Who is the manufacturer of NovaGuide 2 Intelligent Ultrasound?

Novasignal Corporation filed the 510(k) submission for NovaGuide 2 Intelligent Ultrasound (K213279).

What is the FDA product code for NovaGuide 2 Intelligent Ultrasound?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for NovaGuide 2 Intelligent Ultrasound?

510(k) clearance (submission type: Traditional).

What are the predicate devices for NovaGuide 2 Intelligent Ultrasound?

NeuralBot, NovaSignal Corporation (K180445).

Who can help prepare an FDA 510(k) submission like NovaGuide 2 Intelligent Ultrasound?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NovaGuide 2 Intelligent Ultrasound

K213279 · Novasignal Corporation · IYN · Mar 2, 2022 · Radiology

Device Facts

Record ID	K213279
Device Name	NovaGuide 2 Intelligent Ultrasound
Applicant	Novasignal Corporation
Product Code	IYN · Radiology
Decision Date	Mar 2, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2

Intended Use

NovaGuide 2 Intelligent Ultrasound is intended to be used during diagnostic exams and surgical interventions as an adjunct to the standard clinical practices for measuring and displaying cerebral blood flow velocity within the major conducting arteries of the head and neck. Cerebral blood flow velocity within these arteries is visualized using non-invasive pulsed transcranial Doppler ultrasound (TCD). This includes, but is not limited to, insonation of the middle, anterior and posterior cerebral arteries via the temporal windows, the vertebral and basilar arteries via the foramen magnum, and the ophthalmic arteries and internal carotid artery siphons via the patient's transorbital windows. TCD is a common tool for the visualization of cerebral blood flow velocity and the detection of emboli which present as High-Intensity Transient Signals (HITS) in the display of the TCD blood flow.

Device Story

NovaGuide 2 is a cart-mounted, non-invasive transcranial Doppler (TCD) ultrasound system. It processes ultrasound signals to measure cerebral blood flow velocity and detect emboli (HITS). The system includes a computer, Doppler Robotics Unit (DRU), patient headmount, and 2-MHz transducers. In robotic mode, actuators automatically position transducers on temporal windows using TCD signal search algorithms; manual mode is also available. The device provides real-time visualization and automated measurements (e.g., VMR index, shunt grade assist) to assist clinicians in diagnostic exams and surgical interventions. It is operated by trained healthcare professionals in hospitals or clinics. The output aids clinical decision-making by providing hemodynamic data and embolic event detection, potentially benefiting patients by facilitating non-invasive monitoring of cerebral blood flow.

Clinical Evidence

No clinical data was performed. Safety and effectiveness were established through nonclinical bench testing, including acoustic output measurements per IEC 60601-2-37, biocompatibility, electromagnetic compatibility (IEC 60601-1-2), and software verification/validation.

Technological Characteristics

Mobile cart-mounted TCD system. 2-MHz pulsed-wave transducers. Materials: Luran HD-20 (front face), Tecason P (body), 3M-1509 adhesive, ZHB110G foam. Robotic actuators for X, Y, Z positioning. Class 1M laser for head alignment. Connectivity: All-in-one computer with integrated PC board. Power: 100-240 VAC, 50-60 Hz. Software: Moderate level of concern. Sterilization: Non-sterile.

Indications for Use

Indicated for healthcare professionals to measure and display cerebral blood flow velocity and detect transient emboli (HITS) as an adjunct to standard clinical practice. Used via temporal windows (robotic/manual) or other acoustic windows (manual). Not for fetal applications or use inside the sterile field.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

NeuralBot, NovaSignal Corporation (K180445)

Reference Devices

Lucid M1 Transcranial Doppler Ultrasound System, NovaSignal Corporation (K160442)

Related Devices

K122710 — TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND · Shenzhen Delicate Electronics Co., Ltd. · Feb 15, 2013
K213009 — Transcranial Doppler Ultrasound System · Shenzhen Delica Medical Equipment Co., Ltd. · Jul 8, 2022
K180455 — NeuralBot · Neural Analytics, Inc. · May 22, 2018
K092164 — TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA · Shenzhen Delicate Electronics Co., Ltd. · May 13, 2010
K173801 — Transcranial Doppler Ultrasound System · Shenzhen Delica Medical Equipment Co., Ltd. · Jul 11, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. NovaSignal Corporation % Carrene Plummer Senior Regulatory Affairs Manager 2440 S. Sepulveda Blvd., Ste 115 LOS ANGELES CA 90064 # Re: K213279 Trade/Device Name: NovaGuide 2 Intelligent Ultrasound Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, ITX, OQQ Dated: January 24, 2022 Received: January 26, 2022 March 2, 2022 # Dear Carrene Plummer: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see {1}------------------------------------------------ https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jessica Lamb, Ph.D. Assistant Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213279 Device Name NovaGuide 2 Intelligent Ultrasound ## Indications for Use (Describe) NovaGuide 2 Intelligent Ultrasound is a medical ultrasound system intended for use as an adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocity and the occurrence of transient emboli within the bloodstream. The system assists the user in the setup and acquisition of cerebral blood flow velocity via the patient's temporal windows. NovaGuide 2 Intelligent Ultrasound is intended to be used by healthcare professionals qualified by training in its safe and effective use. The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field. | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for NovaSignal. The logo consists of a blue circle with three smaller white circles inside, followed by the text "NovaSignal" in black. The text is in a sans-serif font, and the "NovaSignal" text has a trademark symbol to the upper right. #### 7 510(K) SUMMARY # K213279 #### 7.1 Submitter Information Submitter: NovaSignal Corporation Address: 2440 South Sepulveda Blvd., Ste. 115, Los Angeles, CA 90064 Establishment Registration Number: 3013368530 Contact Person: Raajdeep (Raaj) Venkatesan Phone: (323) 252-4762 Facsimile: (310) 819-1676 Email: raaj@novasignal.com Date Prepared: October 7, 2021 #### 7.2 Name of Device and Classification Trade Name: NovaGuide 2 Intelligent Ultrasound Common Name: NovaGuide 2 Model Numbers: NSC-NVGSYS2 – NovaGuide 2 Intelligent Ultrasound NSC-TCDNG2 - NovaGuide 2 Traditional Classification Name: Ultrasonic pulsed doppler imaging system (21 CFR 892.1550); Transducer, Ultrasonic, Diagnostic (21 CFR 892.1570); Diagnostic Ultrasonic Transducer, Robotic (21 CFR 892.1570) Product Codes: IYN, ITX, OQQ #### 7.3 Predicate Device Primary Predicate Device: NeuralBot, NovaSignal Corporation (K180455) Reference Device: Lucid M1 Transcranial Doppler Ultrasound System, NovaSignal Corporation (K160442) #### 7.4 Device Description #### 7.4.1 NovaGuide 2 Configuration NovaGuide 2 is a mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) ultrasound system. It is intended for use as an adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocity and the occurrence of transient emboli within the bloodstream. NovaGuide 2 is intended to be used by healthcare professionals qualified by training in its safe and effective use. The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for NovaSignal. The logo consists of a blue circle with three smaller white circles inside, followed by the text "NovaSignal" in a simple, sans-serif font. A small trademark symbol appears to the upper right of the word "Signal". NovaGuide 2 is a cart-mounted system for use in hospitals or clinics. The system is comprised of a computer, Doppler Robotics Unit (DRU), probe pods, patient headmount unit (PHU) and two reusable, non-sterile 2-MHz transducers that can be operated in either robotic or manual modes. When used in robotic mode, the operator is guided in positioning the two transducers, one on each side of the patient's head. The transducers are positioned using robotic actuators that adjust the translational and angular positions using TCD signal search algorithms, which assists the operator in monitoring the blood flow velocity of the vessels via the patient's temporal acoustic windows. Visualization and detection of emboli occur through High-Intensity Transient Signals (HITS) in the display of the TCD blood flow. #### 7.4.2 NovaGuide 2 Traditional Configuration NovaGuide 2 Traditional is an adjunctive portable, non-ionizing radiation, point-ofcare TCD ultrasound system. It is designed to measure and display cerebral blood flow velocities and detect emboli within the arteries of the head and neck. NovaGuide 2 Traditional Configuration does not contain the robotic Patient Headmount Unit; therefore, it can only be used in manual mode using the supplied 2MHz handheld transducers. #### 7.4.3 Software Description #### 7.4.3.1 NovaGuide 2 Software The all-in-one computer hosts the NovaGuide 2 application software. The software processes TCD data and provides Graphical User Interface (GUI), and, for NovaGuide 2, setup and procedural and algorithmic search commands to the PHU via the DRU. #### 7.4.3.2 NovaGuide View™ Software Accessory NovaGuide View is an optional and supplemental accessory to NovaSignal medical ultrasound systems. NovaGuide View is intended to transfer, store, convert formats, enhance, and display transcranial Doppler (TCD) ultrasound exam data and results, originating from NovaSignal ultrasound systems. In addition, it allows qualified healthcare personnel to add and approve interpretations of exam data and remotely view live streaming of exams. #### 7.5 Indications for Use NovaGuide 2 Intelligent Ultrasound is a medical ultrasound system intended for use as an adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocity and the occurrence of transient emboli within the bloodstream. The system assists the user in the setup and acquisition of cerebral blood flow velocity via the patient's temporal windows. NovaGuide 2 Intelligent Ultrasound is intended to be used by healthcare professionals qualified by training in its safe and effective use. The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field. #### 7.6 Intended Use NovaGuide 2 Intelligent Ultrasound is intended to be used during diagnostic exams and surgical interventions as an adjunct to the standard clinical practices for measuring and displaying cerebral NovaGuide 2 510(k): K213279 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for NovaSignal. The logo consists of a blue circle with three smaller white circles inside, followed by the text "NovaSignal" in a simple, sans-serif font. The word "NovaSignal" is written in black, and there is a trademark symbol to the upper right of the word. blood flow velocity within the major conducting arteries of the head and neck. Cerebral blood flow velocity within these arteries is visualized using non-invasive pulsed transcranial Doppler ultrasound (TCD). This includes, but is not limited to, insonation of the middle, anterior and posterior cerebral arteries via the temporal windows, the vertebral and basilar arteries via the foramen magnum, and the ophthalmic arteries and internal carotid artery siphons via the patient's transorbital windows. TCD is a common tool for the visualization of cerebral blood flow velocity and the detection of emboli which present as High-Intensity Transient Signals (HITS) in the display of the TCD blood flow. #### 7.7 Predicate Device Comparison - 7.7.1 Device Comparison Similarities | Technological Characteristic | NovaGuide 2 Intelligent Ultrasound | Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) - Lucid TCD | NeuralBot when connected to the Lucid M1 System - NovaBot | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | SUBMISSION DEVICE | (Reference Device) K160442 | (Primary Predicate) K180445 | | Product Code, Class | IYN, ITX, OQQ Class II | IYN, ITX Class II | IYN, ITX, OQQ Class II | | Indications for Use | NovaGuide 2 Intelligent Ultrasound is a medical ultrasound system intended for use as an adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocity and the occurrence of transient emboli within the bloodstream. NovaGuide_2 Intelligent Ultrasound is intended to be used by healthcare professionals qualified by training in its safe and effective use. The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field. | The Lucid M1 System is a medical ultrasound system intended for use as an adjunct to the standard clinical practices for measuring and displaying cerebral blood flow velocity within the major conducting arteries and veins of the head and neck. Additionally, The Lucid M1 System measures the occurrence of transient emboli signals within the blood stream. The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field. | The NeuralBot when used with Lucid M1 System is a medical ultrasound device which assists the user in the setup and acquisition of cerebral blood flow velocity via the patient's temporal windows. It is intended for use as an adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocity and the occurrence of transient emboli within the blood stream. The NeuralBot is intended to be used by healthcare professionals qualified by training in its safe and effective use. The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field. | | Energy Used/ Delivered | Ultrasound Energy | Ultrasound Energy | Ultrasound Energy | | Design | 1. Base Ultrasound Unit (touch screen display, integrated PC Board, TCD ultrasound driver sub-system) | 1. Base Ultrasound Unit (touch screen display, integrated PC Board, TCD ultrasound driver sub-system) | Not Applicable to this System | | Technological Characteristic | NovaGuide 2 Intelligent Ultrasound SUBMISSION DEVICE | Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) - Lucid TCD (Reference Device) K160442 | NeuralBot when connected to the Lucid M1 System - NovaBot (Primary Predicate) K180445 | | | 2. Reusable, non-sterile 2-MHz handheld transducer or headset with 2 reusable, non-sterile 2-MHz monitoring transducers 3. Software/firmware 4. Algorithm | 2. Reusable, non-sterile 2-MHz handheld transducer or headset with 2 reusable, non-sterile 2-MHz monitoring transducers 3. Software/firmware 4. Algorithm | | | Mechanism of Action | Doppler Ultrasound with the following modes: Unilateral, Bilateral, Multichannel, Monitoring, M-mode, Modified M-mode | Doppler Ultrasound with the following modes: Unilateral, Bilateral, Multichannel, Monitoring, M-mode, Modified M-mode | Doppler Ultrasound with the following modes: Unilateral, Bilateral, Multichannel, Monitoring, M-mode | | Performance | Sample Volume: 2 to 12mm in 1mm steps Depth: 23 to 151mm Power %: 0 to 100% where 100% represents Ispta.3 upper- tolerance limit 720 mW/cm² | Sample Volume: 2 to 12mm in 1mm steps Depth: 23 to 151mm Power %: 0 to 100% where 100% represents Ispta.3 upper- tolerance limit 720 mW/cm² | Sample Volume: 10mm Depth: 45 to 60 mm Power %: 0 to 100% where 100% represents Ispta.3 upper-tolerance limit 575 mW/cm² | | Acoustic Output | NovaGuide 2 global maximum derated ISPTA is designed to be <720mW/cm2. NovaGuide 2 global maximum MI is designed to be < 1.0. The design of NovaGuide 2 will exceed a TIC (Cranial Thermal Index) of 1.0. The maximum TIC for the NovaGuide 2 is 2.5. | The Lucid M1 System global maximum derated ISPTA is designed to be <720mW/cm2. The Lucid M1 System global maximum MI is designed to be < 1.0. The design of Lucid M1 System will exceed a TIC (Cranial Thermal Index) of 1.0. The maximum TIC for the Lucid M1 System is 2.5. | The NeuralBot when connected to the Lucid M1 System has a global maximum derated ISPTA <720 mW/cm². The NeuralBot when connected to the Lucid M1 System has a global maximum MI < 1.0. The NeuralBot when connected to the Lucid M1 System will exceed a TIC (Cranial Thermal Index) of 1.0. The maximum TIC for the NeuralBot when connected to the Lucid M1 System is 2.5. | | Clinical Measurements | • Maximum Velocity • Mean Velocity • Minimum Velocity • Pulsatility Index • Cerebrovascular Reactivity • Embolus Count | • Maximum Velocity • Mean Velocity • Minimum Velocity • Pulsatility Index • Cerebrovascular Reactivity • Embolus Count | • Maximum Velocity • Mean Velocity • Minimum Velocity • Pulsatility Index • Cerebrovascular Reactivity • Embolus Count | | Track | Track 3 | Track 3 | Track 3 | | Patient-Contact Materials (Probes) | Transducer Front Face: Luran HD- 20 (BASF) Transducer Body: Tecason P (Ensigner) Registration Dots Adhesive Tape: 3M-1509 Foam, Head Cradle: ZHB110G Cosmetic Foam Foam, Forehead Clamp: ZHB110G Cosmetic Foam | Transducer Front Face: Luran HD- 20 (BASF) Transducer Body: Tecason P (Ensigner) Registration Dots Adhesive Tape: 3M-1509 Foam, Head Cradle: ZHB110G Cosmetic Foam Foam, Forehead Clamp: ZHB110G Cosmetic Foam | Transducer Front Face: Luran HD- 20 (BASF) Transducer Body: Tecason P (Ensigner) Registration Dots Adhesive Tape: 3M-1509 Foam, Head Cradle: ZHB110G Cosmetic Foam Foam, Forehead Clamp: ZHB110G Cosmetic Foam | | Technological Characteristic | NovaGuide 2 Intelligent Ultrasound | Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) - Lucid TCD | NeuralBot when connected to the Lucid M1 System - NovaBot | | | SUBMISSION DEVICE | (Reference Device) K160442 | (Primary Predicate) K180445 | | | Probe Pod Cover: Linear Low- Density Polyethylene | | Probe Pod Cover: Linear Low- Density Polyethylene | | Mains Input | 100 to 240 VAC 50 to 60 Hz | 100 to 240 VAC 50 to 60 Hz | 100 to 240 VAC 50 to 60 Hz | | Rechargeable Battery | Lithium Ion (TCD Driver) Lithium Ion (All in One Computer) | Lithium Ion (TCD Driver) Lithium Ion Polymer (Tablet) | Not Applicable to this System | | Labeling Head Frame | • Electrical Hazard Warnings • Non-temporal window scanning precaution (on-screen caution) • Not intended for fetal use warning • ALARA caution • Physician order caution • Supplemental TIC Bilateral probes adjusted manually and/or automatically | • Electrical Hazard Warnings • Non-temporal window scanning precaution (on-screen caution) • Not intended for fetal use warning • ALARA caution • Physician order caution • Supplemental TIC Not Applicable to this System | • Electrical Hazard Warnings • Non-temporal window scanning precaution (on-screen caution) • Not intended for fetal use warning • ALARA caution • Physician order caution • Supplemental TIC Bilateral probes adjusted manually and/or automatically | | Accessories | • Single-use patient contact materials provided in the NovaKit 2 Exam Pack (pack of 10) • Remote Control accessory | Remote Control accessory | Single-use patient contact materials supplied in a service pack | | Transducers | 2MHz PW 16mm hand - held transducers 2MHz PW 16mm monitoring transducers | 2MHz PW 16mm hand - held transducers 2MHz PW 16mm monitoring transducers | Not Applicable to this System | | Transducer Frequency | 2 MHz | Not Applicable to this System | 2 MHz | | Transducer Frequency Spectrum | FFT 256 | Not Applicable to this System | FFT 256 | | Frequency Ranges | 2 MHz | Not Applicable to this System | 2 MHz | | Depth Measurement | 45 to 60 mm | Not Applicable to this System | 45 to 60 mm | | Axis of Movement | X, Y, Z | Not Applicable to this System | X, Y, Z | | Probe Angle Adjustment | Automatic | Not Applicable to this System | Automatic | | Technological Characteristic | NovaGuide 2 Intelligent Ultrasound | Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) - Lucid TCD | NeuralBot when connected to the Lucid M1 System - NovaBot | | | SUBMISSION DEVICE | (Reference Device) K160442 | (Primary Predicate) K180445 | | Laser | Class 1M laser to assist in head alignment | Not Applicable to this System…