The SONON Ultrasound Imaging System (Model: SONON 300C) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging.

Device Description

The SONON Ultrasound Imaging System, Model: SONON 300C, is a wireless ultrasound system that uses pulsed-echo technology (frequency: 3.5 MHz; module: convex) 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, brightness, contrast, linear/elliptical measurement, 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 B-Mode. 2dimensional scan format. All images and data collected are stored in the mobile app. If the app is removed and reinstalled, all stored information is lost and cannot be recovered.

The SONON Ultrasound Imaging System utilizes pulsed-echo 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

The provided text describes a 510(k) submission for the Healcerion Co., Ltd. SONON Ultrasound Imaging System (Model: SONON 300C). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a dedicated study with performance metrics like accuracy, sensitivity, or specificity.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth establishment are not explicitly provided in this type of regulatory submission. This document highlights compliance with general safety and performance standards for ultrasound devices, but not the kind of detailed performance validation typically seen for AI/software-based diagnostics.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic task. Instead, it demonstrates compliance with recognized safety and performance standards relevant to ultrasound imaging systems.

Acceptance Criteria Category	Reported Device Performance / Compliance
Acoustic Output Levels	- Standard: NEMA UD2-2004 (R2009), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3. - Results (Convex only transducer): - Ispta.3: 0.0627[W/cm2] - TIS: 0.2535 - MI: 0.7861 - Ipa.3@MImax: 11.6369[W/cm2] - Conclusion: Below Track 3 FDA limits in accordance with Sept. 2008 ultrasound systems guidance document.
Clinical Measurement Range and Accuracies	- Test: Used a phantom with vertical, dead zone, horizontal, and linear groups. - Evaluation: Length and vertical/horizontal resolutions. - Conclusion: Results met performance criteria (specific criteria not detailed).
Display Performance	- Test: Assessed using various mobile devices. - Conclusion: Test results demonstrate that the device meets performance specifications (specific specifications not detailed). Display ranges from 4 to 10 inches, similar to predicate devices.
Electrical Safety, EMC, RF Wireless	- Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359. - Conclusion: Device complies with these international standards.
Usability	- Process: Usability engineering process conducted to assess and mitigate risks from usability problems and user errors. - Conclusion: Test results demonstrate the product is reasonably safe and effective for intended users, uses, and environments.
Failure Mode and Risk Analyses	- Standard: ISO 14971. - Process: FMEA and risk analysis performed. Hazards identified, risks estimated, and procedures implemented for control. - Conclusion: All identified hazards were reduced to acceptable levels.
Biocompatibility	- Standard: ISO 10993-1. - Test: Patient-contacting surfaces (probe nosepiece and lens) evaluated for cytotoxicity, skin irritation, and skin sensitization. - Conclusion: Test results demonstrate biocompatibility.
Software Evaluation & Cybersecurity	- Standard: IEC 62304. - Process: Validation and verification activities, cybersecurity evaluation. - Conclusion: Software passed performance requirements and met specifications.

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

Sample Size for Test Set: Not specified for any clinical performance evaluation, as clinical tests were not conducted. For non-clinical tests like acoustic output or phantom studies, specific sample sizes (e.g., number of measurements or phantoms) are not provided.
Data Provenance: Not applicable as clinical data was not used for the primary demonstration of substantial equivalence. The non-clinical tests would have been performed by the manufacturer.

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

This information is not provided. No clinical "ground truth" was established for a test set, as no clinical studies were performed (see "Clinical tests and animal studies - not conducted" under section 7 of the 510(k) Summary).

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring expert adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was performed. The device is an ultrasound imaging system, and the submission focuses on its equivalence to existing ultrasound systems, not on its role as an AI-powered diagnostic aid for human readers.

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

No standalone algorithm performance study was done for diagnostic accuracy. The "algorithm" here refers to the software controlling the ultrasound device and image display, not a diagnostic AI algorithm.

7. The type of ground truth used

For the non-clinical performance evaluations (acoustic output, measurement accuracy, display performance), the "ground truth" would be established by the physical properties of the testing equipment, phantoms, and calibrated measurement devices, according to the specified standards (e.g., NEMA UD2-2004 for acoustic output). There is no "ground truth" in terms of expert consensus, pathology, or outcomes data mentioned, as no clinical studies were conducted.

8. The sample size for the training set

Not applicable. This device is an ultrasound imaging system, not a machine learning model that would require a "training set" for diagnostic algorithm development. The software development follows a software life-cycle process (IEC 62304) and includes verification and validation activities, but this is distinct from training a machine learning model.

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

Not applicable, as no training set for a machine learning model was used.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 10, 2015

Healcerion Co., Ltd. % Ms. Carmelina G. Allis The Allis Law Firm, PLLC 2437 Bav Area Blvd.. #30 HOUSTON TX 77058

Re: K151339

Trade/Device Name: SONON Ultrasound Imaging System (Model: SONON 300C) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: August 10, 2015 Received: August 14, 2015

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 (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.

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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 at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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 yours,

Robert Ocks

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) K151339

Device Name

SONON Ultrasound Imaging System (Model: SONON 300C)

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: K151339 Device Name: SONON Ultrasound Imaging System (Model: SONON 300C) 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)
Fetal Imaging& Other	Ophthalmic
	Fetal	N
	Abdominal	N
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Gynecology)	N

Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)

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

(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: SONON 300C

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

Submitter:	Jaeyeob JungRA ManagerHEALCERION Co., Ltd.(Guro-dong, Changup JiwonCenter)72, Digital-ro 26-gil, Guro-guSeoul, South KoreaPh: +82 70-7569-6326Email: onair0816@healcerion.com	Contact Person:	Carmelina G. AllisThe Allis Law Firm, PLLC2437 Bay Area Blvd., #30Houston, TX 77058Ph: 281-819-0216Email: CAllis@TheAllisLawFirm.com
------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-----------------	----------------------------------------------------------------------------------------------------------------------------------------------------------

August 10, 2015 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: SONON 300C
Device Classification:	Class II

21 C.F.R. Section	Classification Name	Product Code
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
MobiUS Ultrasound Imaging System (Mobisante, Inc.)	K102153
Penrith Elettra Diagnostic Ultrasound System (Penrith Corp.)	K100598

Healcerion is not aware of any design-related recalls regarding the predicate devices. No reference devices were used in this submission.

4) Device Description

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510(k) Summary of Safety and Effectiveness

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

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

Item	Minimum requirements
	iPhone 5 / 5S / 6 / 6 plus
	iPad 3rd / 4th Generation / Air / Mini or later
Target Device	Galaxy S3 / S4 / S5 / Note 3, Note 4
	Galaxy Note Tablet 10.1 2013 version or later
	Galaxy Tab Pro 8.4 2014 version or later
Mobile OS Version	iOS 7.0 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: SONON 300C

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 MobiUS and Penrith Elettra, 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. Both the SONON Ultrasound Imaging System and the Penrith Elettra devices utilize wireless network connectivity to run software and display images. Both the MobiUS and the SONON Ultrasound Imaging System are available in a 3.5 MHz ultrasound probe.

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.

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 MobiUS and Penrith Elettra predicate devices.

Characteristic	Healcerion Co., Ltd.SONON Ultrasound ImagingSystem	Predicate DeviceMobisante, Inc.MobiUS Ultrasound Imaging SystemK102153	Predicate DevicePenrith CorporationPenrith Elettra DiagnosticUltrasound SystemK100598
IntendedUse/Indications forUse	The SONON Ultrasound ImagingSystem (Model: SONON 300C) isintended for diagnostic ultrasoundecho imaging, measurement, andanalysis of the human body forgeneral clinical applications	Indicated for ultrasound imaging,measurement, and analysis of the humanbody for the following clinicalapplications: fetal/OB, abdominal,cardiac, pelvic, pediatric,musculoskeletal, and peripheral vessel	Intended for diagnostic imagingor fluid flow analysis of thehuman body including: fetal,abdominal, intraoperative,intraoperative neurological,pediatric, small organ, neonatal
	Healcerion Co., Ltd.	Predicate Device	Predicate Device
Characteristic	SONON Ultrasound ImagingSystem	Mobisante, Inc.MobiUS Ultrasound Imaging SystemK102153	Penrith CorporationPenrith Elettra DiagnosticUltrasound SystemK100598
	including obstetrics (OB),gynecology (GY) and general(abdominal) imaging.	imaging. Its compact size, portability,and user interface enable it for use inprimary care and special care areas.	cephalic, cardiac, peripheralvessel, musculoskeletal(conventional), musculoskeletal(superficial).
Environment of Use	Hospital, clinic, and medical officesettings	Hospital, clinic, and medical officesettings	Hospital, clinic, and medicaloffice settings
Acoustic OutputLevels	Below Track 3 FDA limits inaccordance with Sept. 2008ultrasound systems guidancedocument	Below Track 3 FDA limits inaccordance with Sept. 2008 ultrasoundsystems guidance document	Below Track 3 FDA limits inaccordance with Sept. 2008ultrasound systems guidancedocument
Imaging Capabilities	pulsed-echo ultrasound•Mode B (2D) scan	pulsed-echo ultrasound•Mode B (2D) scan	pulsed-echo and Doppler•ultrasoundMode B (2D), Color,•Amplitude Doppler
Patient Population	For use in all patients	For use in all patients	For use in all patients
AnatomicStructures/Clinicalapplications	General clinical applications,including fetal/obstetrics,gynecology, abdominal	General clinical applications, including,but not limited to fetal/obstetrics,gynecology, abdominal, cardiac, pelvic,pediatric, musculoskeletal, andperipheral vessel imaging	General clinical applications,including fetal, abdominal,intraoperative, pediatric, smallorgan, cephalic, cardiac,peripheral vessel, andmusculoskeletal
Users	Healthcare professionals	Healthcare professionals	Healthcare professionals
Principle/Method ofOperation	Piezoelectric material in thetransducer is used as an ultrasoundsource to transmit sound wavesinto the body. Sound waves arereflected back to the transducer andconverted to electrical signals thatare processed and displayed asimages 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 and displayedas images of anatomic structures.	Piezoelectric material in thetransducer is used as anultrasound source to transmitsound waves into the body. Soundwaves are reflected back to thetransducer and converted toelectrical signals that areprocessed and displayed asimages of anatomic structures.
Image Display Unit	Mobile device (4 to 10 inchesapproximately)	PC/Host computer (4.1 inchesapproximately)	Video display (unknown size)
Probe Characteristics	Convex, 3.5 MHz frequency	Mechanic, 3.5 MHz to 12 MHzfrequency	L8-3 linear, L12-5 linear, and C5-2 curvilinear
Probe Connection toDisplay	Wireless	Wired (USB)	Wireless or wired
Off-the-shelf operatingsystem	iOS / Android	Win CE	Unknown
Software	Runs as an app on off-the-shelfmobile device	Runs in host computer	Unknown
System Components	• Commercial off-the-shelf iOSor Android mobile device,• SONON Ultrasound ImagingSystem software that runs asan app on the mobile device,• SONON Ultrasound ImagingSystem battery-operated,hand-held ultrasounddiagnostic transducer thatcommunicates wirelessly with	• Host computer,• USB 2.0 interface, and• Portable, handheld, compactultrasound probe	• System console housingelectronic circuitry• Video display• Power supply• User controls• Transducers (L8-3 linear,L12-5 linear, C5-2curvilinear) thatcommunicate wirelessly orvia wire with system console
Characteristic	Healcerion Co., Ltd.SONON Ultrasound ImagingSystem	Predicate DeviceMobisante, Inc.MobiUS Ultrasound Imaging SystemK102153	Predicate DevicePenrith CorporationPenrith Elettra DiagnosticUltrasound SystemK100598
	iOS or Android mobiledevices
Patient-ContactingMaterials	All materials with patient contactare biocompatible and can bedisinfected	All materials with patient contact arebiocompatible and can be disinfected	All materials with patient contactare biocompatible

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: SONON 300C

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510(k) Summary of Safety and Effectiveness

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

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.

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
. 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
IEC 62359: Ultrasonics – Field Characterization – Test Methods for the Determination of Thermal and Mechanical Indices Related to Medical Diagnostic Ultrasonic Fields

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510(k) Summary of Safety and Effectiveness

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

Acoustic Output Levels

The acoustic output exposure levels were measured and calculated following the NEMA UD2-2004 (R2009), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3. Acoustic Output Level Test Results are as follows:

Transducer	Ispta.3	TIS	MI	Ipa.3@MImax
Convex only	0.0627[W/cm2]	0.2535	0.7861	11.6369[W/cm2]

Clinical Measurement Range and Accuracies

Clinical Measurement Range and Accuracies were tested using a phantom with vertical, dead zone, horizontal and linear groups. The length and the vertical and horizontal resolutions were evaluated and results met performance criteria.

Display Performance Testing

The SONON Ultrasound Imaging System (Model: SONON 300C) 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.

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 SONON 300C 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. Test results demonstrate that the patientcontacting surfaces of the probe are biocompatible in accordance with the following standard:

. ISO 10993-1: Biological Evaluation of Medical Devices

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510(k) Summary of Safety and Effectiveness

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

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:

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

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

Risk Analysis
트 Product Specifications
트 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 ultrasound systems with characteristics similar to those of the SONON 300C 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: SONON 300C) 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 and proposed devices, but those differences only indicate that the predicate devices may have secondary or added functionalities as compared to the SONON Ultrasound Imaging System, such as additional probe models or imaging capabilities as in the case of Doppler ultrasound. 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 devices. Therefore, the SONON Ultrasound Imaging System (Model: SONON 300C) is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.