(212 days)
No
The document does not mention the use of AI, DNN, or ML, nor does it describe any image processing capabilities that would typically be associated with an AI model in an ultrasound system. The device description focuses on its hardware and software for acquiring and displaying ultrasound data.
No
The device is described as an "Ultrasound Imaging System" intended for acquiring and displaying real-time ultrasound data for evaluation and fluid flow analysis. Its intended uses (e.g., Fetal, General abdominal imaging, Cardiac) are diagnostic in nature, not therapeutic.
Yes
The "Intended Use / Indications for Use" states that the device is "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." This indicates the device is used to evaluate the human body for medical purposes, which is the definition of a diagnostic device. The listed clinical applications further support its diagnostic nature.
No
The device description explicitly states: "The imaging system consists of a series of wireless transducers employing Wi-Fi-based technology... The imaging system houses a built-in battery, multichannel beamformer, prescan converter and Wi-Fi components". These are physical hardware components critical to the device's function as an ultrasound system, indicating it is not software-only.
No
The device is an Ultrasound Imaging System which is used for diagnostic imaging of the human body, not for in vitro examination of specimens.
N/A
Intended Use / Indications for Use
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.
Product codes
IYN, IYO, ITX
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Ophthalmic, Fetal, General abdominal, 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, Carotid, Pulmonary, Nerve.
Indicated Patient Age Range
Adult, Pediatric, Neonatal (cephalic)
Intended User / Care Setting
Qualified physicians and healthcare professionals in environments where healthcare is provided by trained healthcare professionals. Not intended for use in emergency medical service, ambulance, or aircraft.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 tests of the device meet the essential requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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.
Page 2
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
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
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 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 |
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 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.
Page 9
6. 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
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
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
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
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)
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. |
Page 13
| 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