Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related terms, and the description of the technology focuses on traditional ultrasound processing and beamforming.

Therapeutic

No.
The device is indicated for "diagnostic ultrasound imaging and fluid flow analysis," and the applications listed are all for diagnostic purposes. There is no mention of therapeutic use.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for diagnostic ultrasound imaging and fluid flow analysis" and provides "diagnostic ultrasound imaging" in various modes. The "Device Description" also refers to it as a "diagnostic ultrasound system".

SaMD (Software as a Medical Device)

No

The device description explicitly states the system consists of "a series of wireless transducers" which are hardware components, in addition to the software application.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body.
NUSONO Handheld Ultrasound Scanner Function: The description clearly states that the NUSONO Handheld Ultrasound Scanner is a system for diagnostic ultrasound imaging and fluid flow analysis. This involves using ultrasound waves to create images of internal body structures and assess blood flow within the body.

The device operates by interacting directly with the patient's body (applying the transducer to the skin) to acquire data, which is the opposite of how an IVD functions.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The NUSONO Handheld Ultrasound Scanner is a portable and software-based ultrasound imaging system, indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:

NUSONO-C35
Fetal, Abdominal, Pediatric, Urology, Gynecology, Lung

NUSONO-L75
Pediatric, Small Organ (Thyroid, Prostate, Scrotum, Breast), Musculoskeletal (Superficial and Conventional), Peripheral Vessel, Others (Carotid), Lung

NUSONO-P25
Fetal, Abdominal, Pediatric, Urology, Gynecology, Cardiac (adult and pediatric), Lung

The system provides diagnostic ultrasound imaging in B mode, M mode, Color Doppler mode, Power Doppler mode and combine mode (B+M. B+CD. B+PD), intended for use in environments where healthcare is provided by trained healthcare professionals. The environments where the system can be used include physician offices, clinics, hospitals, and clinical point of care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high.

Product codes

IYN, IYO, ITX

Device Description

The NUSONO Handheld Ultrasound Scanner is a portable, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through an off-the-self (OTS) iOS 14, 15 and Android 12 or higher versions based mobile device. The system consists of a series of wireless transducers employing Wi-Fi-based technology to communicate with the NUSONO App on traditional smartphone/tablet devices via direct Wi-Fi. The NUSONO App provides the interface for mode/setting control and image display, acquisition, and storage functions. The 128-channel beamformer and image signal processing technology maximize the utility of all imaging transducer elements to enhance the diagnostic utility and confidence provided by the system.

This transportable system is intended for use in environments where healthcare is provided by trained healthcare professionals.

The NUSONO Handheld Ultrasound Scanner product include:

Scanner models:

NUSONO-C35;
NUSONO-L75: ●
NUSONO-P25; ●

Components:

Software: ●
- o NUSONO App for iOS 14, 15;
- NUSONO App for Android 12; o
Charging dock ●
USB Type-C charging cable ●
Adaptor ●

Accessories:

Carrying bag
Gel dispenser with cap ●
Probe protecting cap of the corresponding probe ●

Mentions image processing

Yes, "image signal processing technology maximize the utility of all imaging transducer elements to enhance the diagnostic utility and confidence provided by the system."

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Urology, Gynecology, Lung, Small Organ (Thyroid, Prostate, Scrotum, Breast), Musculoskeletal (Superficial and Conventional), Peripheral Vessel, Carotid, Cardiac (adult and pediatric).

Indicated Patient Age Range

Adult and pediatric (specific to Cardiac application), Pediatric (general application), Fetal.

Intended User / Care Setting

Trained healthcare professionals. Physician offices, clinics, hospitals, and clinical point of care.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Non-clinical performance tests include measurement accuracy, system sensitivity, thermal, mechanical, electrical safety, patient-contact materials, cleaning and disinfection, software and acoustic output. Nonclinical performance tests show compliance to the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, IEC 62133-2, IEC 62304, IEC 62366-1, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23, ISO 11737-1, ISO 13485:2016, ISO 14971, ISO 15223-1, ISO 7000, IEC 60417:2002 DB, ISO 7010, 21 CFR 801.109, 2002/96/EC (WEEE), IEC TR 60601-4-2, AAMI TIR69:2017/(R2020), IEEE ANSI USEMCSC C63.27-2021, ANSI/AAMI SW96:2023, ANSI ISA 62443-4-1-2018, AAMI TIR 57:2016, AAMI TIR 97:2019, UL ANSI 2900-2-1 First Edition 2017, NIST Cybersecurity Framework (CSF) 2.0, NIST SP 800-53 Rev. 5, IEC 81001-5-1.
Clinical Performance Test: The NUSONO Handheld Ultrasound Scanner did not require clinical testing to establish substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K222365

Reference Device(s)

K192107, K191235, K121983

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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February 20, 2025

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure, while the FDA acronym and name are written in blue, with the acronym in a square and the name in a sans-serif font.

Nurodata Inc. Hao-Ching Chiu Project Specialist 5F.-3, No. 6-2, Sec.2, Shengyi Rd. Hsinchu Science Park Zhubei. 302058 Taiwan

Re: K242681

Trade/Device Name: NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: January 23, 2025 Received: January 23, 2025

Dear Hao-Ching Chiu:

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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

2

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

YANNA S. KANG -S

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K242681

Device Name

NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25)

ndications for Use (Describe)

The NUSONO Handheld Ultrasound Scanner is a portable and software-based ultrasound imaging system, indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:

NUSONO-C35

Fetal, Abdominal, Pediatric, Urology, Gynecology, Lung

NUSONO-L75

Pediatric, Small Organ (Thyroid, Prostate, Scrotum, Breast), Musculoskeletal (Superficial and Conventional), Peripheral Vessel, Others (Carotid), Lung

NUSONO-P25

Fetal, Abdominal, Pediatric, Urology, Gynecology, Cardiac (adult and pediatric), Lung

The system provides diagnostic ultrasound imaging in B mode, M mode, Color Doppler mode, Power Doppler mode and combine mode (B+M. B+CD. B+PD), intended for use in environments where healthcare is provided by trained healthcare professionals. The environments where the system can be used include physician offices, clinics, hospitals, and clinical point of care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high.

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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Image /page/4/Picture/0 description: The image shows the word "NURODATA" in a stylized font. The first four letters, "NURO," are in blue, while the last four letters, "DATA," are in red. The font is rounded and sans-serif, giving the word a modern and playful appearance.

510(k) Summary

1. Submitter's Information:

| Submitter: | Hsien-chen Chiou
General Manager
Nurodata Inc. |
|----------------|--------------------------------------------------------------------------------------------------------------------|
| Address: | 5F.-3, No. 6-2, Sec. 2, Shengyi Rd.,
Hsinchu Science Park,
Zhubei City, Hsinchu County 302058 Taiwan, R.O.C. |
| Email: | service@nurodata.com |
| Tel: | (+886) 3 6588233 |
| Fax: | (+886) 3 6588232 |
| Website: | www.nurodata.com |
| Date prepared: | 09/06/2024 |

2. Name of Device and Class:

Device Name:	NUSONO Handheld Ultrasound Scanner (NUSONO-C35)
	NUSONO Handheld Ultrasound Scanner (NUSONO-L75)
	NUSONO Handheld Ultrasound Scanner (NUSONO-P25)
Common Name:	Diagnostic Ultrasound System and Accessories
Classification:	Class II
Panel:	Radiology

Classification Name:

21 CFR Section	Classification Name	Product Code
892.1550	Ultrasonic Pulsed Doppler Imaging System	90 IYN
892.1560	Ultrasonic Pulsed Echo Imaging System	90 IYO
892.1570	Diagnostic Ultrasound Transducer	90 ITX

3. Predicate Device:

	Device Name:	510(k) Number:
--	--------------	----------------

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Image /page/5/Picture/0 description: The image shows the logo for NuroData. The word "Nuro" is in blue, and the word "Data" is in red. The font is sans-serif and rounded.

| Primary predicate | Leltek Ultrasound Imaging System (Model:
LU700 Series) | K222365 |
|-------------------|-----------------------------------------------------------|---------|
| Reference | Clarius Ultrasound Scanner | K192107 |
| Reference | Leltek Ultrasound Imaging System | K191235 |
| Reference | UP600 Diagnostic Doppler Ultrasound
System | K121983 |

4. Description of the Device:

The NUSONO Handheld Ultrasound Scanner is a portable, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through an off-the-self (OTS) iOS 14, 15 and Android 12 or higher versions based mobile device. The system consists of a series of wireless transducers employing Wi-Fi-based technology to communicate with the NUSONO App on traditional smartphone/tablet devices via direct Wi-Fi. The NUSONO App provides the interface for mode/setting control and image display, acquisition, and storage functions. The 128-channel beamformer and image signal processing technology maximize the utility of all imaging transducer elements to enhance the diagnostic utility and confidence provided by the system.

Image /page/5/Figure/4 description: The image shows a diagram of a transducer and a screenshot of the NUSONO app. The transducer diagram shows the different components of the device, including the transducer, ultrasound beams and imaging processing, energy management, Wi-Fi connection, and power supply. The NUSONO app screenshot shows an ultrasound image and the app's user interface, which includes controls for depth, contrast, TGC, and filter.

This transportable system is intended for use in environments where healthcare is provided by trained healthcare professionals.

Intended users will be qualified and appropriately trained healthcare professionals with ultrasound.

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The NUSONO Handheld Ultrasound Scanner product include:

1. Scanner models:

NUSONO-C35;
NUSONO-L75: ●
NUSONO-P25; ●

2. Components:

Software: ●
- o NUSONO App for iOS 14, 15;
- NUSONO App for Android 12; o
Charging dock ●
USB Type-C charging cable ●
Adaptor ●

3. Accessories:

Carrying bag
Gel dispenser with cap ●
Probe protecting cap of the corresponding probe ●

5. Intended Use of the Device:

Diagnostic ultrasound imaging and fluid flow analysis of the human body.

Indication for Use:

The NUSONO Handheld Ultrasound Scanner is a portable and software-based ultrasound imaging system, indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:

NUSONO-C35

Fetal, Abdominal, Pediatric, Urology, Gynecology, Lung.

NUSONO-L75

Pediatric, Small Organ (Thyroid, Prostate, Scrotum, Breast), Musculoskeletal (Superficial and Conventional), Peripheral Vessel, Others (Carotid), Lung NUSONO-P25

Fetal, Abdominal, Pediatric, Urology, Gynecology, Cardiac (adult and pediatric), Lung

The system provides diagnostic ultrasound imaging in B mode, M mode, Color Doppler mode, Power Doppler mode and combine mode (B+M, B+CD, B+PD), intended for use in environments where healthcare is provided by trained healthcare professionals. The environments where the system can be used include physician offices, clinics, hospitals, and clinical point of care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high.

7

Image /page/7/Picture/0 description: The image shows the word "NURODATA" in a stylized font. The first four letters, "NURO", are in blue, while the last four letters, "DATA", are in a shade of red. The letters are rounded and connected, giving the word a modern and fluid appearance.

Determination of SE:

The subject device, "NUSONO Handheld Ultrasound Scanner," is a Track 3 system that utilizes the same fundamental scientific technology as the primary predicate device, Leltek Ultrasound Imaging System (K222365), along with the reference devices: Clarius Ultrasound Scanner (K192107), Leftek Ultrasound Imaging System (K191235), and UP600 Diagnostic Doppler Ultrasound System (K121983).

The NUSONO Handheld Ultrasound Scanner shares identical indications for use with the primary predicate device and at least one model of the reference devices. A detailed comparison between the predicate device and the subject device is provided below:

| Items | Application device | Primary Predicate
device | Reference device | Reference device | Reference device |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k number | Current submission | K222365 | K192107 | K191235 | K121983 |
| Device name | NUSONO Handheld
Ultrasound Scanner | Leltek Ultrasound
Imaging System
(Model: LU700
Series) | Clarius Ultrasound
Scanner | Leltek Ultrasound
Imaging System | UP600 Diagnostic
Doppler Ultrasound
System |
| Product code | IYN, IYO, ITX | IYN, IYO, ITX | IYN, IYO, ITX | IYN, IYO, ITX | IYN, IYO, ITX |
| Intended use | Diagnostic
ultrasound imaging
and fluid flow
analysis of the
human body. | Diagnostic
ultrasound imaging
or fluid flow
analysis of the
human body. | Diagnostic
ultrasound imaging
and fluid flow
analysis. | Diagnostic
ultrasound imaging
or fluid flow
analysis of the
human body. | The device is a
general-purpose
ultrasonic imaging
instrument intended
for use by a qualified
physician for
evaluation of
Abdomen, Cardiac,
Small Organ (breast,
testes, thyroid), heart |
| Items | Application device | Primary Predicate
device | Reference device | Reference device | Reference device |
| 510k number | Current submission | K222365 | K192107 | K191235 | K121983 |
| | | | | | soft
tissue, Peripheral
Vascular,
Musculo-skeletal
(Conventional and
Superficial),
Pediatric, Fetal,
Cephalic, Ob/Gyn. |
| Indications
for use | - Fetal

Abdominal
Pediatric
Small organ
Musculoskeletal
(conventional)
Musculoskeletal
(superficial)
Urology
Gynecology
Cardiac adult
Cardiac pediatric | - Ophthalmic
Fetal
Abdominal
Pediatric
Small organ
Neonatal cephalic
Musculoskeletal
(conventional)
Musculoskeletal
(superficial)
Cardiac adult
Cardiac pediatric | - Fetal
Abdominal
Intra-operative
Pediatric
Adult cephalic
Musculoskeletal
(conventional)
Urology
Gynecology
Cardiac adult
Cardiac pediatric | - Abdominal
Small organ
Musculoskeletal
(conventional)
Musculoskeletal
(superficial) | - Abdominal
Neonatal cephalic
Adult cephalic
Cardiac adult
Cardiac pediatric |
| Items | Application device | Primary Predicate
device | Reference device | Reference device | Reference device |
| 510k number | Current submission | K222365 | K192107 | K191235 | K121983 |
| | - Peripheral vessel
Carotid
Lung | - Peripheral vessel
Carotid
Pulmonary
interventional
guidance
(includes free hand
needle/catheter) | - Peripheral vessel | - Peripheral vessel | -

| Modes of
operation | - B mode

M mode
Color doppler (CD)
Power doppler
(PD) | - B mode
M mode
Color doppler (CD)
Power doppler
(PD)
PWD
Combined mode
(B+M, B+CD,
B+PWD) | - B mode
M mode
Color doppler (CD)
Power doppler
(PD)
PWD
Combined mode
(B+M, B+CD,
B+PD, B+PWD) | - B mode
M mode
Color doppler (CD)
Power doppler
(PD)
PWD
Combined mode
(B+M, B+CD,
B+PWD) | - B mode
M mode
Color doppler (CD)
Power doppler
(PD)
PWD
CWD
Combined mode
(B+M, B+CD,
B+PD, B+PWD,
B+CD+PD,
B+PD+PWD) |
| Wireless
capability | Wi-Fi | Wi-Fi | Wi-Fi
Bluetooth | Wi-Fi | N/A |
| Transducer
types | - Convex
(NUSONO-C35)
Linear | - Linear | - Convex
(C3 HD) | - Linear | - |
| Items | Application device | Primary Predicate
device | Reference device | Reference device | Reference device |
| 510k number | Current submission | K222365 | K192107 | K191235 | K121983 |
| | (NUSONO-L75)
Phased array
(NUSONO-P25) | (LU710L)
Phased array
(LU710PA) | - | (LU700L) | - Phased array
(P42) |
| Power source | Rechargable battery
(Li-ion) | Rechargable battery
(Li-ion) | Rechargable battery
(Li-ion) | Rechargable battery
(Li-ion) | Wall powered |
| Display | iOS or Android
mobile device | iOS or Android
mobile device and
Windows | iOS or Android
mobile device | Android mobile
device | Color 15-inch LCD
display |
| 510(k) Track | Track 3 | Track 3 | Track 3 | Track 3 | Track 3 |
| Standards | - IEC 60601-1 (2020)
IEC 60601-1-2
(2020)
IEC 60601-1-6
(2020)
IEC 60601-2-37
(2015)
IEC 60601-4-2
(2016)
UD 2-2004 (R2009)
IEC 62133-2 (2017) | - ANSI/AAMI
ES60601-1 (2012)
IEC 60601-1-2
(2014)
IEC 60601-1-6
(2013)
IEC 60601-2-37
(2015)
UD 2-2004 (R2009)
UD 3-2004 (R2009)
IEC 62133 (2012) | - ANSI/AAMI
ES60601-1 (2012)
IEC 60601-1-2
(2014)
IEC 60601-1-6
(2013)
IEC 60601-1-12
(2014)
IEC 60601-2-37
(2015)
UD 2-2004 (R2009)
IEC 62133 (2012) | - ANSI/AAMI
ES60601-1 (2012)
IEC 60601-1-2
(2014)
IEC 60601-1-6
(2013)
IEC 60601-2-37
(2015)
UD 2-2004 (R2009)
UD 3-2004 (R2009)
IEC 62133 (2012) | - EC 60601-1
EN 60601-1
EN 60601-1-2
EN 60601-2-37
UD 2
UD 3
IEC 62133 (2012) |
| Items | Application device | Primary Predicate
device | Reference device | Reference device | Reference device |
| 510k number | Current submission | K222365 | K192107 | K191235 | K121983 |
| | - IEC 62366-1 (2020)
ISO 10993-1 (2018)
ISO 10993-5 (2009)
ISO 10993-10 (2021)
ISO 10993-23 (2021)
IEC 62304 (2015)
ISO 15223-1 (2021)
ISO 14971 (2019)
ISO 13485 (2016) | - IEC 62366 (2014)
ISO 10993-1 (2009)
ISO 10993-5 (2009)
ISO 10993-10 (2010)
IEC 62304 (2006)
ISO 15223-1 (2016)
ISO 14971 (2019)
ISO 13485 (2016) | - ISO 10993-5 (2009)
ISO 10993-10 (2010)
ISO 10993-11 (2017)
IEC 62304 (2006)
ISO 15223-1 (2012)
ISO 14971 (2007) | - IEC 62366 (2014)
ISO 10993-1 (2009)
ISO 10993-5 (2009)
ISO 10993-10 (2010)
IEC 62304 (2006)
ISO 15223-1 (2016)
ISO 14971 (2019)
ISO 13485 (2016) | -
ISO 10993

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Image /page/12/Picture/0 description: The image shows the word "NURODATA" in a stylized font. The first four letters, "NURO", are in blue, while the last four letters, "DATA", are in red. The letters are rounded and have a modern look. The logo is simple and eye-catching.

6. Non-clinical Performance Test:

Non-clinical performance tests include measurement accuracy, system sensitivity, thermal, mechanical, electrical safety, patient-contact materials, cleaning and disinfection, software and acoustic output. Nonclinical performance tests show compliance to the following standards:

Standard	Title of Standard
IEC 60601-1 Edition 3.2 2020-08
CONSOLIDATED VERSION	Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance
IEC 60601-1-2 Edition 4.1
2020-09 CONSOLIDATED
VERSION
ANSI AAMI IEC 60601-1-2:2014
[Including AMD 1:2021]	Medical electrical equipment – Part 1–2: General
requirements for basic safety and essential
performance - Collateral Standard: Electromagnetic
disturbances - Requirements and tests
IEC 60601-1-6 Edition 3.2
2020-07 CONSOLIDATED
VERSION	Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential
performance - Collateral standard: Usability
IEC 60601-2-37 Edition 2.1 2015	Medical electrical equipment – Part 2–37: Particular
requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and
monitoring equipment
IEC 62133-2 Edition1.0 2017-02	Secondary cells and batteries containing alkaline or
other non-acid electrolytes - Safety requirements for
portable sealed secondary cells, and for batteries made
from them, for use in portable applications - Part 2:
Lithium systems
IEC 62304 Edition 1.1 2015-06
CONSOLIDATED VERSION	Medical Device Software - Software Life Cycle
Processes
IEC 62366-1 Edition 1.1 2020-06
CONSOLIDATED VERSION	Medical devices - Part 1: Application of usability
engineering to medical devices
ISO 10993-1 Fifth edition
2018-08	Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management
process
ISO 10993-5 Third edition
2009-06-01	Biological evaluation of medical devices - Part 5:
Tests for In Vitro Cytotoxicity
ISO 10993-10 Fourth edition	Biological evaluation of medical devices - Part 10:
2021-11	Tests for Skin Sensitization
ISO 10993-23 First edition
2021-01	Biological evaluation of medical devices - Part 23:
Tests for Irritation
ISO 11737-1 Third edition
2018-01 [Including AMD1:2021]	Sterilization of health care products - Microbiological
methods - Part 1: Determination of a population of
microorganisms on products
ISO 13485:2016	Medical Devices - Quality management systems
ISO 14971 Third Edition	Medical devices - Applications of risk management to
medical devices
ISO 15223-1 Fourth edition
2021-07	Medical Devices - Symbols to be used with
information to be supplied by the manufacturer - Part
1: General requirements
ISO 7000 Sixth edition 2019-07	Graphical Symbols for Use on Equipment
IEC 60417:2002 DB
ISO 7010 Third edition 2019-07	Graphical symbols - Safety colors and safety signs -
Registered safety signs
21 CFR 801.109	Code of Federal Regulations Title 21 - FDA -
Prescription devices
2002/96/EC (WEEE)	Waste Electrical and Electronic Equipment Directive
IEC TR 60601-4-2 Edition 1.0
2016-05	Medical electrical equipment - Part 4-2: Guidance and
interpretation - Electromagnetic immunity:
performance of medical electrical equipment and
medical electrical systems
AAMI TIR69:2017/(R2020)	Technical Information Report Risk management of
radio-frequency wireless coexistence for medical
devices and systems
IEEE ANSI USEMCSC
C63.27-2021	American National Standard for Evaluation of
Wireless Coexistence
ANSI/AAMI SW96:2023	Standard For Medical Device Security - Security Risk
Management For Device Manufacturers
ANSI ISA 62443-4-1-2018	Security for industrial automation and control systems
Part 4-1: Product security development life-cycle
requirements.
AAMI TIR 57:2016	Principles for medical device security - Risk
management.
AAMI TIR 97:2019	Principles For Medical Device Security - Postmarket
Risk Management For Device Manufacturers
UL ANSI 2900-2-1 First Edition
2017	Standard for Safety, Software Cybersecurity for
Network-Connectable Products, Part 2-1: Particular
Requirements for Network Connectable Components
of Healthcare and Wellness Systems
NIST Cybersecurity Framework
(CSF) 2.0	Ver. 2024/02/26
NIST SP 800-53 Rev. 5,	Security and Privacy Controls for Information
IEC 81001-5-1 Edition 1.0
2021-12	Health software and health IT systems safety,
effectiveness and security - Part 5-1: Security -
Activities in the product life cycle

13

Image /page/13/Picture/0 description: The image shows the word "NURODATA" in a stylized font. The first four letters, "NURO", are in blue, while the last four letters, "DATA", are in red. The letters are rounded and have a playful appearance.

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Image /page/14/Picture/0 description: The image shows the word "NuroDATA" in a stylized font. The "Nuro" part of the word is in blue, while the "DATA" part is in a shade of red. The letters are rounded and have a playful appearance. The overall design is simple and modern.

7. Clinical Performance Test:

The NUSONO Handheld Ultrasound Scanner did not require clinical testing to establish substantial equivalence.

8. Conclusion:

The NUSONO Handheld Ultrasound Scanner is substantially equivalent to the predicate device. The NUSONO Handheld Ultrasound Scanner functions in a manner similar to and is intended for the same use as the predicate device. Based on the predicate device comparison of indications for use, acoustic output and general safety and effectiveness information, as well as the non-clinical performance test results, it is concluded that this device is as safe and effective as the predicate device for its intended use and performance, and is substantially equivalent to the predicate device.

End of Summary