Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- BSDAnalyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling3Product Code
- LSZVentilator, High Frequency3Product Code
- LYMDevice, Cpr AssistUProduct Code
- MNQStimulator, Hypoglossal Nerve, Implanted, Apnea3Product Code
- NJKValve, Pulmonary3Product Code
- OAZOne-Way Air-Leak ValveFProduct Code
- OIRDiaphragmatic/Phrenic Nerve Laparoscopically-Implanted StimulatorFProduct Code
- OOYBronchial Thermoplasty System3Product Code
- PDRComputer-Assisted Personalized Sedation System3Product Code
- PNCCatheter IntroducerNProduct Code
- POILung Tissue Sealant For Lung Volume ReductionNProduct Code
- PSRImplanted Phrenic Nerve Stimulator For Central Sleep Apnea3Product Code
- QGZElectrical Tumor Treatment Fields3Product Code
- QKSInhaler, Metered Dose Or Dry Powder, Cder Or Cber LedNProduct Code
- QLIVaporizer, Cder Or Cber LedNProduct Code
- QOQNon-Continuous Ventilator For Emergency UseNProduct Code
- QORContinuous Ventilator, Minimal Ventilatory SupportNProduct Code
- QOUEmergency ResuscitatorNProduct Code
- QOWVentilatory Assistance HelmetNProduct Code
- QPRNeurological Stimulation For Emergency UseNProduct Code
- QRSDevice For Sleep Apnea Testing Based On Mandibular Movement2Product Code
- QSFSoftware Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents3Product Code
- QRGUltrasound Guided Nerve Block Assist2Product Code
- QVEAdjunctive Pain Measurement Device For Anesthesiology2Product Code
- QVTMonitor For Opioid Induced Impairment Of Oxygenation2Product Code
- QTBNitric Oxide Generator And Delivery System3Product Code
- QZWOver-The-Counter Device To Assess Risk Of Sleep Apnea2Product Code
- QWEHyperoxia Monitoring Device Adjunct To Pulse Oximetry2Product Code
- QXDSpinal Imaging System For Neuraxial Procedures2Product Code
- SDBTracheal Prosthesis With Cover Material Derived From Human Sources2Product Code
- SDAElectrical Tumor Treatment Fields For Non-Small Cell Lung Cancer3Product Code
- SDLTransvenous Temporary Phrenic Nerve Stimulator3Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—MiscellaneousCFR Sub-Part
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Ultrasound Guided Nerve Block Assist
- Page Type
- Product Code
- Definition
- This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia.
- Physical State
- The software medical device is installed in a PC which connects to a cleared ultrasound device via cable. The ultrasound images are reproduced on the subject device display monitor.
- Technical Method
- The device physically connects to a cleared ultrasound device, reproduces ultrasound images, locates and highlights anatomical landmarks such as nerve bundles. The landmark identification assist in targeted delivery of regional anesthesia.
- Target Area
- • 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 • Suprainguinal fascia iliaca plane
- Regulation Medical Specialty
- Anesthesiology
- Review Panel
- Anesthesiology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 868.1980
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
Product code QRG is linked to regulation 21CFR868.1980, which does not seem to exist yet. It may be pending at the moment.