Who is the manufacturer of LELTEK Ultrasound Imaging System (Model: LU700 Series)?

Leltek, Inc. filed the 510(k) submission for LELTEK Ultrasound Imaging System (Model: LU700 Series) (K210432).

What is the FDA product code for LELTEK Ultrasound Imaging System (Model: LU700 Series)?

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

What is the regulatory pathway for LELTEK Ultrasound Imaging System (Model: LU700 Series)?

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

Who can help prepare an FDA 510(k) submission like LELTEK Ultrasound Imaging System (Model: LU700 Series)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LELTEK Ultrasound Imaging System (Model: LU700 Series)

Q: What are the predicate devices for LELTEK Ultrasound Imaging System (Model: LU700 Series)?

Leltek Ultrasound Imaging System (K191235).

K210432 · Leltek, Inc. · IYN · Nov 3, 2021 · Radiology

Device Facts

Record ID	K210432
Device Name	LELTEK Ultrasound Imaging System (Model: LU700 Series)
Applicant	Leltek, Inc.
Product Code	IYN · Radiology
Decision Date	Nov 3, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Leltek Ultrasound Imaging System (Model: LU700 Series) 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 clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients

Device Story

Portable, handheld ultrasound system; acquires/displays high-resolution, real-time ultrasound data. System consists of wireless transducers (convex, micro-convex, phased, endocavity arrays) with integrated multichannel beamformer, prescan converter, battery, and Wi-Fi components. Operates via app on COTS mobile device (iOS/Android) using touch-based UI. Transducers communicate with mobile device via direct Wi-Fi. Used in physician offices, clinics, hospitals, and point-of-care settings by trained healthcare professionals. Provides B-mode, M-mode, Color Doppler, Power Doppler, and combined modes. Output allows clinicians to perform diagnostic imaging and fluid flow analysis, aiding clinical decision-making. Benefits include portability and real-time visualization of internal structures/flow.

Clinical Evidence

No clinical data. Substantial equivalence established through bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, wireless, thermal, electromagnetic, and mechanical safety testing. Device conforms to AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, and other relevant standards.

Technological Characteristics

Handheld wireless ultrasound transducers; Wi-Fi connectivity; Li-ion rechargeable battery. Imaging modes: B, M, Color Doppler, Power Doppler. Standards: AAMI/ANSI ES60601-1 (2012), IEC 60601-1-2 (2014), IEC 60601-2-37 (2008/2015), ISO 10993-1/5/10 (biocompatibility), IEC 62304 (software), ISO 14971 (risk management). Software-based beamforming and scan conversion.

Indications for Use

Indicated for fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), trans-rectal, trans-vaginal, musculoskeletal (conventional/superficial), urology, gynecology, cardiac (adult/pediatric), peripheral vessel, and carotid imaging. Intended for use by qualified physicians and healthcare professionals.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

Leltek Ultrasound Imaging System (K191235)

Reference Devices

Clarius Ultrasound System (K192107)

Related Devices

K243226 — Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) · Leltek, Inc. · May 8, 2025
K191235 — Leltek Ultrasound Imaging System · Leltek, Inc. · Feb 12, 2020
K222365 — Leltek Ultrasound Imaging System (Model: LU700 Series) · Leltek, Inc. · Oct 25, 2022
K250791 — ASUS Ultrasound Imaging System (LU800 series) · Asustek Computer, Inc. · Dec 4, 2025
K241161 — 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 · Leltek, Inc. · Sep 11, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration". LELTEK, Inc. % Jessie Wang Chief of Marketing 6F-3., No. 293, Sec. 1, Beixin Rd., Xindian Dist., New Taipei City, 23147 TAIWAN. R.O.C November 3, 2021 ## Re: K210432 Trade/Device Name: Leltek Ultrasound Imaging System (Model: LU700 Series) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: September 29, 2021 Received: Otober 4, 2021 Dear Jessie Wang: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210432 #### Device Name Leltek Ultrasound Imaging System (Model: LU700 Series) Indications for Use (Describe) The Leltek Ultrasound Imaging System (Model: LU700 Series) 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 clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-ofcare for diagnosis of patients The modes of operation include B 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: LU700C General abdominal imaging, musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and OB/Gyn. LU700L General abdominal imagine, small organ (breast, thyroid), musculoskeletal (superficial) and peripheral vessel. LU710C Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel. LU710M Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel. LU710PA Fetal, abdominal, pediatric, cardiac adult, cardiac pediatric. LU710E Fetal, abdominal, small organ (thyroid, prostate, scrotum, breast), trans-vaginal, urology, gynecology. Type of Use (Select one or both, as applicable) X 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." {3}------------------------------------------------ # K210432 # 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 | | Fax: | +886-2-2913-7599 | | Website: | www.leltek.com | | Contact: | Jessie wang / Chief of Marketing | | E-mail: | jessie.wang@leltek.com | | Name of Device: | Leltek Ultrasound Imaging System (Model: LU700 Series) | # 2. Class and Predicate Information | Device Name: | Leltek Ultrasound Imaging System | | |----------------------|----------------------------------------------|--------------| | Model: | LU700 series | | | Common Name: | Diagnostic Ultrasound System and Accessories | | | Classification: | Class II | | | Classification Name: | | | | 21 CRF Section | Classification Name | Product Code | | 892.1550 | Ultrasonic Pulsed Doppler Imaging System | 90 IYN | | 892.1560 | Ultrasonic Pulsed Echo Imaging System | 90 IYO | # 3. Substantially Equivalent Devices | Device Name | 510(k) Number | |----------------------------------|---------------| | Leltek Ultrasound Imaging System | K191235 | | Reference Device Device Name | 510(k) Number | | Clarius Ultrasound System | K192107 | {4}------------------------------------------------ #### 4. Indications for Use The Leltek Ultrasound Imaging System (Model: LU700 Series) 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 clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients The modes of operation include B mode, M 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: #### LU700C General abdominal imaging, musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and OB/Gyn. #### LU700L General abdominal imaging, small organ (breast, thyroid), musculoskeletal (conventional), musculoskeletal (superficial) and peripheral vessel. ## LU710C Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel. #### LU710M Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel. ## LU710PA Fetal, abdominal, pediatric, cardiac adult, cardiac pediatric. #### LU710E Fetal, abdominal, small organ (thyroid, prostate, scrotum, breast), trans-rectal, trans-vaginal, urology, gynecology. {5}------------------------------------------------ #### USFDA_510(k) ### 5. Device description The Leltek Ultrasound Imaging System (Model: LU700 Series) 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. - l. 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 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. ## System drawing: Image /page/5/Picture/11 description: The image shows a diagram of a mobile device UI App communicating with a Leltek Ultrasound Imaging System via Wi-Fi. The mobile device is at the top of the image, and the ultrasound imaging system is at the bottom. The Wi-Fi communication is represented by a dashed line and a Wi-Fi symbol in the middle of the image. The text labels the different components of the diagram. {6}------------------------------------------------ # 6. Determination of Substantial Equivalence | Item | Application device | Predicate device | Reference device | Comparison | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | Device name | Leltek Ultrasound Imaging System (Model: LU700 series) | Leltek Ultrasound Imaging System (Model: LU700) | Clarius Ultrasound Scanner | | | 510(k) Number | Current Submission | K191235 | K192107 | | | 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 | Same | | Indications for Use | - Fetal - Abdominal - Pediatric - Small organ - Trans-rectal - Trans-vaginal - Musculoskeletal(conventional) - Musculoskeletal (superficial) - Urology - OB/Gyn - Cardiac adult - Cardiac pediatric - Peripheral vessel - Carotid | - Abdominal - Small organ - Musculoskeletal(conventional) - Musculoskeletal (superficial) - OB/Gyn - Peripheral vessel | - Ophthalmic - Fetal - Abdominal - Intraoperative (Ab/Vasc) - Pediatric - Small organ - Adult cephalic - Trans-rectal - Trans-vaginal - Musculo-skel. (Conv.) - Musculo-skel. (Superfic.) - Urology - Gynecology - Cardiac adult - Cardiac pediatric - Peripheral vessel - Carotid - Needle guidance | Different. LU700 series add more items including invasive subjects. | | Mode of Operations | B Mode M mode PWD Color Doppler Power Doppler | B Mode M mode PWD Color Doppler Power Doppler | B Mode M mode PWD Color Doppler Power Doppler | Same. | | Item | Application device | Predicate device | Reference device | Comparison | | Device name | Leltek Ultrasound Imaging System (Model: LU700 series) | Leltek Ultrasound Imaging System (Model: LU700) | Clarius Ultrasound Scanner | | | | - Combined mode (B+M, B+CD, B+PWD) | - Combined mode (B+M, B+CD, B+PWD) | - Combined mode (B+M, B+CD, B+PD, B+PWD) | | | Connect | Communicates wirelessly via Wi-Fi | Communicates wirelessly via Wi-Fi | Communicates wirelessly via Wi-Fi and Bluetooth | Same | | Transducer Types | Convex HD array (LU710C) MicroConvex array (LU710M) Phased array (LU710PA) Endocavity array (LU710E) | Linear array (LU700L) Convex array (LU700C) | Convex array Linear array Phased array Intracavity | More transducers are added to the LU700 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 | iOS or Android mobile device | iOS or Android mobile device | iOS or Android mobile device | Same | | 510(k) Track | Track 3 | Track 3 | Track 3 | Same | | Compliance Standards | - AAMI/ANSI ES60601-1 (2012) - IEC 60601-1-2 (2014) - IEC 60601-1-6 (2013) - IEC 60601-2-37 (2008) - AIUM/NEMA UD 2- 2004R2009 - AIUM/NEMA UD 3- 2004R2009 - IEC 62133 (2012) | - AAMI/ANSI ES60601-1 (2012) - IEC 60601-1-2 (2014) - IEC 60601-1-6 (2013) - IEC 60601-2-37 (2008) - AIUM/NEMA UD 2- 2004R2009 - AIUM/NEMA UD 3- 2004R2009 - IEC 62133 (2012) | - AAMI/ANSI ES60601-1 (2012) - IEC 60601-1-2 (2014) - IEC 60601-1-6 (2013) - IEC 60601-1-12 (2014) - IEC 60601-2-37 (2015) - UD 2- 2004 (R2009) - IEC 62133 (2012) | Same. As compared to the predicate, the LU700 series comply with the safety and | | Item | Application device | Predicate device | Reference device | Comparison | | Device name | Leltek Ultrasound Imaging System (Model: LU700 series) | Leltek Ultrasound Imaging System (Model: LU700) | Clarius Ultrasound Scanner | - | | | - IEC 62366 (2014) | - IEC 62366 (2014) | - IEC 62366 (2014) | performance tests which meets all the | | | - ISO 10993-1(2009) | - ISO 10993-1(2009) | - ISO 10993-1 (2009) | essential | | | - ISO 10993-5(2009) | - ISO 10993-5(2009) | - ISO 10993-5 (2009) | requirement for its | | | - ISO 10993-10(2010) | - ISO 10993-10(2010) | - ISO 10993-10 (2010) | intended use. | | | - | - | - ISO 10993-11 (2017) | | | | - IEC 62304 (2006) | - IEC 62304 (2006) | - IEC 62304 (2006) | | | | - ISO 15223-1 (2016) | - ISO 15223-1 (2016) | - ISO 15223-1 (2012) | | | | - ISO 14971 (2012) | - ISO 14971 (2012) | - ISO 14971 (2007) | | | | - ISO 13485 (2016) | - ISO 13485 (2016) | - | | {7}------------------------------------------------ {8}------------------------------------------------ This device is a modification of an existing licensed device (K191235) using technologies that exist of the date of this submission. The Leltek Ultrasound Imaging System (Model: LU700 series) meets FDA requirements for Track 3 devices, have biosafety equivalence, and conform to applicable electromedical devices safety standards. The differences specified above have no pragmatic detriments. All the safety and performance tests of the essential requirements. Therefore, the system is substantially equivalent to predicate devices. {9}------------------------------------------------ # 7. Performance standards The Leltek Ultrasound Imaging System has been designed, manufactured, tested, and certified to comply with the following internationally recognized standards: | Reference No. | Year | Title | |---------------------------------------------------------------------------------------------------|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | AAMI/ANSI/ES60601- 1:2005/(R)2012 and A1:2012 and C1:2009/(R)2012 and A2:2010/(R)2012 | 2009 & 2012 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | | 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 | 2013 | Medical electrical equipment Part 1-6 General requirements for basic safety and essential performance Collateral standard Usability | | IEC 60601-2- 37/AMD1 | 2008 & 2015 | Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment | | IEC 62133 | 2012 | Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications | | IEC 62304 | 2014 | Medical device software - Software life-cycle processes | | EC 62366-1 | 2015 | Medical devices -- Part 1: Application of usability engineering to medical devices | | ISO 10993-1 | 2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process | | ISO 10993-5 | 2009 | Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity | | ISO 10993-10 | 2010 | Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization | | ISO 13485 | 2016 | Medical devices - Quality management systems - Requirements for regulatory purposes | | ISO 14971 | 2012 | Medical devices - Application of risk management to medical devices | | ISO 15223-1 | 2016 | Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements | {10}------------------------------------------------ Evaluation per standard AAMI/ANSI/ES60601-1 and IEC 60601-1-2 were performed for use of the transducers with a specific adaptor (Apple Model A1385) to charge the medical device. Use of alternate compatible mobile hardware requires verification by the end user. Further information is provided in the user manual. The Leltek Ultrasound Imaging System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as wireless, thermal, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The Leltek Ultrasound Imaging System did not require clinical testing to establish substantial equivalence. # 8. General Safety and Effectiveness This device is the addition of new transducer models to the Leltek Ultrasound Imaging System, using technologies existing on the market as of this submission. The Leltek Ultrasound Imaging System (Model: LU700 series) meets FDA requirements for Track 3 devices, have biosafety equivalence, and conform to applicable electromedical devices safety standards. The new models comprise LU710C, LU710PA, LU710E, 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 safety and performance tests of the device meet the essential requirements. Therefore, the system is substantially equivalent to predicate devices. # 9. Conclusion Verification and validation testing have been conducted on the Leltek Ultrasound Imaging System and ascertain that it is safe for use by physicians. The 510(k) submission is the modification of the existing licensed device using technologies that exist on the market today and demonstrating the new transducers of the Leltek Ultrasound Imaging System are substantially equivalent in safety and effectiveness to the predicate device.