Home / 510(k) Clearances / K234030

510(k) K234030

Clear Guide SCENERGY by Clear Guide Medical — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2024
Date Received
December 20, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

Other clearances by Clear Guide Medical

  • K201188 — Clear Guide SCENERGY (September 30, 2020)
  • K201898 — Clear Guide SCENERGY (July 31, 2020)
  • K171677 — Clear Guide SCENERGY (December 8, 2017)
  • K153004 — Clear Guide SCENERGY (February 12, 2016)
  • K141806 — CLEAR GUIDE ONE (September 19, 2014)

Other clearances for product code JAK

  • K253649 — Spectral CT Verida Family (March 27, 2026)
  • K252992 — CT Rembra RT; CT Areta RT; CT Rembra (March 23, 2026)
  • K253686 — True Definition DL (March 23, 2026)
  • K253574 — SOMATOM X.cite; SOMATOM X.ceed (March 20, 2026)
  • K253520 — Photonova Spectra, Photonova Spectra Select (March 20, 2026)
  • K252249 — Extremity CT Imaging System (March 13, 2026)
  • K260078 — Aquilion ServeSP (TSX-307B) V2.0 (March 13, 2026)
  • K260167 — Bunkerhill Contrast AVC (March 6, 2026)
  • K260166 — Bunkerhill Contrast CAC (March 6, 2026)
  • K260169 — AV Cardiac CT (March 5, 2026)