Who is the manufacturer of Ultrasound System 2300?

Bk Medical Aps filed the 510(k) submission for Ultrasound System 2300 (K222441).

What is the FDA product code for Ultrasound System 2300?

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

What is the regulatory pathway for Ultrasound System 2300?

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

What are the predicate devices for Ultrasound System 2300?

Ultrasound Scanner System bk2300 (K180737).

Who can help prepare an FDA 510(k) submission like Ultrasound System 2300?

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.

Ultrasound System 2300

K222441 · Bk Medical Aps · IYN · Dec 7, 2022 · Radiology

Device Facts

Record ID	K222441
Device Name	Ultrasound System 2300
Applicant	Bk Medical Aps
Product Code	IYN · Radiology
Decision Date	Dec 7, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric

Intended Use

The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance.

Device Story

The Ultrasound System 2300 is a mobile, software-controlled diagnostic ultrasound system used in professional healthcare environments (hospitals, clinics) by trained professionals. It acquires, processes, and displays ultrasound data via various multi-frequency transducers (linear, phased, convex, endocavity, laparoscopic). The system features a mobile console with a 19-inch monitor and either a conventional keyboard or glass touch interface. It supports multiple imaging modes including 2D (B-mode), M-mode, PWD, CFM, Power Doppler, Contrast Imaging, CW Doppler, and Strain Elastography. The device provides puncture and biopsy guidance and includes an 'LAP Ablation Navigation' option using electromagnetic needle tracking. Output is displayed on the monitor for real-time clinical assessment, aiding in diagnosis, fluid flow analysis, and interventional guidance. The system benefits patients by providing non-invasive diagnostic imaging and precise guidance for surgical and biopsy procedures.

Clinical Evidence

No clinical data was required to support substantial equivalence. Evidence consists of bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety testing in accordance with recognized standards (e.g., IEC 60601-1, IEC 60601-2-37, IEC 62359, ISO 10993-1).

Technological Characteristics

Mobile ultrasound console with 19" optical bonded glass monitor. Features 4 transducer ports and 196 TX/RX channels. Connectivity includes DICOM. Software-controlled with multiple configurations (bk3000, bk5000, bkActiv). Electromagnetic needle tracking uses a tracking control unit, portable EM field generator, and clip-on sensors. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, and ISO 10993-1.

Indications for Use

Indicated for fetal (obstetrics), abdominal, pediatric, intra-operative, intra-operative neuro (neurosurgery), laparoscopic, small organ (small parts), adult cephalic (trans-cranial), neonatal cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional and superficial), cardiac adult, trans-esophageal (cardiac), and peripheral vessel (peripheral vascular) applications. Contraindicated for ophthalmic use or any use causing the acoustic beam to pass through the eye. Cardiac adult application is not intended for direct use on the heart.

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

Ultrasound Scanner System bk2300 (K180737)

Reference Devices

GE Logiq E10 (K211488)

Related Devices

K180737 — Ultrasound Scanner System bk2300 · Bk Medical Aps · Aug 1, 2018
K171233 — Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System · Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · Sep 12, 2017
K172059 — LinkQuest Diagnostic Ultrasound System model SQ860 · Linkquest, Inc. · Oct 5, 2017
K173369 — DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System · Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · Dec 13, 2017
K123503 — DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 13, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ December 7, 2022 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 ADMINISTRATION" in blue text. BK Medical Aps % Sandra Theodoridis SR Regulatory Affairs Specialist Mileparken 34 Herlev. 2730 DENMARK Re: K222441 Trade/Device Name: Ultrasound System 2300 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: October 28, 2022 Received: October 28, 2022 Dear Sandra Theodoridis: 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/cfpmn/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 {1}------------------------------------------------ 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 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 mediation-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, Yanna S. Kang -S Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K222441 Device Name Ultrasound System 2300 Indications for Use (Describe) Intended Use: The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance. Indications to Use: The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Intra-operative Neuro (also known as Neurosurgery), Laparoscopic, Small Organ (also known as Small Parts), Adult Cephalic is also known as Adult Trans-cranial), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, Transesophageal (Cardiac) and Peripheral Vessel (also known as Peripheral Vascular). Modes of Operation: - 2D (B-Mode) including Tissue Harmonic Imaging - M-Mode - PWD Mode - CFM Mode (C, VFI) - Power Doppler - Contrast Imaging - CW Doppler - Strain Elastography Environment: The Ultrasound System 2300 is intended for use in the professional healthcare environment (e.g. hospitals, physician offices) Contraindications: The Ultrasound System 2300 is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye. The Cardiac Adult application is not intended for direct use on the heart. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the alphanumeric string "K222441" in a bold, sans-serif font. The string is horizontally oriented and centered. The characters are uniformly sized and spaced, creating a clear and legible sequence. Image /page/4/Picture/1 description: The image is the logo for BK Medical, a GE Healthcare company. The logo features the letters "bk" in a bold, green sans-serif font stacked on top of the word "medical" in a smaller, green sans-serif font. Below "medical" is the text "a GE Healthcare company" in a smaller, lighter font. To the right of the "bk" is a stylized green graphic that resembles sound waves or a signal emanating from a source. # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS | 1. Submitter: | BK Medical ApS Mileparken 34 Herlev 2730 Denmark | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer: | BK Medical ApS Mileparken 34 Herlev 2730 Denmark | | Primary Contact Person: | Sandra Theodoridis Senior Regulatory Affairs Specialist BK Medical Tel: (978) 578 9353 E-mail: stheodoridis@bkmedical.com | | Date Prepared: | August 11, 2022 | #### 儿 Device Names / Common Names / Classification Names: | Trade Names: | Ultrasound System 2300 | |-----------------------|------------------------------------------| | Common Name: | Ultrasound System | | Classification Name: | Ultrasonic pulsed doppler imaging system | | Product Code: | IYN (primary), IYO, ITX (secondary) | | Class: | II | | Regulation Number: | 21 CFR §892.1550, §892.1560, §892.1570 | | Classification Panel: | Radiology | {5}------------------------------------------------ #### lll. Identification of Predicate or Legally Marketed Devices: - . Primary predicate device: Ultrasound Scanner System bk2300 as cleared under 510(k) premarket notification No K180737. | Trade Name: | Ultrasound System 2300 | | |-----------------------|------------------------------------------|--| | Common Name: | Ultrasound System | | | Classification Name: | Ultrasonic pulsed doppler imaging system | | | Product Code: | IYN (primary), IYO, ITX (secondary) | | | Class: | II | | | Regulation Number: | 21 CFR §892.1550, §892.1560, §892.1570 | | | Classification Panel: | Radiology | | - Reference predicate device: GE Logiq E10 cleared under 510(k) premarket notification No ● K211488. | Trade Name: | GE Logiq E10 | |-----------------------|------------------------------------------| | Common Name: | GE Logiq E10 | | Classification Name: | Ultrasonic pulsed doppler imaging system | | Product Code: | IYN (primary), IYO, ITX (secondary) | | Class: | II | | Regulation Number: | 21 CFR §892.1550 | | Classification Panel: | Radiology | #### IV. Device Description The Ultrasound System 2300 is a multi-purpose mobile, software-controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms which are offered in different configurations/ models intended for urology, general imaging, surgical and anesthesiology applications. The system consists of a mobile console (engine) that provides digital acquisition, processing and display capabilities. The user interface includes a conventional keyboard or a glass touchpad, a 19" Clinical Display Monitor (CDM). In addition, a variety of system accessories are available such as baskets, foot switch, printer start-up kit, remote control, and extra holders. {6}------------------------------------------------ The Ultrasound System 2300 is available in the following marketing configurations: - 1. bk3000 available with a conventional keyboard configuration. The bk3000 is primarily intended for applications such as urology and general imaging - 2. bk5000 available with a conventional keyboard configuration. The bk5000 is primarily intended for surgery applications. - 3. bkActiv is a configuration available with a glass user interface (UI). bkActiv is primarily intended for surgical and anesthesiology applications. All configurations run on the previously cleared SW platform and HW platform (engine) (K180737). The various configurations of the Ultrasound System 2300 are intended to be used for different applications as described above with various transducers and options. The primary difference between the system configurations (also refer to Table 1) are: - bk5000 is the premier product offering with all features and probes available - Bk3000 is a basic product offering with only a subset of features - bkActiv is a configuration available with a glass user interface (UI). bkActiv is ● primarily intended for surgical and anesthesiology applications | Catalog/ Reference (REF) | Model | Model Description | |--------------------------------|---------|------------------------------------------------------------------------------------------------------------------------------------------| | 2300 | 2300-01 | BK3000 ULTRASOUND SYSTEM W/O BATTERY This configuration is primarily intended for Urology and General imaging applications. | | Catalog/ Reference (REF) | Model | Model Description | | 2300 | | BK3000 ULTRASOUND SYSTEM W/BATTERY This configuration is primarily intended for Urology and General imaging applications. | | 2300 | | BK5000 ULTRASOUND SYSTEM W/O BATTERY This configuration is primarily intended for surgical applications. | | 2300 | | BK5000 ULTRASOUND SYSTEM W/BATTERY This configuration is primarily intended for surgical applications. | | Catalog/ Reference (REF) | Model | Model Description | | 2300 | 2300-56 | BKACTIV ULTRASOUND SYSTEM W/O BATTERY This configuration is primarily intended for surgical and anesthesiology applications. | | 2300 | 2300-66 | BKACTIV ULTRASOUND SYSTEM W/ BATTERY This configuration is primarily intended for surgical and anesthesiology applications. | Table 1: Ultrasound Scanner System bk2300 available configurations {7}------------------------------------------------ {8}------------------------------------------------ The various configurations of the Ultrasound System 2300 are intended to be used with various multi-frequency transducers (see Table 2). The indicated uses are different and specific for each transducer listed. - . Linear Array - Phased Linear Array ● - . Convex / Curved Array The interaction with patients is dependent upon the transducer type which may include: - Surface ● - Inter-operative ● - Laparoscopic ● - Endocavity {9}------------------------------------------------ | Transducer | bk3000 | bk5000 | bkActiv | |-----------------------------------------------------------|--------|--------|---------| | 5Cle (9085) CURVED ARRAY TRANSDUCER | X | X | X | | 6C2 (9040) CURVED ARRAY TRANSDUCER | X | X | X | | 6C2s (9023) SMALL CURVED ARRAY TRANSDUCER | X | X | X | | 9C2 (9002) CURVED ARRAY TRANSDUCER | X | X | X | | 14L3 (9051) LINEAR ARRAY TRANSDUCER | X | X | X | | 13L4w (9011) WIDE LINEAR ARRAY TRANSDUCER | X | X | X | | 10L2w (9022) WIDE LINEAR ARRAY TRANSDUCER | X | X | | | 18L5 (9070) SMALL GIGH-FREQUENCY LINEAR ARRAY TRANSDUCER | X | X | X | | 18L5s (9081) SMALL GIGH-FREQUENCY LINEAR ARRAY TRANSDUCER | X | X | X | | 8L2 (9032) LINEAR ARRAY TRANSDUCER | X | X | X | | E13C2 (9029) ENDFIRE ENDOCAVITY TRANSDUCER | X | X | | | E14C4t (9018) TRIPLANE ENDOCAVITY TRANSDUCER | X | X | | | X14CL4b (9048) BIPLANE ENDOCAVITY TRANSDUCER | X | X | | | E10C4 (9019) ENDOCAVITY TRANSDUCER | X | X | | | 20R3 (9052) ANORECTAL TRANSDUCER | X | X | | | N13C5 (9062) CURVED ARRAY TRANSDUCER | X | X | X | | 5P1 (9077) PHASED ARRAY TRANSDUCER | X | X | | | X18L5S (9009) HOCKEY STICK TRANSDUCER | X | X | X | | N11C5S (9063) BURR HOLE TRANSDUCER | X | X | X | | I14C5I (9015) INTRAOPERATIVE I-SHAPE TRANSDUCER | X | X | X | | I14C5T (9016) INTRAOPERATIVE T-SHAPE TRANSDUCER | X | X | X | | I12C5B (9024) INTRAOPERATIVE BIPLANE TRANSDUCER | X | X | X | | 112C5 (9034) MINI-TRANSDUCER | X | X | X | | I12C4f (9066) LAPAROSCOPIC TRANSDUCER | X | X | X | | X12C4 (9026) DROP-IN TRANSDUCER | X | X | X | | X14L4 (9038) 3D ENDOCAVITY TRANSDUCER | X | X | | | Rob12C4 (9096) ROBOTIC TRANSDUCER | X | X | X | | N20P6 (9007) MINIMALLY INVASIVE TRANSDUCER | X | X | X | | 113C3f (9076) | X | X | X | | ADVANCED LAPAROSCOPIC TRANSDUCER | | | | | 113C3fx (9078) | | | X | | ADVANCED LAPAROSCOPIC TRANSDUCER WITH TRACKING | | | | ### Table 2: Transducers used with Ultrasound System 2300 configurations #### > Indications / Intended Use: ### Intended Use: The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance. #### Indications for Use: The clinical applications and exam types include: {10}------------------------------------------------ - Fetal (including obstetrics) ● - Abdominal ● - Pediatric - Intra-operative - Intra-operative Neuro (also known as Neurosurgery) ● - Laparoscopic ● - Small Organ (also known as Small Parts) ● - Adult Cephalic (Cephalic is also known as Adult Trans-cranial) ● - Neonatal Cephalic - Trans-rectal ● - Trans-vaginal ● - Musculo-skeletal (Conventional and Superficial) ● - Cardiac Adult ● - Trans-esophageal (Cardiac) ● - Peripheral vessel (also known as Peripheral Vascular) ### Modes of operation: - B-Mode (including Tissue Harmonic Imaging) - - -M-Mode - PWD Mode - - CFM Mode (C, VFI) - - -Power Doppler - Contrast Imaging - - CW Doppler - - -Strain Elastography ### Environment: The Ultrasound System 2300 is intended for use in the professional healthcare environment (e.g. hospitals, physician offices). ### Contraindications The Ultrasound System 2300 is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye. The Cardiac Adult application is not intended for direct use on the heart. {11}------------------------------------------------ #### VL Comparison of Technological Characteristics with the Predicate Device | | Ultrasound System 2300 | Ultrasound Scanner System bk2300 | Ultrasound System LOGIQ E10 | | |-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | Proposed device (TBD) | Primary predicate (K180737) | (Volume Navigation/GPS tracking option) Reference predicate | Comment on Comparison | | | | | (K211488) | | | Manufacturer | BK Medical ApS | BK Medical ApS | GE Healthcare | N/A | | Common Name | Ultrasound system | Ultrasound system | Ultrasound system | Equivalent | | Name | bk3000 (2300-01, 2300- | bk3000 (2300-01, 2300- | LOGIQ E10 | bkActiv 2300-56 & 66 are | | (Configuration | 11) | 11) | | configurations of the cleared | | models) | bk5000 (2300-51, 2300- | bk5000 (2300-51, 2300- | | system K180737 | | | 61) | 61) | | | | | bkActiv 2300-56, 2300-66 | | | | | Mode of Operation | B, M, PW, CFM, P, THI, | B, M, PW, CFM, P, THI, | B, M, PW Doppler, CW | Identical - Primary predicate | | | CI, SE, CW | CI, SE, CW | Doppler, Color Doppler, | Equivalent - reference | | | | | Color M Doppler, Power | predicate. | | | Combination modes : | Combination modes: | Doppler, Harmonic | | | | 2D+M, 2D+PW, | 2D+M, 2D+PW, | Imaging, Coded Pulse, | | | | 2D+C+PW, 2D+P+PW, | 2D+C+PW, 2D+P+PW, | 3D/4D Imaging mode, | | | | 2D+2D, 2D+2D (Biplane | 2D+2D, 2D+2D (Biplane | Elastography, Shear Wave | | | | Imaging), 2D+(2D+C), | Imaging), 2D+(2D+C), | Elastography (Attenuation | | | | 2D+(2D+P), 2D+THI, | 2D+(2D+P), 2D+THI, | Imaging and Combined | | | | 2D+SE, 2D+CI | 2D+SE, 2D+CI | modes: B/M, B/Color, B/ | | | | | | PWD, B/Color/PWD, | | | | | | B/Power/PWD) | | | Intended Use | Intended Use: | Intended Use: | The LOGIQ E10 is a | Identical - Primary predicate | | | The system is a diagnostic | The system is a diagnostic | general-purpose diagnostic | Equivalent - reference | | | ultrasound imaging system | ultrasound imaging system | ultrasound system intended | predicate. | | | used by qualified and…