Home / 510(k) Clearances / K182079

510(k) K182079

Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask by Medtec Inc. Dba Civco Medical Solutions — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2018
Date Received
August 2, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Medtec Inc. Dba Civco Medical Solutions

  • K121545 — BELLYBOARD, SBRT ACCESSORIES (June 8, 2012)

Other clearances for product code IYE

  • K252937 — ThinkQA 3 (June 12, 2026)
  • K253004 — LUNA 3D (June 4, 2026)
  • K260792 — AerFrame Patient Immobilization System (AFPIS) (May 8, 2026)
  • K252258 — VERIQA RT EPID 3D (April 15, 2026)
  • K253962 — ClearCheck (RADCC V2.7) (April 3, 2026)
  • K253012 — AlignRT Plus (8.0) (March 18, 2026)
  • 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)