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510(k) K250750

INNOVISION-P5 by Dk Medical Systems Co., Ltd. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2025
Date Received
March 12, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type

Other clearances by Dk Medical Systems Co., Ltd.

  • K250790 — INNOVISION-DXII (August 1, 2025)

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