(180 days)
No
The document does not mention AI, ML, deep learning, or any related terms in the device description, intended use, or performance studies. The focus is on standard ultrasound imaging modes and signal processing.
No
The device is described as an "Ultrasound Diagnostic System" intended for "ultrasound imaging, measurement, display and analysis", not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The HD60 Series Ultrasound Diagnostic System is a general-purpose ultrasound system." and "The HD60 series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ, neonatal and adult cephalic, trans-rectal, musculo-skeletal (conventional, superficial), cardiac (adult, peripheral vessel, and urology exams." which clearly indicates its purpose is for diagnosis.
No
The device description clearly states it includes hardware components such as a mobile console, control panel, LCD touch panel, LCD display monitor, optional image storage and printing device, and electronic array transducers.
Based on the provided text, 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.
- Device Function: The description clearly states that the HD60 Series Ultrasound Diagnostic System is a "general-purpose ultrasound system" used for "ultrasound imaging, measurement, display and analysis of the human body and fluid." It uses ultrasound waves to create images of internal structures.
- Lack of Sample Testing: There is no mention of the device analyzing samples taken from the body. Its function is to image the body directly.
Therefore, the HD60 Series Ultrasound Diagnostic System falls under the category of imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The HD60 Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment.
The systems support the following clinical applications:
The HD60 series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ, neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vessel, and urology exams.
Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The HD60 Series consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor and optional image storage and printing device. It includes a variety of electronic array transducers operating in linear, curved, sector/phase array, and real time 3D transducer. HD60 series is a Track 3 diagnostic ultrasound system. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through LAN.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
fetal, abdominal, pediatric, small organ, neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vessel, and urology
Indicated Patient Age Range
adults, pregnant women, pediatric patients and neonates
Intended User / Care Setting
Qualified and trained physician / Hospital environment
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
June 8, 2022
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring a stylized human figure. To the right of the HHS logo is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Qingdao Hisense Medical Equipment Co., Ltd % Yalan Wu Regulatory Affair Manager No. 399 Songling Road, Laoshan District Qingdao, Shandong 266100 P. R. CHINA
Re: K213862
Trade/Device Name: HD60 Series Ultrasound Diagnostic System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: April 29, 2022 Received: May 10, 2022
Dear Yalan Wu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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,
For
Michael D. O'Hara, Ph.D. Deputy Director DHT 8C: Division of Radiological Imaging and Radiation Therapy Devices OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
HD60 Series Ultrasound diagnostic System
Indications for Use (Describe)
The HD60 Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment.
The systems support the following clinical applications:
The HD60 series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ, neonatal and adult cephalic, trans-rectal, musculo-skeletal (conventional, superficial), cardiac (adult, peripheral vessel, and urology exams.
Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/ Power/PWD.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Premarket Notification Submission
510(k) Summary
(K213862)
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date Prepared: | Nov 26, 2021 |
|---|---|
| Manufacturer: | Qingdao Hisense Medical Equipment Co., Ltd |
| No. 399 Songling Road, Laoshan District | |
| 266100, Qingdao, Shandong, P. R. China | |
| Contact Person: | Yalan Wu |
| Regulatory Affair Mananger | |
| Qingdao Hisense Medical Equipment Co., Ltd | |
| Tel: +86-532-55752797 |
wuyalan@Hisense.com
ldentification of the Device:
| Proprietary/Trade Name: | HD60 Series Ultrasound Diagnostic System |
|---|---|
| Classification Name: | Ultrasound Diagnostic System |
| Regulatory Number: | 21 CFR 892.1550, 21 CFR 892.1560, 21 CFR 892.1570 |
| Product Code: | IYN,IYO,ITX |
| Device Class: | Class II |
| Review Panel: | Radiology |
Identification of the Legally Marketed Predicate Device:
| Trade Name: | DC-80/DC-80PRO/DC-80EXP/DC-80S/DC-85
/DC-86/DC-86S/DC-89/DC-TV/DC-TQ |
|--------------------------|-------------------------------------------------------------------------|
| Classification Name: | Ultrasound Diagnostic System |
| Regulatory Number: | 21 CFR 892.1550, 1560, 1570 |
| Product Code: | IYN, ITX, IYO, LLZ |
| Device Class: | Class II |
| Review Panel: | Radiology |
| Submitter/510(k) Holder: | Shenzhen Mindray Bio-medical Electronics
Co., LTD. |
| Clearance: | K192152 (cleared December 13, 2019) |
4
| Reference Device: | |
|---|---|
| Trade Name: | DC-70/DC-70T/DC-70 Pro/DC-70 Exp |
| Classification Name: | Ultrasound Diagnostic System |
| Regulatory Number: | 21 CFR 892.1550, 1560, 1570 |
| Product Code: | IYN, ITX, IYO, LLZ |
| Device Class: | Class II |
| Review Panel: | Radiology |
| Submitter/510(k) Holder: | Shenzhen Mindray Bio-medical Electronics |
| Co., LTD. | |
| Clearance: | K150204 (cleared April 10, 2015) |
Device Description:
The HD60 Series consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor and optional image storage and printing device. It includes a variety of electronic array transducers operating in linear, curved, sector/phase array, and real time 3D transducer. HD60 series is a Track 3 diagnostic ultrasound system. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through LAN.
Indications for Use:
The HD60 Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment.
The systems support the following clinical applications:
The HD60 series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ, neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vessel, and urology exams.
Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
Comparison with Predicate Device:
5
510(k) Premarket Notification Submission
The HD60 series Ultrasound Diagnostic System and its predicate device, the DC-80/DC-80PRO/DC-80EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/ DC-TQ Ultrasound Diagnostic System (K192152), have the same intended use, and similar physical characteristics.
| Description | Subject Device
Hisense HD60 Ultrasound
Diagnostic System | Predicate Device
Mindray DC80 Ultrasound
Diagnostic System
(K192152) |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | It is intended for use in
abdominal, fetal, pediatric,
Small Organ, neonatal and
adult cephalic, trans-rectal,
trans-vaginal,
musculo-skeletal(conventiona
l, superficial), cardiac(adult,
pediatric), peripheral vessel,
and urology exams. | It is intended for use in
abdominal, fetal,
intra-operative(abdominal,
thoracic, and vascular),
pediatric, Small
Organ(breast, thyroid,
testes), neonatal and adult
cephalic, trans-rectal,
trans-vaginal,
musculo-skeletal(conventiona
l, superficial), cardiac(adult,
pediatric),
trans-esoph.(Cardiac),
peripheral vessel, and
urology exams. |
| User | Qualified and trained
physician | Qualified and trained
physician |
| Environment | Hospital environment | Hospital environment |
| Design | Autocorrelation for color
processing and FFT for pulse
Doppler processing.
Supporting Linear, Curve,
Phase array and Volume
probes. | Autocorrelation for color
processing and FFT for pulse
Doppler processing.
Supporting Linear, Curve,
Phase array and Volume
probes. |
| Patient
Contact
Materials | Material meet ISO 10993-1
and FDA guidance | Material meet ISO 10993-1
and FDA guidance |
| Mode
of
operation | 3D/4D Imaging mode, B, M,
PW Doppler, CW Doppler,
Color Doppler, Color M
Doppler, Power Doppler,
Harmonic Imaging, Combined | 3D/4D Imaging mode, B, M,
PW Doppler, CW Doppler,
Color Doppler, Color M
Doppler, Power Doppler,
Harmonic Imaging, Combined |
| Description | Subject Device
Hisense HD60 Ultrasound
Diagnostic System | Predicate Device
Mindray DC80 Ultrasound
Diagnostic System
(K192152) |
| | modes: B/M, B/Color M,
B/PWD or CWD,
B/Color/PWD or CWD,
B/Power/PWD. | modes: B/M, B/Color M,
B/PWD or CWD,
B/Color/PWD or CWD,
B/Power/PWD. |
| Functions | > Spatial compound
imaging | > iBeam |
| | > Frequency compound
imaging | > Frequency compound
imaging |
| | > One-Click Optimization
Speckle reduction
imaging (SRI) | > iTouch (Auto Image
Optimization) |
| | | > iClear image
enhancement |
| | > PDI (power Doppler
imaging), DPDI
(directional power
Doppler imaging), and
TDI (tissue Doppler
imaging) | > PDI (power Doppler
imaging), DPDI
(directional power
Doppler imaging), and
TDI (tissue Doppler
imaging) |
| | > Angle deflection of linear
array probes | > Deflection scanning by
linear array probes |
| | > High-pulse repetition
frequency | > HPRF |
| | > Puncture guidance and
puncture enhancement,
with real-time
double-screen
comparison | > Puncture guidance |
| | > Tissue-specific imaging
Extended imaging
TVI (Tissue Doppler
imaging, TDI)
Curve Anatomical M
Mode
Strain rate imaging | > Tissue-specific imaging
ExFOV (Extended FOV)
Tissue Doppler imaging,
TDI (TVI)
Free Xros CM
Strain rate analysis |
| | > Elastography (Elasticity
imaging) | > Elastography (Elasticity
imaging) |
| Description | Subject Device | Predicate Device |
| | Hisense HD60 Ultrasound | Mindray DC80 Ultrasound |
| | Diagnostic System | Diagnostic System |
| | | (K192152) |
| | > High-resolution blood flow | > High-resolution blood flow |
| | > Image comparison
(dynamic and static
images) | > Image comparison
(dynamic and static
images) |
| | > DICOM | > DICOM |
| | > Teaching System | |
| | > ECG | > ECG |
| Measurements | Basic measurement:
Distance, Area,
Circumference
Volume, Velocity, Time | Basic measurement:
Distance, Area,
Circumference
Volume, Velocity, Time |
| | Measurement kits: | Measurement kits: |
| | Routine measurement | Routine measurement |
| | Abdominal measurement kit | Abdominal measurement kit |
| | Gynecological measurement
kit | Gynecological measurement
kit |
| | Obstetric measurement kit | Obstetric measurement kit |
| | Urological measurement kit | Urological measurement kit |
| | Small part measurement kit | Small part measurement kit |
| | Vascular measurement kit | Vascular measurement kit |
| | Cardiac measurement kit | Cardiac measurement kit |
| | Pediatric measurement kit | Pediatric measurement kit |
| | Emergency measurement kit | Emergency measurement kit |
| | Automatic measurement of
intima-media thickness (IMT) | Automatic measurement of
intima-media thickness (IMT) |
| | Automatic spectrum envelope
measurement | Automatic spectrum envelope
measurement |
| Transducer
Types | Convex array
Phased array
Linear array
Micro convex array
Volume | Convex array
Phased array
Linear array
Micro convex array
Volume |
| Acoustic
Output within
FDA
guidelines | Track 3;
Ispta.3 ≤ 720
mW/cm2
MI ≤ 1.9 | Track 3;
Ispta.3 ≤ 720
mW/cm2
MI ≤ 1.9 |
| Description | Subject Device | Predicate Device |
| | Hisense HD60 Ultrasound
Diagnostic System | Mindray DC80 Ultrasound
Diagnostic System
(K192152) |
| | $TI \le 6.0$ | $TI \le 6.0$ |
| general safety
and
effectiveness
information | ANSI/AAMI ES60601-1
IEC60601-2-37
IEC60601-1-2
ISO 10993-1 | ANSI/AAMI ES60601-1
IEC60601-2-37
IEC60601-1-2
ISO 10993-1 |
| Labeling | Conforms to 21 CFR Part 801 | Conforms to 21 CFR Part 801 |
| Accessories | foot switch
ECG cable and Leadwire
B/W Printer | Foot switch
ECG
B/W Printer |
6
510(k) Premarket Notification Submission
7
510(k) Premarket Notification Submission
8
510(k) Premarket Notification Submission
Technology:
The HD60 Series employs the same fundamental scientific technology as its predicated device.
Determination of substantial equivalence:
The Proposed HD60 Series system are substantially equivalent to the predicate the DC-80/DC-80PRO/DC-80EXP/DC-80S/DC-85/DC-86/DC-86S/ DC-89/DC-TV/DC-TQ Ultrasound Diagnostic System (K192152) with regards to intended use, indication for use, image capabilities, technological characteristics, image mode, and safety effectiveness.
The following is an overview of the differences between the proposed HD60 Series and its predicate device.
Comparison Analysis
Note 1:
Indication for use:
The Indication for use of subject device does not support intra-operative (abdominal, thoracic, and vascular) and trans-esoph.(Cardiac). As the subject device does not support intra-operative and trans-esoph probe. It is less than Predicate device. They can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.
Note 2:
Patient Contact Materials:
The Patient Contact Materials of the probes is equivalent to the predicated device, both the subject and predicated device probe material meet ISO 10993-1 and FDA guidance requirement. They can be considered
9
Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.
Note 3:
Functions:
Teaching System is new functions compare with predicate device. Other functions are same, just name description is minor different for some functions. The teaching feature is same as "iScanhelper" of Diagnostic Ultrasound System model DC-70/DC-70T/DC-70 Pro/DC-70 Exp manufactured by Mindray (K150204 cleared on April 10, 2015). By providing the referential information, such as, displays the standard ultrasonic image, anatomical sketch, scanning approach image and scanning tips, the system helps the doctors to operate the scanning by teaching system. Furthermore, it is a good platform for the self-learning and training of ultrasound scanning technique for doctors. The system also plays a role in the assistant software system in fulfilling training and education. It is verified and meet the requirement. It can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.
The teaching system is intended for off line training and not live guidance during real time imaging. The teaching system is for teaching only and should not be used for diagnostic purposes.
Summary of Non-clinical test:
HD60 Series were evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and have been found to comply with applicable medical device safety standard, The HD60 Series complies with voluntary standards:
-
- AAMI/ANSI ES60601-1: Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance, 2005/A2:2012
-
- IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Disturbance - Requirements and tests, 2014
-
- IEC 60601-2-37 Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, Ed2.1, 2015
-
- ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process, 2018
-
- ISO 10993-5 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity
-
- ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization
10
510(k) Premarket Notification Submission
-
- IEC62359, Ultrasonics-Field characterization- Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2017.
-
- ISO 14971 Medical Devices Applications of Risk Management to Medical Devices. 2019
-
- NEMA PS3.1-3.20. Digital Imaging and Communications in Medicine (DICOM) Set.(radiology), 2016.
- 10.IEC 60601-1-6 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability
-
- IEC 62366 Consolidated Version Medical Devices Application of Usability Engineering to Medical Devices
-
- IEC 62304 Medical Device Software Software Life Cycle Processes
The following quality assurance measures are applied to the development of the system:
Risk Management Requirement review and Design reviews Integration testing (system verification) Performance testing (Verification) Safety testing (Verification)
Transducer material and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, did not require clinical studies to support substantial equivalence.
Conclusion:
Hisense Considers the HD60 Series Ultrasound Diagnostic System to be as safe, as effective, and performance is substantially equivalent to the predicate device.