(167 days)
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.
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.
The provided document describes the regulatory submission for the NUSONO Handheld Ultrasound Scanner, not a study evaluating its acceptance criteria. Therefore, most of the requested information cannot be extracted from the provided text.
Specifically:
- Acceptance Criteria and Reported Device Performance: The document does not list specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy for a particular diagnostic task) or the device's measured performance against such criteria. It notes non-clinical performance tests for compliance with general medical device standards.
- Sample size and data provenance for the test set: Not applicable as a clinical study proving acceptance criteria is not detailed.
- Number of experts and qualifications for ground truth: Not applicable.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone (algorithm only) performance: Not explicitly discussed in terms of a clinical study.
- Type of ground truth: Not applicable as no clinical study is presented.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document focuses on demonstrating substantial equivalence to predicate devices through a comparison of intended use, technological characteristics, and compliance with non-clinical performance standards (electrical safety, EMC, software, biocompatibility, etc.). It explicitly states: "The NUSONO Handheld Ultrasound Scanner did not require clinical testing to establish substantial equivalence."
{0}------------------------------------------------
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.
{1}------------------------------------------------
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (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
{3}------------------------------------------------
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the 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 ChiouGeneral ManagerNurodata 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: | |
|---|---|---|
| -- | -------------- | ---------------- |
{5}------------------------------------------------
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 UltrasoundSystem | 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.
{6}------------------------------------------------
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 Predicatedevice | Reference device | Reference device | Reference device |
|---|---|---|---|---|---|
| 510k number | Current submission | K222365 | K192107 | K191235 | K121983 |
| Device name | NUSONO HandheldUltrasound Scanner | Leltek UltrasoundImaging System(Model: LU700Series) | Clarius UltrasoundScanner | Leltek UltrasoundImaging System | UP600 DiagnosticDoppler UltrasoundSystem |
| Product code | IYN, IYO, ITX | IYN, IYO, ITX | IYN, IYO, ITX | IYN, IYO, ITX | IYN, IYO, ITX |
| Intended use | Diagnosticultrasound imagingand fluid flowanalysis of thehuman body. | Diagnosticultrasound imagingor fluid flowanalysis of thehuman body. | Diagnosticultrasound imagingand fluid flowanalysis. | Diagnosticultrasound imagingor fluid flowanalysis of thehuman body. | The device is ageneral-purposeultrasonic imaginginstrument intendedfor use by a qualifiedphysician forevaluation ofAbdomen, Cardiac,Small Organ (breast,testes, thyroid), heart |
| Items | Application device | Primary Predicatedevice | Reference device | Reference device | Reference device |
| 510k number | Current submission | K222365 | K192107 | K191235 | K121983 |
| softtissue, PeripheralVascular,Musculo-skeletal(Conventional andSuperficial),Pediatric, Fetal,Cephalic, Ob/Gyn. | |||||
| Indicationsfor 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 Predicatedevice | Reference device | Reference device | Reference device |
| 510k number | Current submission | K222365 | K192107 | K191235 | K121983 |
| - Peripheral vessel- Carotid- Lung | - Peripheral vessel- Carotid- Pulmonary- interventionalguidance(includes free handneedle/catheter) | - Peripheral vessel | - Peripheral vessel | --- | |
| Modes ofoperation | - 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) |
| Wirelesscapability | Wi-Fi | Wi-Fi | Wi-FiBluetooth | Wi-Fi | N/A |
| Transducertypes | - Convex(NUSONO-C35)- Linear | - Linear | - Convex(C3 HD) | - Linear | - |
| Items | Application device | Primary Predicatedevice | 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 Androidmobile device | iOS or Androidmobile device andWindows | iOS or Androidmobile device | Android mobiledevice | Color 15-inch LCDdisplay |
| 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/AAMIES60601-1 (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/AAMIES60601-1 (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/AAMIES60601-1 (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 Predicatedevice | 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---- |
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
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 2020-08CONSOLIDATED VERSION | Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance |
| IEC 60601-1-2 Edition 4.12020-09 CONSOLIDATEDVERSIONANSI AAMI IEC 60601-1-2:2014[Including AMD 1:2021] | Medical electrical equipment – Part 1–2: Generalrequirements for basic safety and essentialperformance - Collateral Standard: Electromagneticdisturbances - Requirements and tests |
| IEC 60601-1-6 Edition 3.22020-07 CONSOLIDATEDVERSION | Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essentialperformance - Collateral standard: Usability |
| IEC 60601-2-37 Edition 2.1 2015 | Medical electrical equipment – Part 2–37: Particularrequirements for the basic safety and essentialperformance of ultrasonic medical diagnostic andmonitoring equipment |
| IEC 62133-2 Edition1.0 2017-02 | Secondary cells and batteries containing alkaline orother non-acid electrolytes - Safety requirements forportable sealed secondary cells, and for batteries madefrom them, for use in portable applications - Part 2:Lithium systems |
| IEC 62304 Edition 1.1 2015-06CONSOLIDATED VERSION | Medical Device Software - Software Life CycleProcesses |
| IEC 62366-1 Edition 1.1 2020-06CONSOLIDATED VERSION | Medical devices - Part 1: Application of usabilityengineering to medical devices |
| ISO 10993-1 Fifth edition2018-08 | Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk managementprocess |
| ISO 10993-5 Third edition2009-06-01 | 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 edition2021-01 | Biological evaluation of medical devices - Part 23:Tests for Irritation |
| ISO 11737-1 Third edition2018-01 [Including AMD1:2021] | Sterilization of health care products - Microbiologicalmethods - Part 1: Determination of a population ofmicroorganisms on products |
| ISO 13485:2016 | Medical Devices - Quality management systems |
| ISO 14971 Third Edition | Medical devices - Applications of risk management tomedical devices |
| ISO 15223-1 Fourth edition2021-07 | Medical Devices - Symbols to be used withinformation to be supplied by the manufacturer - Part1: 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 1.02016-05 | Medical electrical equipment - Part 4-2: Guidance andinterpretation - Electromagnetic immunity:performance of medical electrical equipment andmedical electrical systems |
| AAMI TIR69:2017/(R2020) | Technical Information Report Risk management ofradio-frequency wireless coexistence for medicaldevices and systems |
| IEEE ANSI USEMCSCC63.27-2021 | American National Standard for Evaluation ofWireless Coexistence |
| ANSI/AAMI SW96:2023 | Standard For Medical Device Security - Security RiskManagement For Device Manufacturers |
| ANSI ISA 62443-4-1-2018 | Security for industrial automation and control systemsPart 4-1: Product security development life-cyclerequirements. |
| AAMI TIR 57:2016 | Principles for medical device security - Riskmanagement. |
| AAMI TIR 97:2019 | Principles For Medical Device Security - PostmarketRisk Management For Device Manufacturers |
| UL ANSI 2900-2-1 First Edition2017 | Standard for Safety, Software Cybersecurity forNetwork-Connectable Products, Part 2-1: ParticularRequirements for Network Connectable Componentsof 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 1.02021-12 | 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.
{14}------------------------------------------------
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
§ 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.