← Product Code [IYN](/productcode/IYN) · K260123 # EPIQ Series Diagnostic Ultrasound System (K260123) _Philips Ultrasound, LLC · IYN · May 27, 2026 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K260123 ## Device Facts - **Applicant:** Philips Ultrasound, LLC - **Product Code:** [IYN](/productcode/IYN.md) - **Decision Date:** May 27, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1550 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Pediatric ## Indications for Use The intended use of EPIQ Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: - Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. - Modes of operation include: B Mode (3D/4D), M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging. - The clinical environments where EPIQ Series Diagnostic Ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. - When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance. The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure. ## Device Story EPIQ Series Diagnostic Ultrasound System is a software-controlled diagnostic imaging platform. This submission adds the eV14-2v endocavitary transducer, a broadband PureWave curved linear array with multi-row technology (436 elements, 3 rows). The transducer uses a high-voltage multiplexer to switch between inner and full elevation apertures, optimizing near-field clutter and far-field penetration. It supports 2D, PW/Color Doppler, M-mode, 3D/4D, and Elastography. Used in clinics, hospitals, and point-of-care settings by trained healthcare professionals, the system acquires ultrasound data via the transducer, processes it through the console, and displays images for diagnostic assessment. The system integrates with Philips EchoNavigator for live X-ray/echo guidance during cardiovascular procedures. Output assists clinicians in visualizing anatomy and fluid flow to inform clinical decision-making and treatment guidance. ## Clinical Evidence No clinical data was required for this submission. Substantial equivalence was demonstrated through design features, indications for use, fundamental scientific technology, and non-clinical performance testing (bench testing). ## Technological Characteristics Broadband endocavitary curved linear array transducer (eV14-2v); 6 MHz center frequency; 436 elements (3 rows of 218); high-voltage multiplexer for aperture switching (inner vs. full); 3D/4D capable; biocompatible materials (ISO 10993-1); IEC 60601-1 and IEC 60601-2-37 compliant; cart-based system connectivity. ## 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 - 3D9-3V with EPIQ Series Diagnostic Ultrasound System ([K160807](/device/K160807.md)) ## Reference Devices - V9-2 with EPIQ Series Diagnostic Ultrasound System ([K182857](/device/K182857.md)) - C9-4ec with Lumify Diagnostic Ultrasound System ([K242519](/device/K242519.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} FDA U.S. FOOD & DRUG ADMINISTRATION May 27, 2026 Philips Ultrasound, LLC Aditi Chaubal Senior RA Manager 22100 Bothell Everett Hwy Bothell, Washington 98021 Re: K260123 Trade/Device Name: EPIQ Series Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, OBJ, QIH Dated: April 24, 2026 Received: April 27, 2026 Dear Aditi Chaubal: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K260123 - Aditi Chaubal Page 2 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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K260123 - Aditi Chaubal Page 3 assistance/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} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K260123 Device Name EPIQ Series Diagnostic Ultrasound System Indications for Use (Describe) The intended use of EPIQ Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: - Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. - Modes of operation include: B Mode (3D/4D), M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging. - The clinical environments where EPIQ Series Diagnostic Ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. - When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance. The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure. 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." FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 {4} Page 1 of 6 # TRADITIONAL 510(k) Philips Ultrasound EPIQ Series Diagnostic Ultrasound System 510(k) Summary Section 10.02 510(k) Summary 510(k) Number: K260123 This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92. 1. Submitter's name, address, telephone number, contact person(s) Manufacturer: Philips Ultrasound LLC 22100 Bothell Everett Hwy Bothell, WA 98021-8431 Contact Person: Aditi Chaubal Senior RA Manager aditi.chaubal@philips.com 1-425-482-8243 Secondary Contact: Irma Sandoval-Watt Senior RA Manager Irma.Sandoval-Watt@philips.com 1-303-453-3421 Date Prepared: May 26, 2026 2. Name of the device, including the trade of proprietary name if applicable, the common or usual name, and the classification name, if known: Proprietary Name: EPIQ Series Diagnostic Ultrasound System Common Name: Diagnostic ultrasound system and transducers Regulation Description: | Classification Name | 21 CFR § | Product Code | | --- | --- | --- | | Primary | | | | System, imaging, pulsed doppler, ultrasonic | 892.1550 | IYN | | Secondary | | | | System, imaging, pulsed echo, ultrasonic | 892.1560 | IYO | | Transducer, ultrasonic, diagnostic | 892.1570 | ITX | | Automated radiological image processing software | 892.2050 | QIH | | Catheter, ultrasound, intravascular | 870.1200 | OBJ | Device Class: Class II Classification Panel: Radiology {5} Page 2 of 6 # 3. Device Description Summary The Philips EPIQ Series Diagnostic Ultrasound Systems are general purpose, software controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and to display the data in various modes of operation. The systems consist of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics, and the transducer connection points. In addition to the physical knobs and buttons of the main control panel, the user interface consists of a touch screen with soft key controls. The transducers connect to the system console and facilitate ultrasound scanning of patients. There are multiple marketing-named versions of the EPIQ Series Diagnostic Ultrasound systems. Each version of the EPIQ systems can have multiple feature configurations that are based on different software feature options and hardware options. This submission introduces the eV14-2v transducer on the Philips EPIQ Series Diagnostic Ultrasound Systems. # eV14-2v Transducer The eV14-2v is a broadband, endocavitary PureWave transducer with elevation focus. It is 3D/4D capable and features multi-row array technology. It is designed to support obstetric and gynecological applications. The transducer offers a variety of imaging modes, including 2D, PW Doppler, Color Flow, M-mode, 3D/4D, and Elastography. eV14-2v includes a curved linear array with 6 MHz center frequency and 10.5 mm azimuth radius of curvature. The array has a total of 436 elements arranged in 3 rows of 218 elements. The inner row of 218 elements provide an "inner" elevation aperture 3 mm in height. This row is connected to 128 system channels via a high-voltage multiplexer. The two outer rows of 218 elements are electrically connected together and, also via a high-voltage multiplexer, can be selectively connected to the same 128 system channels, resulting in the "full" aperture height of 6 mm. The ability to switch between inner and full apertures provides the means to achieve both low clutter in the near field and penetration in the far field. The same multiplexer provides the ability to translate these apertures in the azimuth direction provides the field of view. The multiplexer is controlled by data signals provided by the system to coordinate azimuth aperture position with the system beamformer. The linear curved array can be mechanically rotated and acquire planar tomographic slices for reconstructing 3D/4D images. The eV14-2v consists of a linear curved array, rotational mechanism and drive train, motor, and interconnect circuitry. A transducer housing assembly encloses the lens module assembly (LMA) and an integral connectorized cable assembly provides interface to the system. The connectorized cable assembly contains a cable and a connector with PCBs providing cable and system interconnect, electrical tuning, multiplexer control, and system interface features. # 4. Intended Use and Indications for Use The intended use of EPIQ Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: - Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. - Modes of operation include: B Mode (3D/4D), M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging. - The clinical environments where EPIQ Series Diagnostic Ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. - When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance. The systems are intended to be installed, used, and operated only in accordance with the safety procedures {6} and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure. ## Indications for Use for eV14-2v Transducer: The indications for use for the eV14-2v transducer are Fetal/OB, Other: Fetal Echo, Other: GYN, Other: Urology, and Transvaginal. ## 5. Substantially Equivalent Devices - Predicate Device (Transducer): 3D9-3V with EPIQ Series Diagnostic Ultrasound System (K160807) - Reference Device 1 (Transducer): V9-2 with EPIQ Series Diagnostic Ultrasound System (K182857) - Reference Device 2 (Transducer): C9-4ec with Lumify Diagnostic Ultrasound System (K242519) ## 6. Technological Comparison to Predicate & Reference Devices | Feature/ Characteristic | EPIQ Series Diagnostic Ultrasound System with eV14-2v Transducer Subject | EPIQ Series Diagnostic Ultrasound System with 3D9-3V Transducer (K160807) Predicate | Comparison/ Discussion/ Comments | | --- | --- | --- | --- | | System level Feature/Characteristics | | | | | Regulation Number | 892.155 | 892.155 | Identical | | Device Classification Name | II | II | Identical | | Primary Product Code | IYN | IYN | Identical | | Secondary Product Codes | IYO, ITX, OBJ, QIH | IYO, ITX, OBJ, QIH | Identical | | Intended Use | Intended for diagnostic ultrasound imaging and fluid flow analysis | Intended for diagnostic ultrasound imaging and fluid flow analysis | Identical | | Indications for Use | Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. | Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. | Identical | | Modes of Operation | B Mode (3D/4D), M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, Harmonic Imaging | B Mode (3D/4D), M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, Harmonic Imaging | Identical | | Scientific Technology | Ultrasound Imaging | Ultrasound Imaging | Identical | | Users | Trained healthcare professionals | Trained healthcare professionals | Identical | Page 3 of 6 {7} | Feature/ Characteristic | EPIQ Series Diagnostic Ultrasound System with eV14-2v Transducer Subject | EPIQ Series Diagnostic Ultrasound System with 3D9-3V Transducer (K160807) Predicate | Comparison/Discussion/Comments | | --- | --- | --- | --- | | | | | | | Use Environment | Clinics, hospitals, and clinical point-of-care for diagnosis of patients. | Clinics, hospitals, and clinical point-of-care for diagnosis of patients. | Identical | | Transducer Features | eV14-2v | 3D9-3V | | | Transducer Model | Endocavitary Curved Linear Transducer | Endocavitary Curved Linear Transducer | Identical | | Indications for Use | Fetal/OB; Fetal Echo; Trans-vaginal; GYN; Urology | Fetal/OB; Fetal Echo; Trans-vaginal; GYN; Urology | Identical | | Acoustic Output | Ispta.3 ≤ 720 (mW/cm2) TI ≤ 6.0 MI ≤ 1.9 | Ispta.3 ≤ 720 (mW/cm2) TI ≤ 6.0 MI ≤ 1.9 | Identical | | Acoustic Working Frequency | Center Frequency 6.1MHz | Center Frequency 5.7 MHz | Similar | | Geometrical Configuration | Curved Linear Array | Curved Linear Array | Identical | | Total Number of elements | 436 addressable elements connected to form dual aperture array with 218 elements per aperture | 128 | Different | | Field of View (Degrees) | 180 degrees | 155.5 degrees | Different | | Transducer Modes of Operation | B (2D); M-mode; PW; Doppler; 3D/4D, Color; MPR | B, M, PWD, Color; 3D/4D; Doppler, Combined | Similar | | Tip Dimensions | Height: 25.3mm Width: 25.3mm Tip Diameter: 25.3 mm | Height: 26.3mm Width:26.3mm Tip Diameter: 26.3 mm | Different | | Connector | Cart-based system transducer connector | Cart-based system transducer connector | Identical | | Weight (Including connector and cable) | < 0.9 kg (including connector and cable) | < 1.2 kg (including connector and cable) | Similar | | Radiated Field Operating Controls | The transducer is controlled via the Ultrasound System's control panel. | The transducer is controlled via the Ultrasound System's control panel. | Identical | | Patient Contact Materials | Biocompatible ISO 10993-1 | Biocompatible ISO 10993-1 | Identical | Page 4 of 6 {8} | Feature/ Characteristic | EPIQ Series Diagnostic Ultrasound System with eV14-2v Transducer Subject | EPIQ Series Diagnostic Ultrasound System with 3D9-3V Transducer (K160807) Predicate | Comparison/ Discussion/ Comments | | --- | --- | --- | --- | | | | | | | Transducer Maximum Surface Temperature (per IEC 60601-2-37, clause 201.11) | Temperatures in °C Still Air: 42.6 Simulated Use: 42.5 | Temperatures in °C Still Air: 41.8 Simulated Use: 42.5 | Similar | | Transducer Element Check Incorporated | Yes | Yes | Identical | | Transducer Provided Sterile | No | No | Identical | | Transducer Recommended use of covers | Yes | Yes | Identical | | Transducer reusable | Yes | Yes | Identical | | Maximum Insertion Portion Width | 25.3 mm | 27.3mm | Similar | | Working Length (Intended Insertion Length) | 150mm | 165mm | Similar | ## 7. Safety Considerations The proposed eV14-2v transducer with EPIQ Series Diagnostic Ultrasound System are categorized as Track 3 devices. ## 8. Non-Clinical Performance Data Philips Ultrasound performed the following testing to ensure the safety and effectiveness of the proposed product: - IEC 62304 Medical device software - Software life cycle processes, 2006 + A 2015 - IEC62366-1 Medical devices – Part 1: Application of usability engineering to medical devices, 2015+ AMD1: 2020 - ISO 14971 Medical devices- Application of risk management to medical devices, 2019 - IEC 60601-1 - Medical electrical equipment – Part 1: General requirements for basic safety and essential performance - IEC 60601-2-37- Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment - IEC 60601-1-2 4.1 ed - Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests; 2020 - IEC 62359, Ultrasonics – Field characterization – Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2017-09 - ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process; 2018 Non-Clinical performance testing has been conducted addressing the system level requirements with the transducer according to the system and design specifications and risk control measures. The activities to assure safe and effective performance of the EPIQ Series Diagnostic Ultrasound System include but are not limited to the following: - Requirements Review - Risk Analysis and Management - Product Specifications - Design Reviews Page 5 of 6 {9} Page 6 of 6 9. Clinical Performance Data The proposed EPIQ Series Diagnostic Ultrasound System with eV14-2v transducer did not require clinical data for determination of substantial equivalence since it demonstrated substantial equivalence based on the following attributes: - Design Features - Indications for Use - Fundamental scientific technology - Non-clinical performance testing - Safety and Effectiveness 10. Conclusion For testing, all pre-determined acceptance criteria were met. Results of these tests show that the proposed transducer eV14-2v for EPIQ Series Diagnostic Ultrasound System, does not affect the use of the device, nor does it introduce any new or significantly modified risks. There is no change in the indications to EPIQ Series Diagnostic Ultrasound System. All comparison points between the subject eV14-2v transducer and the predicate, 3D9-3v transducer (compatible with the predicate EPIQ Series Diagnostic Ultrasound System) and reference devices (V9-2 with EPIQ Series Diagnostic Ultrasound System; C9-4ec with Lumify Diagnostic Ultrasound System) are either identical or equivalent. The differences between the proposed device and the predicate device do not raise new questions of safety and/or effectiveness. Therefore, the proposed EPIQ Series Diagnostic Ultrasound System with eV14-2v transducer is substantially equivalent to the predicate device in terms of indications for use, design, technological characteristics, modes of operations, safety and effectiveness. --- **Source:** [https://fda.innolitics.com/device/K260123](https://fda.innolitics.com/device/K260123) **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