EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System

K181485 · Philips Ultrasound, Inc. · IYN · Jul 27, 2018 · Radiology

Device Facts

• Record ID: K181485
• Device Name: EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System
• Applicant: Philips Ultrasound, Inc.
• Product Code: IYN · Radiology
• Decision Date: Jul 27, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The intended use of the EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 70 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), 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. The clinical environments where the EPIQ and Affiniti 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, and only for the purposes for which it was designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

Device Story

EPIQ and Affiniti systems are software-controlled diagnostic ultrasound platforms. They acquire ultrasound data via various transducers (phased, linear, curved, pencil, TEE, matrix) and display images in modes including B-mode, M-mode, PWD, CWD, and Color Doppler. Systems are used in clinics, hospitals, and point-of-care settings by clinicians for diagnosis. When integrated with Philips EchoNavigator, they provide image guidance for cardiovascular procedures using live X-ray and Echo. Output is displayed on a console for clinician review to support clinical decision-making and patient diagnosis. Benefits include non-invasive visualization of anatomy and blood flow, and guidance for interventional procedures.

Clinical Evidence

No clinical studies were required. Substantial equivalence was demonstrated through design features, indications for use, fundamental scientific technology, non-clinical performance testing, and safety/effectiveness data. Non-clinical testing included system-level verification, risk control, and usability testing with representative users.

Technological Characteristics

General purpose, software-controlled diagnostic ultrasound systems. Transducers include phased, linear, curved, pencil, TEE, and 3D matrix arrays. Frequency range 1.0-18.0 MHz. Connectivity via standard multi-pin connectors. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and IEC 62359. Acoustic output within Track 3 FDA limits (ISPTA.3 ≤ 720 mW/cm2, MI < 1.9, TI < 6.0).

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis of the human body, including abdominal, cardiac (adult, fetal, pediatric), vascular (cerebral, peripheral, intraoperative), cephalic (adult, neonatal), fetal/obstetric, gynecological, musculoskeletal (conventional, superficial), urological, pediatric, and small organ (breast, thyroid, testicle) applications. Used in clinics, hospitals, and point-of-care settings.

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 Diagnostic Ultrasound System (K172607)
• Philips Affiniti Diagnostic Ultrasound System (K172607)

Submission Summary (Full Text)

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July 27, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Philips Ultrasound, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K181485

Trade/Device Name: EPIQ , EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: July 17, 2018 Received: July 18, 2018

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### 510(k) Number (if known)

#### K181485

#### Device Name

EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, EPIQ Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System

#### Indications for Use (Describe)

The intended use of the EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 70 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), 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.

The clinical environments where the EPIQ and Affiniti 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, and only for the purposes for which it was designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

| CONTINUIF ON A SEPARATE PAGE IF NEEDED | | | | | | | | |
|-------------------------------------------------|---------------------------------------------|--|--|--|--|--|--|--|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | | | | | | | |
| Type of Use (Select one or both, as applicable) | | | | | | | | |

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| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|--------------------------------------------|---------------------------------------------------|---|-----|-----|-------------------|---------------------|----------------------------------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / OB | P | P | P | | P | Note: 1,2,3 | Note: 5,6,7,8,9,10,12,13,17 |
| | Abdominal | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,<br>11,12,13,15,16,17,18,19 |
| | Intra-operative (Cardiac) | P | P | P | P | P | Note: 1,2,3 | Note: 5,8,9,10,12,13 |
| | Intra-operative (Vascular) | P | P | P | P | P | Note: 1,2,3 | Note: 5,8,9,10,12,13 |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note: 1,2,3 | Note:<br>5,6,8,9,10,12,13,17,18 |
| | Small Organ (breast, thyroid,<br>testicle) | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,<br>12,13,15,17,19 |
| | Neonatal Cephalic | P | P | P | | P | Note: 1,2,3 | Note: 5,8,9,10,12,13,17 |
| | Adult Cephalic | P | P | P | | P | Note: 1,2,3 | Note: 8,9,10,12,13,17 |
| | Trans-rectal | P | P | P | | P | Note: 1,2,3 | Note:<br>5,6,8,9,10,11,12,13,15,17 |
| | Trans-vaginal | P | P | P | | P | Note: 1,2,3 | Note:<br>5,6,7,8,9,10,11,12,13,15,17 |
| | Trans-urethral | P | P | P | | P | Note: 1,2,3 | Note:<br>5,6,7,8,9,10,11,12,13,15,17 |
| | Trans-esoph. (non-Cardiac) | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13,17 |
| | Musculo-skel. (Conventional) | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13,17 |
| | Musculo-skel. (Superficial) | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13,17 |
| | Intra-luminal | | | | | | | |
| | Other: GYN | P | P | P | | P | Note: 1,2,3 | Note:<br>5,6,7,8,9,10,11,12,13,15,17 |
| | Other: Urology | P | P | P | | P | Note: 1,2,3 | Note:<br>5,6,8,9,10,11,12,13,15,17 |
| Cardiac | Cardiac Adult | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,12,13,14 |
| | Cardiac Pediatric | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,12,13,14 |
| | Trans-esophageal (Cardiac) | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,12,13,14 |
| | Other (Fetal Echo) | P | P | P | P | P | Note: 1,2,3,4 | Note: 5,6,8,10,12,13,14 |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,17 |
| | Cerebral vascular | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,17 |

System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N= new indication P= previously cleared

| *Color Doppler includes Color Amplitude Doppler | Note 10: Harmonic Imaging |
|---------------------------------------------------------------------|--------------------------------|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | Note 11: Contrast Imaging |
| Note 2: Combined modes include: B+M+Color | Note 12: 3D/4D Imaging |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | Note 13: XRES |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | Note 14: TDI |
| Note 5: SonoCT | Note 15: Elastography |
| Note 6: Imaging for guidance of biopsy | Note 16: ElastPQ (for Liver) |
| Note 7: Infertility monitoring of follicle development | Note 17: PercuNav |
| Note 8: Panoramic Imaging | Note 18: ElastQ Imaging |
| Note 9: Color Power Angio (CPA) | Note 19: ElastQ Imaging Linear |
| Previous submission: K172607, EPIQ/Affiniti | |

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| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
|---------------------------|------------------------------------------------------------------------------------|---------------------------------------------------|---|-----|-----|--------------------|---------------------|-----------------------------------|
| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler** | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / OB | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,10,12,13 |
| | Abdominal | | | | | | | |
| | Intra-operative (Cardiac) | | | | | | | |
| | Intra-operative (Vascular) | | | | | | | |
| Fetal Imaging | Laparoscopic | | | | | | | |
| & Other | Pediatric | | | | | | | |
| | Small Organ (breast, thyroid,<br>testicle) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | P | P | P | | P | Note: 1,2,3 | Note: 5,6,7,<br>8,10,11,12,13, 15 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other: GYN | P | | | | | | |
| | Other: Urology | P | P | P | | P | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (Fetal Echo) | P | P | P | | P | Note: 1,2,3 | Note:<br>5,6,8,9,10,12,13 |
| Peripheral | Peripheral vessel | | | | | | | |
| Vessel | Cerebral Vascular | | | | | | | |

EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems System: 3D9-3v

Transducer:

N= new indication; P= previously cleared

Additional Comments: *Color Doppler includes Color Amplitude Doppler Note 10: Harmonic Imaging Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M Note 11: Contrast Imaging Note 12: 3D/4D Imaging Note 2: Combined modes include: B+M+Color Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD Note 13: XRES Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD Note 14: TDI Note 5: SonoCT Note 15: Elastography Note 6: Imaging for guidance of biopsy Note 16: ElastPQ (for Liver) Note 7: Infertility monitoring of follicle development Note 17: Percu Nav Note 8: Panoramic Imaging Note 9: Color Power Angio (CPA) Previous Submission: K172607, EPIQ/Affiniti

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System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems

Transducer: C5-1

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |
|---------------------------------------------------------------------|---------------------------------------------------|---|---|-----|-----|-------------------|------------------------------|----------------------------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / OB | P | P | P | | P | Note: 1,2,3 | Note: 5,6,7,8,9,10,12,13 |
| | Abdominal | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,<br>9,10,11,12,13,16,17,18 |
| | Intra-operative (Cardiac) | | | | | | | |
| | Intra-operative (Vascular) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13,17,18 |
| | Small Organ (breast, thyroid,<br>testicle) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other: GYN | P | P | P | | P | Note: 1,2,3 | Note: 5,6,7,8,9,10,11,12,13,<br>17 |
| | Other: Urology | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8, 9,10,11,12,13,<br>17 |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (Fetal Echo) | P | P | P | | P | Note: 1,2,3 | Note: 5,6,10,12,13 |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,17 |
| | Cerebral vascular | | | | | | | |
| N= new indication | P= previously cleared | | | | | | | |
| | Additional Comments: | | | | | | | |
| | *Color Doppler includes Color Amplitude Doppler | | | | | | Note 10: Harmonic Imaging | |
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | | | | | | | Note 11: Contrast Imaging | |
| Note 2: Combined modes include: B+M+Color | | | | | | | Note 12: 3D/4D Imaging | |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | | | | | | | Note 13: XRES | |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | | | | | | | Note 14: TDI | |
| Note 5: SonoCT | | | | | | | Note 15: Elastography | |
| Note 6: Imaging for guidance of biopsy | | | | | | | Note 16: ElastPQ (for Liver) | |
| Note 7: Infertility monitoring of follicle development | | | | | | | Note 17: PercuNav | |
| Note 8: Panoramic Imaging | | | | | | | Note 18: ElastQ Imaging | |
| Note 9: Color Power Angio (CPA) | | | | | | | | |

Previous submission: K172607, EPIQ/Affiniti

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EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems System: Transducer: C8-5

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |
|---------------------------------------------------------------------|--------------------------------------------------------------------|---------------------------------------------------|--------------------|-----|-----|------------------------|---------------------------------|------------------------|--|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal / OB | | | | | | | | |
| | Abdominal | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 | |
| | Intra-operative (Cardiac) | | | | | | | | |
| | Intra-operative (Vascular) | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 | |
| | Small Organ (breast, thyroid,<br>testicle) | | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other: GYN | | | | | | | | |
| | Other: Urology | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (Fetal Echo) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 | |
| | Cerebral Vascular | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 | |
| | P= previously cleared<br>N= new indication<br>Additional Comments: | | | | | | | | |
| | *Color Doppler includes Color Amplitude Doppler | | | | | | Note 9: Color Power Angio (CPA) | | |
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | | | | | | | Note 10: Harmonic Imaging | | |
| Note 2: Combined modes include: B+M+Color | | | | | | | Note 11: Contrast Imaging | | |
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD | | | | | | Note 12: 3D/4D Imaging | | | |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD | | | | | | Note 13: XRES | | | |
| Note 5: SonoCT | | | | | | | Note 14: TDI | | |
| Note 6: Imaging for guidance of biopsy | | | | | | | Note 15: Elastography | | |
| Note 7: Infertility monitoring of follicle development | | | | | | | Note 16: ElastPQ (for Liver) | | |
| Note 8: Panoramic Imaging | | | Note 17: Percu Nav | | | | | | |

Previous Submission: K172607, EPIQ/Affiniti

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#### System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems

Transducer: C9-2

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|---------------------------------------------------|-----|-----|---------------------------------|---------------------------------|-------------------------------------------|--|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal / OB | P | P | P | | P | Note: 1,2,3 | Note: 5,6,7,8,9,10,12,13,<br>17 | |
| | Abdominal | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,<br>17 | |
| | Intra-operative (Cardiac) | | | | | | | | |
| | Intra-operative (Vascular) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13, 17 | |
| | Small Organ (breast, thyroid,<br>testicle) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Conventional) | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 | |
| | Musculo-skel. (Superficial) | | | | | | | | |
| | Intra-luminal…