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510(k) K221081

iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System by First Source, Inc. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2022
Date Received
April 12, 2022
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.

  • K240009 — iQFlex Pro (July 3, 2024)
  • K203703 — I-Q View (March 24, 2021)

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