# DEN220024: ScanNav Anatomy Peripheral Nerve Block

- Pathway: De Novo (Direct)
- Applicant: Intelligent Ultrasound Limited
- Decided: Oct 18, 2022 after 193 days
- Product code: QRG (Ultrasound Guided Nerve Block Assist)
- Device class: 2
- Regulation: 21 CFR 868.1980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K232787: ScanNav Anatomy Peripheral Nerve Block (2023), 1 descendant of its own
- K250818: Nerveblox (2025), 0 descendants of its own

## Indications for use
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 ScanNav Anatomy Peripheral Nerve Block is an accessory to compatible general-purpose diagnostic ultrasound systems.

Source page: https://510kreport.com/device/DEN220024
Methodology: https://510kreport.com/methodology