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

K163120 · Philips Ultrasound, Inc. · IYN · Jan 10, 2017 · Radiology

Device Facts

• Record ID: K163120
• Device Name: EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System
• Applicant: Philips Ultrasound, Inc.
• Product Code: IYN · Radiology
• Decision Date: Jan 10, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

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

EPIQ and Affiniti diagnostic ultrasound systems are software-controlled, general-purpose imaging devices. They acquire ultrasound data via removable transducers and display it in various modes (B-mode, M-mode, PWD, CWD, Color Doppler). The system console includes a user interface, display, and electronics. The device features ElastQ Imaging for quantitative tissue stiffness measurement. Used in clinics, hospitals, and point-of-care by clinicians for patient diagnosis. Output is visualized on the system display to assist in clinical decision-making, enabling non-invasive assessment of anatomy and fluid flow.

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, acoustic output measurements, and software verification/validation).

Technological Characteristics

General-purpose ultrasound systems with phased, linear, curved, and matrix array transducers. Frequency range 1.0-18.0 MHz. Features include B-mode, M-mode, PWD, CWD, Color Doppler, and ElastQ Imaging. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and IEC 62359. Software-controlled with 128 transmit and 256 receive channels.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in abdominal, cardiac (adult, pediatric, fetal), vascular (cerebral, peripheral, intraoperative), obstetric/fetal, gynecological, musculoskeletal, urological, pediatric, and small organ 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 (K160807)
• Philips Affiniti Diagnostic Ultrasound System (K160807)
• SuperSonic AIXPLORER with ShearWave Elastography (K112255, K142100)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

January 10, 2017

Philips Ultrasound, Inc. % Ms. Peng Cui Senior Regulatory Specialist 3000 Minuteman Road ANDOVER MA 01810

Re: K163120

Trade/Device Name: EPIO 5 Diagnostic Ultrasound System: EPIO 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: November 8, 2016 Received: November 9, 2016

Dear Ms. Cui:

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

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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 O'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)

K163120 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 70 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)

> 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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EPIQ 5 and EPIQ 7 Diagnostic 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>8,9,10,11,12,13,15,16,17,18 |
| | 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 | Laparoscopic | | | | | | | |
| & Other | 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) | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13,15,17 |
| | Neonatal Cephalic | P | P | P | | P | Note: 1,2,3 | Note: 5,8,9,10,12,13,17 |
| | 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: 5,6,8,9,10, 11,12,13,15,17 |
| | Trans-vaginal | P | P | P | | P | Note: 1,2,3 | Note: 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, ,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: 5,6,7,8,9,10,11,12,13,15,17 |
| | Other: Urology | P | P | P | | P | Note: 1,2,3 | Note: 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 | 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 18: ElastQ Imaging |
| Note 9: Color Power Angio (CPA) | |
| Previous submission: K132304, K160807, EPIQ | |

⁵¹⁰⁽k) No:

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510(k) No: ___

| System:<br>Transducer: | EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems<br>3D9-3v | | | | | | | | |
|---------------------------|------------------------------------------------------------------------------------|---------------------------------------------------|---|-----|-----|--------------------|---------------------|---------------------------------|--|
| 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:<br>5,6,8,10,,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,,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<br>Vessel | Peripheral vessel | | | | | | | | |
| | Cerebral Vascular | | | | | | | | |

ERIC-5 LERIC-7.R' (6-11)

## EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems

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; 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 9: Color Power Angio (CPA) | |
| Previous Submission: K043535, HD 11 | |

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510(k) No: EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems System:

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 Imaging<br>& Other | 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) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,<br>,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, 910,11 ,12,13,<br>17 |
| | Other: Urology | P | P | P | | P | Note: 1,2,3 | Note: 5,6,,8, 9,10, ,12,13, 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 | | | | | | | |
| *Color Doppler includes Color Amplitude Doppler | | | Note 9: Color Power Angio (CPA) | | | | | |
| Note 1: Combined modes include: B+PWD: B+Color: B+Amplitude: | | | | | | | | |

| *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 | Note 18: ElastQ Imaging |

{6}------------------------------------------------

510(k) No:

Note 8: Panoramic Imaging

Previous Submission: K132304, EPIQ

EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems System:

Transducer: Intended Use:

C8-2 Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------|---------------------------------------------------|------------------------|---------------------------------------------------|-------------------|----------------------|------------------------------------------|--|
| General | Specific | | | | | Color | Combined* | Other | |
| (Track I only) | (Tracks I & III) | B | M | PWD | CWD | Doppler* | (Spec.) | (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 | Laparoscopic | | | | | | | | |
| & Other | Pediatric | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,,12,13 | |
| | Small Organ (breast, thyroid, | | | | | | | | |
| | 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 | Peripheral vessel | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,,12,13 | |
| Vessel | Cerebral Vascular | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 | |
| | N= new indication<br>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; | | | | Note 10: Harmonic Imaging | | | | |
| B+M | | | | | | | | | |
| 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) | | | | |
| 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: 5,6,8,9,10,11,12,13, 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, ,12,13, 17 | |
| | Small Organ (breast, thyroid, 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 | | | | | | | | |
| | Other: GYN | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10, 12,13, 17 | |
| | Other: Urology | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10, ,12,13, 17 | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (Fetal Echo) | P | P | P | | P | Note: 1,2,3 | Note: 5,6,10,12,13 | |
| Peripheral | Peripheral vessel | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10, 11,12,13, 17 | |
| Vessel | 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 6: Imaging for guidance of biopsy | | | | Note 14: TDI | | | | |
| | Note 7: Infertility monitoring of follicle development | | | | Note 15: Elastography | | | | |
| 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 | P | P | P | | P | Note: 1,2,3 | Note:<br>5,6,7,8,9,10,12,13,17 | |
| | 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: 5,6,7,8,9,10,<br>11,12,13, 15, 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: 5,6,7,8,9,10,<br>12,13,15, 17 | |
|…