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510(k) K251223

HnX-P1, HnX-PB by H&abyz Co., Ltd. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2025
Date Received
April 21, 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 H&abyz Co., Ltd.

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  • K203188 — ADD (March 12, 2021)

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