Cardiovascular · 510(k) · 2023
Vivio LVEDP System
Avicena, LLC. Cleared by FDA on 6 October 2023 under submission K223905, product code QUO (adjunctive heart failure status indicator). What FDA's record says, in FDA's words.
Device record · K223905
- Device. Vivio LVEDP SystemDEVICE
- Company. Avicena, LLCCOMPANY
- Decision. 6 October 2023, 510(k), substantially equivalent (traditional review); received 28 December 2022DECISION
- Panel. CardiovascularPANEL
- Product code. QUO, Adjunctive Heart Failure Status IndicatorCODE
- Regulation. 21 CFR 870.2200, Class IIREG
- Source. FDA database entry · decision document (8 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Vivio System is indicated to non-invasively estimate left ventricular end-diastolic pressure (LVEDP) is above or below 18mmHg. This measurement can aid in the diagnosis of heart failure when used by qualified healthcare professionals as an adjunct alongside other clinically relevant information. For use in adults only.
The product code's definition, from FDA's classification record. The adjunctive heart failure status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting heart failure. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
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.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QUO. 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 QUO, in Cardiovascular, or cleared in 2023. 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.