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510(k) K261132

Healium Intelliscan LX192LC by Healium Intelliscan Corporation — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2026
Date Received
April 6, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

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