FDA 510(k) clearance · back to tracker
TE Air Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. cleared K250024 on 2025-05-30, decision: substantially equivalent
K-number
K250024
Sponsor
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Device
TE Air Diagnostic Ultrasound System
Class
Class II
Decision
Substantially Equivalent
Decision date
2025-05-30
Product code
IYN
Advisory committee
Radiology
Medical specialty
Radiology
Regulation number
892.1550
Official FDA record
Open K250024on 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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