Anesthesiology · De Novo · 2022
ScanNav Anatomy Peripheral Nerve Block
Intelligent Ultrasound Limited. Granted by FDA on 18 October 2022 under submission DEN220024, product code QRG (ultrasound guided nerve block assist). What FDA's record says, in FDA's words.
Device record · DEN220024
- Device. ScanNav Anatomy Peripheral Nerve BlockDEVICE
- Company. Intelligent Ultrasound LimitedCOMPANY
- Decision. 18 October 2022, De NovoDECISION
- Panel. AnesthesiologyPANEL
- Product code. QRG, Ultrasound Guided Nerve Block AssistCODE
- Regulation. 21 CFR 868.1980, Class IIREG
- Source. FDA database entry · decision document (15 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 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. This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia.
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QRG. 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 QRG, in Anesthesiology, from Intelligent Ultrasound Limited, or granted 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.