The Sonosite LX Ultrasound System is a general-purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:

Abdominal
Adult Cephalic
Neonatal Cephalic
Cardiac Adult
Cardiac Pediatric
Dermatological
Fetal OB/GYN
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Ophthalmic
Pediatric
Peripheral vessel
Small Organ (breast, thyroid, testicles, prostate)
Transesophageal (cardiac)
Transrectal
Transvaginal
Needle Guidance

Modes of operation include: B Mode (B), M-Mode (M) (including simultaneous M-mode and anatomical M Mode), PW Doppler (PWD) (including Pulsed Wave Tissue Doppler), Continuous Wave Doppler (CWD), Color Power Doppler (including Velocity Color Doppler), Tissue Harmonic Imaging (THI), Tissue Doppler Imaging (TDI), and Combined modes, including Triplex imaging: B+M, B+PWD, B+CWD, B+C, (B+C)+PWD, (B+C)+CWD.

This device is indicated for Prescription Use Only.

The Sonosite LX Ultrasound System is intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients.

Device Description

The Sonosite LX Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, M Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler (CPD), and color Doppler (Color) or in a combination of these modes. The Sonosite LX is designed as an integrated unit with its kiosk-style stand.

The system includes a variety of accessories including needle guide starter kits. The system includes USB host support for peripherals such as input devices, storage devices, and an Ethernet port. Input devices include wired and wireless devices. The system also includes an ECG-specific port to support the ECG feature. The non-diagnostic ECG module provides ECG tracing of the cardiac signal synchronized with the ultrasound image.

AI/ML Overview

The provided FDA 510(k) clearance letter for the Sonosite LX Ultrasound System (K251830) describes a general-purpose ultrasound system. As such, the clearance does not detail specific acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be associated with AI-powered diagnostic devices. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and compliance with general safety and performance standards.

However, based on the information provided, we can infer some "acceptance criteria" related to the device's technical specifications and safety, and how the study addresses them.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a general-purpose ultrasound system and not an AI/diagnostic algorithm, the acceptance criteria are not in the form of diagnostic performance metrics. Instead, they are related to equivalence with predicate devices, safety, and general performance standards.

Acceptance Criteria (Inferred from Substantial Equivalence and Safety Standards)	Reported Device Performance / Assessment Method
Intended Use Equivalence	Reported: "The Sonosite LX Ultrasound System (this submission) and the predicate device is diagnostic ultrasound imaging or fluid flow analysis of the human body."Evaluation: "The intended use of the Sonosite LX is identical to the predicate and reference devices."
Indications for Use Equivalence	Reported: Covers a broad range of clinical applications (Abdominal, Cardiac, OB/GYN, Musculoskeletal, etc.), with the addition of a "Dermatological" indication via the new UHF46-20 transducer. This new indication was previously cleared on the reference device (Vevo MD Imaging system K190476).Evaluation: "The Indications for Use are similar as what was cleared on Sonosite LX Ultrasound system (primary predicate- K233597). The dermatological indication introduced with Sonosite LX in this submission is previously cleared on the reference device, Vevo MD Imaging system (K190476). The dermatological indication on UHF46-20 supports vessel and superficial exam types and is an extension of the dermatological indication on UHF48 (K190476)."
Technological Characteristics Equivalence	Reported: Similar transducer types, modes of operation, DICOM support, transmit/receive channels, system characteristics (form factor, beamformer, screen, ports, dimensions, weight, battery, ratings, measurement packages). The primary differences noted are the addition of the UHF46-20 transducer, which is equivalent to the UHF48 transducer from the reference device.Evaluation: "The technological characteristics are unchanged from the primary predicate Sonosite LX (K233597) and reference device, Vevo MD imaging system (K190476). The Sonosite LX Ultrasound System employs the same fundamental scientific characteristics as the currently marketed predicate devices."
Acoustic Output within FDA Limits	Reported: Global Maximum Outputs including Ispta.3, TI Type, TI Value, MI, Ipa.3@MI Max values are provided (e.g., Ispta.3: 607 mW/cm^2, MI: 1.72). MI & TI are always displayed.Evaluation: "Acoustic output is within the FDA established limits and same as the primary predicate." and "MI & TI are always displayed, and a power management system ensures that they never exceed the derated FDA limits."
Patient Contact Materials Biocompatibility	Reported: Materials used for transducers and needle guides are listed. The new material Rexolite (for the UHF46-20 lens) is highlighted.Evaluation: "Rexolite is introduced as lens material for the UHF46-20 on the Sonosite LX system, This UHF48-20 has passed biocompatibility testing per ISO 10993-1. The rexolite material used for the lens is also the same as the one used on Vevo MD's UHF48 and UHF70 transducers (K190476). The rest of the ultrasound material is the same as the material used on the previously cleared transducers under (K233597).""All patient contact materials are biocompatible."
Electrical, Thermal, Mechanical, EMC Safety	Reported: The new transducer UHF46-20 was evaluated for these aspects.Evaluation: "The subject ultrasound system Sonosite LX Ultrasound System uses the new transducer UHF46-20, which has been evaluated for electrical, thermal, mechanical, and EMC safety."
Cleaning/Disinfection Effectiveness	Reported: Evaluated for Sonosite LX.Evaluation: "cleaning/disinfection... have been evaluated for Sonosite LX..."
Compliance with Recognized Standards	Reported: Listed compliance with ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, IEC 62304, ISO 14971, IEC 62359.Evaluation: "The Sonosite LX Ultrasound System is designed to comply with the following FDA recognized standards."
Quality System Compliance	Reported: Mention of Design Phase Reviews, Risk Assessment, Requirements Development, System and Software Verification, Hardware Verification, Safety Compliance Verification, and Clinical Validation.Evaluation: "Assurance of quality was established by employing the following elements of product development..." and "FUJIFILM SonoSite, Inc. believes that the Sonosite LX Ultrasound System is substantially equivalent with regards to safety and effectiveness to the predicate devices." (implies QS compliance supports this)
Performance in Clinical Environment	Reported: The device with the new transducer was tested.Evaluation: "The Sonosite LX with new transducer UHF46-20 has been successfully tested in a clinical environment and the device performed as expected."

Regarding specific AI-related questions (2-9), this clearance letter does not pertain to an AI/ML device for diagnostic interpretation. It's for a general-purpose ultrasound system. Therefore, most of these questions are not applicable to the information provided.

However, I will address them to indicate their non-applicability or provide any remotely relevant information.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This submission is for a general-purpose ultrasound system, not an AI/ML algorithm requiring a specific test set for diagnostic performance. The evaluation was primarily based on engineering testing (electrical, thermal, mechanical, EMC safety, biocompatibility, acoustic output, standards compliance) and comparison to predicate devices, rather than a dataset of patient cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No ground truth (in the context of diagnostic accuracy) was established for a test set in this submission, as it's not an AI/ML diagnostic algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set requiring expert adjudication for diagnostic ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI-assisted diagnostic device, so no MRMC study comparing human readers with and without AI assistance was performed or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a hardware device (ultrasound system), not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. The "ground truth" here relates to engineering specifications and safety standards, such as:
- Biocompatibility confirmed by ISO 10993-1 standards (chemical testing, etc.)
- Acoustic output confirmed by IEC 62359 standards.
- Electrical safety confirmed by IEC 60601-1 standards.
- Functional "ground truth" confirmed by successful testing in a clinical environment, meaning it operates as intended for imaging and fluid flow analysis.

8. The sample size for the training set

Not Applicable. This clearance is not for an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. No training set for an AI/ML device.

In summary, the FDA 510(k) clearance for the Sonosite LX Ultrasound System is focused on demonstrating substantial equivalence to pre-existing, legally marketed predicate ultrasound systems and compliance with international safety and performance standards. The "study" proving it meets acceptance criteria primarily involves comprehensive engineering validation and verification testing (electrical, thermal, mechanical, EMC, acoustic output, biocompatibility, cleaning/disinfection) and documented adherence to a robust Quality System, rather than a clinical study evaluating diagnostic accuracy with a patient dataset or the performance of an AI algorithm.

Summary

FDA 510(k) Clearance Letter - Sonosite LX Ultrasound System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

July 10, 2025

FUJIFILM Sonosite, Inc.
℅ Prithul Bom
Regulatory Technology Services, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul, Minnesota 55114

Re: K251830
Trade/Device Name: Sonosite LX Ultrasound System
Regulation Number: 21 CFR 892.1550
Regulation Name: Ultrasonic pulsed doppler imaging system
Regulatory Class: Class II
Product Code: IYN, IYO, ITX
Dated: June 13, 2025
Received: June 13, 2025

Dear Prithul Bom:

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 (the 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 available 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.

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K251830 - Prithul Bom Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K251830 - Prithul Bom Page 3

assistance/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

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FORM FDA 3881 (8/23) Page 1 of 2

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K251830

Device Name: Sonosite LX Ultrasound System

Indications for Use (Describe)

Abdominal
Adult Cephalic
Neonatal Cephalic
Cardiac Adult
Cardiac Pediatric
Dermatological
Fetal OB/GYN
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Ophthalmic
Pediatric
Peripheral vessel
Small Organ (breast, thyroid, testicles, prostate)
Transesophageal (cardiac)
Transrectal
Transvaginal
Needle Guidance

This device is indicated for Prescription Use Only.

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.

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FORM FDA 3881 (8/23) Page 2 of 2

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."

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510(k) Summary

Page 1 of 11

510(K) Summary
K251830

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.

1) Submitter:

Manufacturer Name: FUJIFILM SonoSite, Inc.
Address: 21919 30th Drive SE
Bothell, WA 98021-3904

Corresponding Official: Anoush Frankian
Director, Regulatory Affairs
Email: anoush.frankian@fujifilm.com
Telephone: (425) 951-6824
Facsimile: (425) 951-1201

Date prepared: June 9, 2025

Alternate Contacts: Akanksha Kulshreshtha, Manager, Regulatory Affairs (akanksha.kulshreshtha@fujifilm.com)
Shreya Almaula, RA Associate (shreya.almaula@fujifilm.com)
Abirami Krishnamurthi, RA associate (abirami.krishnamurthi@fujifilm.com)

Telephone: (425) 951-6897
Facsimile: (425) 951-1201

2) Device

Trade Name: Sonosite LX Ultrasound System

Common Name: Diagnostic Ultrasound System and Transducers with Accessories

Regulation Name: Ultrasonic Pulsed Doppler Imaging System
Ultrasonic Pulsed Echo Imaging System
Diagnostic Ultrasound Transducer

Regulation Number: 892.1550
892.1560
892.1570

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Page 2 of 11

Primary Product Code: IYN
Secondary Product Codes: IYO
ITX

Device Class: Class II

Classification Panel: Radiology

3) Predicate Device:

Primary Predicate: Sonosite LX Ultrasound System (K233597)

Regulation Name: Ultrasonic Pulsed Doppler Imaging System
Ultrasonic Pulsed Echo Imaging System
Diagnostic Ultrasound Transducer

Regulation Number: 892.1550
892.1560
892.1570

Primary Product Code: IYN
Secondary Product Codes: IYO, ITX
Device Class: II
Classification Panel: Radiology

Reference Device: SonoSite Vevo MD Imaging System (K190476)

Regulation Name: Ultrasonic Pulsed Doppler Imaging System
Ultrasonic Pulsed Echo Imaging System
Diagnostic Ultrasound Transducer

Regulation Number: 892.1550
892.1560
892.1570

Primary Product Code: IYN
Secondary Product Codes: IYO, ITX
Device Class: II
Classification Panel: Radiology

4) Device Description:

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Page 3 of 11

Intended Use/Indications for Use:

Abdominal
Adult Cephalic
Neonatal Cephalic
Cardiac Adult
Cardiac Pediatric
Dermatological
Fetal – OB/GYN
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Ophthalmic
Pediatric
Peripheral vessel
Small Organ (breast, thyroid, testicles, prostate)
Transesophageal (cardiac)
Transrectal
Transvaginal
Needle Guidance

This device is indicated for Prescription Use Only.

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Page 4 of 11

5) Technological Characteristics:

The Sonosite LX Ultrasound System, subject device of this submission, is equivalent to the previously cleared primary predicate Sonosite LX (K233597) and the reference device, Vevo MD Imaging Systems in terms of both the intended use and technological characteristics. The Sonosite LX (subject device) uses the same fundamental scientific technology as the primary predicate device.

Feature	Sonosite LX Ultrasound System (This submission)	Sonosite LX Ultrasound System (K233597)	Sonosite VevoMD Imaging System (K190476)	Evaluation of Differences
Intended Use	Diagnostic ultrasound imaging or fluid flow analysis of the human body	Diagnostic ultrasound imaging or fluid flow analysis of the human body	Diagnostic ultrasound imaging or fluid flow analysis of the human body	The intended use of the Sonosite LX is identical to the predicate and reference devices.
Indications for Use	Abdominal, Adult Cephalic, Neonatal Cephalic, Cardiac Adult, Cardiac Pediatric, Dermatological, Fetal – OB/GYN, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Ophthalmic, Pediatric, Peripheral vessel, Small Organ (breast, thyroid, testicle, prostate), Transrectal, Transvaginal, Trans-esophageal (cardiac), Needle Guidance	Abdominal, Adult Cephalic, Neonatal Cephalic, Cardiac Adult, Cardiac Pediatric, Fetal – OB/GYN, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Ophthalmic, Pediatric, Peripheral vessel, Small Organ (breast, thyroid, testicle, prostate), Transrectal, Transvaginal, Trans-esophageal (cardiac), Needle Guidance	Abdominal, Neonatal Cephalic, Dermatological, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Ophthalmic, Pediatric, Peripheral Vessel, Small Organ (breast, thyroid, testicles, prostate)	The Indications for Use are similar as what was cleared on Sonosite LX Ultrasound system (primary predicate- K233597). The dermatological indication introduced with Sonosite LX in this submission is previously cleared on the reference device, Vevo MD Imaging system (K190476). The dermatological indication on UHF46-20 supports vessel and superficial exam types and is an extension of the dermatological indication on UHF48 (K190476).
Transducer Types	Linear Array, Curved Linear Array, Phased Array, Intracavitary, Trans-esophageal	Linear Array, Curved Linear Array, Phased Array, Intracavitary, Trans-esophageal	Linear Array	Same as the primary predicate (K233597)
Transducer Frequency	1.0 – 46.0 MHz	1.0-19.0 MHz	1.0- 70 MHz	While the introduction of UHF46-20 has increased the frequency range for the Sonosite LX Ultrasound System, it still falls within the range of previously cleared primary predicate, Sonosite LX (K233597) and the reference device, Vevo MD (K190476).
Global Maximum Outputs/Worst Case Setting	Ispta.3: 607 mW/cm^2 (L12-3), TI Type: TIB (P5-1), TI Value: 4.87 (P5-1), MI: 1.72 (L12-3), Ipa.3@MI Max: 793 mW/cm^2	Ispta.3: 607 mW/cm^2 (L12-3), TI Type: TIB (P5-1), TI Value: 4.87 (P5-1), MI: 1.72 (L12-3), Ipa.3@MI Max: 793 mW/cm^2 (L15-4)	Ispta.3: 455 (UHF48), TI Type: TIS (UHF22), TI Value: 4.15 (UHF22), MI: 1.26 (UHF22), Ipa.3@MI Max:	Acoustic output is within the FDA established limits and same as the primary predicate.

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Page 5 of 11

Feature	Sonosite LX Ultrasound System (This submission)	Sonosite LX Ultrasound System (K233597)	Sonosite VevoMD Imaging System (K190476)	Evaluation of Differences
Acoustic Output Display & FDA Limits	Display Feature for Higher Outputs MI Output Display TI Output Display	Display Feature for Higher Outputs MI Output Display TI Output Display	Display Feature for Higher Outputs MI Output Display TI Output Display	MI & TI are always displayed, and a power management system ensures that they never exceed the derated FDA limits
Modes of Operation	B Mode Grayscale Imaging, Tissue Harmonic Imaging, M-Mode, Simultaneous M-mode, Anatomical M-Mode, Color Power Doppler, Combination Modes, Pulse Wave Doppler (PWD), Tissue Doppler Imaging (TDI), Continuous Wave Doppler (CWD), Speckle reduction algorithm (formerly branded as SonoHD2 Noise Reduction), SonoMB/MBe Image Compounding CW Doppler, Velocity Color Doppler, Simultaneous PWD, HPRF	B-mode Grayscale Imaging, Tissue Harmonic Imaging, M-mode, Simultaneous M-Mode, Anatomical M-Mode, Color Power Doppler, Combination Modes, Pulsed Wave Doppler (PWD), Tissue Doppler Imaging (TDI), Continuous Wave Doppler (CWD), Speckle reduction algorithm (formerly branded as SonoHD2 Noise Reduction), SonoMB/MBe Image Compounding CW Doppler, Velocity Color Doppler, Simultaneous PWD, HPRF	M-Mode, Pulse Wave Doppler Mode (PWD), 2D: B Mode / 2D Mode, Power Doppler Mode, Color Doppler Mode	Same as the primary predicate (K233597)
DICOM	DICOM 3.0, Store, Modality Worklist, Modality Perform Procedure Step (MPPS), Storage Commitment, Structured reports, offline media	DICOM 3.0, Store, Modality Worklist, Modality Perform Procedure Step (MPPS), Storage Commitment, Structured reports, offline media	DICOM 3.0, Store, Print, Modality Worklist, Perform Procedure Step (PPS), Storage Commitment	Same as the primary predicate (K233597)
#Transmit Channels	128 digital channels	128 digital channels	64 digital channels	Same as the primary predicate (K233597)
#Receive Channels	128 digital channels	128 digital channels	64 digital channels	Same as the primary predicate (K233597)

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Feature	Sonosite LX Ultrasound System (This submission)	Sonosite LX Ultrasound System (K233597)	Sonosite VevoMD Imaging System (K190476)	Evaluation of Differences
Patient Contact Materials	Transducers: Silicone Rubber, Polysulfone, PolyVinylChloride (PVC), Silicone, RTV Adhesive Silicone, Polymethyl-pentene, Epoxy Paste Adhesive Polyurethane, FKM rubber, Thermoplastic Polyurethane, Rexolite Needle Guides: Acetal copolymer, Acrylonitrile-butadien-styrene (ABS), Rexolite	Transducers: Silicone Rubber, Polysulfone, PolyVinylChloride (PVC), Silicone, RTV Adhesive Silicone, Polymethyl-pentene, Epoxy Paste Adhesive Polyurethane, FKM rubber, Thermoplastic polyurethane Needle Guides: Acetal copolymer, Acrylonitrile-butadien-styrene (ABS)	Transducer: Silicone Rubber, Polysulfone, Poly-Vinyl-Chloride (PVC), Spectrally Transparent Epoxy, TPX Polymethyl Pentene, Rexolite	Rexolite is introduced as lens material for the UHF46-20 on the Sonosite LX system, This UHF48-20 has passed biocompatibility testing per ISO 10993-1. The rexolite material used for the lens is also the same as the one used on Vevo MD's UHF48 and UHF70 transducers (K190476). The rest of the ultrasound material is the same as the material used on the previously cleared transducers under (K233597).
DICOM	DICOM PS3.15	DICOM PS3.15	NEMA PS3.15 2011	Same as the primary predicate (K233597)

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Feature	Sonosite LX Ultrasound System (This submission)	Sonosite LX Ultrasound System (K233597)	Sonosite VevoMD Imaging System (K190476)	Evaluation of Differences
System Characteristics	Sonosite LX (Kiosk form factor), Beamformer 128/128, 21.3" Projected Capacitive (PCAP) touch screen interface, 2 USB 2.0 Ports, 2 USB 3.0 Ports, 1 USB port for optional printer Stand battery, Dimensions: Storage bin capacity: 11 lbs. (5 kg), Stand depth: 25.4 in. (64.5 cm), Stand width: 23.0 in. (58.4 cm), Height range: max with monitor up 68 in. (172.7 cm); min with monitor down 49 in. (124.5 cm), Weight (system and accessories including safe working load): 151.68 lbs. (68.8 kg), System operates via battery or AC power. Battery Life: 3 hours, Stand battery: Length: 19 in. (48.26 cm), Width: 4 in. (10.16 cm), Depth: 2.2 in. (5.59 cm), Weight: 6 lbs (2.72 kg), Ratings: Stand Input: 100–240 VAC, 50–60 Hz, 6.0–2.5 A, Stand Output: 100–240 VAC, 50–60 Hz, 2.5–1.0 A, Stand battery ratings: 21.6 VDC, 12000mAh, 259.2Wh, Input: 26.7 VDC, 8.24 A (max 220 W), Output: 26.7 VDC, 8.24 A (max 220 W), Various obstetrical, cardiac, volume, M-mode, PW and CW Doppler measurement and calculation packages Non-diagnostic ECG tracing, Wireless 802.11 (a/b/g/n/ac) support for image transfer	Sonosite LX (Kiosk form factor), Beamformer 128/128, 21.3" Projected Capacitive (PCAP) touch screen interface, 2 USB 2.0 Ports, 2 USB 3.0 Ports, 1 USB port for optional printer Stand battery. Dimensions: Storage bin capacity: 11 lbs. (5 kg), Stand depth: 25.4 in. (64.5 cm), Stand width: 23.0 in. (58.4 cm), Height range: max with monitor up 68 in. (172.7 cm); min with monitor down 49 in. (124.5 cm), Weight: (system and accessories including safe working load): 151.68 lbs. (68.8 kg), System operates via battery or AC power. Battery Life: 3 hours, Stand battery: Length: 19 in. (48.26 cm), Width: 4 in. (10.16 cm), Depth: 2.2 in. (5.59 cm), Weight: 6 lbs (2.72 kg), Ratings: Stand Input: 100–240 VAC, 50–60 Hz, 6.0–2.5 A, Stand battery ratings: 21.6 VDC, 12000mAh, 259.2Wh, Input: 26.7 VDC, 8.24 A (max 220 W), Output: 26.7 VDC, 8.24 A (max 220 W), Various obstetrical, cardiac, volume, M-mode, PW and CW Doppler measurement and calculation packages Non-diagnostic ECG tracing, Wireless 802.11 (a/b/g/n/ac) support for image transfer	Sonosite VevoMD, Beamformer 64/64 using SA (configurable), 12.1" touch screen interface, Touch panel with the 19" LED clinical monitor, 4 USB 3.0 ports, Dimensions: Stand base Dimensions: 26.4" L x 21.2" W, Stand Height (with monitor folded) = 48 in (122 in), Weight: 95 kg (209 lbs), Wireless 802.11 (a/b/g/n/ac) support for image transfer, System must be plugged in AC power for operation. Ratings: 100V, 120V and 240V at 50/60Hz, Wireless 802.11 (a/b/g/n/ac) support for image transfer	The system characteristics are the same as the primary predicate device, Sonosite LX system (K233537). The new transducer, UHF46-20 introduced with Sonosite LX in this submission is equivalent to UHF48 transducer in the reference device, Vevo MD system (K190476). The dermatological indication on UHF46-20 supports vessel and superficial exam types and is an extension of the dermatological indication on UHF48 (K190476).

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Feature	Sonosite LX Ultrasound System (This submission)	Sonosite LX Ultrasound System (K233597)	Sonosite VevoMD Imaging System (K190476)	Evaluation of Differences
Additional system features:	Added the UHF46-20 ultra-high frequency transducer and associated exam types	Assisted Cardiac Output (ACO), Anatomical M-Mode, Trapezoid imaging, Label and Measurement in Review (LiMR), High Pulse Repetition Frequency (HPRF), Cardiac Triplex, Voice Assist		The Sonosite LX ultrasound system features are unchanged. The change in this submission is the introduction of the UHF46-20 transducer with the added Dermatological indication. The ultrasound system features are unchanged and already cleared on the Sonosite LX ultrasound system (K233597) and the introduction of UHF460-20 with the dermatological indication is an extension of the dermatological indication on UHF48 cleared on Vevo MD Imaging system (K190476).
510k Track	Track 3	Track 3	Track 3	Same

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6) Determination of Substantial Equivalence:

Summary of Technological Comparison to Predicate Devices:

The Sonosite LX Ultrasound System, subject device of this submission, is enhanced implementation of previous FDA cleared predicate devices Sonosite LX (K233597) and Sonosite Vevo MD Imaging System (K190476).

The technological characteristics are unchanged from the primary predicate Sonosite LX (K233597) and reference device, Vevo MD imaging system (K190476). The primary function of Sonosite LX Ultrasound System (this submission) and the predicate device is diagnostic ultrasound imaging or fluid flow analysis of the human body. The Sonosite LX Ultrasound System employs the same fundamental scientific characteristics as the currently marketed predicate devices. The Sonosite LX Ultrasound device and predicates share indications for use, share modes of operation and have biosafety equivalence.

The following lists an overview of differences between the proposed subject device (Sonosite LX Ultrasound System) and its predicates.

Addition of UHF46-20 transducer, which is substantially equivalent to the UHF48 transducer previously cleared on Sonosite Vevo MD Imaging system (K190476).
Addition of new dermatological indication which is substantially equivalent to the dermatology indication on Vevo MD imaging system (K190476) and supported under the superficial and vessel exam types
Introduction of new transducer material (Rexolite)
Updated transducer frequency range for Sonosite LX system which falls within the range of previously cleared primary predicate, Sonosite LX (K233597) and the reference device, Vevo MD (K190476).

The transducer types for the subject device are all a subset of the primary predicate (Sonosite LX - K233597) and reference device (Sonosite Vevo MD – K190476). The transducer frequency range for Sonosite LX in this submission falls within the range of previously cleared primary predicate, Sonosite LX (K233597) and the reference device, Vevo MD Imaging system (K190476).

The transducers have been tested to performance standards and the acoustic output is less than FDA established limits. Similar to both predicate and the reference devices, MI and TI values are always displayed, and a power management system ensures that they never exceed the derated FDA limits.

The changes implemented on the Sonosite LX leverage existing technological characteristics and features available on both the primary predicate (K233597) and the reference device (K190476). The submission device is substantially equivalent to the predicates with respect to the intended use and technological characteristics.

Summary of Non-Clinical Tests:

The subject ultrasound system Sonosite LX Ultrasound System uses the new transducer UHF46-20, which has been evaluated for electrical, thermal, mechanical, and EMC safety. Additionally, cleaning/disinfection, biocompatibility, and acoustic output have been evaluated for Sonosite LX, and the device has been found to conform to applicable medical device safety standards.

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Assurance of quality was established by employing the following elements of product development: Design Phase Reviews, Risk Assessment, Requirements Development, System and Software Verification, Hardware Verification, Safety Compliance Verification, and Clinical Validation. All patient contact materials are biocompatible.

The Sonosite LX Ultrasound System is designed to comply with the following FDA recognized standards.

Reference No.	Recognition No.	Title
ISO 10993-1	2-258	ISO 10993-1:2018, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
IEC 60601-1	19-46	AAMI / ANSI ES60601- 1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2	19-36	ANSI AAMI IEC 60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
IEC 60601-1-6	5-89	IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-2-37	12-293	IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
IEC 62304	13-79	ANSI AAMI IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes [Including Amendment 1 (2016)
ISO 14971	5-125	ANSI AAMI ISO 14971:2019 Medical devices - Application of risk management to medical devices
IEC 62359	12-316	IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION - Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields

Summary of Clinical Tests:

The Sonosite LX Ultrasound System and transducers, subject of this submission, which uses the new transducer UHF46-20 did not require clinical studies to support the determination of substantial equivalence. The Sonosite LX with new transducer UHF46-20 has been successfully tested in a clinical environment and the device performed as expected.

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Conclusion

Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. The Sonosite LX Ultrasound device and predicates conform to applicable electromedical device safety standards with compliance verified through independent evaluation. The Sonosite LX Ultrasound device and predicates meet FDA requirements for Track 3 devices, share indications for use, have biosafety equivalence and are manufactured using the same ISO 13485 and 21 CFR 820 quality system. FUJIFILM SonoSite, Inc. believes that the Sonosite LX Ultrasound System is substantially equivalent with regards to safety and effectiveness to the predicate devices.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.