(226 days)
Not Found
No
The document describes standard ultrasound image processing techniques and does not mention any AI or ML technologies.
No
The device is described as an "Ultrasound Diagnostic System" intended for "ultrasound imaging, measurement, display and analysis," indicating a diagnostic rather than therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "ultrasound imaging, measurement, display and analysis of the human body and fluid" and for "Ultrasound examination and diagnosis of abdomen, obstetrics, gynecology, small organ... and cardiac." The "Device Description" also refers to it as a "high resolution ultrasound diagnostic system." These phrases clearly indicate its primary function is for diagnostic purposes.
No
The device description explicitly mentions hardware components like probes (linear and convex), digital beam forming, and other hardware-dependent technologies, indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "ultrasound imaging, measurement, display and analysis of the human body and fluid." This describes a medical imaging device used for visualizing internal structures, not for testing samples of bodily fluids or tissues in vitro (outside the body).
- Device Description: The description focuses on the technical aspects of ultrasound imaging, such as digital beam forming, real-time dynamic aperture, and image processing functions. These are characteristic of an ultrasound machine.
- Clinical Applications: The listed clinical applications (abdomen, obstetrics, gynecology, small organ, cardiac) are all areas where ultrasound imaging is used for diagnosis in vivo (within the body).
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or performing tests on bodily fluids or tissues outside of the body, which are hallmarks of IVD devices.
Therefore, this device is a medical imaging device, specifically an ultrasound system, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Color Doppler 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:
Ultrasound examination and diagnosis of abdomen, obstetrics, gynecology, small organ (Thyroid, Galactophore, Testis) and cardiac. Modes of operation include: 3D Imaging mode, B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging,Combined modes: B/M, B/Color M, B/PWD , B/Color/PWD ,B/Power/PWD.
Product codes (comma separated list FDA assigned to the subject device)
IYN, ITX, IYO
Device Description
The Color Doppler Ultrasound Diagnostic System is a high resolution ultrasound diagnostic system. It adopts digital beam forming (DBF), real-time dynamic aperture (RDA), real-time dynamic beam apodization (DRA), real-time dynamic receive focusing (DRF), digital-control dynamic frequency scanning (DFS), and frame correlation technologies. The system has an embedded operating system, a humane operation interface, and a flexible management system. It supports various display modes like B, 2B, 4B, BM, and M, offering real-time imaging, freezing, memory, recall, and cine loop capabilities. Functions include multilevel scanning depth, dynamic range, sound output power, focus number, focus space, and focus position adjustment. It also features controllable frame correlation, gamma correction, image reversing, histogram, depth advance, zoom magnification, and no distortion real-time part magnification for abundant image processing. It has perfect image pigeonhole, browse, and management functions. It includes powerful measure software package and complete measurement, calculation, and report functions. The device supports linear and convex probes and is suitable for clinical diagnosis in areas like abdomen, obstetrics, gynecology, small organs, and cardiology.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
abdomen, obstetrics, gynecology, small organ (Thyroid, Galactophore, Testis) and cardiac. Shallow surface
Indicated Patient Age Range
Not Found
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with IEC 60601-1:2020, IEC 60601-1-2:2014+AMD1:2020 CSV, IEC 60601-2-37:2007+AMD1:2015, IEC 62359:2010/AMD1:2017, ISO 10993-5:2009, ISO 10993-10:2010, IEC 62133-2:2017/AMD1:2021, and IEC TR 60601-4-2:2016. No clinical study was included in this submission.
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.
Not Found
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
Image /page/0/Picture/0 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.
May 2, 2024
Contec Medical Systems Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing 102401 CHINA
Re: K232908
Trade/Device Name: Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, ITX, IYO Dated: September 18, 2023 Received: September 19, 2023
Dear Ray Wang:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(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 OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director 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
2
Indications for Use
510(k) Number (if known) K232908
Device Name
Color Doppler Ultrasound Diagnostic System (CMS1700B); Color Doppler Ultrasound Diagnostic System (CMS1700C)
Indications for Use (Describe)
The Color Doppler 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:
Ultrasound examination and diagnosis of abdomen, obstetrics, gynecology, small organ (Thyroid, Galactophore, Testis) and cardiac. Modes of operation include: 3D Imaging mode. B. M. PW Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD, 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
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K232908
-
- Date of Preparation: 04/26/2024
- Sponsor Identification 2.
Contec Medical System Co., Ltd. No.112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei, 066004, China.
Contact Person: Xueyong Li Position: Quality Manager Tel: 86-355-8015490 Fax: 86-355-8015490 Email: pms.qms(@contecmed.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou District, Beijing, 101121, China
Tel: +86-18910677558 Fax: +86-10-52214696 Email: ray.wang@believe-med.com
4
4. Identification of Proposed Device
Trade Name: Color Doppler Ultrasound Diagnostic System Common Name: Color Doppler Ultrasound Diagnostic System Model(s): CMS1700B,CMS1700C
Regulatory Information
Classification Name: System, Imaging, Pulsed Doppler, Ultrasonic;System, Imaging, Pulsed Echo, Ultrasonic;Transducer, Ultrasonic, Diagnostic
Classification:II Product Code:IYN&IYO & ITX Regulation Number:21 CFR 892.1550&892.1560 & 21 CFR 892.1570 Review Panel:Radiology;
Indication For Use Statement:
The Color Doppler 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:
Ultrasound examination and diagnosis of abdomen, obstetrics, gynecology, small organ (Thyroid, Galactophore, Testis) and cardiac. Modes of operation include: 3D Imaging mode, B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging,Combined modes: B/M, B/Color M, B/PWD , B/Color/PWD ,B/Power/PWD.
Device Description
● The apparatus is high resolution ultrasound diagnostic system, which adopts digital beam forming(DBF), real-time dynamic aperture(RDA), real-time dynamic beam apodization (DRA), real-time dynamic receive focusing (DRF), digital-control dynamic frequency scanning (DFS), frame correlation etc. technologies. The image is clear, stable, and high resolution.
● It adopts embedded operating system, which greatly improve the product security and compatibility, and enhance the data processing ability.
- The apparatus is taken more conveniently for its humane operation interface and management ● system, flexible expansibility and compatibility, pop-up menu and keyboard design.
Users can chose different kinds of display modes,such as:B, 2B, 4B, BM, M. Image real-time, ● freeze, memory, calling up and large capability cine loop can be realized; the device possesses multilevel scanning depth, dynamic range, sound output power and focus number, focus space, focus position adjusting etc. functions.
● With controllable frame correlation, gamma correction, image reversing, histogram, depth advance, zoom magnification, no distortion real-time part magnification etc. abundant image processing functions. It is convenient for choice of optimal diagnostic image with perfect image pigeonhole, browse, management functions. Measure, calculation, and report are even complete and convenient with powerful measure software package and perfect measurement.
● The device supports linear probe and convex probe. It has extensive application that is
5
suitable for clinic diagnosis, such as abdomen, obstetrics, gynecology, small organs, cardiology etc. .
| Device
Model | Transducer Model | Type | Frequency | Applicable clinical part | Radius of curvature
or array length |
|-----------------|------------------|-----------------------|----------------|---------------------------------------------------------------------|----------------------------------------|
| CMS1700B | C52-80R60-BDC | convex array5-80L40-BDC | linear array
probe | 2.0MHz—5.0MH | Abdomen | R=60 |
| CMS1700B | L12
probe | 6.0MHz—12.0MHz | Shallow surface, Small
Organs (Thyroid,
Galactophore, Testis) | L=45 |
| CMS1700C | C52-128R60-BEB | convex array5-128L40-BEB | linear array
probe | 2.0MHz—5.0MH | Abdomen | R=60 |
| CMS1700C | L12
probe | 6.0MHz—12.0MHz | Shallow surface, Small
Organs (Thyroid,
Galactophore, Testis) | L=45 |
Table1 Transducer List
Acoustic output reporting table
System Model:CMS1700B
Transducer Model:C5~2-80R60-BDC
| Mode of operation | |||||||
|---|---|---|---|---|---|---|---|
| Global | |||||||
| Maximum | |||||||
| Output Levels | B | M | B+M | PW | B+PW | B+CF/B+PDI/B | |
| +DPDI | B+CF+PW/B+PDI+ | ||||||
| PW/B+DPDI+P | |||||||
| W | |||||||
| Max ISPTA.3(mW/cm²) | 61.54 | 109.23 | 164.46 | 642.45 | 671.60 | 172.05 | 716.90 |
| Min ISPTA.3(mW/cm²) | 15.36 | 27.31 | 41.10 | 160.61 | 167.90 | 43.01 | 179.22 |
| Max MI | 1.51 | 1.51 | 1.51 | 1.17 | 1.51 | 1.51 | 1.51 |
| Min MI | 0.38 | 0.38 | 0.38 | 0.29 | 0.38 | 0.38 | 0.38 |
| Max TIS | 3.93 | 0.73 | 4.27 | 1.14 | 2.65 | 0.77 | 0.72 |
| Min TIS | 0.98 | 0.18 | 1.07 | 0.29 | 0.66 | 0.77 | 0.72 |
| Max TIB | 0.93 | 1.55 | 5.08 | 3.65 | 5.17 | 3.10 | 5.36 |
| Min TIB | 0.98 | 0.39 | 1.27 | 0.91 | 1.29 | 0.77 | 1.34 |
Transducer Model:L12~5-80L40-BDC
| Global Maximum | Mode of operation | |||||||
|---|---|---|---|---|---|---|---|---|
| Output Levels | B | M | B+M | PW | B+PW | B+CF/B+PDI/B | ||
| +DPDI | B+CF+PW/B+PDI+ | |||||||
| PW/B+DPDI+P | ||||||||
| W | ||||||||
| Max ISPTA.3(mW/cm2) | 82.07 | 77.32 | 150.07 | 559.35 | 601.81 | 185.20 | 718.53 | |
| Min ISPTA.3(mW/cm2) | 20.52 | 19.33 | 37.52 | 139.84 | 150.45 | 46.30 | 179.63 | |
| Max MI | 1.58 | 1.58 | 1.58 | 1.45 | 1.58 | 1.58 | 1.58 | |
| Min MI | 0.39 | 0.39 | 0.39 | 0.36 | 0.39 | 0.39 | 0.39 | |
| Max TIS | 0.80 | 0.11 | 0.82 | 0.64 | 0.93 | 0.67 | 1.18 |
6
| Min TIS | 0.20 | 0.03 | 0.20 | 0.
16 | 0.23 | 0.17 | 0.30 |
|---------|------|------|------|----------|------|------|------|
| Max TIB | 0.80 | 0.32 | 1.03 | 1.72 | 2.04 | 0.67 | 2.29 |
| Max TIB | 0.20 | 0.08 | 0.26 | 0.43 | 0.51 | 0.17 | 0.57 |
System Model:CMS1700cB
Transducer Model:C5~2-128R60-BEB
| Mode of operation | |||||||
|---|---|---|---|---|---|---|---|
| Global | |||||||
| Maximum | |||||||
| Output Levels | B | M | B+M | PW | B+PW | B+CF/B+PDI/B | |
| +DPDI | B+CF+PW/B+PDI+ | ||||||
| PW/B+DPDI+P | |||||||
| W | |||||||
| Max ISPTA.3(mW/cm²) | 47.94 | 135.6 | 177.84 | 610.21 | 627.18 | 220.34 | 717.37 |
| Min ISPTA.3(mW/cm²) | 11.98 | 33.92 | 44.46 | 152.55 | 156.80 | 55.09 | 179.34 |
| Max MI | 1.60 | 1.60 | 1.60 | 1.33 | 1.60 | 1.60 | 1.60 |
| Min MI | 0.40 | 0.40 | 0.40 | 0.33 | 0.40 | 0.40 | 0.40 |
| Max TIS | 2.76 | 0.47 | 2.91 | 0.83 | 1.60 | 2.31 | 1.75 |
| Min TIS | 0.69 | 0.12 | 0.73 | 0.21 | 0.40 | 0.58 | 0.44 |
| Max TIB | 2.76 | 1.21 | 3.64 | 3.96 | 4.76 | 2.31 | 4.88 |
| Min TIB | 0.69 | 0.30 | 0.91 | 0.99 | 1.19 | 0.58 | 1.22 |
Transducer Model:L12~5-128L40-BEB
| Mode of operation | |||||||
|---|---|---|---|---|---|---|---|
| Global | |||||||
| Maximum | |||||||
| Output Levels | B | M | B+M | PW | B+PW | B+CF/B+PDI/B | |
| +DPDI | B+CF+PW/B+PDI+ | ||||||
| PW/B+DPDI+P | |||||||
| W | |||||||
| Max ISPTA.3(mW/cm²) | 52.72 | 78.96 | 126.16 | 598.00 | 644.07 | 122.65 | 715.71 |
| Min ISPTA.3(mW/cm²) | 13.18 | 19.74 | 31.54 | 179.50 | 161.02 | 30.66 | 178.93 |
| Max MI | 1.56 | 1.56 | 1.56 | 1.26 | 1.56 | 1.56 | 1.56 |
| Min MI | 0.39 | 0.39 | 0.39 | 0.32 | 0.39 | 0.39 | 0.39 |
| Max TIS | 0.55 | 0.07 | 0.57 | 0.43 | 0.89 | 0.53 | 0.95 |
| Min TIS | 0.14 | 0.2 | 0.14 | 0.11 | 0.22 | 0.13 | 0.24 |
| Max TIB | 0.55 | 0.23 | 0.73 | 2.22 | 2.69 | 0.53 | 2.73 |
| Min TIB | 0.14 | 0.06 | 0.18 | 0.55 | 0.67 | 0.13 | 0.68 |
- ડ. Identification of Predicate Device(s)
Predicate Device :
510(k) Number: K213862
7
Product Name: HD60 Series Ultrasound Diagnostic System Manufacturer:Qingdao Hisense Medical Equipment Co., Ltd
-
Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: -
IEC 60601-1:2020, Medical Electrical Equipment- Part 1: General requirements for basic safety and a. essential performance
-
IEC 60601-1-2:2014+AMD1:2020 CSV Consolidated version, Medical Electrical Equipment-Part b. 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
-
IEC 60601-2-37:2007+AMD1:2015 Medical electrical equipment Part 2-37: Particular C. requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
-
d. IIEC 62359:2010/AMD1:2017 Amendment 1 - Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
-
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity. e.
-
f. ISO 10993-10:2010 Standard, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity
-
IEC 62133-2:2017/AMD1:2021 Amendment 1 Secondary cells and batteries containing alkaline g. 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 TR 60601-4-2:2016 Medical electrical equipment Part 4-2: Guidance and interpretation h. Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems.
-
Clinical Test Conclusion 7.
No clinical study is included in this submission.
8
8. Substantially Equivalent (SE) Comparison
| Item | Proposed Device(s) | Predicate Device(s) | Remark |
|---|---|---|---|
| Device name | Color Doppler Ultrasound Diagnostic System | HD60 Series Ultrasound Diagnostic System | / |
| Regulation Name | Ultrasonic Pulsed Doppler Imaging System | Ultrasonic Pulsed Doppler Imaging System | SE |
| Product Code | IYN, IYO, ITX | IYN, IYO, ITX | SE |
| Regulation Number | 892.1560 | ||
| 892.1570 | |||
| 892.1550 | 892.1560 | ||
| 892.1570 | |||
| 892.1550 | SE | ||
| Comparison | |||
| Statement | The proposed device has same classification information as the predicate device. | ||
| Intended Use | The Color Doppler 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: Ultrasound examination and diagnosis of abdomen, obstetrics, gynecology, small organ (Thyroid, Galactophore, Testis) and cardiac. Modes of operation include: 3D Imaging mode, B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD , B/Color/PWD ,B/Power/PWD. | 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, | Analyse 1 | ||
| CW 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. | |||
| Comparison | |||
| Statement | The proposed device has similar intended use as the predicate device. | ||
| Main Unit Technical Specifications | |||
| User | Qualified and trained physician | Qualified and trained physician | / |
| Environment | Hospital environment | Hospital environment | SE |
| Design | Autocorrelation for color processing and FFT for pulse | ||
| Doppler processing.Supporting Linear and convex array | |||
| probes. | Autocorrelation for color processing and FFT for pulse | ||
| Doppler processing.Supporting Linear, Curve,Phase array | |||
| and Volume probes. | SE | ||
| Patient Contact | |||
| Materials | Material meet ISO 10993-1 and FDA guidance | Material meet ISO 10993-1 and FDA guidance | SE |
| Mode of operation | 3D Imaging mode, B, M,PW Doppler, Color Doppler, Color M | ||
| Doppler, Power Doppler,Harmonic Imaging, Combinedmodes: | |||
| B/M, B/Color M,B/PWD, B/Color/ PWD ,B/Power/PWD. | 3D/4D Imaging mode, B, M,PW Doppler, CW Doppler,Color | ||
| Doppler, Color M Doppler, Power Doppler,Harmonic Imaging, | |||
| Combinedmodes: B/M, B/Color M,B/PWD or CWD, B/Color/ | |||
| PWD or CWD,B/Power/PWD. | Analyse1 | ||
| Functions | Spatial compound imaging | Spatial compound imaging | Analyse2 |
| Frequency compound imaging | |||
| One-Click Optimization Speckle reduction imaging | |||
| (SRI) | |||
| PDI (power Doppler imaging), DPDI(directional power | |||
| Doppler imaging), and TDI (tissue Doppler imaging) | |||
| Angle deflection of linear array probes | |||
| High-pulse repetition frequency | |||
| Puncture guidance and puncture enhancement. | Frequency compound imaging | ||
| One-Click Optimization Speckle reduction imaging | |||
| (SRI) | |||
| PDI (power Doppler imaging), DPDI(directional | |||
| power Doppler imaging), and TDI (tissue Doppler | |||
| imaging) | |||
| Angle deflection of linear array probes | |||
| High-pulse repetition frequency | |||
| with real-time double-screen comparison Tissue-specific imaging Extended imaging TVI (Tissue Doppler imaging, TDI) Curve Anatomical M Mode Strain rate imaging High-resolution blood flow Image comparison(dynamic and static images) | Puncture guidance and puncture enhancement, with real-time double-screen comparison Tissue-specific imaging Extended imaging TVI (Tissue Doppler imaging, TDI) Curve Anatomical M Mode Strain rate imaging Elastography (Elasticity imaging) High-resolution blood flow Image comparison(dynamic and static images) DICOM Teaching System ECG | ||
| Measurements | Basic measurement: Distance, Area,Circumference Volume, | ||
| Velocity, Time | Basic measurement: Distance, Area,Circumference Volume, | ||
| Velocity, Time | SE | ||
| Convex array | |||
| Linear array | Convex array | ||
| Phased array | |||
| Linear array | |||
| Micro convex array | |||
| Volume | |||
| Transducer Types | Analyse2 | ||
| Track 3; | |||
| $Ispta.3 \le 720 mW/cm^2$ | |||
| MI |