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510(k) K211663

Zap-X Radiosurgical System by Zap Surgical Systems, Inc. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2021
Date Received
June 1, 2021
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

Other clearances by Zap Surgical Systems, Inc.

  • K250392 — ZAP-X Radiosurgery System (ZAP-X) (November 3, 2025)
  • K183698 — Zap-X Radiosurgery System (February 25, 2019)
  • K171804 — Zap-X Radiosurgery System (September 21, 2017)

Other clearances for product code IYE

  • K252977 — Halcyon, Ethos Radiotherapy System (5.0) (January 21, 2026)
  • K252188 — EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infin (January 15, 2026)
  • K254010 — ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface (January 14, 2026)
  • K252988 — ChartCheck (RADCH V1.6) (January 5, 2026)
  • 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)
  • K252948 — TrueBeam, TrueBeam STX, Edge and VitalBeam (October 7, 2025)
  • K252174 — AquaCast Mask (September 3, 2025)