Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory

K202742 · Viasonix , Ltd. · IYN · Jan 25, 2021 · Radiology

Device Facts

• Record ID: K202742
• Device Name: Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory
• Applicant: Viasonix , Ltd.
• Product Code: IYN · Radiology
• Decision Date: Jan 25, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Dolphin/IQ, Dolphin/4D and Dolphin/MAX are medical Doppler devices intended for noninvasive measurements of blood flow velocities in arteries and veins in adults and Pediatric. The Dolphin systems can be used in hospitals, clinics and physician offices. The Dolphin/XF robot accessory, when used with the Dolphin system, is a device which assists the user in the acquisition of cerebral blood flow velocity.

Device Story

Dolphin/IQ, Dolphin/4D, and Dolphin/MAX are transcranial Doppler (TCD) systems for measuring blood flow velocity in intracranial, extracranial, and peripheral vessels. Systems utilize Doppler ultrasound probes (1.6, 2, 4, 8 MHz) to acquire blood flow data. The Dolphin/XF robot accessory, attached via a headset, automates probe positioning in two angular directions to assist clinicians in acquiring cerebral blood flow velocity. The robot performs a grid-based search (16x16 points) to identify optimal signals, displaying results via color-coded maps (red for flow towards, blue for away). Systems are operated by trained medical staff in clinical settings. Output includes velocity parameters (peak, mean, end-diastolic, pulsatility index, resistance index, heart rate) and spectral displays. Data aids clinical decision-making by providing noninvasive hemodynamic assessment. Benefits include improved efficiency and consistency in signal acquisition via robotic assistance.

Clinical Evidence

No clinical study was conducted. Substantial equivalence is supported by bench testing, verification of specifications, and software validation.

Technological Characteristics

Ultrasonic pulsed Doppler imaging system (21 CFR 892.1550). Transducers: 1.6, 2, 4, 8 MHz. Materials: Biocompatible cup for robot probe contact (ISO 10993-1). Connectivity: PACS support, USB/Ethernet. Software: Integrated computer (4D/MAX) or external PC (IQ). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, NEMA UD 3.

Indications for Use

Indicated for noninvasive measurement of blood flow velocities in arteries and veins in adults and pediatric patients. Contraindicated for fetal or neonatal applications. To be used by trained medical personnel in hospitals, clinics, and physician offices.

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

• Dolphin/IQ, Dolphin/4D and Dolphin/MAX (K191023)

Reference Devices

• EMS9UA (K122710)
• NeuralBot (K180455)

Submission Summary (Full Text)

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January 29, 2021

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring a stylized eagle emblem. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

Viasonix Ltd. Dan Manor, CEO 10 Hamelacha Street Raanana, 4366105 ISRAEL

Re: K202742

Trade/Device Name: Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF Robot Accessory Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, ITX, OQQ

Dear Dan Manor:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 25, 2021. Specifically, FDA is updating this SE Letter as an administrative correction because the 510(k) Summary was not included in the SE package.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Thalia Mills, OHT7: Office of In Vitro Diagnostics and Radiological Health by email (Thalia.Mills @fda.hhs.gov) or phone [phone]).

Sincerely,

Michael D. O'Hara For

Thalia T. Mills, Ph.D. 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

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January 25, 2021

Image /page/1/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" in smaller blue letters below.

Viasonix Ltd. % Mr. Dan Manor, CEO 10 Hamelacha Street Raanana, 4366105 ISRAEL

Re: K202742

Trade/Device Name: Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF Robot Accessory Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, ITX, OQQ Dated: December 23, 2020 Received: December 30, 2020

Dear Mr. Manor:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara

Thalia T. Mills, Ph.D. 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

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## Indications for Use

### 510(k) Number (if known) K202742

Device Name Dolphin/IQ, Dolphin/4D and Dolphin/MAX with the Dolphin/XF robot accessory

### Indications for Use (Describe)

Dolphin/Q, Dolphin/4D and Dolphin/MAX are medical Doppler devices intended for noninvasive measurements of blood flow velocities in arteries and vediatric. The Dolphin systems can be used in hospitals, clinics and physician offices

The Dolphin/XF robot accessory, when used with the Dolphin system, is a device which assists the user in the acquisition of cerebral blood flow velocity.

Contraindications : The Dolphin is not intended to be used in fetal or neonatal applications.

Note : The Dolphin is to be used only by trained medical personnel.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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System: Dolphin/IQ, Dolphin/4D and Dolphin/MAX Transducer: 1.6 MHz Hand Held

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Fetal<br>Imaging<br>& Other | Ophthalmic | | | X | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | X | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | X | | | | |
| | Other (Specify) | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | X | | | | |
| Fetal<br>Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | X | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | X | | | | |
| | Other (Specify) | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| (Track 1 Only) | Ophthalmic | | | x | | | | |
| Fetal<br>Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | x | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | x | | | | | |
| | Other (Specify) | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | X | X | | | |
| Fetal<br>Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | X | | X | | | |
| | Other (Specify) | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General | Specific | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| (Track 1 Only) | (Tracks 1 & 3) | | | | | | | |
| Ophthalmic | Ophthalmic | | | × | × | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | × | × | | | |
| | Other (Specify) | | | | | | | |

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System: Dolphin/IQ, Dolphin/4D and Dolphin/MAX Transducer: 2 MHz Hand Held

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System: Dolphin/IQ, Dolphin/4D and Dolphin/MAX Transducer: 2 MHz Monitoring

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System: Dolphin/IQ, Dolphin/4D and Dolphin/MAX Transducer: 4 MHz Hand Held

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System: Dolphin/IQ, Dolphin/4D and Dolphin/MAX Transducer: 8 MHz Hand Held

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## SECTION 5 - 510(K) SUMMARY

| 5.1 ADMINISTRATIVE INFORMATION | K202742 |
|--------------------------------|------------------------------------------------------------------------------------------|
| Date: | 22-January-2021 |
| Submitter: | Viasonix Ltd.<br>10 Hamelacha Street<br>Raanana, ISRAEL 4366105<br>Phone : [phone] |
| Official Correspondent: | Dan Manor, CEO |
| Trade Name: | Dolphin/IQ, Dolphin/4D and Dolphin/MAX with<br>Dolphin/XF robot accessory |
| Primary Classification: | |
| Regulation Name: | Ultrasonic Pulsed Doppler Imaging System |
| Regulation Number: | 21 CFR 892.1550, Product Code: IYN |
| Secondary Classification: | |
| Regulation Name: | Diagnostic Ultrasonic Transducer, |
| Regulation Number: | 21 CFR 1570, Product Codes: ITX, OQQ |
| Device Class: | Class II |
| Primary Predicate Device: | Dolphin/IQ, Dolphin/4D and Dolphin/MAX, K191023 |
| Reference Device: | EMS9UA, K122710 |

### 5.2 DEVICE DESCRIPTION

Dolphin/IQ, Dolphin/4D and Dolphin/MAX systems are part of the Dolphin product family of transcranial Doppler systems. The Dolphin/IQ, Dolphin/4D and Dolphin/MAX are transcranial Doppler (TCD) systems for measurement of blood flow velocity intracranially, extracranially and in the peripheral circulation. All systems share identical Doppler hardware and software. The Dolphin/IQ is a module, that needs to connect to an external computer and display for its' operation while the Dolphin/4D is a complete integrated system that includes an integrated computer system with hard disk, and touch screen display. Dolphin/Max is similar to the Dolphin/4D system, except that it also has an internal rechargeable battery and an external power supply. The functionality and performance of Dolphin/IQ, Dolphin/4D and Dolphin/MAX systems is identical. Dolphin systems support the same Doppler probes: 1.6 MHz PW hand held probe, 2 MHz PW hand held probe, 2 MHz PW monitoring probe, 4 MHz CW/PW hand held probe and 8 MHz CW/PW hand held probe. Dolphin systems support the same accessories: IR wireless remote control, External Channels connection box, wired remote control, foot switch, monitoring head set and Dolphin/XF robot.

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Wherever the term Dolphin is used in this document, it applies to the Dolphin/IQ, Dolphin/4D and Dolphin/MAX. Otherwise, each product is specifically by name. The Dolphin devices are based on Doppler technology and are designed for standard intended use for Transcranial Doppler systems operated only by experienced medical staff.

The Dolphin supports the Dolphin/XF robot accessory. The Dolphin/XF robot accessory, when used with the Dolphin system, is a device which assists the user in the acquisition of cerebral blood flow velocity. This accessory can be unilateral or bilateral, and is attached to the head with a dedicated headset. It is software controlled, and allows scanning in two angular directions in order to assists the user in the acquisition of the cerebral blood flow velocity.

### 5.3 INTENDED USE AND INDICATIONS FOR USE

The Dolphin/IQ, Dolphin/4D and Dolphin/MAX are medical Doppler devices intended for noninvasive measurements of blood flow velocities in arteries and veins in adults and Pediatric. The Dolphin systems can be used in hospitals, clinics and physician offices.

The Dolphin/XF robot accessory, when used with the Dolphin system, is a device which assists the user in the acquisition of cerebral blood flow velocity

Contraindications: The Dolphin is not intended to be used in fetal or neonatal applications.

Note - The Dolphin is to be used only by trained medical personnel

### 5.4 Summary of Technical Characteristics

The Dolphin/IQ, Dolphin/4D and Dolphin/MAX devices are similar to the predicate devices cited above with 1.6MHz, 2MHz, 4MHz and 8MHz transducers intended for transcranial and peripheral vascular Doppler applications and with the Dolphin/XF robot accessory.

The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, the intended use, use environment and target patient population of the Dolphin/4D and Dolphin/MAX devices with the Dolphin/XF robot accessory is substantially equivalent to the predicate devices cited above.

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## 5.4.1 Summary table of Comparison

| Specification | Dolphin devices [4D, IQ and<br>MAX] with Dolphin/XF Robot<br>accessory | Dolphin devices [4D, IQ and<br>MAX] / EMS9UA with<br>Roboprobe Headband<br>[Predicate devices] | Differences discussion |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | Proposed Device | K191023 / K122710 | NA |
| Manufacturer | VIASONIX LTD. | VIASONIX LTD. / Shenzhen<br>Delicate<br>Electronics | NA |
| Product<br>regulation<br>and code | 21 CFR 892.1550<br>Code: IYN, ITX and OQQ | 21 CFR 892.1550 Code: IYN, ITX /<br>21 CFR 892.15 70 Code: IYN, ITX<br>and OQQ | IYN and ITX identical to<br>Dolphin predicate<br><br>OQQ is identical to<br>EMS9UA reference<br>device |
| Indications for<br>use | The Dolphin/IQ, Dolphin/4D and<br>Dolphin/MAX are medical<br>Doppler devices intended for<br>noninvasive measurements of<br>blood flow velocities in arteries<br>and veins in adults and<br>Pediatric. The Dolphin systems<br>can be used in hospitals, clinics<br>and physician offices.<br><br>The Dolphin/XF robot accessory,<br>when used with the Dolphin<br>system, is a device which assists<br>the user in the acquisition of<br>cerebral blood flow velocity. | The Dolphin/IQ, Dolphin/4D and<br>Dolphin/MAX are medical<br>Doppler devices intended for<br>noninvasive measurements of<br>blood flow velocities in arteries<br>and veins in adults and<br>Pediatric. The Dolphin systems<br>can be used in hospitals, clinics<br>and physician offices. /<br>Transcranial Doppler Ultrasound<br>System is intended for use as a<br>diagnostic ultrasound fluid flow<br>analysis system.<br>The Roboprobe Headband<br>facilitates monitoring use by its<br>ability to track the Doppler<br>signal | Identical to the Dolphin<br>predicate with the<br>extended indication to<br>assists the user in the<br>acquisition of cerebral<br>blood flow velocity. This<br>indication is similar to a<br>reference device, the<br>NeuralBot , K180455<br>under the same product<br>code: OQQ .<br>The NeuralBot when<br>used with Lucid M1<br>System is a medical<br>ultrasound device which<br>assists the user in the<br>setup and acquisition of<br>cerebral blood flow<br>velocity via the patient's<br>temporal windows |
| Clinical<br>Applications | Intracranial<br>Extracranial<br>Peripheral | Intracranial<br>Extracranial<br>Peripheral | Identical to Dolphin<br>predicate device |
| Weight (kg) | Dolphin/4D: ~6 Kg<br>Dolphin/IQ: ~2 Kg<br>Dolphin/MAX:~ 6 Kg | Dolphin/4D: ~6 Kg<br>Dolphin/IQ: ~2 Kg<br>Dolphin/MAX:~ 6 Kg | Identical to Dolphin<br>predicate device |
| Dimensions (cm) | Dolphin/4D: 47x30x7<br>Dolphin/MAX: 47x30x7<br>Dolphin/IQ: 26.5x20.5x5.5 | Dolphin/4D: 47x30x7<br>Dolphin/MAX: 47x30x7<br>Dolphin/IQ: 26.5x20.5x5.5 | Identical to Dolphin<br>predicate device |
| Frequency modes<br>/ Transducers | 1.6MHz PW<br>2MHz PW | 1.6MHz PW<br>2MHz PW | Identical to Dolphin<br>predicate device |
| Specification | Dolphin devices [4D, IQ and<br>MAX] with Dolphin/XF Robot<br>accessory | Dolphin devices [4D, IQ and<br>MAX] / EMS9UA with<br>Roboprobe Headband<br>[Predicate devices] | Differences discussion |
| (MHz) | 4MHz PW/CW<br>8MHz PW/CW | 4MHz PW/CW<br>8MHz PW/CW | |
| Patient surface<br>contact materials | Compatible | Compatible | Identical to Dolphin<br>predicate device |
| 2 MHz Monitoring<br>Probe | available | available | Identical to Dolphin<br>predicate device |
| Monitoring<br>headset | available | available | Identical to Dolphin<br>predicate device |
| User controls | Remote control, foot switch,<br>touch screen, key board, mouse | Remote control, foot switch,<br>touch screen, key board, mouse | Identical to Dolphin<br>predicate device |
| Display modes | Unilateral, bilateral, monitoring,<br>external channels, HITS | Unilateral, bilateral, monitoring,<br>external channels, HITS | Identical to Dolphin<br>predicate device |
| Sample Volume (2<br>MHz) | 1-20 mm | 1-20 mm | Identical to Dolphin<br>predicate device |
| Scale (2 MHz) | Up to 32 KHz depth dependent | Up to 32 KHz depth dependent | Identical to Dolphin<br>predicate device |
| Power control | 0-100 % of maximal derated Ispta<br>within FDA guidelines | 0-100 % of maximal derated Ispta<br>within FDA guidelines | Identical to Dolphin<br>predicate device |
| Maximal Acoustic<br>Ispta.3 (mW/cm²) | Below maximal FDA guideline<br>limits | Below maximal FDA guideline<br>limits | Identical to Dolphin<br>predicate device |
| | Comply with FDA limits:<br>Ispta.3 ≤ 720 mW/cm²<br>MI ≤ 1.9 or the global maximum<br>derated ISPPA ≤ 190 W/cm². | Comply with FDA limits:<br>Ispta.3 ≤ 720 mW/cm²<br>MI ≤ 1.9 or the global maximum<br>derated ISPPA ≤ 190 W/cm². | |
| M-mode display | available | available | Identical to Dolphin<br>predicate device |
| Multi-gate<br>windows | Up to 8 | Up to 8 | Identical to Dolphin<br>predicate device |
| HITS detection | Available | Available | Identical to Dolphin<br>predicate device |
| Velocity profile<br>display | Available | Available | Identical to Dolphin<br>predicate device |
| Cursors | Available | Available | Identical to Dolphin<br>predicate device…