The SC1 Ultrasound Imaging System (Model: SC1) 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) through B mode. Flow detection is possible using PWD (Power Doppler) mode.

SC1 is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

Device Description

The SC1 Handheld ultrasound imaging system, Model: SC1, is a general purpose, software-controlled, diagnostic ultrasound system that uses pulsed-echo technology (B Mode (Power Doppler); Frequency: 5 - 13 MHz; module: linear; depth max: 10 cm) to transmit ultrasound images via wired communication to a mobile device that utilizes the Android operating system. Its function is to acquire ultrasound data and to display the data in operation.

The SC1 Handheld ultrasound imaging system is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) the battery-operated, SC1L (Linear type Ultrasound Probe) that communicates wired with Android mobile device, (ii) the software that runs as an app on the mobile device, (iii) batteries, charger (Cradle), cable, power cord, and magnetizers (option), (iv) the instructions for use manual.

The SC1 App software can be downloaded to an Android mobile device and utilizes an icon touch-based user interface. The software enables ultrasound image review, controls for depth, gain, linear measurement.

The SC1 App software allows the user to image in real time and review freeze-frame images on the screen in a B-Mode and PD-Mode, 2-dimensional scan format.

SC1 Handheld ultrasound system is only intended for acquisition and real time diagnosis. SC1 Handheld ultrasound system (SC1 probe and SC1 app) provides functions on patient data (entering new patient information, editing patient data saving, storing, or transferring patient information). It is possible to connect to the PACS DICOM network (hospital network) to get the list of exams and export recorded exams. However, there is no option to export patient data via a USB cable.

Physician who is responsible for interpreting ultrasound images must be available in the room to provide diagnosis in real time.

SC1 Handheld 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.

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

AI/ML Overview

The provided text is a 510(k) summary for the FCU Co., Ltd. SC1 Handheld Ultrasound Imaging system (Model: SC1). While it details the device, its intended use, comparison to predicate devices, and various non-clinical tests conducted (electrical safety, EMC, software validation, biocompatibility), it explicitly states that "No clinical studies were considered necessary and performed."

Therefore, based on the provided document, the device's acceptance criteria related to clinical performance and the study proving it meets those criteria cannot be described as no such studies were conducted or reported in this 510(k) summary.

However, I can extract information regarding the non-clinical performance and the general acceptance criteria inferred from regulatory compliance.

Based on the provided 510(k) summary, here's what can be inferred about acceptance criteria (primarily non-clinical) and the "study" (non-clinical testing) conducted:

Since no clinical studies were performed, the "study that proves the device meets the acceptance criteria" refers to the non-clinical performance testing and regulatory compliance activities.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from Standards & Claims)	Reported Device Performance (from "Non-Clinical Test Summary")
Electrical Safety	Compliance with IEC 60601-1:2005/A1:2012 (3.1 edition) + National Difference: General requirements for basic safety and essential performance.	"The test results demonstrated that the proposed device complies with the following standards: IEC 60601-1:2005/A1:2012 (3.1 edition) + National Difference"
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2:2014 (4.1 edition): General requirements for safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.	"The test results demonstrated that the proposed device complies with the following standards: IEC 60601-1-2:2014 (4.1 edition)"
Usability	Compliance with IEC 60601-1-6:2010/AMD1:2013: General requirements for basic safety and essential performance - Collateral standard: Usability.	"The test results demonstrated that the proposed device complies with the following standards: IEC 60601-1-6:2010/AMD1:2013"
Basic Safety & Essential Performance of Ultrasound Equipment	Compliance with IEC 60601-2-37:2007/AMD1:2015: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.	"The test results demonstrated that the proposed device complies with the following standards: IEC 60601-2-37:2007/AMD1:2015"
Acoustic Output Levels	Below Track 3 FDA limits in accordance with June 2019 ultrasound systems guidance document AND compliance with IEC 60601-2-37:2007+AMD1:2015.	"Compliance with IEC 60601-2-37:2007+AMD1:2015" and "Below Track 3 FDA limits in accordance with June 2019 ultrasound systems guidance document" (as stated in comparison table for both subject and predicate).
Software Validation & Cybersecurity	Basic documentation level of concern according to IEC 62304:2006+AMD1:2015, ANSI/UL 2900-1:2017, and FDA guidances ("The Content of Premarket Submissions for Device Software Functions, June, 2023" and "Cybersecurity in Medical Devices: Quality System considerations and Content of Premarket Submissions, September, 2023"). Risk management in accordance with ISO 14971:2019.	"Software was designed and developed according to a software development process and was verified and validated. The software information is provided in accordance with 'IEC 62304:2006+AMD1:2015', 'ANSI/UL 2900-1:2017' and FDA guidance: The Content of Premarket Submissions for Device Software Functions, June, 2023 and 'Cybersecurity in Medical Devices: Quality System considerations and Content of Premarket Submissions, September, 2023' and 'ISO 14971:2019 Medical Devices - Application of Risk Management to Medical Devices'."
Biocompatibility	Patient-contacting parts conform to ISO 10993-1:2018 (Biological evaluation of medical devices), including Cytotoxicity (ISO 10993-5:2009), Intracutaneous (intradermal) reactivity (ISO 10993-10:2010), and Skin sensitization (ISO 10993-10:2010).	"The part of SC1 in contact with the patient was verified and demonstrated for the safety of materials through the biocompatibility test in accordance with ISO 10993-1:2018. - Cytotoxicity test according to ISO 10993-5:2009 - Intracutaneous (intradermal) reactivity test according to ISO 10993-10:2010 - Skin sensitization test according to ISO 10993-10:2010"
Ultrasound Imaging Performance	Defined performance characteristics (Axial, Lateral Resolution; Axial, Lateral distance; B-mode and Combined(B+PD) mode display; Max depth) are met. (Specific quantitative acceptance values are not provided in this summary, only that tests were conducted).	"The additional performance test has been conducted to support the technological characteristics of the SC1. The performance of the SC1 has been defined as follows: - Axial, Lateral Resolution - Axial, Lateral distance - B-mode and Combined(B+PD) mode display - Max depth" (Implies successful completion without specific results given).

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

Test Set (Non-Clinical): Not applicable in the traditional sense of a clinical test set. The "test set" for non-clinical performance refers to the physical device and its software being subjected to various engineering and lab-based tests. The document does not specify the number of individual devices or software builds tested, but implies that "the proposed device" (singular, referring to the model) underwent these tests.
Data Provenance: The tests were conducted to demonstrate compliance with international standards (IEC, ISO, ANSI/UL) and FDA guidances. The manufacturing and testing entity is FCU Co., Ltd., based in Daejeon, Republic of Korea. The testing would be prospective in the sense that the device was actively tested to demonstrate compliance, not retrospectively analyzed from patient data.

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

Not applicable. As no clinical studies were performed, there was no clinical "ground truth" to establish through expert review for a test set. Ground truth for non-clinical tests is based on physical measurements, software validation protocols, and adherence to engineering specifications and regulatory standards by qualified testing personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. This is a concept related to clinical image interpretation by multiple readers. For non-clinical validation, "adjudication" typically refers to engineering review, quality assurance checks, and regulatory body assessment, not a specific consensus method for data labeling.

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, a MRMC comparative effectiveness study was explicitly NOT done. The document states: "No clinical studies were considered necessary and performed." This device is an imaging system, not an AI-assisted diagnostic tool in the sense of providing automated interpretations.

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

Not Applicable in the context of an AI algorithm. This device is an ultrasound imaging system. Its "performance" is about image acquisition, display, and measurement capabilities, not an AI algorithm making diagnostic decisions. When it refers to "software validation," it's about the functionality, safety, and reliability of the operational software, not an AI model's diagnostic accuracy.

7. The type of ground truth used:

For non-clinical performance: The "ground truth" is adherence to established engineering specifications, published international standards (e.g., IEC for electrical safety, ISO for biocompatibility), and regulatory guidance documents. This is determined through physical measurements, simulated environments, and compliance testing.
For clinical performance: None. No clinical ground truth was established, as no clinical studies were performed.

8. The sample size for the training set:

Not applicable. This device is an ultrasound imaging system, not an AI model trained on a dataset. The software enables image review and control, not AI inference.

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

Not applicable. See point 8.

Summary

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June 26, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

FCU Co., Ltd. % Song Hyuk RA manager B-620/621, Biz Center, 17, Techno 4-ro Yuseong-gu. Daeieon 34013 REPUBLIC OF KOREA

Re: K233579

Trade/Device Name: SC1 Handheld Ultrasound Imaging system (Model: SC1) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO, IYN, ITX Dated: May 31, 2024 Received: May 31, 2024

Dear Song Hyuk:

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.

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).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; medical device reporting 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.

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.

For comprehensive regulatory information about mediation-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

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Indications for Use

Submission Number (if known)

K233579

Device Name

SC1 Handheld Ultrasound Imaging system (Model: SC1)

Indications for Use (Describe)

SC1 is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

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)

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2F, 62-4, Techno 1-ro, Yuseong-gu, Daejeon, Republic c Tel: +82 (42) 936 9078 Fax:+82 (42) 936 9077

510(k) Summary

[As required by 21 CFR 807.92]

Date Prepared 1.

May 31, 2024

2. Submitter's Information & Contact Person

Name of Manufacturer: FCU Co., Ltd.
Address: 2F, 62-4, Techno 1-ro, Yuseong-gu, Daejeon, Republic of Korea (34014)
Contact Name: Song Hyuk/ RA manager
Telephone No .: +82-42-936-9078
Fax No.: +82-42-936-9077
Email Address: h.song(@fcultrasound.com

Trade Name, Common Name, Classification 3.

Common name: Handheld ultrasound imaging system

Trade name: SC1 Handheld Ultrasound Imaging system (Model: SC1)

Classification Description	21 CFR Section	Product Code
Ultrasonic Pulse Doppler Imaging System	21 CFR 892.1550	IYN
Ultrasonic Pulsed Echo Imaging System	21 CFR 892.1560	IYO
Diagnostic Ultrasound Transducer	21 CFR 892.1570	ITX

As stated in 21 CFR, parts 892.1550, and 892.1570, and 892.1570, each of these generic types of devices has been classified as Class II.

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2F, 62-4, Techno 1-ro, Yuseong-gu, Daejeon, Republic of Tel: +82 (42) 936 9078, Fax: +82 (42) 936 9077

4. Predicate Device

The identified predicate devices within this submission are shown as follow:

Primary Predicate device

510(k) Number:	K210468
• Applicant:	FCU Co., Ltd.
• Classification Name:	Diagnostic Ultrasound System and Transducer
• Trade Name:	SC1 Handheld Ultrasound Imaging system (Model: SC1)

Reference device

• 510(k) Number:	K192226
• Applicant:	Philips Healthcare
• Classification Name:	Ultrasonic Pulse Doppler Imaging System
• Trade Name:	Lumify Diagnostic Ultrasound System

These predicates have not been subject to a design-related recall.

No reference devices were used in this submission.

ട. Device Description

The minimum requirements for the mobile devices that utilize the Android operating system for use with the SC1 Handheld ultrasound imaging system, Model: SC1 are as follows:

Item	Minimum Requirement
Recommended Tablet Device	Galaxy Tab S6 or later
Mobile OS Version	Android 14.0 or later

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2F, 62-4, Techno 1-ro, Yuseong-gu, Daejeon, Republic of Korea (34014) Tel: +82 (42) 936 9078, Fax: +82 (42) 936 9077

The SC1 App software allows the user to image in real time and review freeze-frame images on the screen in a B-Mode and PD-Mode, 2-dimensional scan format.

Physician who is responsible for interpreting ultrasound images must be available in the room to provide diagnosis in real time.

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

Indications for Use 6.

SCI is a transportable ultrasound system intended for use in environments where healthcare is provided by qualified and trained healthcare professionals.

7. Comparison of Technical Characteristics with the Predicate Device.

The subject device does not have any hardware changes compared to primary predicate device. There are only software changes. The intended use and basic technical characteristics are the same.

The following technological differences exist between the subject and predicate devices:

· Use of Power doppler Mode, flow detection is possible using PD (Power Doppler) mode.
· Use of DICOM, it provides all the features for patient data (enter new patient information, edit patient data, store, store patient data, send or export patient information). This feature can only connect to the PACS DICOM network (Hospital Network) to get a list of tests and export recorded tests. There is no option to export patient data over a USB cable.

There are no significant differences in the technological characteristics of this device compared to the predicate device which adversely affect safety or effectiveness.

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8. Determination of Substantial Equivalence

Provided below is a table summarizing and comparing the technological characteristics of the subject device and the predicate devices:

	Subject Device	Primary PredicateDevice	Reference Device	SE decision
K Number	To be assigned	K210468	K192226	-
Manufacturer	FCU Co., Ltd.	FCU Co., Ltd.	Philips Healthcare	-
Model	SC1	SC1	Lumify DiagnosticUltrasound System	-
Indications forUse	The SC1 UltrasoundImaging System (Model:SC1) is intended fordiagnostic ultrasound echoimaging, measurement,and analysis of the humanbody for general clinicalapplications includingmusculoskeletal (MSK),vascular, small parts(breast, thyroid) throughB mode.Flow detection ispossible using PD(Power Doppler) mode.SC1 is a transportableultrasound system intendedfor use in environmentswhere healthcare isprovided by healthcareprofessionals.	The SC1 is intended fordiagnostic ultrasoundecho imaging,measurement, andanalysis of the humanbody for general clinicalapplications includingmusculoskeletal (MSK),vascular, small parts(breast, thyroid).SC1 is a transportableultrasound system intendedfor use in environmentswhere healthcare isprovided by healthcareprofessionals.	Philips Lumify DiagnosticUltrasound System isintended for diagnosticultrasound imaging in B(2D), Color Doppler,Combined (B+Color), andM modes. It is indicatedfor diagnostic ultrasoundimaging and fluid flowanalysis in the followingapplications:Fetal/Obstetric,Abdominal, Pediatric,Cephalic, Urology,Gynecological, CardiacFetal Echo, Small Organ,Musculoskeletal,Peripheral Vessel, Carotid,Cardiac.Lumify is a transportableultrasound system intendedfor use in environmentswhere healthcare isprovided by healthcareprofessionals.	Equivalent*
Environmentof Use	Hospital, clinic, andmedical office settings	Hospital, clinic, andmedical office settings	Hospital, clinic, andmedical office settings	Equivalent
AcousticOutputLevels	- Compliance with IEC60601-2-37:2007+AMD1:2015- Below Track 3 FDAlimits in accordance withJune 2019 ultrasoundsystems guidancedocument	- Compliance with IEC60601-2-37:2007+AMD1:2015- Below Track 3 FDAlimits in accordance withJune 2019 ultrasoundsystems guidancedocument	- Compliance with IEC60601-2-37:2007+AMD1:2015- Below Track 3 FDAlimits in accordance withJune 2019 ultrasoundsystems guidancedocument	Equivalent
	Subject Device	Primary PredicateDevice	Reference Device	SE decision
ImagingCapabilities	• Mode B (2D)• Combined (B+PowerDoppler)	• Mode B (2D)	Mode B (2D), ColorDoppler,Combined (B+Color), andM modes	Equivalent*
PatientPopulation	For use in all patients	For use in all patients	For use in all patients	Equivalent
AnatomicStructures	• Musculoskeletal (MSK)• Vascular• Small parts (breast,thyroid)	• Musculoskeletal (MSK)• Vascular• Small parts (breast,thyroid)	• Fetal/Obstetric• Abdominal• Pediatric• Cephalic• Urology• Gynecological• Cardiac Fetal Echo• Small Organ• Musculoskeletal• Peripheral Vessel• Carotid• Cardiac	Equivalent*
Users	Healthcare professionals	Healthcare professionals	Healthcare professionals	Equivalent
Principle/Method ofOperation	Piezoelectric material inthe transducer is used as anultrasound source totransmit sound waves intothe body. Sound waves arereflected back to thetransducer and convertedto electrical signals that areprocessed and displayed asimages of anatomicstructures.	Piezoelectric material inthe transducer is used as anultrasound source totransmit sound waves intothe body. Sound waves arereflected back to thetransducer and convertedto electrical signals that areprocessed and displayed asimages of anatomicstructures.	Piezoelectric materialinthe transducer is used as anultrasound source totransmit sound waves intothe body. Sound waves arereflected back to thetransducer and convertedto electrical signals thatare processed anddisplayed as imagesofanatomic structures.	Equivalent
ProbeCharacteristics	Linear, 5 - 13MHz	Linear, 5 - 13MHz	Linear, 4 – 12 MHzCurved, 2 – 5 MHzPhased, 1 – 4 MHz	Equivalent**
ProbeConnection toDisplay	Wired	Wired	Wired	Equivalent
Off-the-shelfoperatingsystem	Android	Android	Android	Equivalent
Software	Runs as an app on off-the-shelf mobile device	Runs as an app on off-the-shelf mobile device	Runs as an app on off-the-shelf mobile device	Equivalent
SystemComponents	• Ultrasound Probe	• Ultrasound Probe	• Ultrasound Probe• USB transducer cable	Equivalent***
	Subject Device	Primary PredicateDevice	Reference Device	SE decision
	• FCradle (Cradle)• AC/DC adapter includingPower Cable• Communication Cable(USB Cable)• Batteries• Tablet (mobile device):Not provided.• User Manual• Magnetizer (Option)- long/short type- cap cover	• FCradle (Cradle)• AC/DC adapter includingPower Cable• Communication Cable(USB Cable)• Batteries• Tablet (mobile device):Not provided.• User Manual• Magnetizer (Option)- long/short type- cap cover	• USB-C transducer cable• USB Micro-B transducercable• Android device (mobiledevice):• User Manual
Patient-ContactingMaterials	Tested by ISO 10993-5Tested by ISO 10993-10	Tested by ISO 10993-5Tested by ISO 10993-10	Tested by ISO 10993-5Tested by ISO 10993-10	Equivalent

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ECTFCU Co., Ltd.

2F, 62-4, Techno 1-ro, Yuseong-gu, Daejeon, Republic of Korea (34014)

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2F, 62-4. Techno 1-ro. Yuseong-gu. Daeieon. Republic of Korea Tel: +82 (42) 936 9078, Fax: +82 (42) 936 9077

The technical differences comparing with primary predicate device do not raise any new potential safety risks and therefore, there is no impact on safety or efficacy for the proposed device. The proposed device supports only Mode B (2D) to transport the convenience of moving the device. Therefore, the scope of clinical application is more limited than that of the reference device. But the differences do not rasse any new potential safety risks and therefore, we believe there is no impact on safety or efficacy for the proposed device. This is described in the User's Manual, so the user will be aware of this.

** This device supports only linear type probe, and the frequency range of the probe is equivalent with the range of the predicate device and reference device. The differences indicated, do not raise any new potential safety risks and therefore, there is no impact on safety or efficacy for the proposed device.
*** The technical differences do not raise any new potential safety risks and therefore, there is no impact on safety or efficacy for the proposed device.

9. Performance Data

The following performance data were provided in support of the substantial equivalence determination. Non-Clinical Test Summary [21 CFR 807.92(b)(1)]

1. Electrical Safety, Electromagnetic Compatibility Testing
  Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

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2F, 62-4, Techno 1-ro, Yuseong-gu, Daejeon, Republic of Korea Tel: +82 (42) 936 9078, Fax: +82 (42) 936 9077

Standard(Edition)	Standard Title	ConsensusStandard
IEC 60601-1:2005/A1:2012(3.1 edition) + NationalDifference	Medical electrical equipment – Part 1: General requirements for basic safety and essential performance	Yes
IEC 60601-1-2:2014(4.1 edition)	Medical electrical equipment - Part 1-2: General requirements for safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests	Yes
IEC 60601-1-6:2010/AMD1:2013	Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability	Yes
IEC 60601-2-37:2007/AMD1:2015	Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment	Yes

2) Software Validation and Cybersecurity Management

The SC1 contains basic documentation level of concern software was designed and developed according to a software development process and was verified and validated. The software information is provided in accordance with "IEC 62304:2006+AMD1:2015", "ANSI/UL 2900-1:2017" and FDA guidance: The Content of Premarket Submissions for Device Software Functions, June, 2023 and "Cybersecurity in Medical Devices: Quality System considerations and Content of Premarket Submissions, September, 2023" and "ISO 14971:2019 Medical Devices - Application of Risk Management to Medical Devices".

3) Biocompatibility Testing

The part of SC1 in contact with the patient was verified and demonstrated for the safety of materials through the biocompatibility test in accordance with ISO 10993-1:2018.

-Cytotoxicity test according to ISO 10993-5:2009
-Intracutaneous (intradermal) reactivity test according to ISO 10993-10:2010
-Skin sensitization test according to ISO 10993-10:2010

4) Performance Testing

Through compliance with the identified current standards, the safety and effectiveness of the device is supported.

The additional performance test has been conducted to support the technological characteristics of the SC1. The performance of the SC1 has been defined as follows.

Axial, Lateral Resolution ।
Axial, Lateral distance ।
B-mode and Combined(B+PD) mode display -
Max depth

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K233579

2F, 62-4, Techno 1-ro, Yuseong-gu, Daejeon, Republic of K Tel: +82 (42) 936 9078, Fax: +82 (42) 936 9077

Clinical Test Summarv [21 CFR 807.92(b)(2)]

No clinical studies were considered necessary and performed.

10. Conclusion [21 CFR 807.92(b)(3)]

In conclusion, the tests conducted, as well as all verification activities, demonstrate that the design specifications and technological characteristics of the subject SC1 Handheld ultrasound imaging system (Model: SC1) 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 subject device, predicate device and reference device, but those differences do not raise new or different questions of safety or effectiveness as compared to the predicate device and reference device. Therefore, the subject SC1 Handheld ultrasound imaging system (Model: SC1) is substantially equivalent to legally marketed predicate device and reference device.

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.

Yanna S. Kang -S

Indications for Use

Indications for Use (Describe)

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510(k) Summary

Date Prepared 1.

2. Submitter's Information & Contact Person

Trade Name, Common Name, Classification 3.

4. Predicate Device

Reference device

ട. Device Description

Indications for Use 6.

7. Comparison of Technical Characteristics with the Predicate Device.

8. Determination of Substantial Equivalence

ECTFCU Co., Ltd.

9. Performance Data

2) Software Validation and Cybersecurity Management

3) Biocompatibility Testing

4) Performance Testing

Clinical Test Summarv [21 CFR 807.92(b)(2)]

10. Conclusion [21 CFR 807.92(b)(3)]

§ 892.1560 Ultrasonic pulsed echo imaging system.

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