(253 days)
No
The document describes standard ultrasound imaging technologies and features, with no mention of AI or ML.
No
The device is an "Ultrasonic Diagnostic Imaging System" intended for "diagnostic ultrasound imaging analysis." Its function is to "produce ultrasound waves into body tissue and to present the returned echo information on the monitor" to acquire and display images. It is not designed to treat conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the systems "are intended for diagnostic ultrasound imaging analysis." Furthermore, the "Device Description" for several models uses phrases like "ultrasound diagnostic examination" and "diagnostic ultrasound system."
No
The device description explicitly states that the system consists of a "main unit, transducers, and other accessories," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The MEDISONO Ultrasonic Diagnostic Imaging System models described are used to produce and interpret ultrasound waves that pass through the body to create images of internal structures. They do not analyze samples taken from the body.
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging analysis" and lists various anatomical sites within the body.
Therefore, while these are diagnostic devices, they fall under the category of medical imaging devices rather than In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Indications for Use: The MEDISONO Ultrasonic Diagnostic Imaging System models P3 Plus, P9 Plus, P25 Expert, P12 Plus, P11 Plus, and MS55 plus are intended for diagnostic ultrasound imaging analysis of adults, pregnant women, pediatric patients in gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The system is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus, Abdomen, Pediatrics, Small Organ, Neonatal Cephalic, Cardiology, Peripheral Vessel, Musculo-skeleton (both Conventional and Superficial), Urology (including prostate), Transrectal and Transvaginal.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The P3 Plus Ultrasound Diagnostic System is a portable digital B/W compact ultrasound system with diagnostic B/W image quality and PW Doppler capability, applied in ultrasound diagnostic examination of abdominal, Vascular, Small Parts, Musculoskeletal, Obstetrics and Gynecology applications. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor. The resulting information is displayed in six display modes: B-Mode, B+B, 4B Mode, M-Mode, and PW. This system controlled by software employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.5MHz- 11MHz. The system consists of a main unit, transducers, and other accessories.
The P9 Plus Ultrasound Diagnostic System is a portable digital compact ultrasound system with multiple imaging modes applied in ultrasound diagnostic examination of f Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testicle, thyroid); Cardiac (adult & pediatric); Peripheral Vascular; Musculo-skeletal Conventional & Superficial; Transrectal and Transvaginal applications. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor, with multiple imaging modes: B-mode, C-mode, M-mode, CW-mode, PW-mode, and PDI mode that employs an array of probes that include linear, Convex and Phase Array probes with a frequency range of approximately 2MHz- 11MHz. The system consists of a main unit, transducers, and other accessories.
The P11 Plus Portable Digital Color Doppler Ultrasound System is a portable ultrasound system with Cardiac measurements, 4D. Elastography and Stress Echo capabilities. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor; with complete imaging modes: 2D with THI, Color M, CFM, PDI, PW, HPRF, CW. This system contains an array of probes that include full range of Linear, Convex, Phased Array, Endocavity, TEE, Volumetric, and Biplane TRT probes with high density broadband transducers with Frequency up to 16 MHz. The system consists of a main unit, a display and transducers.
The MS55 Plus Digital Color Doppler Ultrasound System is a diagnostic ultrasound system, which applies advanced ultrasonic Doppler technologies such as Harmonic Compound Imaging. Panoramic Imaging, and Spatial Compounding Imaging, with capabilities for applications in of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculoskeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph (Cardiac), Laparoscopic, OB/ Gyn and Urology. Various image parameter adjustments, 22-inch touchscreen and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in Micro F mode, CFM mode, PW mode, SR-Flow mode, PDI/DPDI mode, TDI mode. This system provides a series of probes that include phased array, convex array, and abdominal volume probe.
The P12 Plus Digital Color Doppler Ultrasound System is a diagnostic imaging system, which applies device advanced ultrasonic Doppler technologies such as Harmonic Compound Imaging. Panoramic Imaging, and Spatial Compounding Imaging, with capabilities for applications in Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology. Various image parameter adjustments. 22-inch touch screen and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in Micro F mode, CFM mode, PW mode, PDI/DPDI mode, TDI mode. This system provides a series of probes that include Linear, Convex, Phased Array, Endocavity, TEE, Intraoperative, Volumetric, and Biplane TRT probes, wide scanning Angle Endo-Cavity Probe with frequency ranges of 1.9 MHz to 17MHZ.
The P25 Expert Digital Color Doppler Ultrasound System is a diagnostic imaging system, which applies advanced ultrasonic Doppler technologies such as Harmonic Compound Imaging, Panoramic Imaging, and Spatial Compounding Imaging, with capabilities for applications in Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Transvaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology, Various image parameter adjustments, 22-inch LED, 13.3-inch touch screen and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in 2D with THI, Color M, CFM, PDI, PW, HPRF, CW, Contrast Imaging, Elastography, Stress Echo. This system provides a series of probes that include Linear, Convex, Phased Array, Endocavity, TEE, Intraoperative, Volumetric, and Biplane TRT probes, wide scanning Angle Endo-Cavity Probe probes, wide scanning Angle Endocavity Probe with frequency ranges of 1.9 MHz to 17MHZ.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetus, Abdomen, Pediatrics, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Cardiac, Peripheral Vessel, Musculo-skeleton (both Conventional and Superficial), Urology (including prostate), Transrectal and Transvaginal, Cerebral Vascular, Trans-esoph, Laparoscopic, OB/Gyn
Indicated Patient Age Range
adults, pregnant women, pediatric patients
Intended User / Care Setting
physician or similarly qualified health care professional / gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms
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 product evaluation to demonstrate safety and effectiveness was conducted. Non-clinical testing includes: Software Verification and Validation and Performance Testing (Measurement Accuracy).
Software verification and validation testing were conducted on the Medisono MS55. P25 Expert, P12 Plus, P11 Plus, P9 Plus, P3 Plus and documentation is provided as recommended by FDA's Guidance for the Content of Premarket Submissions for Software Contained Medical Devices. The software for the devices is considered as moderate level of concern, since a failure or latent flaw in the software would lead to a delayed delivery of appropriate medical care. Documentation includes level of concern, software requirements and specifications, design architecture, risk analysis and software validation and verification.
Performance Testing (Measurement Accuracy) was conducted on the Medisono MS55, P25 Expert, P12 Plus, P11 Plus, P9 Plus, P3 Plus to determine measurement accuracy when performing the various distance and area measurements. Acoustic testing, EMC, and doppler sensitivity measurements were also performed. Safety testing includes acoustic output testing as per the IEC 60601-2-37 standard, IEC 60601-1 and IEC 60601-1-2 standards.
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
February 15, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medisono % Jorge Millan Biomedical Director 3016 NW 82nd Ave MIAMI FL 33122
Re: K231659
Trade/Device Name: MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: January 18, 2024 Received: January 19, 2024
Dear Jorge Millan:
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.
1
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 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.
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.
2
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-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 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: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
MS55 Plus Digital Color Doppler Ultrasound System (MS55);
P25 Expert Digital Color Doppler Ultrasound System (P25 Expert);
P12 Plus Digital Color Doppler Ultrasound System (P12 Plus);
P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus);
P9 Plus Ultrasound Diagnostic System (P9 Plus):
P3 Plus Ultrasound Diagnostic System (P3 Plus)
Indications for Use (Describe)
Indications for Use: The MEDISONO Ultrasonic Diagnostic Imaging System models P3 Plus, P9 Plus, P25 Expert, P12 Plus, P11 Plus, and MS55 plus are intended for diagnostic ultrasound imaging analysis of adults, pregnant women, pediatric patients in gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The system is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus, Abdomen, Pediatrics, Small Organ, Neonatal Cephalic, Cardiology, Peripheral Vessel, Musculo-skeleton (both Conventional and Superficial), Urology (including prostate), Transrectal and Transvaginal.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(K) Summary
Submitter Information
| Submitter | Medisono
3016 NW 82 Ave Doral, FL-USA- 33122 |
|------------------|-------------------------------------------------|
| Contact: | Jorge Millan, PhD |
| Telephone number | (786) 416-5587 |
| E-mail | jmillan@sigmabiomedical.com |
| Date prepared: | February 15, 2024 |
Subject Device Name
| Trade/Proprietary Name: | P3 Plus Ultrasound Diagnostic System (P3 Plus), P9 Plus Ultrasound
Diagnostic System (P9 Plus), P11 Plus Portable Digital Color
Doppler Ultrasound system (P11 Plus), P12 Plus Digital Color
Doppler Ultrasound System (P12 Plus), P25 Expert Digital Color
Ultrasound system (P25 Expert), MS55 Plus Digital Color Doppler
Ultrasound system (MS55 Plus) |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number: | 892.1550 |
| Regulation Name: | Ultrasonic pulsed doppler imaging system |
| Product Code: | IYN, IYO, ITX |
| Class | II |
| Panel | Radiology |
Primary Predicate Device
| Predicate Device: | Sonoscape P60 Ultrasound System |
|---|---|
| Sponsor | Sonoscape |
| 510(K) | K171000 |
| Regulation Number: | 892.1550 |
| Regulation Name: | Ultrasonic pulsed doppler imaging system |
| Product Code: | IYN, IYO, ITX |
| Class | II |
| Panel | Radiology |
5
| Reference Device: | ECO 5, ECO 2 |
|---|---|
| Sponsor | Chison |
| 510(K) | K131305 |
| Regulation Number: | 892.1550 |
| Regulation Name: | Ultrasonic pulsed doppler imaging system |
| Product Code: | IYN, IYO, ITX |
| Class | II |
| Panel | Radiology |
| Reference Device: | P20, P15 |
| Sponsor | Sonoscape |
| 510(K) | K172993 |
| Regulation Number: | 892.1550 |
| Regulation Name: | Ultrasonic pulsed doppler imaging system |
| Product Code: | IYN, IYO, ITX |
| Class | II |
| Panel | Radiology |
| Reference Device: | S8 Portable Digital Color Doppler Ultrasound System |
|---|---|
| Sponsor | Sonoscape |
| 510(K) | K132768 |
| Regulation Number: | 892.1550 |
| Regulation Name: | Ultrasonic pulsed doppler imaging system |
| Product Code: | IYN, IYO, ITX |
| Class | II |
| Panel | Radiology |
6
Device Description:
The P3 Plus Ultrasound Diagnostic System is a portable digital B/W compact ultrasound system with diagnostic B/W image quality and PW Doppler capability, applied in ultrasound diagnostic examination of abdominal, Vascular, Small Parts, Musculoskeletal, Obstetrics and Gynecology applications. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor. The resulting information is displayed in six display modes: B-Mode, B+B, 4B Mode, M-Mode, and PW. This system controlled by software employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.5MHz- 11MHz. The system consists of a main unit, transducers, and other accessories.
The P9 Plus Ultrasound Diagnostic System is a portable digital compact ultrasound system with multiple imaging modes applied in ultrasound diagnostic examination of f Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testicle, thyroid); Cardiac (adult & pediatric); Peripheral Vascular; Musculo-skeletal Conventional & Superficial; Transrectal and Transvaginal applications. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor, with multiple imaging modes: B-mode, C-mode, M-mode, CWmode, PW-mode, and PDI mode that employs an array of probes that include linear, Convex and Phase Array probes with a frequency range of approximately 2MHz- 11MHz. The system consists of a main unit, transducers, and other accessories.
The P11 Plus Portable Digital Color Doppler Ultrasound System is a portable ultrasound system with Cardiac measurements, 4D. Elastography and Stress Echo capabilities. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor; with complete imaging modes: 2D with THI, Color M, CFM, PDI, PW, HPRF, CW. This system contains an array of probes that include full range of Linear, Convex, Phased Array, Endocavity, TEE, Volumetric, and Biplane TRT probes with high density broadband transducers with Frequency up to 16 MHz. The system consists of a main unit, a display and transducers.
The MS55 Plus Digital Color Doppler Ultrasound System is a diagnostic ultrasound system, which applies advanced ultrasonic Doppler technologies such as Harmonic Compound Imaging. Panoramic Imaging, and Spatial Compounding Imaging, with capabilities for applications in of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculoskeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph (Cardiac), Laparoscopic, OB/ Gyn and Urology. Various image parameter adjustments, 22-inch touchscreen and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in Micro F mode, CFM mode, PW mode, SR-Flow mode, PDI/DPDI mode, TDI mode. This system provides a series of probes that include phased array, convex array, and abdominal volume probe.
7
The P12 Plus Digital Color Doppler Ultrasound System is a diagnostic imaging system, which applies device advanced ultrasonic Doppler technologies such as Harmonic Compound Imaging. Panoramic Imaging, and Spatial Compounding Imaging, with capabilities for applications in Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology. Various image parameter adjustments. 22-inch touch screen and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in Micro F mode, CFM mode, PW mode, PDI/DPDI mode, TDI mode. This system provides a series of probes that include Linear, Convex, Phased Array, Endocavity, TEE, Intraoperative, Volumetric, and Biplane TRT probes, wide scanning Angle Endo-Cavity Probe with frequency ranges of 1.9 MHz to 17MHZ.
The P25 Expert Digital Color Doppler Ultrasound System is a diagnostic imaging system, which applies advanced ultrasonic Doppler technologies such as Harmonic Compound Imaging, Panoramic Imaging, and Spatial Compounding Imaging, with capabilities for applications in Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Transvaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology, Various image parameter adjustments, 22-inch LED, 13.3-inch touch screen and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in 2D with THI, Color M, CFM, PDI, PW, HPRF, CW, Contrast Imaging, Elastography, Stress Echo. This system provides a series of probes that include Linear, Convex, Phased Array, Endocavity, TEE, Intraoperative, Volumetric, and Biplane TRT probes, wide scanning Angle Endo-Cavity Probe probes, wide scanning Angle Endocavity Probe with frequency ranges of 1.9 MHz to 17MHZ.
Indications for Use:
The MEDISONO Ultrasonic Diagnostic Imaging System models P3 Plus, P25 Expert, P12 Plus, P11 Plus, and MS55 Plus are intended for diagnostic ultrasound imaging analysis of adults, pregnant women, pediatric patients in gynecology rooms, examination rooms, intensive care units, and emergency rooms. The system is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus, Abdomen, Pediatrics, Small Organ, Neonatal Cephalic, Cardiology, Peripheral Vessel, Musculo-skeleton (both Conventional and Superficial), Urology (including prostate), Transrectal and Transvaginal.
Non-Clinical Data:
Non-clinical product evaluation to demonstrate safety and effectiveness was conducted. Non-clinical testing includes:
8
Software Verification and Validation
Software verification and validation testing were conducted on the Medisono MS55. P25 Expert, P12 Plus, P11 Plus, P9 Plus, P3 Plus and documentation is provided as recommended by FDA's Guidance for the Content of Premarket Submissions for Software Contained Medical Devices. The software for the devices is considered as moderate level of concern, since a failure or latent flaw in the software would lead to a delayed delivery of appropriate medical care. Documentation includes level of concern, software requirements and specifications, design architecture, risk analysis and software validation and verification.
Performance Testing (Measurement Accuracy) was conducted on the Medisono MS55, P25 Expert, P12 Plus, P11 Plus, P9 Plus, P3 Plus to determine measurement accuracy when performing the various distance and area measurements. Acoustic testing, EMC, and doppler sensitivity measurements were also performed. Safety testing includes acoustic output testing as per the IEC 60601-2-37 standard, IEC 60601-1 and IEC 60601-1-2 standards.
Predicate Devices
Comparison with the Predicate Devices [21 CFR 807.92(a) (6)]:
The proposed system models are substantially equivalent to diagnostic ultrasound systems cleared for marketing in the US. The MEDISONO model P3 Plus is equivalent to the ECO 2 ultrasound system (K131305) made by Chison; the P9 Plus model is equivalent to the ECO 5 ultrasound system (K131305) made by Chison, the P25 Expert model is equivalent to the P20 Digital Color Doppler Ultrasound System (K172993) made by Sonoscape, the P12 Plus model is equivalent to the P15 made by Sonoscape (K172993), the P11 Plus is equivalent to the S8 Portable Digital Color Doppler Ultrasound system (K132768) made by Sonoscape, and the MS55 Plus ultrasound system is equivalent to the P60 Ultrasound system made by Sonoscape (K171000). The subject and predicate devices incorporate identical software packages, imaging functions, and display functions. The designs of the subject and predicate devices are also the same.
Technical Characteristics Comparison:
The basic and main technical features of the subject device are the predicate device.
Feature Comparison: Subject device has similar features and functionality as the predicate device:
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Product Comparison
| Subject Device | Predicate Device | |
|---|---|---|
| Common Name | MS55 Diagnostic | |
| Imaging System | P60 Diagnostic Ultrasound | |
| System | ||
| Owner | Medisono (K231659) | Sonoscape (K171000) |
| Indications for use | The MEDISONO Ultrasonic | |
| Diagnostic Imaging System | ||
| models P3 Plus, P9 Plus, P25 | ||
| Expert, P12 Plus, P11 Plus, and | ||
| MS55 plus are intended for | ||
| diagnostic ultrasound imaging | ||
| analysis of adults, pregnant | ||
| women, pediatric patients in | ||
| gynecology rooms, obstetrics | ||
| rooms, examination rooms, | ||
| intensive care units, and | ||
| emergency rooms. The system is | ||
| intended for use by or on the | ||
| order of a physician or similarly | ||
| qualified health care professional | ||
| for ultrasound evaluation of | ||
| Fetus, Abdomen, Pediatrics, | ||
| Small Organ, Neonatal Cephalic, | ||
| Cardiology, Peripheral Vessel, | ||
| Musculo-skeleton (both | ||
| Conventional and Superficial), | ||
| Urology (including prostate), | ||
| Transrectal and Transvaginal. | The Digital Color Doppler | |
| Ultrasound System is a general- | ||
| purpose ultrasonic imaging | ||
| instrument intended for use by a | ||
| qualified physician for evaluation | ||
| of Fetal, Abdominal, Pediatric, | ||
| Small Organ (breast, testes, | ||
| thyroid), Cephalic (neonatal and | ||
| adult), Trans-rectal, Trans- | ||
| vaginal, Peripheral Vascular, | ||
| Cerebral Vascular, Musculo- | ||
| skeletal (Conventional and | ||
| Superficial), Cardiac (pediatric | ||
| and adult), Trans-esophageal | ||
| (Cardiac), Laparoscopic, OB/Gyn | ||
| and Urology. | ||
| Display modes | B mode, M Mode, quad mode, | |
| TDI, PDI, PW, CW mode | B mode, M Mode, quad mode, | |
| TDI, PDI, PW, CW mode | ||
| Image Gray Scale | 256 | 256 |
| Storage | 500GB HDD | 500GB HDD |
| Cine Review | Standard cine memory up to | |
| 2729 frames | Standard cine memory up to | |
| 2729 frames | ||
| Depth Adjustment | Fully adjustable depth | |
| adjustment | Fully adjustable depth | |
| adjustment | ||
| Image Conversion | Up/Down flip, Left/Right flip, 90° | |
| rotate, B/W invert | Up/Down flip, Left/Right flip, 90° | |
| rotate, B/W invert | ||
| Auto Image Analysis | Fetus, Thyroid, Pelvic Floor, Endo, | Fetus, Thyroid, Pelvic Floor, Endo, |
| B mode Measurement | Distance, two-point, distance ratio, two-line, length trace, %stenosis difference, polyline, area, trace area, point area, ellipse area, area ratio, %stenosis area, volume, three distance, ellipse+ distance, angle (three-point, two line). | Distance, two-point, distance ratio, two-line, length trace, %stenosis difference, polyline, area, trace area, point area, ellipse area, area ratio, %stenosis area, volume, three distance, ellipse+ distance, angle (three-point, two line). |
| M mode Measurement | Distance, slope, %stenosis distance, distance ratio, time, heart rate, | Distance, slope, %stenosis distance, distance ratio, time, heart rate, |
| Doppler Measurement | Velocity, acceleration, resistivity index measurement, pulsatility index measurement, S/D ratio, auto trace, semi auto trace, manual trace, time, heart rate. | Velocity, acceleration, resistivity index measurement, pulsatility index measurement, S/D ratio, auto trace, semi auto trace, manual trace, time, heart rate. |
| Annotations | Patient ID, patient name, date of birth, sex, description, requested procedure ID, accession #, date/time. | Patient ID, patient name, date of birth, sex, description, requested procedure ID, accession #, date/time. |
| Body Mark | 130 types | 130 types |
| USB Port | USB 2.0 | USB 2.0 |
| Display | LCD 22 inch | LCD 22 inch |
| Operating Voltage | 100V-240V | 100V to 120 V, 200V to 240V |
| Operating Frequency | 50/60 Hz | 50/60Hz |
| Input current | 3.5 amps-7.5 amps | 3.5 amps-7.5 amps |
| Capacity | 9.6Ah/142.08Wh/138.24Wh | 9.6Ah/142.08Wh/138.24Wh |
| Voltage | 14.8V/14.4V | 14.8V/14.4V |
| Average Working time | >1hr | >1hr |
| Maximum charging time | 8 hr. | 8 hr. |
| Ambient Temperature for Operation | 10°C ~ 40°C | 10°C to +40°C |
| Relative Humidity for operation | 30% ~ 75% (no condensation) | 30% ~ 75% (no condensation) |
| Temperature for Transport and Storage | -20°C ~ +55°C | -20°C ~ +55°C |
| Relative humidity range for Transport and Storage | 20% ~ 90% (no condensation | 20% ~ 90% (no condensation |
10
| Item | Candidate Device | Predicate Device |
|---|---|---|
| Common Name | P25 Expert Digital Color | |
| Doppler Ultrasound System | Ultrasonic Diagnostic | |
| Ultrasound system Model P200 | ||
| Owner | Medisono K231659 | Sonoscape (K172993) |
| Indications for use | The MEDISONO Ultrasonic | |
| Diagnostic Imaging System | ||
| models P3 Plus, P9 Plus, P25 | ||
| Expert, P12 Plus, P11 Plus, and | ||
| MS55 plus are intended for | ||
| diagnostic ultrasound imaging | ||
| analysis of adults, pregnant | ||
| women, pediatric patients in | ||
| gynecology rooms, obstetrics | ||
| rooms, examination rooms, | ||
| intensive care units, and | ||
| emergency rooms. The system is | ||
| intended for use by or on the | ||
| order of a physician or similarly | ||
| qualified health care | ||
| professional for ultrasound | ||
| evaluation of Fetus, Abdomen, | ||
| Pediatrics, Small Organ, | ||
| Neonatal Cephalic, Cardiology, | ||
| Peripheral Vessel, Musculo- | ||
| skeleton (both Conventional and | ||
| Superficial), Urology (including | ||
| prostate), Transrectal and | ||
| Transvaginal. | The Digital Color Doppler | |
| Ultrasound System is a general- | ||
| purpose ultrasonic imaging | ||
| instrument intended for use by a | ||
| qualified physician for evaluation | ||
| of Fetal, Abdominal, Pediatric, | ||
| Small Organ (breast, testes, | ||
| thyroid), Cephalic (neonatal and | ||
| adult), Trans-rectal, Trans- | ||
| vaginal, Peripheral Vascular, | ||
| Cerebral Vascular, Musculo- | ||
| skeletal (Conventional and | ||
| Superficial), Cardiac (pediatric | ||
| and adult), Transesophageal | ||
| (Cardiac), Laparoscopic, OB/Gyn | ||
| and Urology. | ||
| Display modes | B mode, M Mode, quad mode, | |
| TDI, PDI, PW, CW mode | B mode, M Mode, quad mode, | |
| TDI, PDI, PW, CW mode | ||
| Image Gray Scale | 256 | 256 |
| Storage | 500 GB HDD | 500 GB HDD |
| Cine Review | 498 frames | 498 frames |
| Depth Adjustment | Adjustable in real time in all | |
| modes. | Adjustable in real time in all | |
| modes. | ||
| Image Conversion | Up/Down flip, Left/Right flip, | |
| 90°rotate, B/W invert, zoom | Up/Down flip, Left/Right flip, | |
| 90°rotate, B/W invert, zoom | ||
| Software Packages | Cardio-vascular Premium PLUS | |
| Kit: TDI / Color M / ECG / Steer | ||
| M / Color 3D | ||
| OB / GYN Premium PLUS Kit: | ||
| Multi Slice View / Oblique View | ||
| / 3D Rendering (S-Live, S-Depth) | ||
| / MagiCut / SmartCut / 3D µscan | ||
| / Auto Face / 3D Measurement / | ||
| Pelvic Floor | ||
| Ultrasound, Abdomen Package | ||
| Gynecology Package | ||
| Obstetrics Package | ||
| Cardiology Package | ||
| Small parts Package | ||
| Urology Package | ||
| Vascular Package | ||
| Pediatrics Package | Cardio-vascular Premium PLUS | |
| Kit: TDI / Color M / ECG / Steer | ||
| M / Color 3D | ||
| OB / GYN Premium PLUS Kit: | ||
| Multi Slice View / Oblique View | ||
| / 3D Rendering (S-Live, S-Depth) | ||
| / MagiCut / SmartCut / 3D µscan | ||
| / Auto Face / 3D Measurement / | ||
| Pelvic Floor | ||
| Ultrasound, Abdomen Package | ||
| Gynecology Package | ||
| Obstetrics Package | ||
| Cardiology Package | ||
| Small parts Package | ||
| Urology Package | ||
| Vascular Package | ||
| Pediatrics Package | ||
| B mode Measurement | Distance, two-point, length | |
| trace, two-line, distance ratio, | ||
| %stenosis distance, area, trace | ||
| area, point area, ellipse area, | ||
| area ratio, %stenosis area, | ||
| volume, angle, | Distance, two-point, length | |
| trace, two-line, distance ratio, | ||
| %stenosis distance, area, trace | ||
| area, point area, ellipse area, | ||
| area ratio, %stenosis area, | ||
| volume, angle, | ||
| M mode Measurement | Distance, slope, %stenosis | |
| distance, distance ratio, time, | ||
| heart rate, | Distance, slope, %stenosis | |
| distance, distance ratio, time, | ||
| heart rate, | ||
| Doppler Measurement | Velocity, acceleration, resistivity | |
| index, pulsatility index, S/D ratio, | ||
| auto trace, manual trace, time, | ||
| heart rate. | Velocity, acceleration, resistivity | |
| index, pulsatility index, S/D ratio, | ||
| auto trace, manual trace, time, | ||
| heart rate. | ||
| Color Flow-Mode Measurement | Doppler area, color flow, flow | |
| velocity, | Doppler area, color flow, flow | |
| velocity, | ||
| Annotations | Patient name, age, sex, time, | |
| date, hospital name, doctor | ||
| name, comment (full screen | ||
| character editing) | Patient name, age, sex, time, | |
| date, hospital name, doctor | ||
| name, comment (full screen | ||
| character editing) | ||
| Body Mark | 130 | 130 |
| USB Port | USB 2.0 | USB 2.0 |
| Display | 21.5" High Resolution LED Color | |
| Monitor | 21.5" High Resolution LED Color | |
| Monitor | ||
| Diagonal Size | 21.5 inch | 21.5 inch |
| Operating Voltage | 100-127V/220-240V | 100-127V/220-240V |
| Operating Frequency | 50/60Hz | 50/60Hz |
11
12
13
| Capacity | 9.6 Ah/142Wh | 9.6 Ah/142Wh |
|---|---|---|
| Voltage | 14.8 V | 14.8 V |
| Average Working time | >1hr | >1hr |
| Main unit dimension | 751×518×1350mm | 751×518×1350mm |
| Net weight | 86 kg | 86 kg |
| Item | Candidate Device | Predicate Device |
|---|---|---|
| Common Name | P12 Plus Digital Color | |
| Doppler Ultrasound System | Ultrasonic Diagnostic | |
| Ultrasound System Model P15 | ||
| Owner | Medisono K231659 | Sonoscape (K172993) |
| Indications for use | The MEDISONO Ultrasonic | |
| Diagnostic Imaging System | ||
| models P3 Plus, P9 Plus, P25 | ||
| Expert, P12 Plus, P11 Plus, | ||
| and MS55 plus are intended | ||
| for diagnostic ultrasound | ||
| imaging analysis of adults, | ||
| pregnant women, pediatric | ||
| patients in gynecology rooms, | ||
| obstetrics rooms, | ||
| examination rooms, intensive | ||
| care units, and emergency | ||
| rooms. The system is | ||
| intended for use by or on the | ||
| order of a physician or | ||
| similarly qualified health care | ||
| professional for ultrasound | ||
| evaluation of Fetus, | ||
| Abdomen, Pediatrics, Small | ||
| Organ, Neonatal Cephalic, | ||
| Cardiology, Peripheral Vessel, | ||
| Musculo-skeleton (both | ||
| Conventional and Superficial), | ||
| Urology (including prostate), | ||
| Transrectal and Transvaginal. | The Digital Color Doppler | |
| Ultrasound System is a general- | ||
| purpose ultrasonic imaging | ||
| instrument intended for use by | ||
| a qualified physician for | ||
| evaluation of Fetal, Abdominal, | ||
| Pediatric, Small Organ (breast, | ||
| testes, thyroid), Cephalic | ||
| (neonatal and adult), Trans- | ||
| rectal, Trans-vaginal, Peripheral | ||
| Vascular, Cerebral Vascular, | ||
| Musculo-skeletal (Conventional | ||
| and Superficial), Cardiac | ||
| (pediatric and adult), | ||
| Transesophageal (Cardiac), | ||
| Laparoscopic, OB/Gyn and | ||
| Urology. | ||
| Display modes | B mode, M Mode, quad | |
| mode, TDI, PDI, PW, CW | ||
| mode | B mode, M Mode, quad mode, | |
| TDI, PDI, PW, CW mode | ||
| Image Gray Scale | 256 | 256 |
| Item | Candidate Device | Predicate Device |
| Common Name | P12 Plus Digital Color Doppler | |
| Ultrasound System | Model P15 Ultrasonic Diagnostic | |
| Ultrasound System | ||
| Owner | Medisono (K231659) | Sonoscape (K172993) |
| Storage | 500 GB HDD | 500GB HDD |
| Cine Review | 498 frames | 498 frames |
| Software Packages | µ-scan speckle reduction, | |
| compound imaging, TDI, stress | ||
| echo, C-Xlasto elastography | ||
| and contrast imaging, Cardio- | ||
| vascular Premium PLUS Kit: | ||
| TDI / Color M / | ||
| ECG / Steer M / Color 3D, OB / | ||
| GYN | ||
| Premium PLUS Kit: Multi Slice | ||
| View | ||
| / Oblique View / 3D Rendering | ||
| (SLive, S-Depth) / MagiCut / | ||
| SmartCut | ||
| / 3D µscan / Auto Face / 3D | ||
| Measurement / Pelvic Floor | ||
| Ultrasound | µ-scan speckle reduction, | |
| compound imaging, TDI, stress | ||
| echo, C-Xlasto elastography and | ||
| contrast imaging, Cardio- | ||
| vascular Premium PLUS Kit: TDI / | ||
| Color M / | ||
| ECG / Steer M / Color 3D, OB / | ||
| GYN | ||
| Premium PLUS Kit: Multi Slice | ||
| View | ||
| / Oblique View / 3D Rendering | ||
| (SLive, S-Depth) / MagiCut / | ||
| SmartCut | ||
| / 3D µscan / Auto Face / 3D | ||
| Measurement / Pelvic Floor | ||
| Ultrasound | ||
| B mode Measurement | Distance, Area, Volume, angle. | Distance, Area, Volume, angle. |
| M mode Measurement | Distance, slope, %stenosis, | |
| distance ratio, time, heart rate. | Distance, slope, %stenosis, | |
| distance ratio, time, heart rate. | ||
| Color Flow-Mode Measurement | Doppler area, color flow, flow | |
| velocity. | Doppler area, color flow, flow | |
| velocity. | ||
| Doppler Measurement | Velocity, acceleration, | |
| resistivity index, pulsatility | ||
| index, S/D ratio, auto trace, | ||
| manual trace, time, heart rate. | Velocity, acceleration, resistivity | |
| index, pulsatility index, S/D ratio, | ||
| auto trace, manual trace, time, | ||
| heart rate. | ||
| Annotations | Patient name, age, sex, time, | |
| date, hospital name, doctor | ||
| name, comment (full-screen | ||
| character editing) | Patient name, age, sex, time, | |
| date, hospital name, doctor | ||
| name, comment (full-screen | ||
| character editing) | ||
| Body Mark | 130 types | 130 types |
| USB Port | USB 2.0, USB 3.0 | USB 2.0, USB 3.0 |
| Display | HD LED | HD LED |
| Diagonal Size | 21.5 inch | 21.5 inch |
| Pixel Number | 1,920x1,080 | 1,920x1,080 |
| Operating Voltage | 100-127V/220-240V | 100-127V/220-240V |
| Operating Frequency | 50/60Hz | 50/60Hz |
| Capacity | 6.2Ah/89.28Wh | 6.2Ah/89.28Wh |
| Voltage | 14.4 V | 14.4 V |
| Average Working time | 90 minutes | 90 minutes |
| Main unit dimension | -With a 18.5 inch monitor, | |
| approx. | ||
| 518mm(W)×1335mm(H)×751 | ||
| mm(D) | ||
| (The height is measured when | ||
| the monitor and control panel | ||
| are in their lowest positions.) | ||
| – With a 21.5 inch monitor, | ||
| approx. | ||
| 526mm(W)×1360mm(H)×751 | ||
| mm(D) | ||
| (The height is measured when | ||
| the monitor and control panel | ||
| are in | ||
| their lowest positions.) | -With a 18.5 inch monitor, | |
| approx. | ||
| 518mm(W)×1335mm(H)×751mm(D) | ||
| (The height is measured when | ||
| the monitor and control panel | ||
| are in their lowest positions.) | ||
| – With a 21.5 inch monitor, | ||
| approx. | ||
| 526mm(W)×1360mm(H)×751mm(D) | ||
| (The height is measured when | ||
| the monitor and control panel | ||
| are in | ||
| their lowest positions.) | ||
| Net weight | 86 kg | 86 kg |
14
15
| Item | Candidate Device | Predicate Device |
|---|---|---|
| Common Name | P11 Plus Portable Digital Color | |
| Doppler Ultrasound System | Ultrasonic Diagnostic | |
| Ultrasound System Model S8 | ||
| Owner | Medisono (K231659) | Sonoscape (K132768) |
| Indications for use | The MEDISONO Ultrasonic | |
| Diagnostic Imaging System | ||
| models P3 Plus, P9 Plus, P25 | ||
| Expert, P12 Plus, P11 Plus, and | ||
| MS55 plus are intended for | ||
| diagnostic ultrasound imaging | ||
| analysis of adults, pregnant | ||
| women, pediatric patients in | ||
| gynecology rooms, obstetrics | ||
| rooms, examination rooms, | ||
| intensive care units, and | ||
| emergency rooms. The system | ||
| is intended for use by or on the | ||
| order of a physician or similarly | ||
| qualified health care | ||
| professional for ultrasound | ||
| evaluation of Fetus, Abdomen, | ||
| Pediatrics, Small Organ, | ||
| Neonatal Cephalic, Cardiology, | ||
| Peripheral Vessel, Musculo- | ||
| skeleton (both Conventional | ||
| and Superficial), Urology | The Sonoscape S8 Exp device is | |
| a general purpose ultrasonic | ||
| imaging instrument intended for | ||
| use by a qualified physician for | ||
| evaluation of Fetal, Abdominal, | ||
| Pediatric, Small Organ (breast, | ||
| testes, thyroid), Cephalic | ||
| (neonatal and adult), Peripheral | ||
| Vascular, Musculo-skeletal | ||
| (Conventional and Superficial), | ||
| Cardiac (neonatal and adult), | ||
| OB/Gyn and Urology. |
16
| | | (including prostate), Transrectal
and Transvaginal. |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display modes | Triplex, B mode, M mode, TDI,
CW, PW, CFM mode, PDI mode. | Triplex, B mode, M mode, TDI,
CW, PW, CFM mode, PDI mode. |
| Image Gray Scale | 256 levels | 256 levels |
| Storage | 500 GB HDD, optional 1TB | 500 GB HDD, optional 1TB |
| Cine Review | 498 frames | 498 frames |
| Depth Adjustment | Adjustable in real time in all
modes. | Adjustable in real time in all
modes. |
| Image Conversion | Up/Down flip, Left/Right flip,
90°rotate, B/W invert | Up/Down flip, Left/Right flip,
90°rotate, B/W invert |
| Software Packages | Stress echo, TDI, Steer M, IMT,
and Automatic flow volume
analysis, | Stress echo, TDI, Steer M, IMT,
and Automatic flow volume
analysis, |
| B mode Measurement | Distance, two-point, length
trace, two-line, distance ratio,
%stenosis distance, area, trace
area, point area, ellipse area,
area ratio, %stenosis area,
volume, ellipse+distance,
angle, three-point angle, two-
line angle. | Distance, two-point, length
trace, two-line, distance ratio,
%stenosis distance, area, trace
area, point area, ellipse area,
area ratio, %stenosis area,
volume, ellipse+distance, angle,
three-point angle, two-line
angle. |
| M mode Measurement | Distance, slope, %stenosis,
distance ratio, time, heart rate. | Distance, slope, %stenosis,
distance ratio, time, heart rate. |
| Doppler Measurement | velocity, acceleration,
resistivity index, pulsatility
index, S/D ratio, auto/manual
trace, time, heart rate. | velocity, acceleration, resistivity
index, pulsatility index, S/D
ratio, auto/manual trace, time,
heart rate. |
| Annotations | Patient name, age, sex, time,
date, hospital name, doctor
name, comment (full screen
character editing) | Patient name, age, sex, time,
date, hospital name, doctor
name, comment (full screen
character editing) |
| Body Mark | 130 | 130 |
| USB Port | USB 2.0 | USB 2.0 |
| Display | LCD anti-glare | LCD anti-glare |
| Diagonal Size | 15 inch | 15 inch |
| Operating Voltage | 110V-240V | 110V-240V |
| Operating Frequency | 50Hz/60Hz | 50Hz/60Hz |
| Capacity | 9.6Ah/142Wh | 9.6Ah/142Wh |
| Voltage | 14.8V | 14.8V |
| Average Working time | >1 hour | >1 hour |
| Ambient Temperature for
Operation | 10°C~+40°C | 10°C~+40°C |
| Relative Humidity for operation | 30%75% (no condensation) | 30%1060hPa |75% (no condensation) |1060hPa | 700hPa
| Atmospheric pressure range for
operation | 700hPa
| Temperature for Transport and
Storage | -20°C~+55°C | -20°C~+55°C |
| Relative humidity range for
Transport and Storage | 20%90% (no condensation) | 20%1060hPa |90% (no condensation) |1060hPa | 700hPa
| Atmospheric temperature range
for storage | 700hPa
17
| Item | Candidate Device | Predicate Device |
|---|---|---|
| Common Name | P9 Plus Ultrasound Diagnostic | |
| System | Ultrasonic Diagnostic Imaging | |
| System Model ECO 5 | ||
| Owner | Medisono (K231659) | Chison (K131305) |
| Indications for use | The MEDISONO Ultrasonic | |
| Diagnostic Imaging System | ||
| models P3 Plus, P9 Plus, P25 | ||
| Expert, P12 Plus, P11 Plus, and | ||
| MS55 plus are intended for | ||
| diagnostic ultrasound imaging | ||
| analysis of adults, pregnant | ||
| women, pediatric patients in | ||
| gynecology rooms, obstetrics | ||
| rooms, examination rooms, | ||
| intensive care units, and | ||
| emergency rooms. The system is | ||
| intended for use by or on the | ||
| order of a physician or similarly | ||
| qualified health care | ||
| professional for ultrasound | ||
| evaluation of Fetus, Abdomen, | ||
| Pediatrics, Small Organ, | ||
| Neonatal Cephalic, Cardiology, | ||
| Peripheral Vessel, Musculo- | ||
| skeleton (both Conventional and | ||
| Superficial), Urology (including | ||
| prostate), Transrectal and | ||
| Transvaginal. | The device is a general-purpose | |
| ultrasonic imaging instrument | ||
| intended for use by a qualified | ||
| physician for evaluation of | ||
| Fetal/OB, Abdominal (GYN & | ||
| Urology); Pediatric; Small Organ | ||
| (breast, testes, thyroid); Cardiac | ||
| (adult & pediatric); Peripheral | ||
| Vascular, Musculo-skeletal | ||
| Conventional & Superficial, | ||
| Transrectal and Transvaginal |
18
| Display modes | B Mode: Single, Dual, Quad C
Mode: B/C(Single, Dual);
Simultaneous dual mode: B+B/C;
Triplex mode B/C/PW PDI/DPDI
Mode:
B/PDI(DPDI)(Single, Dual);
Simultaneous dual mode:
B+B/PDI(DPDI); Triplex mode
B/PDI(DPDI)/PW Mode:
B/PW (duplex, simultaneous);
B+C/PW, B+PDI(DPDI)/PW
(duplex); B/C/PW,
B/PDI(DPDI)/PW (triplex); M
Mode: B/M (Display layout:
Up/down, Left/right,1:1) | B Mode: Single, Dual, Quad C
Mode: B/C(Single, Dual);
Simultaneous dual mode: B+B/C;
Triplex mode B/C/PW PDI/DPDI
Mode:
B/PDI(DPDI)(Single, Dual);
Simultaneous dual mode:
B+B/PDI(DPDI); Triplex mode
B/PDI(DPDI)/PW Mode:
B/PW (duplex, simultaneous);
B+C/PW, B+PDI(DPDI)/PW
(duplex); B/C/PW,
B/PDI(DPDI)/PW (triplex); M
Mode: B/M (Display layout:
Up/down, Left/right,1:1) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image Gray Scale | 256 levels | 256 levels |
| Image magnification | In area Real time: $\times$ 1.2, $\times$ 1.4,
$\times$ 1.6, $\times$ 2.0, $\times$ 2.4, $\times$ 3.0, $\times$ 4.0
Frozen: $\times$ 1.14, $\times$ 1.33, $\times$ 1.6, $\times$ 2.0,
$\times$ 2.67, $\times$ 3.2, $\times$ 4.0 | In area Real time: $\times$ 1.2, $\times$ 1.4,
$\times$ 1.6, $\times$ 2.0, $\times$ 2.4, $\times$ 3.0, $\times$ 4.0 ;
Frozen: $\times$ 1.14, $\times$ 1.33, $\times$ 1.6, $\times$ 2.0,
$\times$ 2.67, $\times$ 3.2, $\times$ 4.0 |
| Storage | 16 GB SSD | 504 MB |
| Cine Review | 409 frames (Color) /
1227frames (Black & White) | 409 frames (Color) /
1227frames (Black & White) |
| Depth Adjustment | Adjustable in real time in all
modes | Adjustable in real time in all
modes |
| Image Conversion | Up/Down flip, Left/Right flip, 90°
rotate, B/W invert | Up/Down flip, Left/Right flip,
90°rotate, B/W invert |
| Software Packages | Abdomen, obstetric, small parts,
gynecology, cardiology, urology,
vascular. | Abdomen, obstetric, small parts,
gynecology, cardiology, urology,
vascular and Pediatrics. |
| B mode Measurement | Distance, circumference, area,
volume, ratio, % stenosis, angle,
and histogram. | Distance, circumference, area,
volume, ratio, % stenosis, angle,
and histogram. |
| M mode Measurement | Distance, time, slope, and heart
rate | Distance, time, slope, and heart
rate |
| Doppler Measurement | Time, heart rate, velocity,
acceleration, RI, PI and Auto
(auto trace) | Time, heart rate, velocity,
acceleration, RI, PI and Auto
(auto trace) |
| Annotations | Patient name, age, sex, time,
date, hospital name, doctor
name, comment (full screen
character editing) | Patient name, age, sex, time,
date, hospital name, doctor
name, comment (full-screen
character editing) |
| Body Mark | 130 types | 130 types |
19
| USB Port | USB 2.0 | USB 1.1 |
|---|---|---|
| Operating Voltage | 100V-250V | 100V-240V |
| Operating Frequency | 50 Hz/60 Hz | 50 Hz/60 Hz |
| Input current | 1.8A-0.8A | 1.8A-0.8A |
| Capacity | 6400 mAh | 6400 mAh |
| Voltage | 14.8 VDC | 14.8 VDC |
| Average Working time | 1.5 h | 1.5 h |
| Maximum charging time | 8 h | 8 h |
| Cycle Life | 300 times | 300 times |
| Ambient Temperature for | ||
| Operation | 10 °C〜40 °C | +5 °C ~ +40 °C |
| Relative Humidity for operation | 30%~75%RH | 25% RH ~ 80% RH |
| (noncondensing) | ||
| Atmospheric pressure range for | ||
| operation | 700hPa~1060hPa | 860 hPa ~ 1060 hPa |
| Temperature for Transport and | ||
| Storage | -5° C ~ 40° C | -20 °C ~ +55 °C |
| Relative humidity range for | ||
| Transport and Storage | ≤ 80% non-condensing | 25% RH ~ 93% RH |
| (noncondensing) | ||
| Atmospheric pressure range for | ||
| Transport and Storage | 700hPa ~ 1060hPa | 700 hPa ~ 1060 hPa |
| Item
| Common Name | Candidate Device | Predicate Device |
|---|---|---|
| P3 Plus Ultrasound | ||
| Diagnostic System | ||
| Medisono (K231659) | Ultrasonic Diagnostic | |
| System ECO 2 | ||
| Chison (K131305) | ||
| Owner | The MEDISONO Ultrasonic | |
| Diagnostic Imaging System | ||
| models P3 Plus, P9 Plus, P25 | ||
| Expert, P12 Plus, P11 Plus, and | ||
| MS55 plus are intended for | ||
| diagnostic ultrasound imaging | ||
| analysis of adults, pregnant | ||
| women, pediatric patients in | ||
| gynecology rooms, obstetrics | ||
| rooms, examination rooms, | ||
| intensive care units, and | ||
| emergency rooms. The system is | ||
| intended for use by or on the | ||
| order of a physician or similarly | ||
| qualified health care | ||
| professional for ultrasound | The device is a general-purpose | |
| ultrasonic imaging instrument | ||
| intended for use by a qualified | ||
| physician for evaluation of | ||
| Fetal/OB, Abdominal (GYN & | ||
| Urology); Pediatric; Small Organ | ||
| (breast, testes, thyroid); Cardiac | ||
| (adult & pediatric); Peripheral | ||
| Vascular, Musculo-skeletal | ||
| Conventional & Superficial, | ||
| Transrectal and Transvaginal | ||
| evaluation of Fetus, Abdomen, | ||
| Pediatrics, Small Organ, | ||
| Neonatal Cephalic, Cardiology, | ||
| Peripheral Vessel, Musculo- | ||
| skeleton (both Conventional and | ||
| Superficial), Urology (including | ||
| prostate), Transrectal and | ||
| Transvaginal. | ||
| Display modes | B-Mode, B+B, 2B, 4B Mode, M | |
| Mode, B+M Mode, and PW | B, 2B, 4B, B+M, M, and PW | |
| Mode | ||
| Image Gray Scale | 256 levels | 256 levels |
| Image magnification | x1 .0. x1 .2, x1 .4, x1 .6, x2.0, | |
| x2.4, x3.0, x4.0 in distance | In area Real time: 100%, | |
| 144%,196%, 256%, 400%, 576%, | ||
| 900%, 1600% Frozen (only | ||
| available in B mode): 100%, | ||
| 178%, 400%,1600 | ||
| Storage | 504 MB | 504 MB |
| Cine Review | 256 frames | 256 frames |
| Depth Adjustment | Adjustable in real time in B, 2B, | |
| 4B, B+M, M, and PW modes | Adjustable in real time in B, 2B, | |
| 4B, B+M, M, and PW modes | ||
| Frame Correlation Coefficient | 8 levels to adjust (0~7), (B, 2B, | |
| 4B, B+M modes, ineffective | ||
| when freezing) | 8 levels to adjust (0~7), (B, 2B, | |
| 4B, B+M modes, ineffective | ||
| when freezing) | ||
| Image Conversion | Up/Down flip, Left/Right flip, | |
| 90°rotate | Up/Down flip, Left/Right flip, | |
| 90°rotate | ||
| Software Packages | Obstetric, small parts, | |
| gynecology, orthopedics, | ||
| cardiology, urology, or vascular | Obstetric, small parts, | |
| gynecology, orthopedics, | ||
| cardiology, urology, or vascular | ||
| B mode Measurement | Distance, circumference, area, | |
| volume, ratio, % stenosis, | ||
| histogram and angle | Distance, circumference, area, | |
| volume, ratio, % stenosis, | ||
| histogram and angle | ||
| M mode Measurement | Distance, time, slope, and heart | |
| rate | Distance, time, slope, and heart | |
| rate | ||
| Doppler Measurement | Time, | |
| heart rate, velocity, | ||
| acceleration, trace, and RI | Time, | |
| heart rate, velocity, | ||
| acceleration, trace, and RI | ||
| Annotations | ID, patient name, doctor's name, | |
| birthday (It can be automatically | ||
| calculated when input age), age | ||
| (It can be automatically | ||
| calculated when input birthday), | ||
| sex. | ID, patient name, doctor's name, | |
| birthday (It can be automatically | ||
| calculated when input age), age | ||
| (It can be automatically | ||
| calculated when input birthday), | ||
| sex. | ||
| Body Mark | 130 types | 130 types |
| USB Port | USB 2.0 | USB 2.0 |
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| Display | TFT-LCD | TFT-LCD |
|---|---|---|
| Diagonal Size | 12.1-inch | 12.1-inch |
| View Angle | Horizontal: ΘxTyp.: 80°; Vertical: | |
| θyTyp .: 80°; see the figure | ||
| below. | Horizontal: ΘxTyp.: 80°; Vertical: | |
| θyTyp .: 80°; see the figure | ||
| below. | ||
| Pixel Number | 1024*768 | 1024*768 |
| Center Luminance of White | Typ .: 450 cd/m² | Typ .: 450 cd/m2 |
| Contrast Ratio | Typ.: 700 | Typ.: 700 |
| Operating Voltage | 100-240V | 100 V-240 V~ |
| Operating Frequency | 50Hz-60Hz | 50 Hz/60 Hz |
| Input Power | 1.8A~0.8A | 1.8A~0.8A |
| Capacity | 6400 mAh | 6400 mAh |
| Voltage | 14.8 VDC | 14.8 VDC |
| Average Working time | 2 h | 2 h |
| Maximum charging time | 8 h | 8 h |
| Cycle Life | 300 times | 300 times |
| Main unit dimension | 335mm(13.0") ( L) | |
| x155mm(6.1") (W) | ||
| x350mm(13.7") ( H) | 335mm(13.0")(L)x155mm(6.1") | |
| (W) x350mm(13.7") ( H) | ||
| Net weight | 6.0 kg | 7.1 kg |
Evaluation of similarities and differences:
The Medisono MS55 Plus, P25 Expert, P12 Plus, and P11 Plus have similar intended use, functionality, similar technologies as well as safety and performance characteristics than the Sonoscape P60, Sonsoscape P20, Sonoscape P15, and Sonoscape S8, respectively. The Medisono models P9 Plus and P3 Plus have similar intended use, functionality, similar technologies as well as safety and performance characteristics as the Chison Eco 5, Chison Eco 2 ultrasound systems respectively. There are no differences among the Medisono devices and the corresponding predicate devices except for device network connectivity as the Medisono devices are not intended to be connected to a network.
Conclusion:
The subject device has similar technological characteristics and has similar intended use and functionality as the predicate devices. There are no differences between the devices that affect the usage, safety and effectiveness, thus no new question is raised regarding the safety and effectiveness. The non-clinical performance test data and software verification demonstrate that the Medisono MS55 Plus, P25 Expert, P12 Plus, P11 Plus, P9 Plus, P3 Plus performs comparably to and it is as safe and effective as the predicate devices. In accordance with the 21 CFR Part 807 and based on the information provided in this premarket notification, Medisono MS55, P25 Expert, P12 Plus, P11 Plus, P9 Plus, P3 Plus is substantially equivalent to the predicate that is currently marketed for the same intended use.