Radiology · De Novo · 2023
Caption Interpretation Automated Ejection Fraction Software
Caption Health, Inc. Granted by FDA on 24 February 2023 under submission DEN220063, product code QVD (radiological machine learning based quantitative imaging software with change control plan). What FDA's record says, in FDA's words.
Device record · DEN220063
- Device. Caption Interpretation Automated Ejection Fraction SoftwareDEVICE
- Company. Caption Health, IncCOMPANY
- Decision. 24 February 2023, De NovoDECISION
- Panel. RadiologyPANEL
- Product code. QVD, Radiological Machine Learning Based Quantitative Imaging Software With Change Control PlanCODE
- Regulation. 21 CFR 892.2055, Class IIREG
- Source. FDA database entry · decision document (11 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.
The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation. The Caption Interpretation Automated Ejection Fraction Software is indicated for use in adult patients.
The product code's definition, from FDA's classification record. A radiological machine learning quantitative imaging software with predetermined change control plan is a software-only device which employs machine learning algorithms on radiological images to provide quantitative imaging outputs. The device includes functions to support outputs such as view selection, segmentation and landmarking. The design specifications include planned modifications that may be made to the device consistent with an established predetermined change control plan.
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
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsmeasurement or quantification
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QVD. 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 QVD, in Radiology, from Caption Health, Inc, or granted in 2023. The whole record is at FDA AI-enabled medical devices.
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