Philips 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

K172607 · Philips Health Care · IYN · Oct 4, 2017 · Radiology

Device Facts

• Record ID: K172607
• Device Name: Philips 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 Health Care
• Product Code: IYN · Radiology
• Decision Date: Oct 4, 2017
• 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 series, Affiniti 30 and Affiniti 70 system is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Fetal/Obstetric, Abdominal, Intraoperative (Vascular), Intraoperative (Cardiac), Pediatric, Small Organ (Breast, Thyroid, Testicle), Cephalic (Neonatal), Cephalic (Adult), Transrectal, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial) Gynecological, Other: Urology, Cardiac Adult, Cardiac Pediatric, Transesophageal (Cardiac), Cardiac other (Fetal), Peripheral Vessel, Cerebral Vascular. When Philips EPIQ system is 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 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.

Device Story

Diagnostic ultrasound systems (EPIQ 5/7, Affiniti 30/50/70) acquire and display ultrasound data for diagnostic imaging and fluid flow analysis. Systems consist of a console (user interface, display, electronics) and removable transducers connected via multipin connectors. When integrated with Philips EchoNavigator, systems provide image guidance during cardiovascular disease treatment using live X-ray and live Echo. Operated by clinicians in hospitals, clinics, and point-of-care settings. Output is displayed on the console for real-time clinical decision-making, assisting interventionalists and surgeons in procedures. Benefits include non-invasive visualization and guidance for diagnosis and treatment.

Clinical Evidence

Bench testing only. No clinical data required. Evidence includes system-level verification and validation testing, usability testing with representative users, and compliance with electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and acoustic output (IEC 60601-2-37, IEC 62359) standards. Biocompatibility evaluated per ISO 10993.

Technological Characteristics

General-purpose, software-controlled diagnostic ultrasound systems. Features phased, linear, curved, and 3D matrix array transducers (1.0-18.0 MHz). Console includes user interface, display, and electronics. Connectivity includes USB, video output, and ECG/printer peripherals. Compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and IEC 62359. Acoustic output limits: ISPTA.3 ≤ 720 mW/cm2, MI < 1.9, TI < 6.0. Not supplied sterile.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis of the human body, including Fetal/Obstetric, Abdominal, Intraoperative (Vascular/Cardiac), Pediatric, Small Organ (Breast, Thyroid, Testicle), Cephalic (Neonatal/Adult), Transrectal, Transvaginal, Musculoskeletal (Conventional/Superficial), Gynecological, Urology, Cardiac (Adult/Pediatric/Fetal/Transesophageal), Peripheral Vessel, and Cerebral Vascular 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 (K163120)
• Philips Affiniti Diagnostic Ultrasound System (K163120)
• Philips EchoNavigator (K121781)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave.

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

October 4, 2017

PHILIPS HEALTHCARE C/O Mr. Mark Job Responsible Third Party Official 1394 25th Street, NW Buffalo MN 55313

Re: K172607

Trade/Device Name: Philips 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: II Product Code: IYN, IYO, ITX Dated: August 28, 2017 Received: August 30, 2017

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. O'Hara For

Robert Ochs 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<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: 06/30/2020 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Indications for Use | See PRA Statement below |
| 510(k) Number (if known)<br>K172607 | |
| Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System<br>Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System<br>Device Name | |
| The intended use of the EPIQ series, Affiniti 50 and Affiniti 70 system is diagnostic ultrasound imaging and<br>fluid flow analysis of the human body with the following Indications for Use:<br>Indications for Use (Describe) | |
| Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiat Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obsteric, Gynecological, Intraoperative (Cardiac), Intraoperat<br>Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast,<br>Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal | |
| The clinical environments where the EPIQ system can be used include Clinics, Hospitals, and clinical point-of-care for<br>diagnosis of patients. | |
| guidance during treatment of cardisvascular disease in which the X-ray and live Echo Guidance<br>When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image | |
| instructions given in the product user information, and only for the purposes for which it was designed. However, nothing<br>The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating<br>stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure. | |
| | |
| | |
| | |
| > Prescription Use (Part 21 CFR 801 Subpart D)<br>or both, as applicable)<br>Type of Use (Select one | _ Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995 | |
| *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the<br>time to review instructions, search existing data sources, gather and maintain the data needed and completer aspect<br>of this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human Services<br>Paperwork Reduction Act (PRA) Staff<br>Office of Chief Information Officer<br>Food and Drug Administration<br>[e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of<br>information unless it displays a currently valid OMB number." | |
| Page 1 of 1<br>FORM FDA 3881 (7/17) | EF<br>PSC Publishing Services [phone] |

As

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#### 5 10(k) No: _______________________________________
System: EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems
Intended Use:

#### Additional Comments:

| *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: K163120 EPIQ/Affiniti | |

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510(k) No:

Note: Note: 5,6,8,10,,12,1 Note: 5,6,7,
8,10,,12,13, 15 Other
(Spec.) Note: 1,2,3 Note: 1,2,3 Note: 1,2,3 an A y and L. Fat - Bragnotic Official of Colorno
SD9-37 Storio ultrasound in the More of the human body as follows:
Diagnosic ultrasound imaging or finales of Operation ("Mo d d d d EPIQ 5 and EPIQ 7 Diagnostic Ultrasound System d d d d പ d d d d d d പ്ര
പ Small Organ (breast, thyroid Intra-operative (Cardiac)
Intra-operative (Vascular) Neonatal Cephalic
Adult Cephaliic
Trans-rectal
Trans-rectal
Trans-vaginal Cerebral Vascular Peripheral vessel Specific
(Tracks I & III) aparoscopic Ophthalmic Abdominal Fetal / OB Pediatric testicle) Clinical Application System:
Transducer:
Intended Use: Fetal Imaging
& Other General
(Track | only)
Ophthalmic Peripheral Cardiac Vessel

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

#### Additional Comments

| *Color Doppler includes Color Amplitude Doppler | Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M | 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+CWD | 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: K163120 EPIQ/Affiniti |
|-------------------------------------------------|------------------------------------------------------------------|-------------------------------------------|--------------------------------------------------------------|---------------------------------------------------------------------|-----------------------|----------------------------------------|--------------------------------------------------------|---------------------------|---------------------------------|--------------------------------------------|
| Note 10: Harmonic Imaging | Note 11: Contrast Imaging | Note 12: 3D/4D Imaging | Note 13: XRES | Note 14: TDI | Note 15: Elastography | Note 16: ElastPQ (for Liver) | Note 17: PercuNav | | | |

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#### 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 | | | | | | | |

| | 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 | | | | |
| | 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,<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 | | | | | | | | |

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; 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: PercuNav |
| Previous submission: K163120 EPIQ/Affiniti | Note 18: ElastQ Imaging |

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#### 510(k) No: ___________________________________________________________________________________________________________________________________________________________________ C8-5 Intended Use: Transducer:

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 | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 |
| | Intra-operative (Cardiac) | | | | | | | |
| | Intra-operative (Vascular) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13 |
| | Pediatric | | | | | | | |
| | Small Organ (breast, thyroid, testicle) | | | | | | | |
| | Neonatal Cephalic | P | 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 | Cardiac Adult | | | | | | | |
| | 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 |

Note 11: Contrast Imaging

Note 12: 3D/4D Imaging

Note 13: XRES Note 14: TDI

Note 4: Combined modes include: B+CWD; B+Color+CWD;

B+Amplitude+CWD

Note 5: SonoCT

Note 2: Combined modes include: B+M+Color
Note 3: Combined modes include: B+Color+PWD;
Note 3: Combined modes include: B+Color+PWD;

Note 7: Infertility monitoring of follicle development

Note 6: Imaging for guidance of biopsy

Previous Submission: K163120 EPIQ/Affiniti

Note 8: Panoramic Imaging

Note 16: ElastPQ (for Liver)

Note 15: Elastography Note 17: Percu Nav

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: 510(k) No: ___________________________________________________________________________________________________________________________________________________________________ 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 | P | Note: 1,2,3 | Note: 5,6,7,8,9,10,12,13,<br>17 |
| | Abdominal | P | 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) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,12,13,<br>17 |
| | Small Organ (breast, thyroid, testicle) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Conventional) | P | 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 | P | Note: 1,2,3 | |
| | Other: Urology | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10, 12,13, 17<br>Note: 5,6,8,9,10,, 12, 13,<br>17 |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (Fetal Echo) | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,10,12,13 |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10, 11,12,13,<br>17 |
| | Cerebral Vascular | | | | | | | |
| N= new indication P= previously cleared<br>Additional Comments:<br>*Color Doppler includes Color Amplitude Doppler<br>Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; Note 9: Color Power Angio (CPA)<br>Note 10: Harmonic Imaging | | | | | | | | |
| | 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:<br>5,6,7,8,9,10,12,13,17 |
| | Abdominal | | | | | | | |
| | Intra-operative (Cardiac) | | | | | | | |
| | Intra-operative (Vascular) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (breast, thyroid, 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 | 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:<br>*Color Doppler includes Color Amplitude Doppler<br>Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; Note 9: Color Power Angio (CPA)<br>Note 10: Harmonic Imaging | | | | | | | | |

Note 11: Contrast Imaging

Note 12: 3D/4D Imaging

Note 13: XRES Note 14: TDI

______________________________________________________________________________________________________________________________________________________________________________

Note 5: SonoCT

Note 3: Combined modes include: B+Color+PWD; Note 2: Combined modes include: B+M+Color

Note 6: Imaging for guidance of biopsy
Note 7: Infertility monitoring of follicle development
Note 8: Panoramic Imaging
Previous submission: K163120 EPIQ/Affiniti

Note 15: Elastography
Note 16: ElastPQ (for Liver)
Note 16: ElastPQ (for Liver)
Note 17: PercuNav

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| 510(k) No: | |
|---------------|------------------------------------------------------------------------------------|
| System: | EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems |
| Transducer: | C10-3v |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |

| | Note 9: Color Power Angio (CPA) | Note 10: Harmonic Imaging | Note 11: Contrast Imaging | Note 12: 3D/4D Imaging | Note 13: XRES | Note 14: TDI | Note 15: Elastography | Note 16: ElastPQ (for Liver) | Note 17: PercuNav | |
|----------------------|-------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------|-----------------------------------------------------------------|------------------------------------------------------------------------|----------------|----------------------------------------|--------------------------------------------------------|---------------------------|--------------------------------------------|
| Additional Comments: | *Color Doppler includes Color Amplitude Doppler | Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;<br>B+M | Note 2: Combined modes include: B+M+Color | Note 3: Combined modes include: B+Color+PWD;<br>B+Amplitude+PWD | Note 4: Combined modes include: B+CWD; B+Color+CWD;<br>B+Amplitude+CWD | Note 5: SonoCT | Note 6: Imaging for guidance of biopsy | Note 7: Infertility monitoring of follicle development | Note 8: Panoramic Imaging | Previous Submission: K163120 EPIQ/Affiniti |

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

# 510(k) No: ___________________________________________________________________________________________________________________________________________________________________

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

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

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