Home / 510(k) Clearances / K231631

510(k) K231631

BriefCase-Quantification by Aidoc Medical , Ltd. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2023
Date Received
June 5, 2023
Clearance Type
Traditional
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 Aidoc Medical , Ltd.

  • K253578 — BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; L (February 26, 2026)
  • K251195 — BriefCase-Triage (January 27, 2026)
  • K252970 — BriefCase-Triage: CARE Multi-triage CT Body (January 7, 2026)
  • K253265 — BriefCase-Triage (November 6, 2025)
  • K251406 — BriefCase-Triage (May 30, 2025)
  • K250248 — BriefCase-Triage (February 14, 2025)
  • K243548 — BriefCase-Triage (December 11, 2024)
  • K242203 — BriefCase-Quantification (November 22, 2024)
  • K242837 — BriefCase-Triage (October 18, 2024)
  • K241727 — BriefCase-Triage (July 12, 2024)

Other clearances for product code JAK

  • K260078 — Aquilion ServeSP (TSX-307B) V2.0 (March 13, 2026)
  • K252249 — Extremity CT Imaging System (March 13, 2026)
  • K260167 — Bunkerhill Contrast AVC (March 6, 2026)
  • K260166 — Bunkerhill Contrast CAC (March 6, 2026)
  • K260169 — AV Cardiac CT (March 5, 2026)
  • K253173 — uCT 780 with uWS-CT-Dual Energy Analysis (January 20, 2026)
  • K252217 — CT VScore+ (November 28, 2025)
  • K251805 — syngo.CT Dual Energy (October 15, 2025)
  • K250662 — Bunkerhill MAC (October 3, 2025)
  • K250766 — LungQ 4 (October 2, 2025)