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510(k) DEN190040

Caption Guidance by Bay Labs, Inc. — Product Code QJU

DEN190040 is an FDA 510(k) premarket notification submitted by Bay Labs, Inc. for the device "Caption Guidance". The FDA issued a decision of De Novo Granted on February 7, 2020. The device falls under product code QJU (Image Acquisition And/Or Optimization Guided By Artificial Intelligence), a Class II device regulated under 21 CFR 892.2100. Bay Labs, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
February 7, 2020
Date Received
August 27, 2019
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Device Class
Class II
Regulation Number
892.2100
Review Panel
RA
Submission Type

A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals. The device interfaces with the acquisition system, analyzes its output, and provides guidance and/or feedback to the operator for improving image and/or signal quality.

Other clearances by Bay Labs, Inc.

  • K173780 — EchoMD Automated Ejection Fraction Software (June 14, 2018)

Other clearances for product code QJU

  • K260338 — ThinkSono Guidance (July 15, 2026)
  • K260780 — HeartFocus (June 3, 2026)
  • K251416 — UltraSight Guidance (December 17, 2025)
  • K242807 — HeartFocus (V.1.1.1) (April 4, 2025)
  • K243065 — Cardiac Guidance (January 15, 2025)
  • K223347 — UltraSight AI Guidance (July 24, 2023)
  • K201992 — Caption Guidance (September 18, 2020)
  • K200755 — Caption Guidance (April 16, 2020)

FDA data resources