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510(k) K240009

iQFlex Pro by First Source, Inc. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2024
Date Received
January 2, 2024
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 First Source, Inc.

  • K221081 — iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System (June 13, 2022)
  • K203703 — I-Q View (March 24, 2021)

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  • K243473 — PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS (July 29, 2025)
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