EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Device Facts
| Record ID | K250177 |
|---|---|
| Device Name | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System |
| Applicant | Philips Ultrasound, LLC |
| Product Code | IYN · Radiology |
| Decision Date | Apr 10, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The intended use of EPIQ Ultrasound Diagnostic System 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, 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 and Affiniti Series are diagnostic ultrasound systems for imaging and fluid flow analysis. New Remote Software Management (RSM) feature enables remote deployment of OS packages, device/printer drivers, BIOS/UEFI versions, and application packages; supports automatic/scheduled downloads and installations; includes automatic backup/restore of system settings. Systems connect to Philips Remote Server via Philips Support Connect. No hardware or transducer changes. Operated by trained healthcare professionals in clinics/hospitals/point-of-care. RSM enhances workflow by allowing remote major software upgrades, replacing manual field service engineer-led updates. EchoNavigator integration assists interventionalists/surgeons with live X-ray/echo guidance for cardiovascular procedures. Benefits include streamlined maintenance, reduced downtime, and ensured system currency.
Clinical Evidence
No clinical data required. Substantial equivalence demonstrated through design features, indications for use, fundamental scientific technology, and non-clinical performance testing (bench testing).
Technological Characteristics
Diagnostic ultrasound system; B-mode, M-mode, Doppler (PW/CW/Color/Power), and Harmonic Imaging. Connectivity via Philips Remote Server for RSM. Software version 12.0. Complies with IEC 62304 (software lifecycle) and ISO 14971 (risk management). No hardware changes; utilizes existing commercialized transducers.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis of the human body across various clinical applications including abdominal, cardiac (adult/pediatric/fetal), vascular, obstetric, gynecological, musculoskeletal, ophthalmic, urological, and small organ imaging. Used in clinics, hospitals, and point-of-care settings by trained healthcare professionals.
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
- EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System (K242020)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
April 10, 2025
Philips Ultrasound LLC
Swetha Paritala
Senior Regulatory Affairs Specialist
22100 Bothell Everett Highway
Bothell, Washington 98021
Re: K250177
Trade/Device Name: EPIQ Series Diagnostic Ultrasound System; Affiniti 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: January 21, 2025
Received: January 22, 2025
Dear Swetha Paritala:
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
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K250177 - Swetha Paritala
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 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-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-
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K250177 - Swetha Paritala
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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
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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.
Submission Number (if known)
# K250177
Device Name
EPIQ Series Diagnostic Ultrasound System;
Affiniti Series Diagnostic Ultrasound System
Indications for Use (Describe)
EPIQ:
The intended use of EPIQ Ultrasound Diagnostic System 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, 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.
Affiniti:
The intended use of Affiniti 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), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M
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Mode, Power Doppler, and Harmonic Imaging.
The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
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.
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PHILIPS
K250177
510(k) Summary
#K
This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92.
Date Prepared: January 10, 2025
# I. Submitter
Manufacturer Name and Address
Philips Ultrasound LLC
22100 Bothell Everett Hwy
Bothell, WA 98021-8431 USA
Contact Information
SwethaRao Paritala
Senior Regulatory Affairs Specialist
22100 Bothell Everett Hwy
Bothell, WA 98021-8431 USA
Swetharao.partitala@philips.com
1-412-969-1010
Secondary Contact
Amy Yang
Regulatory Affairs Director
22100 Bothell Everett Hwy
Bothell, WA 98021-8431 USA
amy.yang@philips.com
1-304-266-8208
# II. Device
Proprietary Name
EPIQ Series Diagnostic Ultrasound System
Affiniti Series Diagnostic Ultrasound System
Common Name
Diagnostic Ultrasound System and Transducers
Product Code; Regulation Description; Regulation Number
IYN; Ultrasonic Pulsed Doppler Imaging System; 21 CFR 892.1550 (Primary)
IYO; Ultrasonic Pulsed Echo Imaging System; 21 CFR 892.1560
ITX; Diagnostic Ultrasonic Transducer; 21 CFR 892.1570
OBJ; Diagnostic Intravascular Catheter; 21 CFR 870.1200
QIH; Medical Image Management and Processing System; 21 CFR 892.2050
Device Class
Class II
Review Panel
Radiology
Predicate Device
K242020; EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System
# III. Device Description
The purpose of this Traditional 510(k) Pre-Market Notification is to introduce Remote Software Management (RSM) software feature onto the EPIQ and Affiniti Series Diagnostic Ultrasound Systems. The proposed EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound Systems with new RSM software feature, which is a workflow-enhancement software feature, is equivalent to predicate device, K242020.
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PHILIPS
The Philips RSM feature provides the capabilities to remotely upgrade EPIQ/Affiniti Systems, with the existing RSM capabilities, only patch upgrade was possible, and full upgrade (including OS components) was not supported.
## Enhancement Overview:
The full RSM feature provides the capabilities to perform a remote upgrade to EPIQ/Affiniti Systems.
The RSM feature is capable of deploying following packages onto the system:
- OS Packages
- Device Drivers
- Printer Drivers
- BIOS/UEFI version
- Application Packages
- Service Application Packages
- Automatic backup/restore of existing system settings
Along with the above functionalities, it also supports Automatic and Scheduled software downloads/Installation.
No hardware changes to the EPIQ or Affiniti Systems are required when using RSM software feature, and existing, commercialized Philips transducers are used for the RSM software feature. The feature is supported by EPIQ and Affiniti models running software version 12.0.
## IV. Indications for Use
### EPIQ:
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, 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.
### Affiniti:
The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:
#
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PHILIPS
Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging.
The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
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.
# V. Comparison of Technological Characteristics with the Predicate
The purpose of the submission is to introduce the RSM software feature onto the EPIQ and Affiniti Series Diagnostic Ultrasound Systems. The proposed EPIQ and Affiniti Series Diagnostic Ultrasound Systems are all Track 3 Devices and comply with the referenced standards as well as the FDA Ultrasound Guidance Document, Guidance for Industry and FDA Staff – Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, issued in February 2023. The subject devices are substantially equivalent to the predicate devices (K242020).
| Feature | EPIQ and Affiniti Series Diagnostic Ultrasound System Proposed Device | EPIQ and Affiniti Series Diagnostic Ultrasound System (K242020) Predicate Device | Comparison |
| --- | --- | --- | --- |
| USA FDA Classification | Class II | Class II | Identical |
| Primary Product Code | IYN | IYN | Identical |
| Primary Regulation Number | 21 CFR 892.1550 | 21 CFR 892.1550 | Identical |
| Marketing Name of Application | Remote Software Management | Remote Software Management | Subject of this submission |
| Application Description | Remote Software Management provides capabilities to remotely upgrade to major software releases on EPIQ and Affiniti. RSM is capable of deploying the following packages onto the system:OS PackagesDevice DriversPrinter Drivers | The Remote Software Management feature allows remote update capabilities, such as bug fixes and patches. System upgrades are performed by Field Service Engineer | The proposed RSM will provide the patch upgrade, major releases, Automatic and scheduled downloads of the software where the predicated RSM had only the bug fixed and patch upgrades. The subject of this submission is to provide upgrades with the full RSM. |
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PHILIPS
| Feature | EPIQ and Affiniti Series Diagnostic Ultrasound System Proposed Device | EPIQ and Affiniti Series Diagnostic Ultrasound System (K242020) Predicate Device | Comparison |
| --- | --- | --- | --- |
| | BIOS/UEFI Version
Application Packages
Service Application Packages
Automatic backup/restore of existing system settings
Along with the above functionalities, it also supports Automatic and Scheduled software downloads/installation. | | |
| User Interface Presentation | The system must be connected to the Philips Remote Server. The user can go into Philips Support Connect and navigate the download and installation process for system updates and upgrades. Additionally, Remote Software Management supports automatic and scheduled software downloads and installations. | The system must be connected to the Philips Remote Server. The user can go into Philips Support Connect and navigate the download and installation process for system updates only. | The proposed RSM will provide an automatic, Scheduled download to the user where the predicate device requires the user to connect Philips Support and navigate system manually. There is no change to the user's functionality with full RSM feature. |
| Application performance | Remote Service Engineer performs verification post installation, verify all settings and customizations are retained. Installation is verified through the Philips Remote Service portal. | Field service engineer performs full upgrade activities. | Subject of this Submission. Verification and Validation Testing has been conducted on the RSM feature to support the Application performance is equivalent to the predicate device. |
## VI. Safety Considerations
The subject device comply with the referenced standards as well as the FDA ultrasound guidance document, Guidance for Industry and FDA Staff – Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, issued on February 2023.
## VII. Non-Clinical Performance Data
The proposed modification of the EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems was tested in accordance with Philips Internal Procedures. The design process incorporated IEC 62304 Medical Device Software – Software life cycle processes, 2006 + A 2015 and Risk Management procedures were applied in accordance with ISO 14971 Medical devices - Application of risk management to medical devices, to ensure the continued safe and effective performance. All software verification tests met the acceptance criteria.
## VIII. Clinical Data
The proposed EPIQ and Affiniti Series Diagnostic Ultrasound System did not require clinical data for determination of substantial equivalence since substantial equivalence was demonstrated based on the following attributes:
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PHILIPS
- Design features
- Indications for use
- Fundamental scientific technology
- Non-clinical performance testing
- Safety and effectiveness
IX. Conclusion
For testing, all pre-determined acceptance criteria were met. Results of these tests show that the proposed Remote Software Management software feature meets the intended use. The proposed devices and predicate device:
- Are indicated for the diagnostic ultrasonic imaging and fluid flow analysis.
- Have identical intended users and use environments.
- Have the same device classification, product codes.
- Have identical software.
- Are introducing no new hardware or transducers.
The differences between the proposed device and predicate device do not raise new questions of safety and/or effectiveness. The major differences include:
- The Remote Software Management feature recommends particular frames that user can go into Philips Support Connect and navigate the download and installation process for system updates and upgrades. Additionally, Remote Software Management supports automatic and scheduled software downloads and installations, where the predicate devices require user can go into Philips Support Connect and navigate the download and installation process for system updates only.
Therefore, the proposed Remote Software Management feature for the EPIQ and Affiniti Series Diagnostic Ultrasound Systems is substantially equivalent to the predicate EPIQ and Affiniti Series Diagnostic Ultrasound Systems in terms of safety and effectiveness.
