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510(k) K250099

Mobius3D (4.1) by Varian Medical Systems — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2025
Date Received
January 14, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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Other clearances for product code IYE

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  • K252919 — IDENTIFY (5.0) (December 16, 2025)
  • K250392 — ZAP-X Radiosurgery System (ZAP-X) (November 3, 2025)
  • K250696 — AccuCheck (October 24, 2025)
  • K250911 — MOSkin Radiation Measurement System (October 17, 2025)
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