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

K182857 · Philips Ultrasound, Inc. · IYN · Nov 9, 2018 · Radiology

Device Facts

• Record ID: K182857
• Device Name: EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
• Applicant: Philips Ultrasound, Inc.
• Product Code: IYN · Radiology
• Decision Date: Nov 9, 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, EPIQ 5, EPIQ7, Affiniti 30, Affiniti 50, and 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), 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. The clinical environments where the Philips EPIQ Diagnostic Ultrasound Systems and Philips 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

General-purpose, software-controlled diagnostic ultrasound systems; console-based with removable transducers. Inputs: ultrasound signals from transducers. Processing: system console performs signal processing, image reconstruction, and display. Outputs: real-time ultrasound images and fluid flow analysis (B-mode, M-mode, Doppler, 3D/4D). Used in clinics, hospitals, and point-of-care by physicians and sonographers. Integrated with Philips EchoNavigator for interventional cardiovascular guidance using live X-ray and Echo. Benefits: non-invasive diagnostic imaging and procedural guidance for cardiovascular disease treatment.

Clinical Evidence

No clinical studies were required. Substantial equivalence is supported by non-clinical performance data, including verification and validation testing, risk analysis, and compliance with international standards (IEC 60601-1, IEC 60601-2-37, IEC 62359, ISO 10993).

Technological Characteristics

Software-controlled diagnostic ultrasound systems. Transducers: phased, linear, curved, pencil, multi-plane TEE, motorized, and 3D matrix arrays. Frequency range: 1.0-18.0 MHz. Connectivity: standard multi-pin connectors, optional peripherals (ECG, printers). Compliance: IEC 60601-1, IEC 60601-2-37, IEC 62359. Acoustic output: ISPTA < 720 mW/cm2, MI < 1.9.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis of the human body, including 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 and Philips Affiniti Diagnostic Ultrasound System (K181485)

Reference Devices

• TOMTEC-ARENA TTA2 (K150122)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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.

November 9, 2018

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

Re: K182857

Trade/Device Name: EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 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: Class II Product Code: IYN, IYO, ITX Dated: October 30, 2018 Received: November 2, 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. 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 located 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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.

Hole 2. Nils

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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## Indications for Use

## 510(k) Number (if known)

### K182857

#### 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), 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.

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 judgment and best clinical procedure.

| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
| <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) No: _K182857

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

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 | Specific | | | PWD | CWD | Color | Combined | Other |
| (Track I only) | (Tracks I & III) | B | M | | | Doppler* | (Spec.) | (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,<br>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 | 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,<br>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: 5,6,8,9,10,<br>11,12,13,15,17 |
| | 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) | 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: 5,6,8,9,10,11,12,13,15,17 |
| Cardiac | Cardiac Adult | P | P | P | P | P | Note:<br>1,2,3,4 | Note: 10,11,12,13,14 |
| | Cardiac Pediatric | P | P | P | P | P | Note:<br>1,2,3,4 | Note: 10, ,12,13,14 |
| | Trans-esophageal (Cardiac) | P | P | P | P | P | Note:<br>1,2,3,4 | Note: 10, ,12,13,14 |
| | Other (Fetal Echo) | P | P | P | P | P | Note:<br>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; 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: K181485 | |

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# 510(k) No: K182857

System: Transducer: EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems

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** |
| 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<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: 5,6,7,8,10,12,<br>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: 5,6,8,9,10,<br>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; 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: K181485 | |

{5}------------------------------------------------

510(k) No: _K182857

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

Transducer: C5-1

Note 6: Imaging for guidance of biopsy

Note 8: Panoramic Imaging

Note 9: Color Power Angio (CPA)

Previous submission: K181485

Note 7: Infertility monitoring of follicle development

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 | Specific | | | | | Color | Combined* | Other |
| (Track I only) | (Tracks I & III) | B | M | PWD | CWD | Doppler* | (Spec.) | (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 | Laparoscopic | | | | | | | |
| & Other | 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, 9,10,11<br>,12,13, 17 |
| | Other: Urology | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8, 9,10,<br>,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 | Peripheral vessel | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,<br>11,12,13,17 |
| Vessel | Cerebral vascular | | | | | | | |
| | N= new indication<br>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 16: ElastPQ (for Liver)

Note 19: ElastQ Imaging Linear

Note 18: ElastQ Imaging

Note 17: Percu Nav

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

# 510(k) No: K182857

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

Transducer: C8-E

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 | Specific | B | M | PWD | CWD | Color | Combined* | Other |
| (Track I only) | (Tracks I & III) | | | | | 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 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 15: Elastography

Note 17: Percu Nav

Note 16: ElastPQ (for Liver)

Note 18: ElastQ Imaging Note 19: ElastQ Imaging Linear

| Note 2: Combined modes include: B+M+Color |
|------------------------------------------------------------------|
| Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD |
| Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+ |
| Note 5: SonoCT |
| Note 6: Imaging for guidance of biopsy |
| Note 7: Infertility monitoring of follicle development |

Note 8: Panoramic Imaging

Note 9: Color Power Angio (CPA) Previous Submission: K181485

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

510(k) No: K182857

### System: EPIQ, EPIQ 5 and EPIQ 7 Diagnostic 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:<br>5,6,8,9,10,11,12,13, 17 |
| Fetal Imaging<br>& Other | Intra-operative (Cardiac) | | | | | | | |
| Fetal Imaging<br>& Other | Intra-operative (Vascular) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10, ,12,13,<br>17 |
| | Small Organ (breast, thyroid,<br>testicle) | | | | | | | |
| Fetal Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | |
| Fetal Imaging<br>& Other | Trans-rectal | | | | | | | |
| Fetal Imaging<br>& Other | Trans-vaginal | | | | | | | |
| Fetal Imaging<br>& Other | Trans-urethral | | | | | | | |
| Fetal Imaging<br>& Other | Trans-esoph. (non-Cardiac) | | | | | | | |
| Fetal Imaging<br>& Other | Musculo-skel. (Conventional) | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10, 12,13 |
| | Musculo-skel. (Superficial) | | | | | | | |
| Fetal Imaging<br>& Other | Intra-luminal | | | | | | | |
| Fetal Imaging<br>& Other | Other: GYN | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10, 12,13,<br>17 |
| | Other: Urology | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10, ,12,13,<br>17 |
| Cardiac | 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,<br>11,12,13, 17 |
| Vessel | 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) | Note 19: ElastQ Imaging Linear |
| Previous submission: K181485 | |

{8}------------------------------------------------

510(k) No: K182857

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

Transducer: C10-3v

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 | Specific | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| (Track I only) | (Tracks I & III) | | | | | | | |
| 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 | 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: 5,6,7,8,9,10,<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 |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (Fetal Echo) | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,10,12,13 |
| Peripheral | Peripheral vessel | | | | | | | |
| Vessel | Cerebral Vascular | | | | | | | |

N= new indication P= previously cleared

Additional Comments: *Color Doppler includes Color Amplitude Doppler Note 10: Harmonic Imaging Note 11: Contrast Imaging Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M 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: Percu Nav Note 8: Panoramic Imaging Note 18: ElastQ Imaging Note 19: ElastQ Imaging Linear Note 9: Color Power Angio (CPA) Previous Submission: K181485

{9}------------------------------------------------

# 510(k) No:

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>5,6,8,9,10,12,13,17 | | |
| | 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 | | P | P | P | | P | Note: 1,2,3 | Note: 5,6,7, 8,9,10,<br>1112,13,17 | | |
| | Trans-vaginal | | P | P | P | | P | Note: 1,2,3 | Note: 5,6,7, 8,9,10,<br>12,13,17 | | |
| | 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: 5,6,7,8,9,10,<br>12,13,17 | | |
| | Other: Urology | | P | P | P | | P | Note: 1,2,3 | Note:<br>5,6,7,8,9,10,11,12,13,17 | | |
| | Cardiac Adult | | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | | | |
| | Other (Fetal Echo) | | P | P | P | | P | Note: 1,2,3 | Note: 5,8,9,10,12,13 | | |
| Peripheral | Peripheral vessel | | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10, 12,13,<br>17 | | |
| Vessel | Cerebral Vascular | | | | | | | | | | |
| | N= new indication<br>P= previously cleared<br>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 | | |

| *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: K181485 | |

{10}------------------------------------------------

510(k) No: K182857

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

Transducer: D2cwc

Note 9: Color Power Angio (CPA)

Previous Submission: K181485

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 | | | | | | | |
| | 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 | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | |
| | Musculo-skel.<br>(Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other: GYN | | | | | | | |
| | Other: Urology | | | | | | | |
| Cardiac | Cardiac Adult | | | | P | | | |
| Cardiac | Cardiac Pediatric | | | | P | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (Fetal Echo) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Cerebral Vascular | | | | | | | |
| | N= new indication<br>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 | | |…