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

K160807 · Philips Ultrasound, Inc. · IYN · Apr 6, 2016 · Radiology

Device Facts

• Record ID: K160807
• Device Name: EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
• Applicant: Philips Ultrasound, Inc.
• Product Code: IYN · Radiology
• Decision Date: Apr 6, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

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

Device Story

Diagnostic ultrasound systems (EPIQ 5/7, Affiniti 50/70) acquire and display ultrasound data for clinical diagnosis. Systems consist of a console (user interface, display, electronics) and various transducers (phased, linear, curved, TEE, 3D matrix). Principle of operation involves generating electronic voltage pulses transmitted to transducers, which convert them into ultrasonic pressure waves; reflected echoes are processed to generate images or Doppler flow data. Used in clinics, hospitals, and point-of-care by healthcare professionals. Features include image-guided navigation/fusion (PercuNav), OLAB Heart Model, and measurement analysis packages. Output is displayed on-screen for anatomical measurement and diagnostic decision-making, potentially improving patient management through non-invasive imaging.

Clinical Evidence

No clinical data was required to demonstrate safety and effectiveness. Substantial equivalence is supported by bench testing, including software verification and validation, and compliance with electrical safety (IEC 60601-1) and acoustic output (IEC 60601-2-37, IEC 62359) standards.

Technological Characteristics

Systems utilize phased, linear, curved, TEE, and 3D matrix array transducers (1.0–18.0 MHz). Console includes LCD monitor, touch screen, and keyboard. Connectivity via network, DVR, DVD, and USB. Software-controlled signal processing for B-mode, M-mode, PW/CW Doppler, Color Doppler, and Tissue Doppler. Compliant with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-37. Non-sterile.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in abdominal, cardiac (adult, pediatric, fetal), 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 (K132304)

Reference Devices

• ClearVue 350/550 (K120321)
• HD 11 (K043535)
• HD 15 (K081661)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 6, 2016

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

Re: K160807 Trade/Device Name: EPIO 5 Diagnostic Ultrasound System EPIQ 7 Diagnostic Ultrasound System Affiniti 50 Diagnostic Ultrasound System 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: March 22, 2016 Received: March 24, 2016

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D.'Hara

For

Robert 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

# K160807

Device Name

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

### Indications for Use (Describe)

Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric,

Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetabl/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transvaginal.

The clinical environments where the EPIQ 5, EPIQ 7, Affiniti 50 Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

| Type of Use (Select one or both, as applicable) | <table><tr><td><div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div></td><td><div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div></td></tr></table> | <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | | |

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510(k) No: _

EPIQ 5 and EPIQ 7 Ultrasound Systems System:

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: 5,6,7,8,9,10,12,13,17 | |
| | Abdominal | P | P | P | | P | Note: 1,2,3 | Note: 5,6,<br>8,9,10,11,12,13,15,16,17, | |
| | Intra-operative (Cardiac) | P | P | P | P | P | Note: 1,2,3 | Note: 5,8,9,10,11,12,13 | |
| | Intra-operative (Vascular) | P | P | P | | P | Note: 1,2,3 | Note: 5,8,9,10,11,12,13 | |
| Fetal Imaging | Laparoscopic | | | | | | | | |
| & Other | Pediatric | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,17 | |
| | Small Organ (breast, thyroid,<br>testicle) | P | P | P | | P | Note: 1,2,3 | Note:<br>5,6,8,9,10,11,12,13,15,17 | |
| | Neonatal Cephalic | P | P | P | | P | Note: 1,2,3 | Note: 5,8,9,10,11,12,13,17 | |
| | Adult Cephalic | P | P | P | | P | Note: 1,2,3 | Note: 8,9,10,11,12,13,17 | |
| | 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 | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Conventional) | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,17 | |
| | Musculo-skel. (Superficial) | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,17 | |
| | 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: 10,11,12,13,14 | |
| | Trans-esophageal (Cardiac) | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,12,13,14 | |
| | Other (Fetal Echo) | P | P | P | P | P | Note: 1,2,3,4 | Note: 5,6,8,10,12,13,14 | |
| Peripheral | Peripheral vessel | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,17 | |
| Vessel | Cerebral vascular | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,17 | |

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;<br>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;<br>B+Amplitude+PWD | Note 13: XRES |
| Note 4: Combined modes include: B+CWD; B+Color+CWD;<br>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 9: Color Power Angio (CPA) | |
| Previous submission: K132304, EPIQ | |

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510(k) No: __

3D9-3v

### EPIQ 5 and EPIQ 7 Ultrasound Systems

Transducer:

System:

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

| | Clinical Application | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|--------------------------------------------|---------------------------------------------------|---|-----|-----|--------------------|---------------------|-----------------------------------|
| | | B | M | PWD | CWD | Color<br>Doppler** | Combined<br>(Spec.) | Other<br>(Spec.) |
| General<br>(Track I only) | Specific<br>(Tracks I & III) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / OB | P | P | P | | P | Note: 1,2,3 | Note:<br>5,6,8,10,11,12,13 |
| | Abdominal | | | | | | | |
| | Intra-operative (Cardiac) | | | | | | | |
| | Intra-operative (Vascular) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | 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>5,6,8,9,10,11,12,13 |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Cerebral Vascular | | | | | | | |

N= new indication; P= previously cleared (; E= previously cleared by earlier letter to file

| *Color Doppler includes Color Amplitude Doppler | Note 10: Harmonic Imaging |
|------------------------------------------------------------------------|------------------------------|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;<br>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;<br>B+Amplitude+PWD | Note 13: XRES |
| Note 4: Combined modes include: B+CWD; B+Color+CWD;<br>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 9: Color Power Angio (CPA) | |
| Previous Submission: K043535, HD 11 | |

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### 510(k) No:

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

C5-1

Transducer:

Intended Use:

| 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 | |
| | Intra-operative (Cardiac) | | | | | | | | |
| | Intra-operative (Vascular) | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,17 | |
| | Small Organ (breast, thyroid,<br>testicle) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other: GYN | P | P | P | | P | Note: 1,2,3 | Note: 5,6,7,8, 910,11,12,13,<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 9: Color Power Angio (CPA) | | | | |
| | Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;<br>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;<br>B+Amplitude+PWD | | | | | Note 12: 3D/4D Imaging | |
| | Note 4: Combined modes include: B+CWD; B+Color+CWD;<br>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<br>Note 8: Panoramic Imaging | | | | | Note 16: ElastPQ (for Liver)<br>Note 17: PercuNav | |
| | | | | | | | | | |
| | Previous submission: K132304, EPIQ | | | | | | | | |
| 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: 5,6,8,9,10,11,12,13 | |
| | Intra-operative (Cardiac) | | | | | | | | |
| | Intra-operative (Vascular) | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13 | |
| | 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 | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13 | |
| Vessel | Cerebral Vascular | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13 | |

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#### 510(k) No: 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:

| *Color Doppler includes Color Amplitude Doppler | Note 9: Color Power Angio (CPA) |
|------------------------------------------------------------------------|---------------------------------|
| Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;<br>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;<br>B+Amplitude+PWD | Note 12: 3D/4D Imaging |
| Note 4: Combined modes include: B+CWD; B+Color+CWD;<br>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: PercuNav |
| Previous Submission: K132304, EPIΩ | |

{7}------------------------------------------------

510(k) No: _

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

Transducer: C9-2

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

| 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: 5,6,8,9,10,11,12,13,<br>17 | | |
| | Small Organ (breast, thyroid, testicle) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | | |
| | Musculo-skel. (Conventional) | N | N | N | | N | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13 | | |
| | Musculo-skel. (Superficial) | | | | | | | | | |
| | Intra-luminal | | | | | | | | | |
| | Other: GYN | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,<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,<br>17 | | |
| | Cerebral Vascular | | | | | | | | | |
| | N= new indication<br>P= previously cleared<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;<br>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;<br>B+Amplitude+PWD | | | | | Note 12: 3D/4D Imaging | | | | | |
| | Note 4: Combined modes include: B+CWD; B+Color+CWD;<br>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: PercuNav | | | | | |
| | Previous submission: K132304, EPIQ | | | | | | | | | |
| 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 | P | P | P | | P | Note: 1,2,3 | Note:<br>5,6,7,8,9,10,12,13,17 | | |
| Fetal Imaging<br>& Other | Fetal / OB | P | P | P | | P | Note: 1,2,3 | Note:<br>5,6,7,8,9,10,11,12,13, 15,<br>17 | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative (Cardiac) | | | | | | | | | |
| | Intra-operative (Vascular) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (breast, thyroid,<br>testicle) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | P | P | P | | P | Note: 1,2,3 | Note:<br>5,6,7,8,9,10,11,12,13, 15,<br>17 | | |
| | 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:<br>5,6,7,8,9,10,11,12,13,15,<br>17 | | |
| | Other: Urology | P | P | P | | P | Note: 1,2,3 | Note:<br>5,6,7,8,9,10,11,12,13,15,<br>17 | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | | |
| | Other (Fetal Echo) | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,10,12,13 | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | |
| | Cerebral Vascular | | | | | | | | | |
| N= new indication P= previously cleared<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;<br>B+Amplitude+PWD | | |…