← Product Code [IYN](/productcode/IYN) · K240676 # ULTIMUS Series Ultrasound Diagnostic System (K240676) _Vinno Technology (Suzhou) Co.,Ltd · IYN · Dec 16, 2024 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K240676 ## Device Facts - **Applicant:** Vinno Technology (Suzhou) Co.,Ltd - **Product Code:** [IYN](/productcode/IYN.md) - **Decision Date:** Dec 16, 2024 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1550 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Pediatric ## Indications for Use The ULTIMUS Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospitals or clinics environment. ## Device Story The ULTIMUS Series is a mobile, console-based diagnostic ultrasound system used in hospitals and clinics by qualified physicians or sonographers. It utilizes various electronic array transducers (linear, curved, sector/phased, endocavity, and 3D) to acquire ultrasound signals. The system processes these signals to generate real-time images, measurements, and analysis of human anatomy and fluids. It supports multiple imaging modes, including B, M, PW/CW Doppler, Color/Power Doppler, and 3D/4D imaging. The system provides clinicians with visual diagnostic data to assist in clinical decision-making across various specialties, including obstetrics, cardiology, and vascular assessment. It features automated optimization tools for image and Doppler spectrum analysis to improve workflow efficiency. ## Clinical Evidence No clinical studies were required to support substantial equivalence. Evidence is based on bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety testing in compliance with recognized standards (e.g., IEC 60601-1, IEC 60601-2-37, ISO 10993). ## Technological Characteristics Mobile console with height-adjustable control panel, color LCD touch panel, and LCD monitor. Transducers: linear, curved, sector/phased array, endocavity, and 3D. Connectivity: DICOM compliant. Software: IEC 62304 compliant. Safety standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359. Biocompatibility: ISO 10993-1, -5, -10, -23. Power: Lithium battery (IEC 62133-2). ## Regulatory 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 - GE LOGIQ E10 Ultrasound Diagnostic System ([K231966](/device/K231966.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font. December 16, 2024 Vinno Technology (Suzhou) Co.,Ltd Jeff Zhou Regulatory Registered Engineer 5F Building A.4F Building C No. 27 Xinfa Rd. Suzhou Industrial Park Suzhou, Jiangsu 215123 CHINA Re: K240676 Trade/Device Name: ULTIMUS Series Ultrasound Diagnostic System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, Dated: June 3, 2024 Received: June 3, 2024 ### Dear Jeff Zhou: 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 (that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of {1}------------------------------------------------ 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 OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn {2}------------------------------------------------ (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 Mansanto Submission Number (if known) K240676 Device Name ULTIMUS Series Ultrasound Diagnostic System #### Indications for Use (Describe) The ULTIMUS Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospitals or clinics environment. The systems support the following clinical applications: This device is indicated for Abdominal; Fetal/Obstetrics; Gynecology; Transvaginal; Urology(including prostate); Transrectal; Cardiac(adult and child); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle, Musculo-skeletal Conventional and Superficial); Pediatrics(including neonatal cephalic); interventional(nerve block and vascular access); Adult Cephalic diagnostic Ultrasound applications. Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for VINNO, a company that focuses on vision in innovation. The word "VINNO" is written in large, bold letters at the top of the logo. Below the company name, the words "VISION IN INNOVATION" are written in a smaller font. The logo is simple and modern, and it conveys the company's focus on innovation. # K240676 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: | Date Prepared:
Manufacturer: | Feb 28, 2024
VINNO Technology (Suzhou) Co., Ltd
5F Building A, 4F Building C No. 27 XinFa Rd.
Suzhou Industrial Park, SuZhou 215123
Jiangsu China | |---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Jeff Zhou
Regulatory Registered Engineer
VINNO Technology (Suzhou) Co., Ltd
Tel: +86 512 6287380
Fax: +86 512 62873801 | email: Jeff.zhou@vinno.com ### ldentification of the Device: | Trade Name: | ULTIMUS Series Ultrasound Diagnostic System | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Model Name: | ULTIMUS 9E、ULTIMUS 9P、ULTIMUS 9、ULTIMUS 8E、ULTIMUS 8P、ULTIMUS 8、ULTIMUS 7E、ULTIMUS 7P、ULTIMUS 7、ULTIMUS 6E、ULTIMUS 6P、ULTIMUS 6、ULTIMUS 5E、ULTIMUS 5P、ULTIMUS 5 | | Classification Name: | Ultrasound Diagnostic System | | Regulation Name: | Ultrasonic Pulsed Doppler Imaging System | | Regulatory Number: | 21 CFR 892.1550, 21 CFR 892.1560, 21 CFR 892.1570 | | Product Code: | IYN, IYO, ITX | | Device Class: | Class II | | Review Panel: | Radiology | # Primary Predicate Device: | Proprietary/Trade Name: | LOGIQ E10 | |--------------------------|------------------------------------------------------| | Classification Name: | Ultrasound Diagnostic System | | Regulation Name: | Ultrasonic Pulsed Doppler Imaging System | | Regulatory Number: | 21 CFR 892.1550, 21 CFR 892.1560, 21 CFR
892.1570 | | Product Code: | IYN, IYO, ITX | | Device Class: | Class II | | Review Panel: | Radiology | | Submitter/510(k) Holder: | GE Medical Systems Ultrasound and Primary | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for VINNO, a company that specializes in vision and innovation. The logo is composed of the company name in bold, sans-serif font, with the tagline "VISION in innovation" written in a smaller font size underneath. The logo is simple and modern, and it conveys the company's focus on innovation and technology. Clearance: Care Diagnostics, LLC K231966 (cleared Nov 07, 2022) # Device Description: The ULTIMUS Series consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor device. It includes a variety of electronic array transducers operating in linear, curved, sector/phase array, endocavity, and real time 3D transducer. The ULTIMUS series is a Track 3 diagnostic ultrasound system. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage. ### Indications for Use: The ULTIMUS Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospitals or clinics environment. The systems support the following clinical applications: This device is indicated for Abdominal; Fetal/Obstetrics; Gynecology; Transvaginal; Urology(including prostate); Transrectal; Cardiac(adult and child); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle, Musculoskeletal Conventional and Superficial); Pediatrics(including neonatal cephalic); interventional(nerve block and vascular access); Adult Cephalic diagnostic Ultrasound applications. Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. ### Comparison with Predicate Device: The ULTIMUS Series and its predicate device, the GE LOGIQ E10 Ultrasound Diagnostic System (K231966), have the equivalent intended use, and similar physical characteristics. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for VINNO, a company that focuses on vision in innovation. The logo is in black and white, with the word "VINNO" in large, bold letters. Below the company name is the phrase "vision in innovation" in a smaller font. The logo is simple and modern, and it conveys the company's focus on innovation. | Description | Subject Device | Predicate Device | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | ULTIMUS Ultrasound Diagnostic
System | GE LOGIQ E10 Ultrasound Diagnostic
System (K231966) | | Model | ULTIMUS 9E, ULTIMUS 9P, ULTIMUS
9, ULTIMUS 8E, ULTIMUS 8P,
ULTIMUS 8, ULTIMUS 7E, ULTIMUS
7P, ULTIMUS 7, ULTIMUS 6E,
ULTIMUS 6P, ULTIMUS 6, ULTIMUS
5E, ULTIMUS 5P, ULTIMUS 5 | LOGIQ E10 | | Indications
for use | The ULTIMUS Series Ultrasound
Diagnostic System is a general-
purpose ultrasound system. It is
intended for use by, or under the
direction of a qualified and trained
physician for ultrasound imaging,
measurement, display and analysis of
the human body and fluid. The device
is intended for use in a hospitals or
clinics environment.
The systems support the following
clinical applications:
This device is indicated for Abdominal;
Fetal/Obstetrics; Gynecology;
Transvaginal; Urology(including
prostate); Transrectal; Cardiac(adult
and child); Peripheral Vascular; Small
Organs/Parts(thyroid, breast, testicle,
Musculo-skeletal Conventional and
Superficial); Pediatrics(including
neonatal cephalic);
interventional(nerve block and
vascular access); Adult Cephalic
diagnostic Ultrasound applications. | LOGIQ E10 is intended for use by a
qualified physician for ultrasound
evaluation of Fetal / Obstetrics;
Abdominal (including Renal,
Gynecology/Pelvic); Pediatric; Small
Organ (Breast, Testes, Thyroid);
Neonatal Cephalic; Adult Cephalic;
Cardiac (Adult and Pediatric);
Peripheral V ascular; Musculo-skeletal
Conventional and Superficial; Urology
(including Prostate); Transrectal;
Transvaginal; Transesophageal and
Intraoperative (Abdominal and
Vascular).
The LOGIQ E10 is intended to be used
in a hospital or medical clinic. | | User
qualification | Qualified healthcare professionals | Qualified physicians or sonographers | | Environme
nt | hospitals or clinics environment | hospitals or clinics environment | | Description | Subject Device
ULTIMUS
Ultrasound
Diagnostic
System | Predicate Device
GE LOGIQ E10 Ultrasound Diagnostic
System (K231966) | | Design | This device is designed for the safety
of the patient and operator.
This product is designed to fully comply
with the EN60601-1-2 (IEC60601-1-2),
Class A, in medical electric equipment
EMC regulations.
And compliance with IEC60601-1,
60601-2-37 | This device is designed for the safety
of the patient and opeartor.
This product is designed to fully
comply with the EN60601-1-2
(IEC60601-1-2),
Class A, in medical electric equipment
EMC regulations.
And compliance with IEC60601-1,
60601-2-37 | | Patient
contact
materials | Material meet ISO 10993-1 and FDA
guidance | Material meet ISO 10993-1 and FDA
guidance | | Operating
modes | • B mode
• HAR mode
• M mode
• CF mode
• Multi-Angle M mode
• Color M(CM) mode
• PDI mode
• Tissue Doppler (TD) mode
• PW mode
• CW mode
• Tissue Velocity Imaging (TVI) mode
• Tissue Power Imaging (TPI) mode
• Tissue Velocity M (TVM) mode
• 3D/Free 3D mode
• 4D/ STIC mode
• Contrast Bubble Imaging(CBI)mode
• Elastography Imaging (EI) mode
• Pulse wave velocity imaging (PWV)
mode
• Strain and strain rate imaging mode
• Shear Wave Elastography (SWE)
mode (VShear) | • B-Mode (B)
• Harmonics (HAR)
• M-Mode (M)
• Color Flow Mode (CF)
• M-Mode
• Color M mode
• Power Doppler Imaging (PDI)
• Tissue Doppler Imaging (TD)
• Pulse Wave Mode (PW)
• Continuous Wave Mode (CW)
• Tissue Velocity Imaging (TVI)
• Tissue Power
• Tissue Velocity Doppler (TVD)
• 3D/Easy 3D/Advance 3D/Tur 3D
• 4D mode
• Contrast Enhanced Ultrasound
(CEUS)
• Elastography (ELASTO)
• PW Doppler with High PRF (PW)
• Strain and strain rate imaging mode
• Shear Wave Elastography (SWE)
mode | | Description | Subject Device | Predicate Device | | | ULTIMUS
Ultrasound
Diagnostic | GE LOGIQ E10 Ultrasound Diagnostic | | | System | System (K231966) | | Functions | • Har mode | • Coded Harmonic Imaging, | | | • Steer | • Steering, | | | • Vfusion | • CrossXBeam | | | • Vspeckle | • SRI | | | • Vsharpen | • Edge Enhance, | | | • Persistence | • Frame Averaging, | | | • GrayFilter | • Rejection, | | | • Smooth | • B Softener, | | | • Vtissue | • Suppression | | | • 2D Automatic Optimization | • Auto Tissue Optimization: ATO, | | | • PW automatic optimization | • Auto Spectrum Optimization: ASO, | | | • Auto spectrum trace | • Doppler auto trace | | | • Auto trace | • Auto trace | | | • Tview | • Virtual Convex, | | | • Pview | • LOGIQView, | | | • Dual & Quad view | • Independent Dual B/PW Display,
Quad Screen Display | | | • Image rotation, invert and zoom | • Zoom: Write/Read/Pan, Image
Rotation | | | • Duplex and Triplex | • Duplex, Real-time Triplex Mode at
any Depth and PRF, | | | • Stress echo | • Stress echo, | | | • 4D rendering | • Render, Texture | | | • Mcut | • Tomographic Ultrasound Imaging
(TUI), | | | • Color 3D | • HDlive Flow | | | • Light Lab | • HDlive Studio | | | • VLuminous flowing | • Radiantflow™ | | | • MCP(Micro Contrast Perfusion) | • MVI(CEUS) | | | • SMF (Super Micro Flow) | • Micro Vascular Imaging | | Description | Subject Device | Predicate Device | | | ULTIMUS Ultrasound Diagnostic
System | GE LOGIQ E10 Ultrasound Diagnostic
System (K231966) | | Measureme
nt | Measurements:
• Abdominal measurements
• Obstetrics Measurements
• Gynecology Measurements
• Cardiac Measurements
• Vessel measurements
• Urology Measurements
• Small organ measurements
• Pediatric Measurements | Categories include the following:
• Abdomen
• Obstetrics
• Gynecology
• Cardiology
• Vascular
• Urology
• Small Parts
• Pediatrics | | Probe types | Phased array S1-6P
Convex array X2-6C
Micro convex (Endocavity) X4-9E
Linear array X6-16L
Volume convex array D2-6C… --- **Source:** [https://fda-staging.innolitics.com/device/K240676](https://fda-staging.innolitics.com/device/K240676) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com