EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)

Q: Who is the manufacturer of EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)?

Edgelife Technologies, LLC filed the 510(k) submission for EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) (K234153).

Q: What is the FDA product code for EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)?

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

Q: What is the regulatory pathway for EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)?

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

Q: Who can help prepare an FDA 510(k) submission like EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)?

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.

K234153 · Edgelife Technologies, LLC · IYN · Sep 18, 2024 · Radiology

Device Facts

Record ID	K234153
Device Name	EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)
Applicant	Edgelife Technologies, LLC
Product Code	IYN · Radiology
Decision Date	Sep 18, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric

Intended Use

The EdgeLife Handheld Wireless Ultrasound System is a general-purpose, handheld, wireless, portable software-controlled ultrasonic diagnostic system that uses pulsed-echo technology to acquire and display ultrasound data in B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) modes. The EdgeLife Handheld Wireless Ultrasound System is intended for diagnostic ultrasound echo imaging, measurement, and fluid flow analysis of the human body for the following clinical applications. The specific clinical applications and exam types for the linear transducer include vascular, musculoskeletal (conventional and superficial), small organs, thoracic/lung, abdominal, intraoperative (excluding neurological, central nervous system, non-central cardiovascular system), urology, gynecology, pediatric, fetal, peripheral vessel, carotid, interventional and procedure guidance of needles into the body. The specific clinical applications and exam types for the convex transducer include: abdominal, pulmonary, thoracic, intra-operative (abdominal organs & vascular), pediatric, small organ, urology, gynecology, obstetrics, musculoskeletal (conventional and superficial), vascular, carotid, and cardiac (adult and pediatric). The specific clinical applications and exam types for the Endocavitary transducer include gynecology, obstetrics, urology, transvaginal, transrectal, and interventional procedures. The system is a portable ultrasound system intended for use in environments where is provided by trained healthcare professionals.

Device Story

Handheld, wireless, portable ultrasound system; uses pulsed-echo technology via piezoelectric transducers; acquires/displays B-Mode, M-Mode, Color Doppler, and PW Doppler data. System comprises dual-headed scanner (E8200: convex/linear; E8220: convex/endocavitary), mobile app on iOS device, and wireless Qi charger. Operated by trained healthcare professionals in hospitals/clinics. Scanner transmits images to app via Wi-Fi. Healthcare providers view images on mobile device for diagnostic imaging, measurement, and fluid flow analysis. Facilitates clinical decision-making through real-time visualization and needle guidance. Benefits include portability and wireless operation for point-of-care diagnostics.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via biocompatibility (ISO 10993), electrical/mechanical safety (ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 62359), battery safety (IEC 62133-2), wireless coexistence (ANSI C63.27), and cleaning/disinfection validation (AAMI TIR30/TIR12). Measurement accuracy verified via internal methods.

Technological Characteristics

Handheld wireless ultrasound; piezoelectric transducer elements; 128 elements per transducer. Frequencies: Convex (2-5 MHz), Linear (4-12 MHz), Endocavitary (4-9 MHz). Connectivity: Wi-Fi (IEEE 802.11n/5GHz) with WPA2 security. Power: Internal Li-ion battery, Qi wireless charging. Form factor: Dual-headed probe. Software-controlled via iOS app. Biocompatibility per ISO 10993-1. Acoustic output: Track 3.

Indications for Use

Indicated for diagnostic ultrasound echo imaging, measurement, and fluid flow analysis in adult and pediatric populations. Clinical applications include vascular, musculoskeletal, small organs, thoracic/lung, abdominal, intraoperative, urology, gynecology, obstetrics, fetal, carotid, and cardiac exams, plus interventional needle guidance.

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

Vscan Air (K202035)

Reference Devices

Clarius Ultrasound Scanner (K192107)

Related Devices

K210432 — LELTEK Ultrasound Imaging System (Model: LU700 Series) · Leltek, Inc. · Nov 3, 2021
K222365 — Leltek Ultrasound Imaging System (Model: LU700 Series) · Leltek, Inc. · Oct 25, 2022
K211321 — Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) · Guangzhou Sonostar Technologies Co., Ltd. · Oct 13, 2022
K191235 — Leltek Ultrasound Imaging System · Leltek, Inc. · Feb 12, 2020
K241051 — Vave Wireless Ultrasound System · Vave Health, Inc. · Aug 30, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ September 18, 2024 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an abstract design. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below. EdgeLife Technologies LLC % Quinn Place Chief Operating Officer 485 Brickell Avenue Suite 4802 Miami, Florida 33031 Re: K234153 Trade/Device Name: EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: December 13, 2023 Received: August 23, 2024 Dear Quinn Place: 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. {1}------------------------------------------------ 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 (OS) 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 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-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 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. {2}------------------------------------------------ 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, # 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 {3}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K234153 ### Device Name EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) ### Indications for Use (Describe) The EdgeLife Handheld Wireless Ultrasound System is a general-purpose, handheld, wireless, portable softwarecontrolled ultrasonic diagnostic system that uses pulsed-echo technology to acquire and display ultrasound data in B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) modes. The EdgeLife Handheld Wireless Ultrasound System is intended for diagnostic ultrasound echo imaging, measurement, and fluid flow analysis of the human body for the following clinical applications. The specific clinical applications and exam types for the linear transducer include vascular, musculoskeletal (conventional and superficial), small organs, thoracic/lung, abdominal, intraoperative (excluding neurological, central nervous system, non-central cardiovascular system), urology, gynecology, pediatric, fetal, peripheral vessel, carotid, interventional and procedure guidance of needles into the body. The specific clinical applications and exam types for the convex transducer include: abdominal, pulmonary, thoracic, intra-operative (abdominal organs & vascular), pediatric, small organ, urology, obstetrics, musculoskeletal (conventional and superficial), vascular, carotid, and cardiac (adult and pediatric). The specific clinical applications and exam types for the Endocavitary transducer include gynecology, obstetrics, urology, transvaginal, transrectal, and interventional procedures. The system is a portable ultrasound system intended for use in environments where is provided by trained healthcare professionals. 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 NEEDEDThis section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Edge Life Technologies. The word "EDGE" is in large, bold, blue letters. Below the word "EDGE" is the phrase "LIFE . TECHNOLOGIES", with the word "LIFE" in blue, a red dot in the middle, and the word "TECHNOLOGIES" in blue. ## K234153 ### EdgeLife Handheld Wireless Ultrasound System - 510(k) Summary The following 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR § 807.92. | Subject Device Trade Name: | EdgeLife Handheld Wireless Ultrasound System | |-------------------------------|----------------------------------------------| | Subject Device Model Numbers: | E8200, E8220 | | Common Name: | Diagnostic Ultrasound System and Accessories | | Regulation Number | Regulation Name | Product Code | |-------------------|---------------------------------------------|--------------| | 21 CFR § 892.1550 | Ultrasonic Pulsed Doppler Imaging System | IYN | | 21 CFR § 892.1560 | Ultrasonic Pulsed Doppler Imaging System | IYO | | 21 CFR § 892.1570 | Diagnostic Ultrasonic Transducer | ITX | ### Regulation Number, Name and Product Codes 1.1 | FDA 510(k) Review Panel: | Radiology | |-------------------------------|------------------------------------------------------------------------------------------| | Classification: | Class II | | Manufacturer: | Edge Life Technologies 485 Brickell Avenue, Suite 4802 Miami, Florida 33031 U.S.A. | | Contact Name: | Quinn Place, Chief Operating Officer qplace@edgelifetech.com | | Date 510(k) Summary Prepared: | December 20, 2023 | | Predicate Device: | Vscan Air K202035 | | Reference Device: | Clarius Ultrasound Scanner K192107 | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Edge Life Technologies. The word "EDGE" is written in large, bold, blue letters. Below the word "EDGE" is the phrase "LIFE • TECHNOLOGIES", with the word "LIFE" in black, a red dot in the middle, and the word "TECHNOLOGIES" in black. The logo is simple and modern. ### 1.2 Device Description The EdgeLife Handheld Wireless Ultrasound System, including Scanners, follows Track 3. The EdgeLife Handheld Wireless Ultrasound System is a general-purpose, handheld, wireless, portable software-controlled ultrasonic diagnostic system that uses pulsed-echo technology to acquire and display ultrasound data in B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) modes. The EdgeLife Ultrasound Scanner receives instructions from and transmits images to the EdgeLife Ultrasound App running on a paired mobile device that utilizes the iOS operating system via wireless Wi-Fi communication. The system is a transportable ultrasound system intended for use in environments where healthcare is provided. The EdgeLife Handheld Wireless Ultrasound System consists of: - EdgeLife Handheld Ultrasound Scanner: - o Model E8200 with convex and linear transducers - o Model E8220 with convex and endocavitary transducers - EdgeLife Ultrasound App . - Standard off-the-shelf Wireless Qi charger (not a medical device) ● #### Indications for Use 1.2.1 The EdgeLife Handheld Wireless Ultrasound System is a general-purpose, handheld, wireless, portable software-controlled ultrasonic diagnostic system that uses pulsed-echo technology to acquire and display ultrasound data in B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) modes. The EdgeLife Handheld Wireless Ultrasound System is intended for diagnostic ultrasound echo imaging, measurement, and fluid flow analysis of the human body for the following clinical applications. The specific clinical applications and exam types for the linear transducer include vascular/peripheral vascular, musculoskeletal (conventional and superficial), small organs, thoracic/lung, abdominal, intraoperative (excluding neurological, central nervous system, {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Edge Life Technologies. The word "EDGE" is written in large, bold, blue letters. Below the word "EDGE" is the phrase "LIFE • TECHNOLOGIES" in smaller, gray letters. The bullet point between the words "LIFE" and "TECHNOLOGIES" is red. non-central cardiovascular system), urology, gynecology, pediatric, fetal, peripheral vessel, carotid, interventional and procedure guidance of needles into the body. The specific clinical applications and exam types for the convex transducer include: abdominal, pulmonary, thoracic, intra-operative (abdominal organs & vascular), pediatric, small organ, urology, gynecology, obstetrics, musculoskeletal (conventional and superficial), vascular, carotid, and cardiac (adult and pediatric). The specific clinical applications and exam types for the Endocavitary transducer include gynecology, obstetrics, urology, transvaginal, transrectal, and interventional procedures. The system is a portable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals. ### 1.2.2 Comparison of Subject Device and Predicate Device Comparison of intended use and technological characteristics between EdgeLife Handheld Wireless Ultrasound Scanner and the predicate device, Vscan Air, is presented in the following table. | | EdgeLife Handheld Wireless Ultrasound System | Vscan Air (K202035) | Substantial Equivalence Comparison | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Scanner Type | Dual-Headed | Dual-Headed | Same | | Transducer | Convex and Linear (E8200) Convex and Endocavitary (E8220) | Convex and Linear | Similar | | | | | The subject and predicate have the same convex and linear transducers. The subject device also includes an endocavitary transducer on one of the dual headed probes. Endocavitary transducers are commonly found in current ultrasound systems including the predicate device. Performance test results support that this | | | EdgeLife Handheld Wireless Ultrasound System | Vscan Air (K202035) | Substantial Equivalence Comparison | | | | | difference does not raise new questions of safety and effectiveness. | | Classification | Class II | Class II | Same | | Product Codes | IYN, IYO, ITX | ITX, IYN, IYO | Same | | Clinical Settings | Hospitals, clinics and other professional healthcare facility settings | Hospitals, clinics and medical office settings, home, emergency environments | Similar. The only difference is that the subject device is not intended for use in home health or road/air ambulance environments. This difference does not raise new questions of safety and effectiveness. | | Users | Trained Healthcare professionals | Trained Healthcare professionals | Same | | Patient Population | adult and pediatric | adult and pediatric | Same | | Intended Use | Diagnostic ultrasound imaging and fluid flow analysis. | Diagnostic ultrasound imaging and fluid flow analysis | Same | | Indications for Use | The EdgeLife Handheld Wireless Ultrasound System is a general-purpose, handheld, wireless, portable software-controlled ultrasonic diagnostic system that uses pulsed-echo technology to acquire and display ultrasound data in B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) modes. The EdgeLife Handheld Wireless Ultrasound System is intended for | Refer to K202035 510(k) Summary. | Similar. Both subject and predicate devices are intended for diagnostic ultrasound echo imaging, measurement and analysis of the human body for the same applications. The subject device also includes an endocavitary transducer that allows for clinical applications including gynecology, obstetrics, urology, transvaginal, transrectal, and interventional procedures. These | | EdgeLife Handheld Wireless Ultrasound System | Vscan Air (K202035) | Substantial Equivalence Comparison | | | imaging, measurement, and fluid flow analysis of the human body for the following clinical applications. The specific clinical applications and exam types for the linear transducer include vascular/peripheral vascular, musculoskeletal (conventional and superficial), small organs, thoracic/lung, abdominal, intraoperative (excluding neurological, central nervous system, non-central cardiovascular system), urology, gynecology, pediatric, fetal, peripheral vessel, carotid, interventional and procedure guidance of needles into the body. The specific clinical applications and exam types for the convex transducer include: abdominal, pulmonary, thoracic, intra-operative (abdominal organs & vascular), pediatric, small organ, urology, gynecology, obstetrics, musculoskeletal (conventional and superficial), vascular, carotid, and cardiac (adult and pediatric). | | application types are found in other legally marketed ultrasound systems including the Reference Device and are not novel. Performance data support the indications for use. Therefore, these differences do not raise new questions of safety and effectiveness. | | | | EdgeLife Handheld Wireless Ultrasound System | Vscan Air (K202035) | Substantial Equivalence Comparison | | | The specific clinical applications and exam types for the Endocavitary transducer include gynecology, obstetrics, urology, transvaginal, transrectal, and interventional procedures. The system is a portable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals. | | | | Portability | Handheld portable | Handheld portable | Same | | System Components | Dual-headed probes Mobile app Charger | Dual-headed probe Mobile app Charger | Same. | | Frequency | Convex:2-5 MHz with center frequency of 3.2 MHz Linear 4-12 MHz, with center frequency of 7.5 MHz Endocavitary: 4-9 MHz with the center frequency of 6.5 MHz | Convex: from 2 - 5 MHz with center frequency of 3.3 MHz Linear: From 3 - 12 MHz with center frequency of 7.7 MHz | Similar. The differences don't raise any issues about safety and effectiveness of the device. | | Elements | All transducers have 128 elements | GE: Linear 192, convex: 192 | Similar. The differences don't raise any issues about safety and effectiveness of the device. | | Display | iOS device | iOS or Android device | Similar. This difference does not raise new questions of safety or effectiveness. | | | EdgeLife Handheld Wireless Ultrasound System | Vscan Air (K202035) | Substantial Equivalence Comparison | | Software | Mobile app downloads on iOS viewing device | Mobile app downloads on iOS and Android viewing device | Similar. This difference does not raise new questions of safety or effectiveness. | | Image Format | JPG and DICOM, DICOM transfer to PACS or imaging archive systems | JPG and DICOM, DICOM transfer to PACS or imaging archive systems | Same | | Penetration depth | Convex up to 30 cm Linear < 8 cm Endocavity < 12 cm | Convex up to 24 cm and linear up to 8 cm | Similar. The linear end has the same maximum penetration depth. Performance data support that the penetration depths of the Subject devices don't raise any issues about safety and effectiveness of the device. | | Principle of Operation | Piezoelectric transducer elements. | Piezoelectric transducer elements | Same. | | Power Source | Built in lithium-ion Battery | Built in lithium-ion Battery | Same | | Charging Plate | Anker and other off-the shelf charging plates. | Anker | Similar. The performance doesn't raise any issues about safety and effectiveness of the device. | | Battery And Charging…