Home / 510(k) Clearances / DEN170022

510(k) DEN170022

QuantX by Quantitative Insights, Inc. — Product Code POK

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
July 19, 2017
Date Received
April 7, 2017
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Device Class
Class II
Regulation Number
892.2060
Review Panel
RA
Submission Type

Assist users in characterizing lesions identified on acquired medical images

Other clearances by Quantitative Insights, Inc.

  • K170195 — QuantX (May 17, 2017)

Other clearances for product code POK

  • K251769 — RevealAI-Lung (January 30, 2026)
  • K252294 — Fetal EchoScan (v1.2) (December 8, 2025)
  • K250221 — StrokeSENS ASPECTS Software Application (July 1, 2025)
  • K251071 — Fetal EchoScan (v1.1) (May 2, 2025)
  • K243614 — Sonio Suspect (February 21, 2025)
  • K243294 — Brainomix 360 e-ASPECTS (February 14, 2025)
  • K242130 — Koios DS (November 15, 2024)
  • K242342 — Fetal EchoScan (November 14, 2024)
  • K241245 — EchoSolv AS (October 4, 2024)
  • K234141 — AISAP Cardio V1.0 (August 1, 2024)