Radiology · De Novo · 2020
Caption Guidance
Bay Labs, Inc.. Granted by FDA on 7 February 2020 under submission DEN190040, product code QJU (image acquisition and/or optimization guided by artificial intelligence). What FDA's record says, in FDA's words.
Device record · DEN190040
- Device. Caption GuidanceDEVICE
- Company. Bay Labs, Inc.COMPANY
- Decision. 7 February 2020, De NovoDECISION
- Panel. RadiologyPANEL
- Product code. QJU, Image Acquisition And/Or Optimization Guided By Artificial IntelligenceCODE
- Regulation. 21 CFR 892.2100, Class IIREG
- Source. FDA database entry · decision document (12 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
.” Caption Guidance operates with the 3200t-compatible Terason 4V2A linear phased array probe (called a “transducer” in the Terason manual). Do not operate Caption Guidance with any other probe. The uSmart 3200t Plus ultrasound system, with which Caption Guidance functions as a software accessory, complies with the Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (UD3-2004). It is important to observe the MI and TI values that are displayed during scanning. Follow the ALARA principle—exposure of the patient to ultrasound energy at a level that is As Low as Reasonably Achievable—when conducting ultrasound exams in order. PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedultrasound
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QJU. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QJU, in Radiology, from Bay Labs, Inc., or granted in 2020. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.