The SONON Ultrasound Imaging System (Model: 300L) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including musculoskeletal (MSK), vascular, small parts (breast, thyroid), and thoracic/pleural motion and fluid detection imaging.

Device Description

The SONON Ultrasound Imaging System, Model: 300L, is a wireless ultrasound system that uses pulsed-echo/Doppler technology (Color Flow Doppler (CF Mode)/B Mode (2D): frequency: 5 MHz/7.5 MHz/10 MHz; module: linear; depth max: 10 cm) to transmit ultrasound images via wireless communication to a mobile device that utilizes the iOS or Android operating system.

The SONON Ultrasound Imaging System is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS or Android mobile device, (ii) the SONON Ultrasound Imaging System software that runs as an app on the mobile device, (iii) the battery-operated, hand-held SONON Ultrasound Imaging System transducer that communicates wirelessly with iOS or Android mobile devices, and (iv) the instructions for use manual, battery, charger, and power cords.

The SONON software can be downloaded to an iOS or Android mobile device and utilizes an icon touch-based user interface. The software enables ultrasound image capture and review, controls for time gain, dynamic range, display of mirror image, focal length, depth, brightness, contrast, linear/elliptical measurement, color flow, and image annotation, as well as storage and email transmission of images and videos. The SONON Ultrasound Imaging System allows the user to image in real time and review cine or freeze-frame images on the screen in a Color Flow Doppler/B-Mode, 2-dimensional scan format.

The SONON Ultrasound Imaging System utilizes pulsed-echo/Doppler technology to determine the depth and location of tissue interfaces, and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Ultrasound waves are emitted from the transducer, propagate through tissues, and return to the transducer as reflected echoes. The returned echoes are then converted into electrical impulses by transducer crystals and further processed in order to form the ultrasound image presented on the screen.

AI/ML Overview

This document is a 510(k) Summary of Safety and Effectiveness for the Healcerion Co., Ltd. SONON Ultrasound Imaging System, Model: 300L. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria with quantifiable metrics. Therefore, several aspects of your request (e.g., sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC study results, specific ground truth types) cannot be fully extracted from this document, as they pertain to clinical efficacy studies which were not conducted for this submission (as stated on page 10-11).

However, I can extract the acceptance criteria based on compliance with various international standards and reported performance in certain non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criterion (Standard/Test)	Reported Device Performance
Electrical Safety	IEC 60601-1 (Basic Safety and Essential Performance)	Complies with the standard.
Usability	IEC 60601-1-6 (Usability – Collateral Standard) & IEC 62366 (Application of Usability Engineering)	Complies with the standard. The usability engineering process demonstrated the product is "reasonably safe and effective for the intended users, intended uses, and intended use environments."
Electromagnetic Compatibility (EMC)	IEC 60601-1-2 (EMC – Collateral Standard)	Complies with the standard.
Ultrasound Safety (Acoustic Output)	IEC 60601-2-37 (Particular requirements for ultrasonic equipment) & IEC 62359 (Field Characterization) & NEMA UD3 (Acoustic Output Measurement Standard)	Complies with standards. Acoustic output exposure levels were measured and calculated following NEMA UD3 and "met FDA levels."
Clinical Measurement Range & Accuracy	Internal "performance criteria" (tested with a phantom)	Resolutions were evaluated, and "results met performance criteria." (Specific range/accuracy values not provided)
Display Performance	Internal "performance specifications" (assessed with various mobile devices)	Test results "demonstrate that the device meets performance specifications." (Specific metrics/values not provided) The display ranges from 4 to 10 inches, similar to predicate devices.
Failure Mode & Risk Analyses	ISO 14971 (Application of Risk Management to Medical Devices)	Conducted FMEA and risk analysis. "All identified hazards were reduced to acceptable levels."
Biocompatibility	ISO 10993-1 (Biological Evaluation of Medical Devices)	Patient-contacting surfaces (probe nosepiece and lens) evaluated for cytotoxicity, skin irritation, and skin sensitization. Test results "demonstrate that the patient-contacting surfaces of the probe are biocompatible." These are identical to the predicate device 300C.
Software Evaluation & Cybersecurity	IEC 62304 (Medical Device Software Life-Cycle Processes)	Validation and verification activities were conducted. Cybersecurity evaluation was done. "The software passed its performance requirements and met specifications."
Other Standards Compliance	ISO 15223-1 (Symbols for Medical Device Labels)	Ensured compliance.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: This document explicitly states, "Clinical tests and animal studies - not conducted" on page 10 and 11. Therefore, there is no clinical test set of patients or medical images that would have a sample size for evaluating the AI component (if any) or reader performance. The non-clinical tests predominantly used phantoms or focused on technical compliance.
Data Provenance: Not applicable, as no clinical data for a "test set" was used for performance evaluation. The compliance tests were conducted on the device hardware and software.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts & Qualifications: Not applicable. Since no clinical tests were conducted and no patient data was used to establish a 'ground truth' for diagnostic performance, no experts were needed for this purpose.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable, as no clinical test set requiring expert adjudication for ground truth establishment was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. The document states, "The Healcerion SONON Ultrasound Imaging System ultrasound system does not introduce new indications for use, modes, features, or technologies relative to the predicate devices that would require evaluation through clinical or animal testing." This implies no human-in-the-loop performance evaluation against a baseline or with AI assistance was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: The document does not describe a standalone algorithm performance study for diagnostic accuracy using patient data. The device is an ultrasound imaging system, and the "software" referenced runs as an app providing image capture, review, and display functionalities for a human user, not an autonomous diagnostic algorithm. Its performance evaluation was based on meeting technical specifications, not diagnostic accuracy.

7. The Type of Ground Truth Used

Type of Ground Truth: For the non-clinical performance tests mentioned (e.g., Clinical Measurement Range and Accuracies), the "ground truth" would be established by the known physical properties of the phantom used for testing or the defined parameters of the technical standards (e.g., known acoustic output levels, specified electrical safety limits). No clinical ground truth (e.g., pathology, outcomes data, expert consensus on patient images) was used for performance validation in this submission.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. The document describes a medical device (ultrasound system) that relies on established ultrasound physics and engineering principles, with software providing image display and control. It does not mention any machine learning or AI models that would require a "training set" of data for development.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as no training set was used.

Summary

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October 12, 2017

Healcerion Co., Ltd % Ms. Carmelina Allis Official Correspondent The Allis Law Firm, Pllc 2437 Bay Area Blvd., #30 HOUSTON TX 77058

Re: K170085

Trade/Device Name: SONON Ultrasound Imaging System (Model: 300L) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: September 8, 2017 Received: September 13, 2017

Dear Ms. Allis:

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K170085

Device Name SONON Ultrasound Imaging System (Model: 300L)

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Diagnostic Ultrasound Indications for Use Form

510(k) Number: K170085
Device Name: SONON Ultrasound Imaging System (Model: 300L)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
Fetal Imaging& Other	Pediatric
	Small Organ (Thyroid, Breast))	N				N
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N				N
	Musculo-skeletal (Superficial)	N				N
	Intravascular	N				N
	Other [1]	N				N
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	N				N
	Other (Carotid)	N				N

N = new indication; P = previously cleared by FDA; E = added under this appendix

[1] Thoracic/Pleural Motion and Fluid Detection

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics and Radiological Health XX Prescription Use -- Yes

(Part 21 CFR 801 Subpart D)

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510(k) Summary of Safety and Effectiveness Healcerion Co., Ltd. SONON Ultrasound Imaging System, Model: 300L

1) Submitter's name, address, telephone number; Contact person

Submitter: Jaeyeob Jung	Contact Person: Carmelina G. Allis
RA Manager	The Allis Law Firm, PLLC
HEALCERION Co., Ltd.	2437 Bay Area Blvd., #30
804ho, 38-21, Digital-ro 31-gil,	Houston, TX 77058
Guro-gu, Seoul, Korea	Ph: 281-819-0216
Ph: +82 70-7569-6326	Email: CAllis@TheAllisLawFirm.com
Email: onair0816@healcerion.com

October 6, 2017 Date prepared:

2) Name of the device, including the trade or proprietary name, if applicable, the common or usual name, and the classification name, if known

Device Common/Usual Name:	Diagnostic Ultrasound System and Transducer
Device Proprietary Name:	SONON Ultrasound Imaging System, Model: 300L
Device Classification:	Class II

21 C.F.R. Section	Classification Name	Product Code
892.1550	System, Imaging, Pulsed Doppler, Ultrasonic	90-IYN
892.1560	System, Imaging, Pulsed Echo, Ultrasonic	90-IYO
892.1570	Transducer, Ultrasonic, Diagnostic	90-ITX

3) Substantially Equivalent Devices

Device Name	510(k)
	Number
SONON Ultrasound Imaging System, Model: 300C (Healcerion Co., Ltd.)	K151339
Clarius Ultrasound System (Clarius Mobile Health Corp.)	K163138

Healcerion is not aware of any design-related recalls regarding the predicate devices.

Reference Device:

Device Name GE Vscan-Compact Diagnostic Ultrasound System 510(k) Number K092756

None of the predicate devices include a thoracic/pleural motion and fluid detection indication. The GE Vscan device was used by Healcerion to support this indication. The performance

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510(k) Summary of Safety and Effectiveness

Healcerion Co., Ltd. SONON Ultrasound Imaging System, Model: 300L

characteristics of the SONON 300L are comparable to those of the Vscan for this particular indication and raise no new or different questions of safety and effectiveness.

4) Device Description

The minimum requirements for the mobile devices that utilize the iOS or Android operating system for use with the SONON Ultrasound Imaging System. Model: 300L are as follows:

Item	Minimum requirements
	iPad Air / iPad Air 2/ iPad Mini 2 / iPad Mini 3 / iPad Mini 4
	iPhone 5S, 6, 6 plus, 6S, 6S plus
Target Device	Galaxy S5 / S6 / Note 3, Note 4 or later
	Galaxy Note Tablet 10.1 2013 version or later
	Galaxy Tab Pro 8.4 2014 version or later
Mobile OS Version	iOS 9.0 or later
	Android 4.3 or later

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510(k) Summary of Safety and Effectiveness Healcerion Co., Ltd. SONON Ultrasound Imaging System, Model: 300L

The device components are not supplied sterile and do not require sterilization prior to use.

5) Indications for Use

6) Technological Comparison to Predicate Devices

The SONON Ultrasound Imaging System and its predicate devices, the 300C and Clarius ultrasound systems, are Track 3 systems that employ the same basic scientific technology for the acquisition and display of ultrasound images. They all operate in the same manner in that piezoelectric material in the transducer is used as a source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2-dimensional images. The SONON Ultrasound Imaging System and the predicate devices allow for the visualization and measurement of body structures. All devices are intended to be used in clinical environments, including hospitals, clinics, and medical office settings, for the diagnosis of patients.

All devices are compact, portable, general-purpose, software-controlled diagnostic ultrasound imaging systems with hand-held probes. The SONON Ultrasound Imaging System and all predicates utilize wireless network connectivity to run software and display images. All devices have the same intended use.

The patient-contacting surfaces of the subject and predicate devices have been found to be biocompatible for their intended application. The SONON Ultrasound Imaging System is manufactured and designed to the same electrical and safety standards as the predicate devices.

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510(k) Summary of Safety and Effectiveness

Healcerion Co., Ltd. SONON Ultrasound Imaging System, Model: 300L

The SONON Ultrasound Imaging System display ranges from 4 to 10 inches depending on whether a mobile phone or tablet is used. This is similar to the range of display options available for the predicate devices.

Comparison of Technological Characteristics with Predicate Devices

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510(k) Summary of Safety and Effectiveness

Healcerion Co., Ltd. SONON Ultrasound Imaging System, Model: 300L

7) Determination of Substantial Equivalence

The SONON Ultrasound Imaging System is substantially equivalent to the predicate devices identified above with respect to intended use, principles of operation, and technological characteristics. As described below, the system has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety, and has been found to conform to applicable standards and product specifications that demonstrate that the SONON Ultrasound Imaging System is substantially equivalent to the predicate devices.

The GE Vscan device was used by Healcerion as a reference device to support the thoracic/pleural motion and fluid detection indication. The performance characteristics of the SONON 300L are comparable to those of the Vscan for this particular indication and raise no new or different questions of safety and effectiveness.

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510(k) Summary of Safety and Effectiveness

Healcerion Co., Ltd. SONON Ultrasound Imaging System, Model: 300L

Non-clinical performance data

Non-clinical tests relied on this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards.

Electrical safety, EMC, and RF Wireless Capabilities

Electrical safety, electromagnetic compatibility, and RF wireless capabilities were evaluated per international standards and the device complies with the following standards:

. IEC 60601-1: Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance
I IEC 60601-1-6: Medical Electrical Equipment - General Requirements for Safety -Collateral Standard: Usability
트 IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests
IEC 60601-2-37: Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
트 IEC 62366: Medical devices - Application of usability engineering to medical devices
트 IEC 62359: Ultrasonics – Field Characterization – Test Methods for the Determination of Thermal and Mechanical Indices Related to Medical Diagnostic Ultrasonic Fields

Acoustic Output Levels

The acoustic output exposure levels were measured and calculated following the NEMA UD3, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 and met FDA levels.

Clinical Measurement Range and Accuracies

Clinical Measurement Range and Accuracies were tested using a phantom. Resolutions were evaluated and results met performance criteria.

Display Performance Testing

The SONON Ultrasound Imaging System (Model: 300L) displays ranges from 4 to 10 inches depending on whether a mobile phone or tablet is used. This is similar to the range of display options available for the predicate devices. The display performance of the device was assessed using various mobile devices, and the test results demonstrate that the device meets performance specifications.

Usability Report

The usability engineering process was conducted by Healcerion to assess and mitigate risks caused by usability problems associated with the correct use of the device as well as user errors. The test results demonstrate that the product has been found to be reasonably safe and effective for the intended users, intended uses, and intended use environments through usability engineering process.

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510(k) Summary of Safety and Effectiveness Healcerion Co., Ltd. SONON Ultrasound Imaging System, Model: 300L

Failure Mode and Risk Analyses

Healcerion conducted a Failure Mode and Effects Analysis and a risk analysis in accordance with ISO 14971. The risk analysis of 300L was performed by taking into account the risks of the device, such as design, production, storage, related international standards, state of art of risk management, and the foreseeable risks related to the intended use of the device. The hazards were identified, the risks were estimated, and procedures were implemented to control them. All identified hazards were reduced to acceptable levels.

Biocompatibility

Biocompatibility testing was conducted in accordance with the international standard below. The patient-contacting surfaces of the device (probe nosepiece and lens) were evaluated for cytotoxicity, skin irritation and skin sensitization and are all identical to the predicate device 300C. Test results demonstrate that the patient-contacting surfaces of the probe are biocompatible in accordance with the following standard:

트 ISO 10993-1: Biological Evaluation of Medical Devices

Software Evaluation and Cybersecurity Management

Furthermore, Healcerion conducted validation and verification activities on the SONON Ultrasound Imaging System software. Cybersecurity evaluation was also conducted. The software passed its performance requirements and met specifications per the following standard:

IEC 62304: Medical Device Software Software Life-Cycle Processes ■

Additional Standards

Healcerion also relied on the following standards to ensure the substantial equivalence of the SONON Ultrasound Imaging System to predicate devices:

I ISO 14971: Application of Risk Management to Medical Devices
트 ISO 15223-1: Symbols to be used with Medical Device Labels

Healcerion applied quality assurance measures to the system design and development, including, but not limited to:

트 Risk Analysis
Product Specifications
Design Reviews
트 Verification and Validation Activities

Clinical tests and animal studies - not conducted

The Healcerion SONON Ultrasound Imaging System ultrasound system does not introduce new indications for use, modes, features, or technologies relative to the predicate devices that would require evaluation through clinical or animal testing. The clinical safety and effectiveness of

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510(k) Summary of Safety and Effectiveness

Healcerion Co., Ltd. SONON Ultrasound Imaging System, Model: 300L

ultrasound systems with characteristics similar to those of the 300L are well accepted for the predicate and subject devices.

8) Conclusion

In conclusion, the tests conducted, as well as all verification and validation activities. demonstrate that the design specifications and technological characteristics of the SONON Ultrasound Imaging System (Model: 300L) meet applicable requirements and standards for the safety and effectiveness of the device for its intended use. There are some differences in technological characteristics between the predicate, reference, and proposed devices, but those differences only indicate that the predicate and reference devices may have secondary or different functionalities as compared to the SONON Ultrasound Imaging System, such as additional probe models or imaging capabilities. The testing and validation activities conducted demonstrate that any differences between the devices do not raise new or different questions of safety or effectiveness as compared to the predicate and reference devices. Therefore, the SONON Ultrasound Imaging System (Model: 300L) is substantially equivalent to legally marketed devices.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Comparison of Technological Characteristics with Predicate Devices
	New Device	Predicate Device	Predicate Device
Characteristic	Healcerion Co., Ltd.SONON Ultrasound ImagingSystem (Model 300L)K170085	Healcerion Co., Ltd.SONON Ultrasound ImagingSystem (Model 300C)K151339	Clarius Mobile Health Corp.Clarius Ultrasound SystemK163138
IntendedUse/Indications forUse	Intended for ultrasound echoimaging, measurement, andanalysis of the human body forgeneral clinical applicationsincluding musculoskeletal(MSK), vascular, small parts(breast, thyroid), andthoracic/pleural motion and fluiddetection imaging.	Intended for diagnostic ultrasoundecho imaging, measurement, andanalysis of the human body forgeneral clinical applicationsincluding obstetrics (OB),gynecology (GY) and general(abdominal) imaging.	Indicated for use in point-of-careimaging of medical conditions on thegeneral public, including: emergencytriage exam to look at traumaconditions; procedure guidance toguide needles into the body; and otherapplications (fetal, fetal echo,abdominal, small organ, musculo-skeletal (conventional), musculo-skeletal (superficial), urology,gynecology, cardiac adult, cardiacpediatric, peripheral vessel, pediatric,carotid). Not intended for emergencymedical service, ambulance or aircraft;only for use by trained professionals.
Environment of Use	Hospital, clinic, and medicaloffice settings	Hospital, clinic, and medicaloffice settings	Hospital, clinic, and medical officesettings
Acoustic OutputLevels	Below Track 3 FDA limits inaccordance with Sept. 2008ultrasound systems guidancedocument	Below Track 3 FDA limits inaccordance with Sept. 2008ultrasound systems guidancedocument	Below Track 3 FDA limits inaccordance with Sept. 2008 ultrasoundsystems guidance document
Imaging Capabilities	• pulsed-echo and Dopplerultrasound• Mode B (2D), Color scan	• pulsed-echo ultrasound• Mode B (2D) scan	• pulsed-echo and Dopplerultrasound• Mode B (2D) scan
Patient Population	For use in all patients	For use in all patients	For use in all patients
AnatomicStructures/Clinicalapplications	General clinical applications,including musculoskeletal(MSK), vascular, small parts(breast, thyroid) andthoracic/pleural motion and fluiddetection	General clinical applications,including fetal/obstetrics,gynecology, abdominal	General clinical applications,including, but not limited to fetal,abdominal, small organ, musculo-skeletal (conventional, superficial),urology, gynecology, cardiacadult/pediatric, peripheral vessel,pediatric, carotid
Users	Healthcare professionals	Healthcare professionals	Healthcare professionals
Principle/Method ofOperation	Piezoelectric material in thetransducer is used as anultrasound source to transmitsound waves into the body.Sound waves are reflected backto the transducer and convertedto electrical signals that areprocessed and displayed asimages of anatomic structures.	Piezoelectric material in thetransducer is used as an ultrasoundsource to transmit sound wavesinto the body. Sound waves arereflected back to the transducerand converted to electrical signalsthat are processed and displayedas images of anatomic structures.	Piezoelectric material in the transduceris used as an ultrasound source totransmit sound waves into the body.Sound waves are reflected back to thetransducer and converted to electricalsignals that are processed anddisplayed as images of anatomicstructures.
	New Device	Predicate Device	Predicate Device
Characteristic	Healcerion Co., Ltd.SONON Ultrasound ImagingSystem (Model 300L)K170085	Healcerion Co., Ltd.SONON Ultrasound ImagingSystem (Model 300C)K151339	Clarius Mobile Health Corp.Clarius Ultrasound SystemK163138
Image Display Unit	Mobile device (4 to 10 inchesapproximately)	Mobile device (4 to 10 inchesapproximately)	Mobile device (4 to 10 inchesapproximately)
Probe Characteristics	Linear, 5MHz / 7.5MHz /10MHz frequency	Convex, 3.5 MHz frequency	C3 convex (Frequency: 2-6 MHz;Depth: 3-30 cm), L7 linear (Frequency:4-13 MHz; Depth: 1-7 cm)
Probe Connection toDisplay	Wireless	Wireless	Wireless
Off-the-shelfoperating system	iOS / Android	iOS / Android	iOS / Android
Software	Runs as an app on off-the-shelfmobile device	Runs as an app on off-the-shelfmobile device	Runs as an app on off-the-shelf mobiledevice
System Components	Commercial off-the-shelf iOS or Android mobile device SONON Ultrasound Imaging System software that runs as an app on the mobile device SONON Ultrasound Imaging System battery-operated, hand-held ultrasound diagnostic transducer that communicates wirelessly with iOS or Android mobile devices	Commercial off-the-shelf iOS or Android mobile device SONON Ultrasound Imaging System software that runs as an app on the mobile device SONON Ultrasound Imaging System battery-operated, hand-held ultrasound diagnostic transducer that communicates wirelessly with iOS or Android mobile devices	Commercial off-the-shelf iOS or Android mobile device Imaging software that runs as an app on the mobile device Battery-operated, hand-held ultrasound diagnostic transducer that communicates wirelessly with iOS or Android mobile devices
Patient-ContactingMaterials	All patient-contact materials arebiocompatible and can bedisinfected	All patient-contact materials arebiocompatible and can bedisinfected	All patient-contact materials arebiocompatible and can be disinfected