Anesthesiology · 510(k) · 2023
ScanNav Anatomy Peripheral Nerve Block
Intelligent Ultrasound Limited. Cleared by FDA on 6 October 2023 under submission K232787, product code QRG (ultrasound guided nerve block assist). What FDA's record says, in FDA's words.
Device record · K232787
- Device. ScanNav Anatomy Peripheral Nerve BlockDEVICE
- Company. Intelligent Ultrasound Limited (GB)COMPANY
- Decision. 6 October 2023, 510(k), substantially equivalent (special review); received 11 September 2023DECISION
- Panel. AnesthesiologyPANEL
- Product code. QRG, Ultrasound Guided Nerve Block AssistCODE
- Regulation. 21 CFR 868.1980, Class IIREG
- Source. FDA database entry · decision document (10 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.
ScanNav Anatomy Peripheral Nerve Block is indicated to assist qualified healthcare professionals to identify and label the below mentioned anatomy in live ultrasound images in preparation for ultrasound guided regional anesthesia prior to needle insertion for patients 18 years of age or older. The highlighting of structures in the following anatomical regions is supported: • Axillary level brachial plexus • Erector spinae plane • Interscalene level brachial plexus • Popliteal level sciatic nerve • Rectus sheath plane • Sub-sartorial femoral triangle / Adductor canal • Superior trunk of brachial plexus • Supraclavicular level brachial plexus • Longitudinal suprainguinal fascia iliaca plane • Femoral block ScanNav Anatomy Peripheral Nerve Block is an accessory to compatible general-purpose diagnostic ultrasound systems.
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.
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
- Mentionsdetection or identification of findings
- 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 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 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.