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510(k) K052118

DOSE VERIFICATION SYSTEM by Sicel Technologies, Inc. — Product Code LHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2006
Date Received
August 4, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Radiation Therapy, Charged-Particle, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Other clearances by Sicel Technologies, Inc.

  • K083035 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM (November 13, 2008)
  • K081859 — MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM (August 4, 2008)
  • K080004 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM (January 23, 2008)
  • K071399 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION (June 20, 2007)
  • K061051 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTIO (June 13, 2006)
  • K040687 — ONEDOSE PATIENT DOSIMETRY SYSTEM (June 25, 2004)

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  • K242418 — P-Cure Proton Therapy System (PPTS) (May 12, 2025)
  • K232032 — PROBEAT-FR (January 12, 2024)
  • K231863 — ProBeam 360° Proton Therapy System v2.0 (Multiroom) (October 6, 2023)
  • K221996 — P-Cure Proton Beam Therapy System (March 20, 2023)
  • K220883 — Small Field Applicator (December 15, 2022)
  • K221791 — ProBeam 360° Proton Therapy System (December 1, 2022)
  • K201798 — myQA iON (July 17, 2020)
  • K201042 — PROBEAT-CR (July 13, 2020)