Anesthesiology · 510(k) · 2022
VISIONAIR
PacificMD Biotech Llc. Cleared by FDA on 5 October 2022 under submission K221892, product code BXQ (rhinoanemometer (measurement of nasal decongestion)). What FDA's record says, in FDA's words.
Device record · K221892
- Device. VISIONAIRDEVICE
- Company. PacificMD Biotech LlcCOMPANY
- Decision. 5 October 2022, 510(k), substantially equivalent (traditional review); received 29 June 2022DECISION
- Panel. AnesthesiologyPANEL
- Product code. BXQ, Rhinoanemometer (Measurement Of Nasal Decongestion)CODE
- Regulation. 21 CFR 868.1800, 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 cleared it for
The Indications for Use statement, verbatim, from the decision document.
The VISIONAIR system is a software application intended to be used with third-party endoscopic systems in the measurement of the nasal respiratory airway. The VISIONAIR system measures the nasal respiratory airway from the endoscopic images taken in the region of the internal nasal valve (INV) and nasal cavum (NC).
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 namedendoscopy
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code BXQ. 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 BXQ, in Anesthesiology, 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.