S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System
Device Facts
| Record ID | K201059 |
|---|---|
| Device Name | S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System |
| Applicant | Sonoscape Medical Corp. |
| Product Code | IYN · Radiology |
| Decision Date | Jul 30, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
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-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology. The Modes of Operation include B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Tissue Harmonic Imaging, Power Doppler Imaging, Directional Power Doppler Imaging, Tissues Doppler Imaging, Pulse Inversion Harmonic Imaging, 3D/4D Imaging mode, Elastography Imaging, Contrast imaging, Panoramic Imaging, Trapezoid Imaging and their combination modes, and the system is intended to be used in a hospital or medical clinic.
Device Story
Mobile, software-controlled digital color Doppler ultrasound system; transmits ultrasonic energy into patient body; processes received echoes to generate real-time images of anatomic structures and fluid flow. Used in hospitals/clinics by physicians. Input: ultrasound data from various probes (linear, convex, phased, micro-curved arrays). Output: visual display of B-mode, M-mode, Doppler (PW/CW/Color/Power/Directional Power), Tissue Harmonic, 3D/4D, Elastography, and Contrast imaging. Healthcare providers use images for clinical diagnosis and evaluation of various body systems. Benefits include non-invasive visualization of internal structures and blood flow to aid clinical decision-making.
Clinical Evidence
No clinical data. Bench testing only, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), acoustic output (IEC 60601-2-37, AIUM/NEMA UD 2), and software verification/validation (IEC 62304).
Technological Characteristics
Mobile console with touch screen, keyboard, and color LCD monitor. Supports linear, convex, phased, and micro-curved array probes. Imaging modes: B, M, PW/CW Doppler, Color/Power/Directional Power Doppler, Tissue Harmonic, 3D/4D, Elastography, Contrast, Panoramic, Trapezoid. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5/10, AIUM/NEMA UD 2.
Indications for Use
Indicated for use by qualified physicians for diagnostic ultrasound evaluation of fetal, abdominal, pediatric, small organ (breast, testes, thyroid), cephalic (neonatal/adult), trans-rectal, trans-vaginal, peripheral/cerebral vascular, musculo-skeletal, cardiac (pediatric/adult), trans-esophageal, laparoscopic, OB/Gyn, and urological applications.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- S60 Series Digital Color Doppler Ultrasound System (K172082)
Reference Devices
- EPIQ 5/EPIQ 7 Diagnostic Ultrasound System (K172607)
- P10 Series Digital Color Doppler Ultrasound System (K173058)
Related Devices
- K142815 — S22 Digital Color Doppler Ultrasound System · Sonoscape Company Limited · Jan 28, 2015
- K233697 — SonoMax Series Digital Color Doppler Ultrasound System · CHISON Medical Technologies Co., Ltd. · Aug 9, 2024
- K240115 — Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 22, 2024
- K221300 — Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 29, 2022
- K160258 — X5 Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · Apr 1, 2016
Submission Summary (Full Text)
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July 30, 2020
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.
Sonoscape Medical Corp. % Toki Wu Regulatory Affairs Manager Room 201 & 202, 12th Building, Shenzhen Software Park Phase II 1 Keji Middle 2nd Rd, Yuehai Subdistrict, Nanshan District Shenzhen, Guangdong 518057 CHINA
#### Re: K201059
Trade/Device Name: S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: July 2, 2020 Received: July 6, 2020
#### Dear Toki 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) 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 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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K201059
#### Device Name
S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System
#### Indications for Use (Describe)
The Digital Color Doppler Ultrasound System is a general-purpose ultrasonic 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, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph (Cardiac), Laparoscopic, OB/Gyn and Urology. The Modes of Operation include B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Tissue Harmonic Imaging, Power Doppler Imaging, Directional Power Doppler Imaging, Tissues Doppler Imaging, Pulse Inversion Harmonic Imaging, 3D/4D Imaging mode, Elastography Imaging, Contrast imaging, Panoramic Imaging, Trapezoid Imaging and their combination modes, and the system is intended to be used in a hospital or medical clinic.
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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# 510(k) Summary
K201059
# 1. Submitter [21 CFR807.92 (a) (1)]
| Submitter: | SONOSCAPE MEDICAL CORP. |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Room 201 & 202, 12th Building, Shenzhen Software Park Phase II,<br>1 Keji Middle 2nd Road, Yuehai Subdistrict, Nanshan District,<br>Shenzhen, 518057, Guangdong, China |
| Contact Person: | Toki Wu |
| Fax: | +86 755 26722850 |
|------|------------------|
|------|------------------|
Email: ra@sonoscape.net
Date Prepared July 2, 2020
# 2. Device [21 CFR807.92 (a) (2)]
| Trade Name: | S60 Elite Series/S70 Series Digital Color Doppler Ultrasound<br>System |
|--------------|--------------------------------------------------------------------------------------------------------------------------------|
| Models: | S60 Expert, S60 Classic, S60 Nov, S60 Super, S60 Speci, S60<br>Elite, S-Light, S70 Exp, S70, S70 Pro, S70S, S70 VO, S60S, S60N |
| Common Name: | Diagnostic Ultrasound System and Transducers |
Classification Regulatory:
| | | CFR Number | Product Code |
|------------------------------------------|-----------|------------|--------------|
| Ultrasonic Pulsed Doppler Imaging System | | 892.1550 | 90-IYN |
| (Primary) | | | |
| Ultrasonic Pulsed Echo Imaging System | | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | | 892.1570 | 90-ITX |
| Classification Panel: | Radiology | | |
| Device Class: | II | | |
## 3. Predicate Device(s) [21 CFR 807.92(a) (3)]
The identified predicate device within this submission is as follows:
| Type | Manufacturer | Device | 510 (K) Number |
|-------------------|---------------|---------------------------|----------------|
| Primary Predicate | SonoScape | S60 Series Digital Color | K172082 |
| Device | Medical Corp. | Doppler Ultrasound System | |
| Reference | Philips | EPIQ 5/EPIQ 7 Diagnostic | K172607 |
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| Devices | Ultrasound, Inc. | Ultrasound System |
|-----------|------------------|----------------------------------|
| Reference | SonoScape | P10 Series Digital Color K173058 |
| Devices | Medical Corp. | Doppler Ultrasound System |
#### 4. Device Description [21 CFR 807.92(a) (4)]
This SonoScape S60 Elite Series Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body.
This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.
This system consists of a mobile console with touch screen and keyboard control panel, power supply module, color LCD monitor and optional probes.
This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler, Power Doppler and Directional Power Doppler Imaging, or the combination of these modes, Contrast lmaging, Elastography, 3D/4D.
Note 1: The S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System is considered as two serial products of S60 Elite Series (including S60 Expert, S60 Classic, S60 Nov, S60 Speci, S60 Speci, S60 Elite, S-Light models) and S70 Series (including S70 Exp, S70, S70 Pro, S70S, S70 VO, S60S, S60N models), but they are the same except partial functions, including the same indications for use, configuration probe, design, hardware, software, mechanic construction, power supply board, main board, specification and etc.
#### 5. Intended Use/Indications for Use [21 CFR 807.92(a) (5)]
#### 5.1 Intended use
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,
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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-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.
5.2 Indications for use
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-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.
The Modes of Operation include B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Tissue Harmonic Imaging, Power Doppler Imaging, Directional Power Doppler Imaging, Tissues Doppler Imaging, Pulse Inversion Harmonic Imaging, 3D/4D Imaging mode, Elastography Imaging, Contrast imaging, Panoramic Imaging, Trapezoid Imaging and their combination modes, and the system is intended to be used in a hospital or medical clinic.
#### 6. Comparison with the Predicate device [21 CFR 807.92(a) (6)]
S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System is comparable with and substantially equivalent to the predicate device:
| Type | Manufacturer | Device | 510 (K) Number |
|--------------------------|--------------------------|----------------------------------------------------|----------------|
| Primary Predicate Device | SonoScape Medical Corp. | S60 Series Digital Color Doppler Ultrasound System | K172082 |
| Reference Devices | Philips Ultrasound, Inc. | EPIQ 5/EPIQ 7 Diagnostic Ultrasound System | K172607 |
| Reference Devices | SonoScape Medical Corp. | P10 Series Digital Color Doppler Ultrasound System | K173058 |
S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System has the same intended uses, complies with the same regulation and safety standards, has the consistent acoustic output levels, has similar probes and has the same technical characteristics as the predicate device legally marketed S60 Series (K172082).
#### Intended Use Comparison:
Compared with the predicate device S60 Series (K172082), the Subject Device S60 Elite Series/S70 Series has the same intended use.
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| Subject Device<br>SonoScape S60 Expert/S60<br>Classic/S60 Nov/S60 Super/S60<br>Speci/S60 Elite/S-Light/S70 Exp/<br>S70/S70 Pro/S70S/S70<br>VO/S60S/S60N | Primary Predicate Device<br>Legally marketed<br>SonoScape S60 Exp/S60/S60<br>Pro/S60 VO/S60 Maso/S59<br>(K172082) | Remark |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| The Digital Color Doppler Ultrasound 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-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology. | 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-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology. | Same |
#### Table 2 Intended use Comparison
#### Technical Characteristics Comparison:
Compared with the predicate device S60 Series (K172082), the Subject Device S60 Elite Series/S70 Series has the similar technical characteristics, including Design, Operation Controls, Display Modes, Operation Modes, Measurement Items, Cine Loop, Operating and Storage Condition. And the differences will not raise new risk and different questions of safety and effectiveness.
#### Probes Comparison:
Subject device S60 Elite Series/S70 Series has the similar probes as the predicate device SonoScape S60 Series (K172082).
#### Table 3 a) Probes Comparison
| Subject Device | Primary Predicate Device | Remark |
|--------------------------|--------------------------|--------|
| SonoScape S60 Expert/S60 | Legally marketed | |
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| Classic/S60 Nov/S60 Super/S60 | SonoScape S60 Exp/S60/S60 | |
|--------------------------------------------------|---------------------------------|------------------|
| Speci/S60 Elite/S-Light/S70 Exp/ | Pro/S60 VO/S60 Maso/S59 | |
| S70/S70 Pro/S70S/S70 | (K172082) | |
| VO/S60S/S60N | | |
| C322 Micro-curved Array | C322 Micro-curved Array | |
| 3C-A Curved Array | 3C-A Curved Array | |
| C1-6 Curved Array | C1-6 Curved Array | |
| C1-6A Curved Array | C1-6A Curved Array | |
| 6CT-A Curved Array | 6CT-A Curved Array | SE |
| 6CI-A Curved Array | 6CI-A Curved Array | Analysis 1 |
| C2-9 Curved Array | C2-9 Curved Array | |
| C613 Micro-curved Array | C613 Micro-curved Array | |
| VC2-9 Curved Array | VC2-9A Curved Array | |
| VC6-2 Micro-curved Array | VC2-9 Curved Array | |
| 6V1 Micro-curved Array | 6V3 Micro-curved Array | |
| 6V3 Micro-curved Array | 6V3A Micro-curved Array | |
| 6V3A Micro-curved Array | 6V7 Micro-curved Array | |
| 6V7 Micro-curved Array | BCC9-5 Micro-curved Array | |
| BCC9-5 Micro-curved Array | BCL10-5 Biplane (Micro-curved + | SE |
| BCL10-5 Biplane (Micro-curved +<br>Linear Array) | Linear Array) | Analysis 1 |
| VE9-5 Micro-curved Array | VE9-5 Micro-curved Array | |
| C3-10V Micro-curved Array | 12C-ER Micro-curved Array | |
| | C3-10V Micro-curved Array | |
| 8P1 Phased Array | | |
| 4P-A Phased Array | 8P1 Phased Array | |
| S1-5 Phased Array | 4P-A Phased Array | SE |
| 7P-A Phased Array | S1-5 Phased Array | Analysis 2 |
| 3P-A Phased Array | 7P-A Phased Array | |
| 7P-B Phased Array | | |
| 1012 Linear Array | 1012 Linear Array | |
| 9L-A Linear Array | 9L-A Linear Array | |
| 12L-A Linear Array | 12L-A Linear Array | SE |
| 12L-B Linear Array | VL12-5 Linear Array | Analysis 3 |
| 13L-A Linear Array | 12L-B Linear Array | |
| 18L-A Linear Array | 13L-A Linear Array | SE<br>Analysis 4 |
| 12LT-A Linear Array | 18L-A Linear Array | |
| 12LI-A Linear Array | ML3-18 Linear Array | |
| L742 Linear Array | 12LT-A Linear Array | |
| L741 Linear Array | 12LI-A Linear Array | |
| L3-9 Linear Array | | |
| CWD2.0 CW | PWD2.0 Doppler | |
| MPTEE Phased Array | CWD5.0 CW | |
| MPTEE mini Phased Array | MPTEE Phased Array | |
| LAP7 Linear Array | MPTEE mini Phased Array | |
| | LAP7 Linear Array | |
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510(k) Submission
#### SE Analysis 1:
Compared with the predicate device, there are two new Micro-curved Array probes as followed: VC6-2, which is similar with the probe VC2-9 cleared with predicate device SonoScape S60 Series (K172082); and 6V1, which is similar with the probe 6V3 cleared with predicate device SonoScape S60 Series (K172082). All of these new transducers have been cleared in the P10 Series Digital Color Doppler Ultrasound System (K173058) and other series, manufactured by SONOSCAPE MEDICAL CORP.
#### SE Analysis 2:
Compared with the predicate device, there are two new Phased Array probes as followed: 3P-A, which is similar with the probe 4P-A cleared with predicate device SonoScape S60 Series (K172082). The new probe 7P-B which is similar with the probe 7P-A cleared with predicate device SonoScape S60 Series (K172082). All of these new transducers have been cleared in the P10 Series Digital Color Doppler Ultrasound System (K173058) and other series, manufactured by SONOSCAPE MEDICAL CORP.
#### SE Analysis 3:
Compared with the predicate device, there are two new Linear Array probes as followed: L742 and L3-9, which is similar with the probe 9L-A cleared with predicate device SonoScape S60 Series (K172082). The new transducers L742 have been cleared in the P10 Series Digital Color Doppler Ultrasound System (K173058) and other series, manufactured by SONOSCAPE MEDICAL CORP., and L3-9 is also legally marketed in S60 Series Digital Color Doppler Ultrasound System (K172082) and other series, manufactured by SONOSCAPE MEDICAL CORP.
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#### SE Analysis 4:
Compared with the predicate device, there is a new CW probes as followed: CWD2.0, which is similar with the probe CWD5.0 cleared with predicate device SonoScape S60 Series (K172082). The new transducers CWD2.0 have been cleared in the P10 Series Digital Color Doppler Ultrasound System (K173058) and other series, manufactured by SONOSCAPE MEDICAL CORP.
Therefore, they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.
#### Functional Comparison of probes
Compared with the predicate device SonoScape S60 Series (K172082), there is new function of contrast imaging in probes (3C-A, C1-6A, C1-6, C2-9, C322, 6CT-A, 6CI-A, 12L-A, 12L-B, 9L-A, L3-9, L741, L742, 10I2, 12LT-A, 12LI-A, 4P-A, 3P-A, S1-5, VE9-5, 6V1, 6V3, 6V7), which is similar with the probes (C6-2, L12-5, S5-1, C10-3v and C10-4ec) cleared with reference device EPIQ 5/EPIQ 7 Diagnostic Ultrasound System (K172607). The clinical application is the same, the performance or frequency is similar, and the difference of these doesn't affect the safety, effectiveness and clinical use.
The engineering drawings of the new function transducers(probes) (3C-A, C1-6, C2-9, C322, 6CT-A, 6CI-A, 12L-A, 12L-B, 9L-A, L3-9, L741, L742, 1012, 12LT-A, 12LI-A, 4P-A, 3P-A, S1-5, VE9-5, 6V1, 6V3, 6V7), and the further comparison are provided as followed.
| Comparis<br>on Items | Subject Device<br>SonoScape S60 Expert/S60<br>Classic/S60 Nov/S60<br>Super/S60 Speci/S60<br>Elite/S-Light/S70 Exp/<br>S70/S70 Pro/S70S/S70<br>VO/S60S/S60N | Reference Device<br>Legally marketed<br>EPIQ 5/EPIQ 7 Diagnostic<br>Ultrasound System<br>(K172607) | Remark |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------|
| Probe 1 | 3C-A | C6-2 | / |
| Photo | Image: 3C-A | Image: C6-2 | / |
#### Table 3 b) Further Comparison for 3C-A Probe
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510(k) Submission
| Probe<br>Type | Curved Array | Curved Array | Same |
|------------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Frequency | 1.0-7.0MHz | 2.0-6.0MHz | SE<br>Analysis 5 |
| Indication<br>for use | Fetal,<br>Other(Ob/GYN),<br>Abdominal, | General purpose abdominal<br>(adult and pediatric, including<br>vascular), bowel, obstetrical,<br>gynecological, prostate and<br>interventional applications | Same |
| Operation<br>Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE<br>Analysis 6 |
| Acoustic<br>Output<br>Limits | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Same |
| Functions | Compound<br>Imaging,<br>Contrast<br>Imaging,<br>Elastography | Compound Imaging, CPA,<br>harmonic Imaging, Contrast<br>Imaging, 3D/4D<br>Imaging,<br>XRES, Elastography | SE<br>Analysis 7 |
## Table 3 c) Further Comparison for C1-6A Probe
| Comparis<br>on Items | Subject Device<br>SonoScape S60 Expert/S60<br>Classic/S60 Nov/S60<br>Super/S60 Speci/S60<br>Elite/S-Light/S70 Exp/<br>S70/S70 Pro/S70S/S70<br>VO/S60S/S60N | Primary Predicate Device<br>Legally marketed<br>EPIQ 5/EPIQ 7 Diagnostic<br>Ultrasound System<br>(K172607) | Remark |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------|
| Probe 2 | C1-6A | C6-2 | / |
| Photo | Image: C1-6A Probe | Image: C6-2 Probe | / |
| Probe<br>Type | Curved Array | Curved Array | Same |
| Frequency | 1.0-8.0MHz | 2.0-6.0MHz | SE<br>Analysis 5 |
{11}------------------------------------------------
510(k) Submission
| Indication<br>for use | Fetal,<br>Other(Ob/GYN) | Abdominal, | General purpose abdominal<br>(adult and pediatric, including<br>vascular), bowel, obstetrical,<br>gynecological, prostate and<br>interventional applications | Same |
|------------------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Operation<br>Mode | B,THI,M,CFM,PDI,DPDI, PW | B,THI,M,CFM,PDI,PW | | SE<br>Analysis 6 |
| Acoustic<br>Output<br>Limits | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | | Same |
| Functions | Compound Imaging,<br>Contrast<br>Elastography | Compound Imaging, CPA,<br>harmonic Imaging, Contrast<br>Imaging, 3D/4D Imaging,<br>XRES, Elastography | | SE<br>Analysis 7 |
# Table 3 d) Further Comparison for C1-6 Probe
| Comparis<br>on Items | Subject Device<br>SonoScape S60 Expert/S60<br>Classic/S60 Nov/S60<br>Super/S60 Speci/S60<br>Elite/S-Light/S70 Exp/<br>S70/S70 Pro/S70S/S70<br>VO/S60S/S60N | Reference Device<br>Legally marketed<br>EPIQ 5/EPIQ 7 Diagnostic<br>Ultrasound System<br>(K172607) | Remark |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------------------|
| Probe 3 | C1-6 | C6-2 | / |
| Photo | Image: SonoScape S60 Expert/S60 Probe | Image: EPIQ 5/EPIQ 7 Diagnostic Ultrasound System Probe | / |
| Probe<br>Type | Curved Array | Curved Array | Same |
| Frequency | 1.0-8.0MHz | 2.0-6.0MHz | SE<br>Analysis 5 |
| Indication<br>for use | Fetal, Abdominal, Other(Ob/GYN) | General purpose abdominal (adult and pediatric, including vascular), bowel, obstetrical, gynecological, prostate and | Same |
{12}------------------------------------------------
510(k) Submission
| | | interventional applications | |
|------------------------------|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------|
| Operation<br>Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE<br>Analysis 6 |
| Acoustic<br>Output<br>Limits | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Same |
| Functions | Compound Imaging,<br>Contrast Imaging,<br>Elastography | Compound Imaging,<br>CPA,<br>harmonic Imaging, Contrast Imaging,<br>3D/4D Imaging,<br>XRES, Elastography | SE<br>Analysis 7 |
## Table 3 e) Further Comparison for C2-9 Probe
| Comparis<br>on Items | Subject Device<br>SonoScape S60 Expert/S60<br>Classic/S60 Nov/S60<br>Super/S60 Speci/S60<br>Elite/S-Light/S70 Exp/<br>S70/S70 Pro/S70S/S70<br>VO/S60S/S60N | Reference Device<br>Legally marketed<br>EPIQ 5/EPIQ 7 Diagnostic<br>Ultrasound System<br>(K172607) | Remark |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Probe 4 | C2-9 | C6-2 | / |
| Photo | Image: Ultrasound probe C2-9 | Image: Ultrasound probe C6-2 | / |
| Probe<br>Type | Curved Array | Curved Array | Same |
| Frequency | 2.0-13.0MHz | 2.0-6.0MHz | SE<br>Analysis 5 |
| Indication<br>for use | Fetal, Abdominal,<br>Other(Ob/GYN) | General purpose abdominal<br>(adult and pediatric, including<br>vascular), bowel, obstetrical,<br>gynecological, prostate and<br>interventional applications | Same |
| Operation<br>Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE<br>Analysis 6 |
{13}------------------------------------------------
510(k) Submission
| Acoustic<br>Output<br>Limits | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Same |
|------------------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|------------------|
| Functions | Compound Imaging,<br>Contrast Imaging | Compound Imaging, CPA,<br>harmonic Imaging, Contrast Imaging,<br>3D/4D Imaging,<br>XRES, Elastography | SE<br>Analysis 7 |
# Table 3 f) Further Comparison for C322 Probe
| Comparis<br>on Items | Subject Device<br>SonoScape S60 Expert/S60<br>Classic/S60 Nov/S60<br>Super/S60 Speci/S60<br>Elite/S-Light/S70 Exp/<br>S70/S70 Pro/S70S/S70<br>VO/S60S/S60N | Reference Device<br>Legally marketed<br>EPIQ 5/EPIQ 7 Diagnostic<br>Ultrasound System<br>(K172607) | Remark |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Probe 5 | C322 | C6-2 | / |
| Photo | Image: SonoScape S60 Expert/S60 Probe | Image: EPIQ 5/EPIQ 7 Diagnostic Ultrasound System Probe | / |
| Probe<br>Type | Micro-curved Array | Curved Array | Same |
| Frequency | 2.0-7.0MHz | 2.0-6.0MHz | SE<br>Analysis 5 |
| Indication<br>for use | Fetal,<br>Abdominal,<br>Other(Ob/GYN) | General purpose abdominal<br>(adult and pediatric, including<br>vascular), bowel, obstetrical,<br>gynecological, prostate and<br>interventional applications | Same |
| Operation<br>Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE<br>Analysis 6 |
| Acoustic<br>Output<br>Limits | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Same |
{14}------------------------------------------------
| Functions | Compound Imaging, Contrast Imaging | Compound Imaging, CPA,<br>THI, harmonic Imaging, Contrast<br>Imaging, 3D/4D Imaging,<br>XRES, Elastography | <b>SE</b> Analysis 7 |
|-----------|------------------------------------|------------------------------------------------------------------------------------------------------------|----------------------|
|-----------|------------------------------------|------------------------------------------------------------------------------------------------------------|----------------------|
# Table 3 g) Further Comparison for 6CT-A Probe
| Comparis<br>on Items | Subject Device<br>SonoScape S60 Expert/S60<br>Classic/S60 Nov/S60<br>Super/S60 Speci/S60<br>Elite/S-Light/S70 Exp/<br>S70/S70 Pro/S70S/S70<br>VO/S60S/S60N | Reference Device<br>Legally marketed<br>EPIQ 5/EPIQ 7 Diagnostic<br>Ultrasound System<br>(K172607) | Remark |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Probe 6 | 6CT-A | C6-2 | / |
| Photo | Image: 6CT-A Probe | Image: C6-2 Probe | / |
| Probe<br>Type | Curved Array | Curved Array | Same |
| Frequency | 3.0-15.0MHz | 2.0-6.0MHz | SE<br>Analysis 5 |
| Indication<br>for use | Fetal,<br>Abdominal,<br>Other(Ob/GYN) | General purpose abdominal<br>(adult and pediatric, including<br>vascular), bowel, obstetrical,<br>gynecological, prostate and<br>interventional applications | Same |
| Operation<br>Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE<br>Analysis 6 |
| Acoustic<br>Output<br>Limits | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Same |
| Functions | Compound Imaging,<br>THI,<br>Contrast Imaging | Compound Imaging,<br>CPA,<br>harmonic Imaging,<br>Contrast<br>Imaging,<br>3D/4D<br>Imaging, | SE<br>Analysis 7 |
{15}------------------------------------------------
| Comparis<br>on Items | Subject Device<br>SonoScape S60 Expert/S60<br>Classic/S60 Nov/S60<br>Super/S60 Speci/S60<br>Elite/S-Light/S70 Exp/<br>S70/S70 Pro/S70S/S70<br>VO/S60S/S60N | Reference Device<br>Legally marketed<br>EPIQ 5/EPIQ 7 Diagnostic<br>Ultrasound System<br>(K172607) | Remark |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Probe 7 | 6CI-A | C6-2 | / |
| Photo | Image: SonoScape S60 Expert/S60 Probe | Image: EPIQ 5/EPIQ 7 Diagnostic Probe | / |
| Probe<br>Type | Curved Array | Curved Array | Same |
| Frequency | 3.0-15.0MHz | 2.0-6.0MHz | SE<br>Analysis 5 |
| Indication<br>for use | Fetal, Abdominal,<br>Other(Ob/GYN) | General purpose abdominal<br>(adult and pediatric, including<br>vascular), bowel, obstetrical,<br>gynecological, prostate and<br>interventional applications | Same |
| Operation<br>Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE<br>Analysis 6 |
| Acoustic<br>Output<br>Limits | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Same |
| Functions | Compound Imaging, THI,<br>Contrast Imaging | Compound Imaging, CPA,<br>harmonic Imaging, Contrast<br>Imaging, 3D/4D Imaging,<br>XRES, Elastography | SE<br>Analysis 7 |
# Table 3 h) Further Comparison for 6CI-A Probe
# Table 3 i) Further Comparison for 12L-A Probe
| Comparis | Subject Device | Reference Device | Remark |
|----------|----------------|------------------|--------|
|----------|----------------|------------------|--------|
{16}------------------------------------------------
| on Items | SonoScape S60 Expert/S60<br>Classic/S60 Nov/S60<br>Super/S60 Speci/S60<br>Elite/S-Light/S70 Exp/<br>S70/S70 Pro/S70S/S70<br>VO/S60S/S60N | Legally marketed<br>EPIQ 5/EPIQ 7 Diagnostic<br>Ultrasound System<br>(K172607) | |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------|
| Probe 8 | 12L-A | L12-5 50 | / |
| Photo | Image: 12L-A | Image: L12-5 50 | / |
| Probe<br>Type | Linear Array | Linear Array | Same |
| Frequency | 3.0-17.0MHz | 5.0-12.0MHz | SE<br>Analysis 5 |
| Indication<br>for use | Small Organ (breast, thyroid, testes), Musculo-skeletal<br>(Conventional & Superficial), Peripheral vessel | Breast, thyroid and superficial small parts; musculoskeletal<br>tendon, abdomen bowel, and vascular applications | Same |
| Operation<br>Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE<br>Analysis 6 |
| Acoustic<br>Output<br>Limits | Derated ISPTA: 720mW/cm2 maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Derated ISPTA: 720mW/cm2 maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Same |
| Functions | Compound Imaging, Contrast<br>Imaging, Elastography | Compound Imaging, CPA,<br>harmonic Imaging, Contrast<br>Imaging, 3D/4D Imaging,<br>XRES, Elastography | SE<br>Analysis 7 |
## Table 3 j) Further Comparison for 12L-B Probe
| Comparis<br>on Items | Subject Device<br>SonoScape S60 Expert/S60<br>Classic/S60 Nov/S60<br>Super/S60 Speci/S60<br>Elite/S-Light/S70 Exp/<br>S70/S70 Pro/S70S/S70 | Reference Device<br>Legally marketed<br>EPIQ 5/EPIQ 7 Diagnostic<br>Ultrasound System<br>(K172607) | Remark |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------|
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------|
{17}------------------------------------------------
510(k) Submission
| | VO/S60S/S60N | | |
|------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------|
| Probe 9 | 12L-B | L12-5 50 | / |
| Photo | Image: 12L-B probe | Image: L12-5 50 probe | / |
| Probe<br>Type | Linear Array | Linear Array | Same |
| Frequency | 3.0-17.0MHz | 5.0-12.0MHz | SE<br>Analysis 5 |
| Indication<br>for use | Small Organ (breast, thyroid,<br>testes), Musculo-skeletal<br>(Conventional & Superficial),<br>Peripheral vessel | Breast, thyroid and superficial<br>small parts; musculoskeletal<br>tendon, abdomen bowel, and<br>vascular applications | Same |
| Operation<br>Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE<br>Analysis 6 |
| Acoustic<br>Output<br>Limits | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Same |
| Functions | Compound Imaging, Contrast<br>Imaging, Elastography | Compound Imaging, CPA,<br>harmonic Imaging, Contrast<br>Imaging, 3D/4D Imaging,<br>XRES, Elastography | SE<br>Analysis 7 |
## Table 3 k) Further Comparison for 9L-A Probe
| Comparis<br>on Items | Subject Device<br>SonoScape S60 Expert/S60<br>Classic/S60 Nov/S60<br>Super/S60 Speci/S60<br>Elite/S-Light/S70 Exp/<br>S70/S70 Pro/S70S/S70<br>VO/S60S/S60N | Reference Device<br>Legally marketed<br>EPIQ 5/EPIQ 7 Diagnostic<br>Ultrasound System<br>(K172607) | Remark |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------|
| Probe 10 | 9L-A | L12-5 50 | / |
| Photo | Image: 9L-A probe | Image: L12-5 50 probe | / |
510(k) Summary
page 15 of 29
{18}------------------------------------------------
510(k) Submission
| Probe<br>Type | Linear Array | Linear Array | Same |
|------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------|
| Frequency | 2.0-13.0MHz | 5.0-12.0MHz | SE<br>Analysis 5 |
| Indication<br>for use | Small Organ (breast, thyroid,<br>testes), Musculo-skeletal<br>(Conventional & Superficial),<br>Peripheral vessel | Breast, thyroid and superficial<br>small parts; musculoskeletal<br>tendon, abdomen bowel, and<br>vascular applications | Same |
| Operation<br>Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE<br>Analysis 6 |
| Acoustic<br>Output<br>Limits | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Same |
| Functions | Compound Imaging, Contrast<br>Imaging, Elastography | Compound Imaging, CPA,<br>harmonic Imaging, Contrast<br>Imaging,<br>3D/4D<br>Imaging,<br>XRES, Elastography | SE<br>Analysis 7 |
# Table 3 I) Further Comparison for L3-9 Probe
| Comparis<br>on Items | Subject Device<br>SonoScape S60 Expert/S60<br>Classic/S60 Nov/S60<br>Super/S60 Speci/S60<br>Elite/S-Light/S70 Exp/<br>S70/S70 Pro/S70S/S70<br>VO/S60S/S60N | Reference Device<br>Legally marketed<br>EPIQ 5/EPIQ 7 Diagnostic<br>Ultrasound System<br>(K172607) | Remark |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|------------------|
| Probe 11 | L3-9 | L12-5 50 | / |
| Photo | Image: Ultrasound probe | Image: Ultrasound probe | / |
| Probe<br>Type | Linear Array | Linear Array | Same |
| Frequency | 2.0-13.0MHz | 5.0-12.0MHz | SE<br>Analysis 5 |
| Indication<br>for use | Small Organ (breast, thyroid,<br>testes),<br>Musculo-skeletal<br>(Conventional & Superficial), | Breast, thyroid and superficial<br>small parts; musculoskeletal<br>tendon, abdomen bowel, and | Same |
{19}------------------------------------------------
| | Peripheral vessel | vascular applications | |
|------------------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|------------------|
| Operation<br>Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE<br>Analysis 6 |
| Acoustic<br>Output<br>Limits | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Same |
| Functions | Compound Imaging, Contrast<br>Imaging, Elastography | Compound Imaging, CPA,<br>harmonic Imaging, Contrast<br>Imaging, 3D/4D Imaging,<br>XRES, Elastography | SE<br>Analysis 7 |
# Table 3 m) Further Comparison for L741 Probe
| Comparis<br>on Items | Subject Device<br>SonoScape S60 Expert/S60<br>Classic/S60 Nov/S60<br>Super/S60 Speci/S60<br>Elite/S-Light/S70 Exp/<br>S70/S70 Pro/S70S/S70<br>VO/S60S/S60N | Reference Device<br>Legally marketed<br>EPIQ 5/EPIQ 7 Diagnostic<br>Ultrasound System<br>(K172607) | Remark |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------|
| Probe 12 | L741 | L12-5 50 | / |
| Photo | Image: Ultrasound probe L741 | Image: Ultrasound probe L12-5 50 | / |
| Probe<br>Type | Linear Array | Linear Array | Same |
| Frequency | 4.0-16.0MHz | 5.0-12.0MHz | SE<br>Analysis 5 |
| Indication<br>for use | Small Organ (breast, thyroid,<br>testes),<br>Musculo-skeletal<br>(Conventional & Superficial),<br>Peripheral vessel | Breast, thyroid and superficial<br>small parts; musculoskeletal<br>tendon, abdomen bowel, and<br>vascular applications | Same |
| Operation<br>Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE<br>Analysis 6 |
| Acoustic<br>Output<br>Limits | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Same |
{20}------------------------------------------------
| Functions | Compound Imaging, Contrast<br>Imaging, Elastography | Compound Imaging, CPA,<br>harmonic Imaging, Contrast<br>Imaging, 3D/4D Imaging,<br>XRES, Elastography | SE<br>Analysis 7 |
|-----------|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------|------------------|
|-----------|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------|------------------|
# Table 3 n) Further Comparison for L742 Probe
| Comparis<br>on Items | Subject Device<br>SonoScape S60 Expert/S60<br>Classic/S60 Nov/S60<br>Super/S60 Speci/S60<br>Elite/S-Light/S70 Exp/<br>S70/S70 Pro/S70S/S70<br>VO/S60S/S60N | Reference Device<br>Legally marketed<br>EPIQ 5/EPIQ 7 Diagnostic<br>Ultrasound System<br>(K172607) | Remark |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------|
| Probe 13 | L742 | L12-5 50 | / |
| Photo | Image: Ultrasound probe | Image: Ultrasound probe | / |
| Probe<br>Type | Linear Array | Linear Array | Same |
| Frequency | 4.0-16.0MHz | 5.0-12.0MHz | SE<br>Analysis 5 |
| Indication<br>for use | Small Organ (breast, thyroid,<br>testes), Musculo-skeletal<br>(Conventional & Superficial),<br>Peripheral vessel | Breast, thyroid and superficial<br>small parts; musculoskeletal<br>tendon, abdomen bowel, and<br>vascular applications | Same |
| Operation<br>Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE<br>Analysis 6 |
| Acoustic<br>Output<br>Limits | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Same |
| Functions | Compound Imaging, Contrast<br>Imaging, Elastography | Compound Imaging, CPA, harmonic Imaging, Contrast Imaging, 3D/4D Imaging, XRES, Elastography | SE<br>Analysis 7 |
# Table 3 o) Further Comparison for 10I2 Probe
{21}------------------------------------------------
| Comparis<br>on Items | Subject Device<br>SonoScape S60 Expert/S60<br>Classic/S60 Nov/S60<br>Super/S60 Speci/S60<br>Elite/S-Light/S70 Exp/<br>S70/S70 Pro/S70S/S70<br>VO/S60S/S60N | Reference Device<br>Legally marketed<br>EPIQ 5/EPIQ 7 Diagnostic<br>Ultrasound System<br>(K172607) | Remark |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|------------------|
| Probe 14 | 1012 | L12-5 50 | / |
| Photo | Image: SonoScape S60 Expert/S60 Probe | Image: EPIQ 5/EPIQ 7 Diagnostic Ultrasound System Probe | / |
| Probe<br>Type | Linear Array | Linear Array | Same |
| Frequency | 4.0-16.0MHz | 5.0-12.0MHz | SE<br>Analysis 5 |
| Indication<br>for use | Small Organ (breast, thyroid, testes), Musculo-skeletal (Conventional & Superficial), Peripheral vessel | Breast, thyroid and superficial small parts; musculoskeletal tendon, abdomen bowel, and vascular applications | Same |
| Operation<br>Mode | B,THI,M,CFM,PDI,DPDI,PW | B,THI,M,CFM,PDI,PW | SE<br>Analysis 6 |
| Acoustic<br>Output<br>Limits | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Derated ISPTA: 720mW/cm2<br>maximum<br>TIS/TIB/TIC: 6.0 maximum<br>MI: 1.9 maximum | Same |
| Functions | Compound Imaging, Contrast<br>Imaging | Compound Imaging, CPA, harmonic Imaging, Contrast Imaging, 3D/4D Imaging, XRES Elastography | SE<br>Analysis 7 |
# Table 3 p) Further Comparison for 12LT-A Probe
| Comparis<br>on Items | Subject Device | Reference Device | Remark |
|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|------------------|--------|
| SonoScape S60 Expert/S60<br>Classic/S60 Nov/S60<br>Super/S60 Speci/S60<br>Elite/S-Light/S70 Exp/ | Legally marketed<br>EPIQ 5/EPIQ 7 Diagnostic<br>Ultrasound System<br>(K172607) | | |
{22}------------------------------------------------
510(k) Submission
| | S70/S70 Pro/S70S/S70<br>VO/S60S/S60N | | |
|------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------|
| Probe 15 | 12LT-A | L12-5 50 | / |
| Photo | Image: 12LT-A Probe | Image: L12-5 50 Probe | / |
| Probe<br>Type | Linear Array | Linear Array | Same |
| Frequency | 4.0-16.0MHz | 5.0-12.0MHz | SE<br>Analysis 5 |
| Indication<br>for use | Small Organ (breast, thyroid,<br>testes),<br>Musculo-skeletal<br>(Conventional & Superficial),<br>Peripheral vessel | Breast, thyroid and superficial<br>small parts; musculoskeletal<br>tendon, abdomen bowel, and<br>vascular applications | Same |
| Operation<br>Mode…
