

Sponsor

Shantou Institute of Ultrasonic Instruments Co., Ltd.

Device

Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6)

Class

Class II

Decision

Substantially Equivalent

Decision date

2024-12-10

Product code

IYN

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1550

Official FDA record

Open K243132on 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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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

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