Cardiovascular · 510(k) · 2022
AHI System
Fifth Eye Inc.. Cleared by FDA on 14 July 2022 under submission K221203, product code QNV (adjunctive hemodynamic indicator with decision point). What FDA's record says, in FDA's words.
Device record · K221203
- Device. AHI SystemDEVICE
- Company. Fifth Eye Inc.COMPANY
- Decision. 14 July 2022, 510(k), substantially equivalent (special review); received 26 April 2022DECISION
- Panel. CardiovascularPANEL
- Product code. QNV, Adjunctive Hemodynamic Indicator With Decision PointCODE
- Regulation. 21 CFR 870.2220, Class IIREG
- Source. FDA database entry · decision document (5 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 could not be read from a public decision document for this submission on the retrieval date (the document is absent, scanned without text, or filed under another number). FDA's database entry is the place to read it.
The product code's definition, from FDA's classification record. An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information.
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QNV. 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 QNV, in Cardiovascular, from Fifth Eye Inc., or cleared in 2022. 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.