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Diagnostic Ultrasound System (Resona I10W)

by Shenzhen Mindray Bio-Medical Electronics Co., LTD United States 510(k)

510(k) K261617

Product code IYN

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK261617 Date8 Oct 2026ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
IYN
FDA applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K261617-1 24 fields · synced 22 Oct 2026