EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

K240850 · Philips Ultrasound, LLC · IYN · Apr 24, 2024 · Radiology

Device Facts

• Record ID: K240850
• Device Name: EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
• Applicant: Philips Ultrasound, LLC
• Product Code: IYN · Radiology
• Decision Date: Apr 24, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: AI/ML, Pediatric

Intended Use

The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body. The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body.

Device Story

EPIQ and Affiniti ultrasound systems receive ultrasound image data from transthoracic echocardiography (TTE) exams. Two new software features are introduced: Smart View Select (SVS) and Segmental Wall Motion (SWM). SVS uses a deep learning AI engine to classify images by view and a heuristic algorithm to select optimal image triplets (A4C, A2C, A3C) for left ventricle (LV) analysis. SWM uses machine learning to perform border detection and tracking on these views to evaluate regional LV function, providing segmental wall motion scores and a Wall Motion Score Index (WMSI). The device is operated by trained healthcare professionals in clinics and hospitals. Output is displayed to the clinician for review and potential manual adjustment of scores. These features assist in the assessment of cardiovascular disease, supporting clinical decision-making by automating image selection and regional function quantification.

Clinical Evidence

Bench testing only. Two retrospective data analysis studies were performed. Study 1 (SVS workflow): Compared SVS-selected clips to manual selection for GLS and EF calculation; Pearson's correlation 0.911 (GLS) and 0.941 (EF), meeting acceptance criteria (lower confidence bound >0.8). Study 2 (SWM): Compared integrated SWM algorithm to LVivo SWM ground truth; Pearson's correlation 0.957 (manual workflow) and 0.913 (SVS workflow), meeting acceptance criteria (lower confidence bound >0.8).

Technological Characteristics

Software-only modification to existing Class II ultrasound systems. Features include deep learning-based view classification and machine learning-based segmental wall motion quantification. Complies with IEC 62304 (software lifecycle), IEC 62366-1 (usability), and ISO 14971 (risk management). Connectivity via DICOM. No hardware, acoustic, or biocompatibility changes.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis of the human body, including abdominal, cardiac (adult, fetal, pediatric), cerebral vascular, cephalic (adult, neonatal), fetal/obstetric, gynecological, intraoperative (vascular, cardiac), intra-luminal, intra-cardiac echo, musculoskeletal (conventional, superficial), ophthalmic, urology, pediatric, peripheral vessel, small organ (breast, thyroid, testicle), transesophageal (cardiac), transrectal, transvaginal, and lung applications. 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

• Philips EPIQ Series Diagnostic Ultrasound System (K233788)
• Philips Affiniti Series Diagnostic Ultrasound System (K233788)

Reference Devices

• LVivo Seamless (K212466)
• LVivo Software Application with LVivo SG (K161382)
• AutoStrain LV (K190913)

Submission Summary (Full Text)

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April 24, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.

Philips Ultrasound LLC Michael Chambers Sr. Regulatory Affairs Specialist 22100 Bothell Everett Highway BOTHELL WA 98021

# Re: K240850

Trade/Device Name: EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, QIH, OBJ Dated: March 25, 2024 Received: March 27, 2024

# Dear Michael Chambers:

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.

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).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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 (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 ([e-mail]) or phone [phone] 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

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# Indications for Use

Submission Number (if known)

K240850

Device Name

EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

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), Transvaginal, Lung.

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 quidance 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.

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

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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)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 2HIL

# Special 510(k) Summary

This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92.

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Date Prepared: March 27, 2024

### l. Submitter

| Manufacturer Name and<br>Address | Philips Ultrasound LLC<br>22100 Bothell Everett Hwy Bothell,<br>WA 98021-8431 USA |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information | Mike Chambers<br>Senior Regulatory Affairs Specialist<br>22100 Bothell Everett Hwy<br>Bothell, WA 98021-8431 USA<br>[phone] |
| Secondary Contact | Erdit Gremi<br>Director, Requlatory Affairs<br>Philips Ultrasound LLC<br>22100 Bothell Everett Hwy<br>Bothell, WA 98021-8431 USA<br>[phone] |

### II. Device

| Proprietary Name | EPIQ Series Diagnostic Ultrasound System<br>Affiniti Series Diagnostic Ultrasound System | | |
|------------------------|----------------------------------------------------------------------------------------------------------------------------|----------|--------------------|
| Common Name | Diagnostic Ultrasound System and Transducers | | |
| Regulation Description | Classification Description | 21 CFR § | Product Code |
| | <b>Primary</b> | | |
| | System, imaging, pulsed doppler,<br>ultrasonic | 892.1550 | IYN |
| | <b>Secondary</b> | | |
| | System, imaging, pulsed echo,<br>ultrasonic | 892.1560 | IYO |
| | Transducer, ultrasonic, diagnostic | 892.1570 | ITX |
| | Automated Radiological Image<br>Processing Software | 892.2050 | QIH |
| | Diagnostic Intravascular Catheter | 870.1200 | OBJ*<br>*EPIQ only |
| Device Class | Class II | | |
| Review Panel | Radiology | | |
| Predicate Device | K233788; Philips EPIQ Series Diagnostic Ultrasound System<br>K233788; Philips Affiniti Series Diagnostic Ultrasound System | | |
| Reference Devices | K212466; LVivo Seamless<br>K161382; LVivo Software Application with LVivo SG | | |

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#### III. Device Description

The purpose of this Special 510(k) Pre-Market Notification is to introduce the Smart View Select (SVS) software application onto the EPIQ Series Diagnostic Ultrasound Systems and to introduce the Segmental Wall Motion software application onto both the EPIQ and Affiniti Series Diagnostic Ultrasound Systems.

Smart View Select is an automated software feature that assists the user in selection of images for analysis with the existing Philips AutoStrain LV or 2D Auto LV application in Adult Echo Transthoracic (TTE) examination. This feature automatically classifies each acquired image by view and selects an appropriate set of images for left ventricle (LV) analysis. The classification is based on a Deep Learning Al interface engine; the selection is a non-Al algorithm that considers the view classification and image depth to select the optimal set of images.

The Segmental Wall Motion software automatically evaluates the segmental (regional) function of the left ventricle (LV) from adult TTE echo examinations. For input, the SWM algorithm uses 3 apical views (A4C, A2C and A3C) and performs border detection and tracking to identify each of the LV segments based on the three views. The application then provides segmental wall motion scores for each of the 17 segments of the LV by using machine learning algorithms and an overall wall motion score index (WMSI) is calculated as the average of the segmental scores.

No hardware changes to the EPIQ or Affiniti systems are required when using SVS or SWM, and existing, cleared Philips TTE transducers are used with these software applications.

The SVS feature is supported by all EPIQ models running software version 11.0 or higher including EPIQ CVx/CVxi, EPIQ Elite Advanced, EPIQ Elite, EPIQ 7, EPIQ 5. The SWM feature is supported by the same EPIQ models running software version VM11.0 or higher, as well as all Affiniti models including Affiniti CVx, Affiniti 70, Affiniti 50, and Affiniti 30. The SVS and SWM software are associated with the cardiac adult indication.

#### IV. Intended Use and Indications for Use

## EPIQ Intended Use

The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body.

## EPIQ 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.

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 quidance.

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.

Note: There are no changes to the EPIQ Ultrasound System Indications for Use due to the introduction

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of the SVS or SWM software applications. These software applications are associated with the Cardiac Adult indication.

# Affiniti Intended Use:

The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body.

## Affiniti Indications for Use:

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), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.

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.

Note: There are no changes to the Affiniti Ultrasound System Indications for Use due to the introduction of the SWM software application. This software applications is associated with the Cardiac Adult indication.

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# PHILIPS

#### V. Comparison of Technological Characteristics with the Predicate

The purpose of the submission is to introduce the SVS software application feature to the EPIQ Series Diagnostic Ultrasound System and the SWM software application to both EPIQ and Affiniti. The subject device is substantially equivalent to the predicate device (K233788).

| Feature | EPIQ Series Diagnostic<br>Ultrasound System<br>Features: SVS and SWM<br>Proposed Device | EPIQ Series Diagnostic<br>Ultrasound System<br>K233788<br>Predicate Device | LVivo Seamless<br>K212466<br>Reference Device | LVivo Software<br>Application<br>Feature: LVivo SG K161382<br>Reference Device | Comparison |
|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | Abdominal, Cardiac<br>Adult, Cardiac other<br>(Fetal), Cardiac<br>Pediatric, Cerebral<br>Vascular, Cephalic<br>(Adult), Cephalic<br>(Neonatal),<br>Fetal/Obstetric,<br>Gynecological,<br>Intraoperative<br>(Vascular),<br>Intraoperative<br>(Cardiac), intra-luminal,<br>intra-cardiac echo,<br>Musculoskeletal<br>(Conventional),<br>Musculoskeletal<br>(Superficial),<br>Ophthalmic, Other:<br>Urology, Pediatric,<br>Peripheral Vessel,<br>Small Organ (Breast,<br>Thyroid, Testicle),<br>Transesophageal<br>(Cardiac), Transrectal,<br>Transvaginal, Lung. | Abdominal, Cardiac<br>Adult, Cardiac other<br>(Fetal), Cardiac<br>Pediatric, Cerebral<br>Vascular, Cephalic<br>(Adult), Cephalic<br>(Neonatal),<br>Fetal/Obstetric,<br>Gynecological,<br>Intraoperative<br>(Vascular),<br>Intraoperative<br>(Cardiac), intra-luminal,<br>intra-cardiac echo,<br>Musculoskeletal<br>(Conventional),<br>Musculoskeletal<br>(Superficial),<br>Ophthalmic, Other:<br>Urology, Pediatric,<br>Peripheral Vessel,<br>Small Organ (Breast,<br>Thyroid, Testicle),<br>Transesophageal<br>(Cardiac), Transrectal,<br>Transvaginal, Lung. | LVivo platform is<br>intended for non-<br>invasive processing of<br>ultrasound images to<br>detect, measure, and<br>calculate relevant<br>medical parameters of<br>structures and function<br>of patients with<br>suspected disease. | LVivo platform is<br>intended for non-<br>invasive processing of<br>ultrasound images to<br>detect, measure, and<br>calculate relevant<br>medical parameters of<br>structures and function<br>of patients with<br>suspected disease. | Identical to predicate |
| | Trained healthcare<br>professionals | Trained healthcare<br>professionals | Trained healthcare<br>professionals | Trained healthcare<br>professionals | Identical to predicate |
| Intended Users | Intended for<br>sonographers,<br>physicians, and<br>biomedical engineers<br>who operate and<br>maintain your product. | Intended for<br>sonographers,<br>physicians, and<br>biomedical engineers<br>who operate and<br>maintain your product. | | | |
| | Before use of the<br>system and user<br>information, the user<br>must be familiar with<br>ultrasound techniques.<br>Sonography training<br>and clinical procedures<br>are not included in the<br>User Manual or with the<br>EPIQ Series Diagnostic<br>Ultrasound System. | Before use of the<br>system and user<br>information, the user<br>must be familiar with<br>ultrasound techniques.<br>Sonography training<br>and clinical procedures<br>are not included in the<br>User Manual or with the<br>EPIQ Series Diagnostic<br>Ultrasound System. | | | |
| Intended User<br>Environment | Clinics, hospitals, and<br>clinical point-of-care for<br>diagnosis of patients. | Clinics, hospitals, and<br>clinical point-of-care for<br>diagnosis of patients. | Professional healthcare<br>environments | Professional healthcare<br>environments | Identical to predicate |
| Feature | EPIQ Series Diagnostic<br>Ultrasound System<br>Features: SVS and SWM<br>Proposed Device | EPIQ Series Diagnostic<br>Ultrasound System<br>K233788<br>Predicate Device | LVivo Seamless<br>K212466<br>Reference Device | LVivo Software<br>Application<br>Feature: LVivo SG<br>K161382<br>Reference Device | Comparison |
| USA FDA<br>Classification | Class II | Class II | Class II | Class II | Identical to predicate |
| Primary<br>Product Code | IYN | IYN | QIH | LLZ | Identical to predicate |
| Primary<br>Regulation<br>Name | System, Imaging,<br>Pulsed Doppler,<br>Ultrasonic | System, Imaging,<br>Pulsed Doppler,<br>Ultrasonic | Automated Radiological<br>Image<br>Processing Software | Medical image<br>management and<br>processing system. | Identical to predicate |
| Primary<br>Regulation<br>Number | 21 CFR 892.1550 | 21 CFR 892.1550 | 21 CFR 892.2050 | 21 CFR 892.2050 | Identical to predicate |
| Secondary<br>Product Codes | ITX<br>IYO<br>OBJ<br>QIH | ITX<br>IYO<br>OBJ<br>QIH | N/A | N/A | Identical to predicate |
| Secondary<br>Regulation<br>Name | Diagnostic ultrasonic<br>transducer<br>Ultrasonic pulsed echo<br>imaging<br>system<br>Diagnostic<br>intravascular catheter<br>Automated Radiological<br>Image<br>Processing Software | Diagnostic ultrasonic<br>transducer<br>Ultrasonic pulsed echo<br>imaging<br>system<br>Diagnostic<br>intravascular catheter<br>Automated Radiological<br>Image<br>Processing Software | N/A | N/A | Identical to predicate |
| Secondary<br>Regulation<br>Number | 21 CFR 892.1570<br>21 CFR 892.1560<br>21 CFR 870.1200<br>21 CFR 892.2050 | 21 CFR 892.1570<br>21 CFR 892.1560<br>21 CFR 870.1200<br>21 CFR 892.2050 | N/A | N/A | Identical to predicate |
| Reusable-<br>Systems and<br>Transducers | Yes | Yes | No, software-only…