Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos
Device Facts
| Record ID | K260846 |
|---|---|
| Device Name | Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos |
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | May 11, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
MU9, MU9S, MU9T, MU9 Exp, MU9 Pro, MU9 Super, MU9P, MU9A, MU7, MU7S, MU7T, MU7 Exp, MU7 Pro, MU7 Super, MU7P, MU7A Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculoskeletal(conventional), musculo-skeletal(superficial), thoracic/pleural, cardiac adult, cardiac pediatric, peripheral vessel and urology exams. This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic. Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode(Color+B, Power+B), Tissue Harmonic Imaging, iScape View, TDI.
Device Story
Mobile, software-controlled diagnostic ultrasound system; acquires/displays ultrasound images; performs measurements/analysis of anatomical structures and fluid. Inputs: ultrasonic energy transmitted into patient; received echoes processed. Outputs: onscreen display of anatomic structures and flow. Used in hospitals/clinics by qualified healthcare professionals. Supports modes: B, M, PWD, CWD, Color/Amplitude Doppler, Combined modes, Tissue Harmonic Imaging, iScape View, TDI. Assists clinicians in diagnosis via imaging and measurement tools.
Clinical Evidence
Bench testing only. No clinical data required for substantial equivalence. Conformance demonstrated via acoustic output measurements (NEMA UD 2-2004), electrical/mechanical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and usability engineering (IEC 62366-1).
Technological Characteristics
Mobile ultrasound system; ultrasonic pulsed Doppler/echo imaging. Materials: patient-contact components (transducers/needle-guides) compliant with ISO 10993-1. Connectivity: standard ultrasound interface. Software: IEC 62304 compliant. Sterilization: per manufacturer cleaning/disinfection protocols. Standards: NEMA UD 2, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37.
Indications for Use
Indicated for adults, pregnant women, pediatric patients, and neonates for fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, thoracic/pleural, cardiac, peripheral vessel, and urology exams.
Regulatory Classification
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.
Predicate Devices
- Consona N5 (K251853)
Reference Devices
- MX7 (K251192)
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
May 11, 2026
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Xiaolong Fan
Mindray Bldg., Keji 12th Rd. S., Hi-Tech Industrial Park, Nanshan
Shenzhen, Guangdong 518057
CHINA
Re: K260846
Trade/Device Name: Diagnostic Ultrasound System (MU9); Diagnostic Ultrasound System (MU9S); Diagnostic Ultrasound System (MU9T); Diagnostic Ultrasound System (MU9 Exp); Diagnostic Ultrasound System (MU9 Pro); Diagnostic Ultrasound System (MU9 Super); Diagnostic Ultrasound System (MU9P); Diagnostic Ultrasound System (MU9A); Diagnostic Ultrasound System (MU7); Diagnostic Ultrasound System (MU7S); Diagnostic Ultrasound System (MU7T); Diagnostic Ultrasound System (MU7 Exp); Diagnostic Ultrasound System (MU7 Pro); Diagnostic Ultrasound System (MU7 Super); Diagnostic Ultrasound System (MU7P); Diagnostic Ultrasound System (MU7A)
Regulation Number: 21 CFR 892.1550
Regulation Name: Ultrasonic pulsed doppler imaging system
Regulatory Class: Class II
Product Code: IYN, IYO, ITX
Dated: March 15, 2026
Received: March 16, 2026
Dear Xiaolong Fan:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
{1}
K260846 - Xiaolong Fan
Page 2
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).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
{2}
K260846 - Xiaolong Fan
Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-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 | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K260846 | ? |
| Please provide the device trade name(s). | | ? |
| Diagnostic Ultrasound System (MU9); Diagnostic Ultrasound System (MU9S); Diagnostic Ultrasound System (MU9T); Diagnostic Ultrasound System (MU9 Exp); Diagnostic Ultrasound System (MU9 Pro); Diagnostic Ultrasound System (MU9 Super); Diagnostic Ultrasound System (MU9P); Diagnostic Ultrasound System (MU9A); Diagnostic Ultrasound System (MU7); Diagnostic Ultrasound System (MU7S); Diagnostic Ultrasound System (MU7T); Diagnostic Ultrasound System (MU7 Exp); Diagnostic Ultrasound System (MU7 Pro); Diagnostic Ultrasound System (MU7 Super); Diagnostic Ultrasound System (MU7P); Diagnostic Ultrasound System (MU7A) | | |
| Please provide your Indications for Use below. | | ? |
| MU9, MU9S, MU9T, MU9 Exp, MU9 Pro, MU9 Super, MU9P, MU9A, MU7, MU7S, MU7T, MU7 Exp, MU7 Pro, MU7 Super, MU7P, MU7A Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculoskeletal(conventional), musculo-skeletal(superficial), thoracic/pleural, cardiac adult, cardiac pediatric, peripheral vessel and urology exams. This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic. Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode(Color+B, Power+B), Tissue Harmonic Imaging, iScape View, TDI. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☑ Neonates/Newborns (Birth to < 29 days old) ☑ Infants (29 days old to < 2 years old) ☑ Children (2 years old to < 12 years old) ☑ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? |
{4}
# 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92(c).
The assigned 510(k) number: K260846
## 1. Submitter
Shenzhen Mindray Bio-medical Electronics Co., LTD
Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
Tel: +86 755 8188 7215
Fax: +86 755 2658 2680
## Contact Person
Fan Xiaolong
Shenzhen Mindray Bio-medical Electronics Co., LTD
Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
**Date Prepared**: April 28, 2026
## 2. Device Name
- Diagnostic Ultrasound System (MU9);
- Diagnostic Ultrasound System (MU9S);
- Diagnostic Ultrasound System (MU9T);
- Diagnostic Ultrasound System (MU9 Exp);
- Diagnostic Ultrasound System (MU9 Pro);
- Diagnostic Ultrasound System (MU9 Super);
- Diagnostic Ultrasound System (MU9P);
- Diagnostic Ultrasound System (MU9A);
- Diagnostic Ultrasound System (MU7);
- Diagnostic Ultrasound System (MU7S);
- Diagnostic Ultrasound System (MU7T);
- Diagnostic Ultrasound System (MU7 Exp);
- Diagnostic Ultrasound System (MU7 Pro);
- Diagnostic Ultrasound System (MU7 Super);
- Diagnostic Ultrasound System (MU7P);
{5}
Diagnostic Ultrasound System (MU7A)
## Classification
Regulatory Class: II
Review Category: Tier II
21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (IYN)
21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO)
21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)
## 3. Predicate devices
MU9/MU7 series Diagnostic Ultrasound System is comparable with and substantially equivalent to the predicate devices listed below. Consona N5 is the main predicate devices.
| Device | Manufacturer | Model | Device Class | Product Code | 510K Number |
| --- | --- | --- | --- | --- | --- |
| 1. Main predicate device | Mindray | Consona N5 | II | IYN, IYO, ITX | K251853 |
| 2. Reference device | Mindray | MX7 | II | IYN, IYO, ITX | K251192 |
The result shows the conformance of subject device to the predicate devices.
Regulation name and code
21 CFR 892.1550 Ultrasonic Pulsed Dopple Imaging System (IYN)
21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO)
21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)
## 4. Device Description:
The MU9, MU9S, MU9T, MU9 Exp, MU9 Pro, MU9 Super, MU9P, MU9A, MU7, MU7S, MU7T, MU7 Exp, MU7 Pro, MU7 Super, MU7P, MU7A Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode(Color+B, Power+B), Tissue Harmonic Imaging, iScape View, TDI.
The MU9, MU9S, MU9T, MU9 Exp, MU9 Pro, MU9 Super, MU9P, MU9A, MU7, MU7S, MU7T, MU7 Exp, MU7 Pro, MU7 Super, MU7P, MU7A Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.
{6}
5. Intended Use:
MU9, MU9S, MU9T, MU9 Exp, MU9 Pro, MU9 Super, MU9P, MU9A, MU7, MU7S, MU7T, MU7 Exp, MU7 Pro, MU7 Super, MU7P, MU7A Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional), musculo-skeletal(superficial), thoracic/pleural, cardiac adult, cardiac pediatric, peripheral vessel and urology exams.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode(Color+B, Power+B), Tissue Harmonic Imaging, iScape View, TDI.
6. Comparison with Predicate Devices:
Subject device MU9, MU9S, MU9T, MU9 Exp, MU9 Pro, MU9 Super, MU9P, MU9A, MU7, MU7S, MU7T, MU7 Exp, MU7 Pro, MU7 Super, MU7P, MU7A Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices mentioned in 3. Predicate Devices with regards to intended use, imaging modes, features and functions and technological characteristics.
- All systems transmit ultrasonic energy into patients, perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, as well as calculations.
- Subject device MU9, MU9S, MU9T, MU9 Exp, MU9 Pro, MU9 Super, MU9P, MU9A, MU7, MU7S, MU7T, MU7 Exp, MU7 Pro, MU7 Super, MU7P, MU7A Diagnostic Ultrasound System has the same intended uses as the predicated device Consona N5 (K251853) and are subsets of the Consona N5(K251853). Compared with the predicate device Consona N5 (K251853), the subject device MU9, MU9S, MU9T, MU9 Exp, MU9 Pro, MU9 Super, MU9P, MU9A, MU7, MU7S, MU7T, MU7 Exp, MU7 Pro, MU7 Super, MU7P, MU7A Diagnostic Ultrasound System has removed intra-operative (abdominal, thoracic, and vascular) uses.
{7}
The patient contact materials of the transducers and needle-guided brackets of subject device MU9, MU9S, MU9T, MU9 Exp, MU9 Pro, MU9 Super, MU9P, MU9A, MU7, MU7S, MU7T, MU7 Exp, MU7 Pro, MU7 Super, MU7P, MU7A Diagnostic Ultrasound System are the same to the predicate devices or tested under ISO 10993-1.
The acoustic power levels of MU9, MU9S, MU9T, MU9 Exp, MU9 Pro, MU9 Super, MU9P, MU9A, MU7, MU7S, MU7T, MU7 Exp, MU7 Pro, MU7 Super, MU7P, MU7A Diagnostic Ultrasound System are below the limits of FDA, which are the same as the predicated devices Consona N5 (K251853).
MU9, MU9S, MU9T, MU9 Exp, MU9 Pro, MU9 Super, MU9P, MU9A, MU7, MU7S, MU7T, MU7 Exp, MU7 Pro, MU7 Super, MU7P, MU7A Diagnostic Ultrasound System is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device Consona N5 (K251853).
MU9, MU9S, MU9T, MU9 Exp, MU9 Pro, MU9 Super, MU9P, MU9A, MU7, MU7S, MU7T, MU7 Exp, MU7 Pro, MU7 Super, MU7P, MU7A Diagnostic Ultrasound System has the equivalent features and functions as the predicated devices Consona N5 (K251853).
For the differences compared to the predicate devices:
| Indications for use | Compared with the predicate device Consona N5 (K251853), the subject device MU9, MU9S, MU9T, MU9 Exp, MU9 Pro, MU9 Super, MU9P, MU9A, MU7, MU7S, MU7T, MU7 Exp, MU7 Pro, MU7 Super, MU7P, MU7A Diagnostic Ultrasound System has removed intra-operative (abdominal, thoracic, and vascular) uses. |
| --- | --- |
| Options software | Compared to the predicate device Consona N5 (K251853), the subject device MU9, MU9S, MU9T, MU9 Exp, MU9 Pro, MU9 Super, MU9P, MU9A, MU7, MU7S, MU7T, MU7 Exp, MU7 Pro, MU7 Super, MU7P, MU7A Diagnostic Ultrasound System has removed the following features: 4D, TDI QA, Contrast Imaging, Contrast Imaging QA, LVO, Strain Elastography, Tissue Tracking QA, Smart 3D, iPage+, SCV+, iLive, Color 3D, Niche, Smart Volume, Smart Face, Smart OB, Smart NT, AutoEF, Smart Hip, and iVocal. |
| Transducers | Compared to the predicate device Consona N5 (K251853), the subject device MU9, MU9S, MU9T, MU9 Exp, MU9 Pro, MU9 Super, MU9P, MU9A, MU7, MU7S, MU7T, MU7 Exp, MU7 Pro, MU7 Super, MU7P, MU7A Diagnostic Ultrasound System has removed the following transducers: C6-1m, C5-1m, L14-3m, L13-3m, V11-3m, SP5-1m, D7-2m, D6-2m, V11-3m-B, L9-3m, HS14-5Lm, P8-2m, CW2s, CW5s, and mC11-3m. |
{8}
7. Non-clinical Tests:
MU9, MU9S, MU9T, MU9 Exp, MU9 Pro, MU9 Super, MU9P, MU9A, MU7, MU7S, MU7T, MU7 Exp, MU7 Pro, MU7 Super, MU7P, MU7A Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and this device has been designed to conform with applicable medical safety standards.
This device has been tested and evaluated under the following standards:
- NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3.
- ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)].
- IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- 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.
- 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.
- ISO 14971 Third Edition 2019-12, Medical devices - Application of risk management 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.
- IEC 62304 Edition 1.1 2015-06, 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.
These non-clinical tests relied on in this premarket notification submission can support the determination of substantial equivalence of the subject device.
8. Clinical Studies
{9}
Not applicable. The subject of this submission, MU9, MU9S, MU9T, MU9 Exp, MU9 Pro, MU9 Super, MU9P, MU9A, MU7, MU7S, MU7T, MU7 Exp, MU7 Pro, MU7 Super, MU7P, MU7A Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.
## 9. Summary
Based on the performance data as documented in the study, MU9, MU9S, MU9T, MU9 Exp, MU9 Pro, MU9 Super, MU9P, MU9A, MU7, MU7S, MU7T, MU7 Exp, MU7 Pro, MU7 Super, MU7P, MU7A Diagnostic Ultrasound System was found to have a safety and effectiveness profile that is similar to the predicate device.
## 10. Conclusion:
Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the MU9, MU9S, MU9T, MU9 Exp, MU9 Pro, MU9 Super, MU9P, MU9A, MU7, MU7S, MU7T, MU7 Exp, MU7 Pro, MU7 Super, MU7P, MU7A Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to the predicate devices.
