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510(k) K221612

ClearRead CT by Riverain Technologies, Inc. — Product Code OEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2022
Date Received
June 3, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lung Computed Tomography System, Computer-Aided Detection
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

To assist radiologists in the review of multi-slice computed tomography (msct) exams of the chest and highlight potential nodules that the radiologist should review. A computer aided diagnosis, lung computed tomography system is a class 3 device under product code NRR.

Other clearances by Riverain Technologies, Inc.

  • K242188 — ClearRead CT CAC (December 3, 2024)
  • K213566 — ClearRead Xray Pneumothorax (March 10, 2022)
  • K161201 — ClearRead CT (September 9, 2016)
  • K123526 — CLEARREAD +CONFIRM (December 27, 2012)

Other clearances for product code OEB

  • K251203 — AVIEW Lung Nodule CAD (December 3, 2025)
  • K240554 — InferRead Lung CT.AI (May 16, 2025)
  • K242919 — V5med Lung AI (March 27, 2025)
  • K231157 — syngo.CT Lung CAD (Version VD30) (July 19, 2023)
  • K221592 — AVIEW Lung Nodule CAD (February 24, 2023)
  • K203258 — syngo.CT Lung CAD (March 31, 2021)
  • K201501 — Veolity (February 23, 2021)
  • K192880 — InferRead Lung CT.AI (July 2, 2020)
  • K193216 — syngo.CT Lung CAD (March 9, 2020)
  • K161201 — ClearRead CT (September 9, 2016)