The Ultrasound Imaging System is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body. The modes of operation include B mode, M mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD). Specific clinical applications and exam types including:

LX Series:
Ophthalmic,Fetal,General abdominal imaging,Pediatric,Small organ (Nerve, prostate, scrotum, breast),Neonatal cephalic,Trans-rectal,Trans-vaginal,Urology,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,Other (Carotid),Pulmonary,Nerve

128 Series:
Ophthalmic,Fetal,General abdominal imaging,Pediatric,Small organ (Nerve, prostate, scrotum, breast),Neonatal cephalic,Trans-rectal,Trans-vaginal,Urology,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

LU700 Series:
Ophthalmic,Fetal,General abdominal imaging,Pediatric,Small organ (Nerve, prostate, scrotum, breast),Neonatal cephalic,Trans-rectal,Trans-vaginal,Urology,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

The device is intended for use in environments where healthcare is provided by trained healthcare professionals, but not intended for use in emergency medical service, ambulance, or aircraft.

Device Description

The Ultrasound Imaging System is a portable, software controlled, handheld ultrasound system used to acquire and display hi-resolution, real-time ultrasound data through a commercial off-the-shelf (COTS) mobile device.

I. The imaging system software runs as an app on a mobile device.

II. The imaging system software can be download to a commercial off-the-shelf (COTS) mobile device and utilizes an icon touch-based user interface.

III. The imaging system consists of a series of wireless transducers employing Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range portable personal device.

IV. The imaging system houses a built-in battery, multichannel beamformer, prescan converter and Wi-Fi components

A complete list of all the probes and indications including:

Dual headed probe

LX Series:

LX128LC
Linear transducer: Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

Convex transducer: Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

LX128LP
Linear transducer: Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

Phased Array transducer: ,Fetal,General abdominal imaging,Pediatric,Cardiac (adult),Cardiac (pediatric),Pulmonary,FAST/EFAST,Nerve

LX192LC
Linear transducer: Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superf-dotorial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

Convex transducer: ,Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

Single headed probe

128 Series:

LK128C
Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

LK128L
Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

LK128LH
Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

LK128M
Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter)

LK128PA
Fetal,General abdominal imaging,Pediatric,Cardiac (adult),Cardiac (pediatric),Pulmonary,FAST/EFAST,Nerve

LK128E
Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Trans-rectal,Trans-vaginal,Urology,OB/Gyn,interventional guidance (free hand needle/ catheter)

LU700 Series:

LU700L
General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

LU710L
Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

LU710LH
Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

LU700C
General abdominal imaging,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

LU710C
Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

LU710M
Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter)

LU710PA
Fetal,General abdominal imaging,Pediatric,Cardiac (adult),Cardiac (pediatric),Pulmonary,FAST/EFAST,Nerve

LU710E
Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Trans-rectal,Trans-vaginal,Urology,OB/Gyn,interventional guidance (free hand needle/ catheter)

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for Leltek Inc.'s Ultrasound Imaging Systems (K243226) address the addition of new dual-headed probes (LX series) to existing cleared devices. While it asserts that the new models meet safety and performance standards, the document does not provide specific acceptance criteria or detailed study results for device performance in the format requested.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K241161) and compliance with various recognized standards (e.g., IEC 60601 series, ISO 10993 series). It states that "No additional clinical testing is required" due to the nature of the changes being additions of transducers with established technologies.

Therefore, the requested information cannot be fully extracted directly from this document. However, I can reconstruct what parts are mentioned or implied.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:

Request for Acceptance Criteria and Study Details

The provided document (FDA 510(k) Clearance Letter - Leltek Inc. Ultrasound Imaging Systems, K243226) details a submission for adding new dual-headed probes (LX series) to an already cleared Ultrasound Imaging System. It asserts that the new models meet safety and performance standards equivalent to the predicate device, thereby requiring no additional clinical testing.

The document does not provide specific acceptance criteria or detailed study results for device performance in the format of a comparative table or a comprehensive study description as requested for a new AI/software-based medical device. Instead, it relies on the principle of substantial equivalence and compliance with recognized standards for hardware modifications.

However, it does provide information on the safety and performance evaluations conducted to support the substantial equivalence.

Requested Information Breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided as clear, quantifiable acceptance criteria or reported device performance metrics in the given document.
The document states that the devices comply with various standards, which inherently means they meet the performance requirements within those standards. It mentions:

"full compliance with acoustic output, biocompatibility, cleaning, and disinfection effectiveness"
"maximum acoustic output level is under the FDA recommended limit"
"All the safety and performance tests of the device meet the essential requirements."

Without specific numerical targets for metrics like accuracy, sensitivity, or specificity (which are common for AI/software devices, but not the primary focus here for a hardware add-on to an imaging system), a table cannot be constructed. The performance is assessed against the established safety and performance of the predicate device and relevant industry standards.

2. Sample size used for the test set and the data provenance

Not applicable in the context of this 510(k) submission for new transducers.
The submission focuses on the safety and performance of the hardware (new transducers) and their integration with existing software. It explicitly states, "No additional clinical testing is required." Therefore, there is no mention of a clinical "test set" with patient data or its provenance. The testing would be on the physical device's characteristics (e.g., acoustic output, EMC, biocompatibility).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no clinical "test set" or diagnostic performance study is described, there's no mention of experts establishing ground truth for such a test.

4. Adjudication method for the test set

Not applicable. As no clinical "test set" or diagnostic performance study is described, there's no mention of an adjudication method.

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

No. This is not an AI/Software as a Medical Device (SaMD) submission focused on aiding diagnosis, but rather a submission for a new hardware component (ultrasound transducers) to an imaging system. Therefore, no MRMC study or AI assistance effect size is mentioned.

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

No. This is not an AI/SaMD submission.

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

Not applicable. For this type of submission, the "ground truth" for demonstrating safety and performance relates to engineering specifications, physical measurements (e.g., acoustic output, electrical safety), and material properties (e.g., biocompatibility testing results), rather than clinical diagnostic accuracy against pathology or expert consensus.

8. The sample size for the training set

Not applicable. This submission is for hardware. There is no mention of a "training set" in the context of an algorithm or AI.

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

Not applicable. As there is no training set mentioned, this information is not available.

Summary of Device Safety and Performance Assessment (from the Document):

The document indicates that the substantial equivalence is established based on the following:

Compliance with recognized standards: A comprehensive list of IEC and ISO standards for medical electrical equipment, usability, software lifecycle, biological evaluation (biocompatibility), risk management, and quality management is provided (Pages 14-15).
Acoustic Output: The device is tested and determined to be in "full compliance with acoustic output" and the "maximum acoustic output level is under the FDA recommended limit" (Page 16).
Biocompatibility: The new models are deemed to have "biosafety equivalence" and passed "biocompatibility" tests (Page 16).
Cleaning and Disinfection: Demonstrated "cleaning, and disinfection effectiveness" (Page 16).
Software and Hardware Equivalence: The new LX Series probes "utilizes the same software, cover material, and transducer specifications as the 128 Series but replaces a similar PCBA with a dual-headed probe, maintaining the same block diagram." (Page 16)
No Pragmatic Detriments: The changes "have no pragmatic detriments" (Page 16).

In essence, Leltek Inc. demonstrated that the new LX series transducers behave similarly to their predicate devices and comply with relevant safety standards, thus no further clinical performance studies were deemed necessary for this specific 510(k) submission.

Summary

FDA 510(k) Clearance Letter - Leltek Inc. Ultrasound Imaging Systems

Page 1

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

Doc ID # 04017.07.05

May 8, 2025

Leltek Inc.
Paul Chang
Manager
6F.-3, No.293, Sec 1, Beixin Rd., Xindian Dist.,
New Taipei City, 23147
Taiwan

Re: K243226
Trade/Device Name: Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)
Regulation Number: 21 CFR 892.1550
Regulation Name: Ultrasonic Pulsed Doppler Imaging System
Regulatory Class: Class II
Product Code: IYN, IYO, ITX
Dated: April 14, 2025
Received: April 14, 2025

Dear Paul Chang:

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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K243226 - Paul Chang 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-

Page 3

K243226 - Paul Chang 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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Indications for Use

Submission Number (if known)
K243226

Device Name
Ultrasound Imaging System (LX Series);
Ultrasound Imaging System (128 Series);
Ultrasound Imaging System (LU700 Series)

Indications for Use (Describe)

The Ultrasound Imaging System is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body. The modes of operation include B mode, M mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD).Specific clinical applications and exam types including:

LX Series:
Ophthalmic,Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Trans-rectal,Trans-vaginal,Urology,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,Other (Carotid),Pulmonary,Nerve

128 Series:
Ophthalmic,Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Trans-rectal,Trans-vaginal,Urology,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

LU700 Series:
Ophthalmic,Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Trans-rectal,Trans-vaginal,Urology,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

The device is intended for use in environments where healthcare is provided by trained healthcare professionals, but not intended for use in emergency medical service, ambulance, or aircraft.

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.

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."

Page 5

USFDA_510(k) LELTEK 510(k) Summary

K243226

1. Submitter's Information

Manufacturer: Leltek Inc.
Address: 6F.-3, NO.293, SEC 1, BEIXIN RD., XINDIAN DIST., NEW TAIPEI CITY 23147, TAIWAN (R.O.C.)
Tel: (886)2-2913-7577 #205
Fax: 886-2-2913-7599
Website: info@Leltek.com
Contact: Paul Chang/Manager
E-mail: Paul.Chang@leltek.com

2. Basic Information of application

Route: Special 510(k) Premarket Notification Submission
Date: 2024/09/10
Device Name:

Ultrasound Imaging System(LX Series)
Ultrasound Imaging System(128 Series)
Ultrasound Imaging System(LU700 Series)

General Information

Trade Name	Ultrasound Imaging System
Proprietary name	LU700 Series, 128 Series, LX Series
Common Name	Diagnostic Ultrasound System and Accessories
Regulatory number	21 CRF Section
892.1550	Ultrasonic Pulsed Doppler Imaging System
892.1560	Ultrasonic Pulsed Echo Imaging System
892.1570	Diagnostic Ultrasound Transducer

Product Code: IYO, IYN, ITX
Classification: Class II
Review Panel: Radiology
Predicate 510(k): K241161
Reference 510(k): K231301
Manufacturer: Leltek Inc.
Reason for Submission: Following changes have been made compared to the cleared device (Predicate Device #1)

Add the new dual headed probe LX series (LX128LC, LX128LP, LX192LC) with the same clinical applications.

Page 6

510(k) Summary

K243226

1. Submitter's Information

2. Basic Information of application

Route: Special 510(k) Premarket Notification Submission
Date: 2024/09/10
Device Name:

Ultrasound Imaging System(LX Series)
Ultrasound Imaging System(128 Series)
Ultrasound Imaging System(LU700 Series)

General Information

Trade Name	Ultrasound Imaging System
Proprietary name	LU700 Series, 128 Series, LX Series
Common Name	Diagnostic Ultrasound System and Accessories
Regulatory number	21 CRF Section
892.1550	Ultrasonic Pulsed Doppler Imaging System
892.1560	Ultrasonic Pulsed Echo Imaging System
892.1570	Diagnostic Ultrasound Transducer

Add the new dual headed probe LX series (LX128LC, LX128LP, LX192LC) with the same clinical applications.

Page 7

3. Substantially Equivalent Devices

Primary Predicate Device

Device Name	510(k) Number
Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging System (LU710E)	K241161

Device Name

510(k) Number

Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging System (LU710E)

K241161

Reference Device

Device Name	510(k) Number
Vsacn Air	K231301

4. Reason for Submission

Add the new dual probe LX series (LX128LC, LX128LP, LX192LC) with the same clinical applications.

Page 8

5. Indications for Use

The device is intended for use in environments where healthcare is provided by trained healthcare professionals, but not intended for use in emergency medical service, ambulance, or aircraft.

Page 9

6. Device description

I. The imaging system software runs as an app on a mobile device.

II. The imaging system software can be download to a commercial off-the-shelf (COTS) mobile device and utilizes an icon touch-based user interface.

IV. The imaging system houses a built-in battery, multichannel beamformer, prescan converter and Wi-Fi components

A complete list of all the probes and indications including:

Dual headed probe

LX Series:

Page 10

Phased Array transducer: ,Fetal,General abdominal imaging,Pediatric,Cardiac (adult),Cardiac (pediatric),Pulmonary,FAST/EFAST,Nerve

LX192LC
Linear transducer: Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

Single headed probe

128 Series:

LK128PA
Fetal,General abdominal imaging,Pediatric,Cardiac (adult),Cardiac (pediatric),Pulmonary,FAST/EFAST,Nerve

LK128E
Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Trans-rectal,Trans-vaginal,Urology,OB/Gyn,interventional guidance (free hand needle/ catheter)

LU700 Series:

LU710LH

Page 11

Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve

LU700C
General abdominal imaging,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve

LU710PA
Fetal,General abdominal imaging,Pediatric,Cardiac (adult),Cardiac (pediatric),Pulmonary,FAST/EFAST,Nerve

LU710E
Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Trans-rectal,Trans-vaginal,Urology,OB/Gyn,interventional guidance (free hand needle/ catheter)

Page 12

7. Determination of Substantial Equivalence

Item	Application device	Primary Predicate	Reference Device	Comparison
Device name	Ultrasound Imaging System(LX Series) Ultrasound Imaging System(128 Series) Ultrasound Imaging System(LU700 Series)	Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging System (LU710E)	Vscan Air	-
510(k) Number	Current Submission	K241161	K231301	-
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	Same
Indications for Use	Ophthalmic Fetal Abdominal Pediatric Small organ Neonatal cephalic Trans-rectal Trans-vaginal Musculoskeletal(conventional) Musculoskeletal (superficial) Urology OB/Gyn Cardiac adult Cardiac pediatric Peripheral vessel Carotid Pulmonary interventional guidance (includes free hand needle/ catheter) FAST/EFAST, Nerve,	Ophthalmic Fetal Abdominal Pediatric Small organ Neonatal cephalic Trans-rectal Trans-vaginal Musculoskeletal(conventional) Musculoskeletal (superficial) Urology OB/Gyn Cardiac adult Cardiac pediatric Peripheral vessel Carotid Pulmonary interventional guidance (includes free hand needle/ catheter) FAST/EFAST, Nerve,	Ocular Fetal / Fetal Echo Abdominal, Pediatric, Small Organ (including breast, scrotum, thyroid), Musculo-skeletal (conventional Musculo-skeletal (superficial) Urology, Obstetric/ Gynecological, Cephalic (adult), Peripheral Vessel, Carotid, Lung, Needle Guidance FAST/EFAST, Nerve,	Different. 128 series add more items including invasive subjects.
Mode of Operations	B Mode (Ophthalmic and others) M mode Pulsed wave Doppler (PWD)	B Mode (Ophthalmic and others) M mode Pulsed wave Doppler (PWD)	B Mode M mode Pulsed wave Doppler	Same.

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Item	Application device	Primary Predicate	Reference Device	Comparison
Device name	Ultrasound Imaging System(LX Series) Ultrasound Imaging System(128 Series) Ultrasound Imaging System(LU700 Series)	Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging System (LU710E)	Vscan Air	-
(PWD)	Color flow Doppler(CF / CD) Power Doppler(PD) Combined mode (B+M, B+CF, B+PWD)	Color flow Doppler(CF / CD) Power Doppler(PD) Combined mode (B+M, B+CF, B+PWD)	Color Doppler(CD) Power Doppler(PD) Combined mode (B+M, B+CD, B+PWD)
Connect	Wireless communication via IEEE 802.11 a/b/g/n	Wireless communication via IEEE 802.11 a/b/g/n	Wireless communication via IEEE 802.11g/n	Same
Transducer Types	Linear (LK128L,LK128LH,LU700L,LU710L,LU710LH, LX128LC,LX128LP,LX192LC) Convex array (LK128C, LU700C,LU710C, LX128LC ,LX192LC) MicroConvex array (LK128M, LU710M) Phased array (LK128PA, LU710PA, LX128LP) Endocavity array (LK128E, LU710E)	Linear (LK128L, LK128LH, LU700L, LU710L, LU710LH) Convex array (LK128C, LU700C,LU710C) Micro Convex array (LK128M, LU710M) Phased array (LK128PA, LU710PA) Endocavity array (LK128E, LU710E)	Linear array Convex array	More transducers are added to the 128 series.
Portability	Portable ultrasound system	Portable ultrasound system	Portable ultrasound system	Same
Power Source	Rechargeable battery (Li-ion)	Rechargeable battery (Li-ion)	Rechargeable battery (Li-ion)	Same
Display or OTC	iOS, Android mobile device or Windows	iOS, Android mobile device or Windows	iOS or Android mobile device	Same
510(k) Track	Track 3	Track 3	Track 3	Same
Compliance	IEC 60601-1 Edition 3.2 2020-08 IEC 60601-1-2 Edition 4.1 2020-09	IEC 60601-1 Edition 3.2 2020-08 IEC 60601-1-2 Edition 4.1 2020-09	ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012	Same.

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Item	Application device	Primary Predicate	Reference Device	Comparison
Standards	IEC 60601-1-6 Edition 3.2 2020-07 IEC60601-1-12 Edition 1.1 2020-07 IEC 60601-2-37 Edition 2.1 2015 AIUM/NEMA UD 2- 2004 R2009 AIUM/NEMA UD 3- 2004 R2009 IEC 62133-2:2017+ AMD1:2021 IEC 62366 (2014) ISO 10993-1:2018 ISO 10993-5(2009) ISO 10993-10:2021 ISO 10993-23(2021) ANSI AAMI IEC 62304:2006/A1:2016 ISO 15223-1 Fourth edition 2021-07 ISO 14971 (2019) ISO 13485 (2016)	IEC 60601-1-6 Edition 3.2 2020-07 IEC60601-1-12 Edition 1.1 2020-07 IEC 60601-2-37 Edition 2.1 2015 AIUM/NEMA UD 2- 2004 R2009 AIUM/NEMA UD 3- 2004 R2009 IEC 62133-2:2017+ AMD1:2021 IEC 62366 (2014) ISO 10993-1:2018 ISO 10993-5(2009) ISO 10993-10:2021 ISO 10993-23(2021) ANSI AAMI IEC 62304:2006/A1:2016 ISO 15223-1 Fourth edition 2021-07 ISO 14971 (2019) ISO 13485 (2016)	ANSI/AAMI IEC 60601-1-2:2014 IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 IEC 60601-2-37:2007+ AMD1:2015 AIUM/NEMA UD 2- 2004 R2009 ISO 10993-1:2018 ISO 62304 ISO 15223-1 ISO 14971	As compared to the predicate, the 128 series comply with the safety and performance tests, which meets all the essential requirement for its intended use.

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8. Performance standards

The Ultrasound Imaging System has been designed, manufactured, tested, and certified to comply with the following internationally recognized standards:

Date of Entry	Recognition Number	Standard Developing Organization	Standard Designation Number/Date	Title of Standard
05/30/2022	19-46	ANSI AAMI	ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 MOD) [Including Amendment 2 (2021)]
12/21/2020	19-36	ANSI AAMI	IEC 60601-1-2:2014 [Including AMD 1:2021]	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)]
12/21/2020	5-132	IEC	60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
12/21/2020	19-38	IEC	60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
06/27/2016	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
12/23/2019	19-33	IEC	62133-2 Edition1.0 2017-02	Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells and for batteries made from them for use in portable applications - Part 2: Lithium systems
01/14/2019	13-79	ANSI AAMI	IEC 62304:2006/A1:2016	Medical device software - Software life cycle processes [Including Amendment 1 (2016)]
07/06/2020	5-129	ANSI AAMI	IEC 62366-1:2015+AMD1:2020 (Consolidated Text)	Medical devices Part 1: Application of usability engineering to medical devices including Amendment 1
01/14/2019	2-258	ISO	10993-1 Fifth edition 2018-08	Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
12/23/2016	2-245	ISO	10993-5 Third edition 2009-06-01	Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
12/19/2022	2-296	ISO	10993-10 Fourth edition 2021-11	Biological evaluation of medical devices - Part 10: Tests for skin sensitization
06/07/2021	2-291	ISO	10993-23 First edition 2021-01	Biological evaluation of medical devices - Part 23: Tests for irritation
12/20/2021	5-134	ISO	15223-1 Fourth edition 2021-07	Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
12/23/2019	5-125	ISO	14971 Third Edition 2019-12	Medical devices - Application of risk management to medical devices

9. General Safety and Effectiveness

This device is the addition of new transducer models to the Ultrasound Imaging System, using technologies existing on the market as of the date of this submission. The Ultrasound Imaging System (Model: LX Series, 128 Series, LU700 Series) meets FDA requirements for Track 3 devices, have biosafety equivalence, and conform to applicable electromedical devices safety standards.

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The new models which are tested and determined to be in full compliance with acoustic output, biocompatibility, cleaning, and disinfection effectiveness, and have no pragmatic detriments. No additional clinical testing is required. The maximum acoustic output level is under the FDA recommended limit, and the power level is displayed all the time. All the safety and performance tests of the device meet the essential requirements. Therefore, the system is substantially equivalent to the primary predicate device.

10. Conclusion

The Ultrasound Imaging System (Model: LX series) utilizes the same software, cover material, and transducer specifications as the 128 Series but replaces a similar PCBA with a dual-headed probe, maintaining the same block diagram. This modification can be applied to the existing legally marketed devices, LU700 Series and 128 Series (K241161).

Pre-clinical test outcomes provide evidence that the LX Series models meet FDA requirements for Track 3 devices, exhibit biosafety equivalence, and conform to applicable electromedical device safety standards. The specified differences present no practical drawbacks. All safety and performance

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.