The intended use of the EPIQ series, Affiniti 50 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.

Device Description

The proposed EPIO and Affiniti Diagnostic Ultrasound Systems are general purpose. software controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and to display the data in various modes of operation. The devices consist of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics and optional peripherals (ECG, printers).
The removable transducers are connected to the system using a standard technology, multipin connectors.

AI/ML Overview

The acceptance criteria for the Philips EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems, and Affiniti 30, 50, and 70 Diagnostic Ultrasound Systems, are detailed via compliance with several international and FDA-recognized consensus standards for medical electrical equipment and diagnostic ultrasound. The reported performance is that the devices meet these standards and are substantially equivalent to their predicate devices.

Here's an breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Safety and Essential Performance Standards	IEC 60601-1: General requirements for basic safety and essential performance (2005, Amendment 1, 2012)	The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems comply with this standard.
	IEC 60601-1-2: Electromagnetic Compatibility (2007)	The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems comply with this standard.
	IEC 60601-1-6: Usability (2010)	The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems comply with this standard.
	IEC 60601-2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (2007)	The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems comply with this standard.
	IEC 62359: Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields (2010)	The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems comply with this standard.
Acoustic Output Limits	Ispta.3 ≤ 720 mW/cm2	The system acoustic output limits are met.
	MI < 1.9	The system acoustic output limits are met.
	TI < 6.0	The system acoustic output limits are met.
Biocompatibility	ISO 10993: Biological evaluation of medical devices (specific parts not detailed, but implied by compliance for patient contact materials)	The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems comply, and there are "No changes from EPIQ K163120" for patient contact materials, indicating ongoing compliance. The materials are manufactured of materials with equivalent biosafety to predicate devices.
FDA Guidance Document	Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (September 9, 2008)	The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems comply with this guidance document and meet acceptance criteria and are adequate for their intended use.
Quality Assurance Measures	Risk Analysis, Product Specifications, Design Reviews, Verification and Validation, and general compliance with equivalent quality systems as predicate devices. The devices are designed and manufactured to the same electrical and physical safety standards as predicate devices.	Quality assurance measures were applied to the system design and development, covering risk analysis, product specifications, design reviews, and verification and validation. The devices are manufactured under equivalent quality systems and to the same electrical and physical safety standards as the predicate devices.
Substantial Equivalence	Demonstrating substantial equivalence to predicate devices (Philips EPIQ Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System, K163120, and Philips EchoNavigator, K121781).	Substantial equivalence was demonstrated based on design features, indications for use, fundamental scientific technology, non-clinical performance testing, and safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a test set in the context of diagnostic performance (e.g., image interpretation accuracy). The testing described is primarily focused on non-clinical verification and validation testing against technical and safety standards. This includes:

Compliance with various IEC safety standards (electrical, EMC, usability, ultrasound-specific safety).
Acoustic output measurements.
Biocompatibility (stated as no changes from predicate, implying prior testing or material equivalence).

The data provenance is not explicitly mentioned as retrospective or prospective in relation to diagnostic performance studies. Instead, the document discusses non-clinical performance data obtained through testing to ensure safety and effectiveness of the proposed devices against established standards and predicate devices (K163120 and K121781). The nature of these tests suggests they were performed in a controlled, prospective manner in a lab or engineering environment to demonstrate compliance. There is no mention of patient data being used for the purpose of proving the device meets its acceptance criteria.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document, as the clearance is based on non-clinical performance testing (technical and safety standards) and substantial equivalence to predicate devices. There is no mention of a diagnostic performance study that would require expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation primarily involved non-clinical testing against technical specifications and safety standards, rather than diagnostic interpretation requiring adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or at least not mentioned in this summary. The submission focuses on demonstrating substantial equivalence to predicate devices through technical performance and safety compliance, rather than comparative diagnostic effectiveness with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not specified or applicable to the type of device. The devices are diagnostic ultrasound systems, which inherently involve a human operator (sonographer/clinician) to acquire and interpret images. The EchoNavigator integration is described as assisting the interventionalist, implying human-in-the-loop, not standalone AI performance. There is no mention of an algorithm operating independently for diagnostic purposes.

7. The Type of Ground Truth Used

For the non-clinical performance testing, the "ground truth" would be the specified parameters and thresholds in the international and FDA-recognized consensus standards (e.g., maximum acoustic output levels, electrical safety limits, EMC compatibility levels). For biocompatibility, the ground truth would be the ISO 10993 standards. These are objective, quantifiable criteria established by regulatory and standards bodies.

8. The Sample Size for the Training Set

This information is not applicable as this device is a diagnostic ultrasound system and not an AI/ML algorithm that requires a training set of data for its primary function. While the system may incorporate advanced processing, the document does not describe it as an AI/ML algorithm requiring a distinct "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

Summary

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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020
Indications for Use	See PRA Statement below
510(k) Number (if known)K172607
Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound SystemAffiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound SystemDevice Name
The intended use of the EPIQ series, Affiniti 50 and Affiniti 70 system is diagnostic ultrasound imaging andfluid flow analysis of the human body with the following Indications for Use:Indications for Use (Describe)
Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiat Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obsteric, Gynecological, Intraoperative (Cardiac), IntraoperatConventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast,Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal
The clinical environments where the EPIQ system can be used include Clinics, Hospitals, and clinical point-of-care fordiagnosis of patients.
guidance during treatment of cardisvascular disease in which the X-ray and live Echo GuidanceWhen 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, nothingThe systems are intended to be installed, used, and operated only in accordance with the safety procedures and operatingstated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.



> Prescription Use (Part 21 CFR 801 Subpart D)or both, as applicable)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 thetime to review instructions, search existing data sources, gather and maintain the data needed and completer aspectof this information collection, including suggestions for reducing this burden, to:
Department of Health and Human ServicesPaperwork Reduction Act (PRA) StaffOffice of Chief Information OfficerFood and Drug AdministrationPRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number."
Page 1 of 1FORM FDA 3881 (7/17)	EFPSC Publishing Services (301) 443-6740

ﺭﺱ ﺍﻟ

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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: ___________________________________________________________________________________________________________________________________________________________________

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic

	Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(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: 5,6,8,9,10,11,12,13,16,17,18
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,,12,13,17,18
	Small Organ (breast, thyroid,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, 910,11,12,13,17
	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
PeripheralVessel	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(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(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& 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)
PeripheralVessel	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(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P	P	P	Note: 1,2,3	Note: 5,6,7,8,9,10,12,13,17
	Abdominal	P	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& Other	Laparoscopic
	Pediatric	P	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	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, 17Note: 5,6,8,9,10,, 12, 13,17
	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
PeripheralVessel	Peripheral vessel	P	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 clearedAdditional Comments:*Color Doppler includes Color Amplitude DopplerNote 1: Combined modes include: B+PWD; B+Color; B+Amplitude; Note 9: Color Power Angio (CPA)Note 10: Harmonic Imaging
	Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal / OB	P	P	P	P		Note: 1,2,3	Note: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: 5,6,7,8,9,10,11,12,13, 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:5,6,7,8,9,10,11,12,13,15,17
	Other: Urology	P	P	P	P		Note: 1,2,3	Note: 5,6,7,8,9,10,12,13,15, 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
PeripheralVessel	Peripheral vessel
	Cerebral Vascular
N= new indication P= previously clearedAdditional Comments:*Color Doppler includes Color Amplitude DopplerNote 1: Combined modes include: B+PWD; B+Color; B+Amplitude; 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 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;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	Previous Submission: K163120 EPIQ/Affiniti

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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(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
General(Track I only)
Ophthalmic	Ophthalmic	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13,17
Fetal Imaging& 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: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)
PeripheralVessel	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 clearedAdditional Comments:*Color Doppler includes Color Amplitude DopplerNote 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;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
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(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, 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
	Other: Urology
Cardiac	Cardiac Adult			P
	Cardiac Pediatric			P
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel
	Cerebral Vascular
N= new indication P= previously cleared
Additional Comments:
*Color Doppler includes Color Amplitude Doppler
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M Note 9: Color Power Angio (CPA)
Note 2: Combined modes include: B+M+Color Note 10: Harmonic Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD Note 11: Contrast Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD Note 12: 3D/4D Imaging
Note 5: SonoCT Note 13: XRES
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)
Previous Submission: K163120 EPIQ/Affiniti Note 17: PercuNav

Previous Submission: K163120 EPIQ/Affini

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

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

{11}------------------------------------------------

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

Clinical Application	Mode of Operation (*includes simultaneous B-mode)
	General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)
Ophthalmic		Ophthalmic
Fetal Imaging& Other		Fetal / OB
		Abdominal
		Intra-operative (Cardiac)
		Intra-operative (Vascular)
		Laparoscopic
		Pediatric
		Small Organ (breast, thyroid, testicle)
		Neonatal Cephalic
		Adult Cephalic			P
		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)

PeripheralVessel		Peripheral vessel			P
		Cerebral Vascular

| Cerebral Vascular
N= new indication

Additional Comments:

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;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
Previous Submission: K163120 EPIQ/Affiniti

{12}------------------------------------------------

Dow -510(k) No: ___________________________________________________________________________________________________________________________________________________________________ Intended Use:

General(Track I only)	Clinical ApplicationSpecific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, 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
	Other: Urology
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel							P
	Cerebral Vascular							P
Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,9,10, 12,13, 17
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,9,10, 12, 13, 17
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, testicle)	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,9,10, 12,13, 17
	Neonatal Cephalic	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,9,10, 12,13, 17
	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, 13,17
	Musculo-skel. (Superficial)	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,9,10, 12,13, 17
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,9, 10, 11, 12, 13,17
	Cerebral Vascular	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,9,10,11 12,13
N= new indication P= previously clearedAdditional Comments:

Note 9: Color Power Angio (CPA) Note 10: Harmonic Imaging Note 11: Contrast Imaging Note 14: TDI
Note 15: Elastography
Note 16: ElastPQ (for Liver)
Note 17: PerculNav Note 12: 3D/4D Imaging Note 13: XRES Note 3: Combined modes include: B+Color+PWD;
Note of Borner.
Note 6: Imaging for guidance of follicle development
Note 7: Infertility monitoring of follicle development
Note 8: Panoramic Imaging
Previous Submission: Note 2: Combined modes include: B+M+Color SonoCT B+M Note 1: Note 5:

{13}------------------------------------------------

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

{14}------------------------------------------------

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

	Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13
	Abdominal	P	P	P		P	Note: 1,2,3	Note:5,6,8,9,10,11,12,13,15,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10, 12,13, 17
	Small Organ (breast, thyroid, testicle)	P	P	P		P	Note: 1,2,3	Note:5,6,8,9,10,11,12,13,15,17
	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, 12,13,17
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10, 12,13,17
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10, 12,13,17
	Cerebral Vascular	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10, 12,13
N= new indication P= previously clearedAdditional Comments:*Color Doppler includes Color Amplitude DopplerNote 9: Color Power Angio (CPA)

Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;B+M	Note 9: Color Doppler includes Color Power Angio (CPA)
Note 2: Combined modes include: B+M+Color	Note 10: Harmonic Imaging
Note 3: Combined modes include: B+Color+PWD;B+Amplitude+PWD	Note 11: Contrast Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;B+Amplitude+CWD	Note 12: 3D/4D Imaging
Note 5: SonoCT	Note 13: XRES
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)
Previous Submission: K163120 EPIQ/Affiniti	Note 17: PercuNav

{15}------------------------------------------------

	Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)	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& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,,12,13
	Small Organ (breast, thyroid, testicle)	P	P	P		P	Note: 1,2,3	Note: 5,8,10,,12,13
	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: 5,8,9,10,12,13
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,12,13
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,,12,13
	Cerebral Vascular	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,,12,13
N= new indication P= previously clearedAdditional 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

{16}------------------------------------------------

diagnostic ultrasound indications for use statement

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

Lucer-
el84
diameter

diameter
internal
internal
diameter

Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	N	N	N	N	N	Note: 1,2,3	Note: 5,6,7,8,9,10,12,13,17
	Abdominal	N	N	N	N	N	Note: 1,2,3	Note: 5,6, 8,9,10,12,13,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic	N	N	N	N	N	Note: 1,2,3	Note: 5,6,8,9,10,12,13,17
	Pediatric	N	N	N	N	N	Note: 1,2,3	Note: 5,6,8,9,10,12,13,17
	Small Organ (breast, thyroid, testicle)	N	N	N	N	N	Note: 1,2,3	Note:5,6,8,9,10,11,12,13,15,17
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	N	N	N	N	N	Note: 1,2,3	Note: 5,6,8,9,10,12,13,17
	Musculo-skel. (Superficial)	N	N	N	N	N	Note: 1,2,3	Note: 5,6,8,9,10,12,13,17
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel	N	N	N	N	N	Note: 1,2,3	Note: 5,6,8,9,10,12,13,17
	Cerebral Vascular	N	N	N	N	N	Note: 1,2,3	Note: 5,6,8,9,10,12,13,17
N= new indication P= previously cleared
Additional Comments:

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: K163130 EBIO/Affiniti

{17}------------------------------------------------

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,,12,13
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,,12,13,17
	Abdominal	P	P	P		P	Note: 1,2,3
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,, 12, 13
	Pediatric	P	P	P		P	Note: 1,2,3
	Small Organ (breast, thyroid,testicle)	P	P	P		P	Note: 1,2,3	Note:5,6,8,9,10,12,13,15,17
	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)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,, 12, 13
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,, 12, 13
	Cerebral Vascular	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,, 12, 13

*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 ERIO/Affiniti

{18}------------------------------------------------

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic	P	P	P		P	Note: 1,2,3	Note: 6,8,9,10,12,13, 17
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 6,8,9,10, 12,13,17
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 6,8,9,10, 12,13,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic	P	P	P		P	Note: 1,2,3	Note: 6,8,9,10, 12,13, 17
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 6,8,9,10, 12,13, 17
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	Note: 1,2,3	Note: 8,9,10,,12,13, 17
	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	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14, 17
	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: 10, 12,13,14, 17
	Trans-esophageal (Cardiac)	P	P	P	P	P	Note: 1,2,3,4	Note: 10,13,14
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 6,8,9,10, 12,13, 17
	Cerebral Vascular

*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)
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
Previous Submission: K162120 ERIO/Affiniti

{19}------------------------------------------------

510(k) No: ___________________________________________________________
System:

	Mode of Operation (*includes simultaneous B-mode)
Clinical Application	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
General(Track I only)	Ophthalmic
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, 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
	Other: Urology
Cardiac	Cardiac Adult	P	P	P	P	P	Note: 1,2,3,4	Note: 10,,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)
	Peripheral vessel
PeripheralVessel	Peripheral vessel
	Cerebral Vascular
N= new indication P= previously cleared
Additional Comments:
*Color Doppler includes Color Amplitude Doppler
Note 1: Combined modes include: B+PWD: B+Color: B+Amplitude:
Note 9: Color Power Angio (CPA)

*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

hote 15: Elastography
Note 16: ElastPQ (for Liver)
Note 16: ElastPQ (for Liver)
Note 17: PercuNav Note 6: Imaging for guidance of biopsy
Note 7: Infertility monitoring of follicle development
Note 8: Panoramic Imaging
Previous Submission: K.I.63120 EPIQ/Affiniti

{20}------------------------------------------------

38-3 Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Intended Use:
	Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 7,8,10,12,13
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
Fetal Imaging& Other	Pediatric	P	P	P		P	Note: 1,2,3	Note:,7,8,10,,12,13
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic	P	P	P		P	Note: 1,2,3	Note: 8,10,12,13
	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 AdultCardiac PediatricTrans-esophageal (Cardiac)Other (Fetal Echo)	P	P	P	P	P	Note: 1,2,3,4Note: 1,2,3,4	Note: 10,,12,13,14Note: 10,,12,13,14

P= previously cleared ral

Peripheral
Vessel

Additional Comments:

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;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 ImagingPrevious Submission: K163120 ERIO/Affiniti

{21}------------------------------------------------

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

	Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 8,10,,12,13
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic	P	P	P		P	Note: 1,2,3	Note: 8, 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	P	P	P	P	P	Note: 1,2,3,4	Note: ,12,13,14
	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: ,12,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel
	Cerebral Vascular
N= new indication P= previously cleared
Additional Comments:

Additional Comments:
Color, Dome: Includes Color, Amplitude, Doppler

*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

{22}------------------------------------------------

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

v6-2
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Intended Use: Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows:						Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Clinical ApplicationSpecific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,9,10, 12, 13
	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& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, 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
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P	P	P	Note: 1,2,3	Note: 5,9,10, 13
PeripheralVessel	Peripheral vessel
	Cerebral Vascular
	N= new indicationP= previously cleared
	Additional Comments:
	*Color Doppler includes Color Amplitude DopplerNote 1: Combined modes include: B+PWD; B+Color; B+Amplitude;					Note 9: Color Power Angio (CPA)
B+M	Note 2: Combined modes include: B+M+Color					Note 10: Harmonic Imaging
	Note 3: Combined modes include: B+Color+PWD;B+Amplitude+PWD					Note 11: Contrast Imaging
	Note 4: Combined modes include: B+CWD; B+Color+CWD;B+Amplitude+CWD				Note 12: 3D/4D Imaging
Note 5: SonoCT	Note 13: XRES				Note 14: TDI
	Note 6: Imaging for guidance of biopsyNote 7: Infertility monitoring of follicle development				Note 15: Elastography
	Note 8: Panoramic ImagingNote 16: ElastPQ (for Liver)				Note 17: PercuNav
	Previous Submission: K163120 EPIQ/Affiniti

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler**	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,,12,13
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,,12,13
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,,12,13
	Small Organ (breast, thyroid, testicle)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,,12,13
	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: 5,6,8,10,,12,13
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,,12,13
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,,12,13
	Cerebral Vascular	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,,12,13

{23}------------------------------------------------

System:
Transducer:
Intended Use:

EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems

VL13-5
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

w indication; P= previously clea

Additional Comments :

Note 9: EFOV including Amplitude Doppler	Note 10: Harmonic Imaging	Note 11: Contrast Imaging	Note 12: 3D 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;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	Previous Submission: K163120 EPIQ/Affiniti

{24}------------------------------------------------

agnostic ultrasound indications for use statemen

EPIQ 7 Diagnostic Ultrasound Systems
X5-1
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: 510(k) No:
System:
Transducer:
Transducer:
Intended Use:

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

	Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	Ophthalmic	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB		P	P	P		P	Note: 1,2,3	Note: 8,9,10,,12,13
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric		P	P	P		P	Note: 1,2,3	Note: 8,9,10, 12,13
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic		P	P	P		P	Note: 1,2,3	Note: 8,9,10, 12,13
	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		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)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel
	Cerebral Vascular
N= new indication P= previously cleared
Additional Comments:
*Color Doppler includes Color Amplitude Doppler Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; Note 10: Harmonic Imaging
B+M

*Color Doppler includes Color Amplitude Doppler (CPA)	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;	Note 12: 3D/4D Imaging
B+Amplitude+PWD
Note 4: Combined modes include: B+CWD; B+Color+CWD;	Note 13: XRES
B+Amplitude+CWD
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

{25}------------------------------------------------

EPIQ 7 Diagnostic Ultrasound Systems 510(k) No:
System:
Transducter:
Intended Use:

X6-1
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follow

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
		B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
General(Track I only)	Specific(Tracks I & III)
Ophthalmic	Ophthalmic	P
Fetal Imaging& Other	Fetal / OB	P	P	P	P	P	Note: 1,2,3	Note: 6,8,9,10,12,13
	Abdominal	P	P	P	P	P	Note: 1,2,3	Note: 6,8,9,10,11 12,13,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric	P	P	P	P	P	Note: 1,2,3	Note: 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)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN	P	P	P	P	P	Note: 1,2,3	Note: 6,8,9,10, 12,13
	Other: Urology
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
	PeripheralVessel	Peripheral vessel	P	P	P	P	P	Note: 1,2,3
		Cerebral Vascular	P	P	P	P	P	Note: 1,2,3
	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(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler**	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic	P	P	P
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 6,7,8,10,,12,13
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 6,7,8,10,,12,13
	Small Organ (breast, thyroid, 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
	Other: Urology
	Cardiac Adult	P	P		P	P	Note: 1,2,3,4	Note: 10,,13,14
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: 10,,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P		P	P	Note: 1,2,3,4	Note: 10,,13,
PeripheralVessel	Peripheral vessel						Note: 1,2,3
	Cerebral Vascular

Note 14: TDI
Note 15: Elastography
Note 16: ElastPQ (for Liver)
Note 17: PercuNav

Note 6: Imaging for guidance of biopsy
Note 7: Infertility monitoring of follicle development
Note 8: Panoramic Imaging
Previous Submission: K.I 63 I20 EPIQ/Affiniti

Note 5: SonoCT

{26}------------------------------------------------

510(k) No:

EPIQ 7 Diagnostic Ultrasound Systems

ultrasound imaging or fluid flow analysis of the human body X7-2
Diagnostic System:
Transducer:
Intended Use:

indication; ﺎﻥ =

Additional Comments:

*Color Doppler includes Color Amplitude Doppler	Note 9: EFOV including Amplitude Doppler
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 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

{27}------------------------------------------------

agnostic ultrasound indications for use statemen

510(k) No:
System:
Transducer:
Transducer:
Intended Use:

EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems
X7-2t
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, 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
	Other: Urology
Cardiac	Cardiac Adult	P	P	P	P	P		Note: 1,2,3,4Note: 10,,12,13,14
	Cardiac Pediatric	P	P	P	P	P		Note: 1,2,3,4Note: 10,,12,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel
	Cerebral Vascular
N= new indication P= previously clearedAdditional Comments:

Additional Comments:

Department of Public Works

*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;
B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;	Note 13: XRES
B+Amplitude+CWD
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

{28}------------------------------------------------

EPIQ 7 Diagnostic Ultrasound Systems 510(k) No:
System:
Transducer:
Intended Use:

X8-2t
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follow

General(Track I only)	Clinical ApplicationSpecific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, 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
	Other: Urology
Cardiac	Cardiac Adult	P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: 10,,12,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
	Peripheral vessel
PeripheralVessel	Cerebral Vascular

General(Track I only)	Clinical ApplicationSpecific(Tracks I & III)					Mode of Operation (*includes simultaneous B-mode)
Ophthalmic	Ophthalmic	B	M	PWD	CWD	ColorDoppler*	Combined*	Other(Spec.)	Other(Spec.)
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, 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
	Other: Urology
Cardiac	Cardiac Adult			P	P	P	P	P	Note: 10,11,12,13,14Note: 1,2,3,4
	Cardiac Pediatric			P	P	P	P	P	Note 10, 13,14Note: 1,2,3,4
	Trans-esophageal (Cardiac)			P	P	P	P	P	Note: 10,12,13,14Note: 1,2,3,4
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel
	Cerebral Vascular
N= new indication P= previously clearedAdditional Comments:*Color Doppler includes Color Amplitude DopplerNote 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+MNote 9: Color Power Angio (CPA)Note 10: Harmonic Imaging

Note 14: TDI
Note 15: Elastography
Note 16: ElastPQ (for Liver)
Note 17: PercuNav

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

Note 5: SonoCT

{29}------------------------------------------------

System:

Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;B+M	Note 9: Color Power Angio (CPA)
Note 2: Combined modes include: B+M+Color	Note 10: Harmonic Imaging
Note 3: Combined modes include: B+Color+PWD;B+Amplitude+PWD	Note 11: Contrast Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;B+Amplitude+CWD	Note 12: 3D/4D Imaging
Note 5: SonoCT	Note 13: XRES
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)
Previous Submission: K163120 EPIO/Affiniti	Note 17: PercuNav

Previous Submission: K163120 PERIO Affidaviti

{30}------------------------------------------------

x8-2ti

transducer:

System:

	Clinical Application					Mode of Operation (*includes simultaneous B-mode)
		B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
General(Track I only)	Specific(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, 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
	Other: Urology
Cardiac	Cardiac Adult	N	N	N	N	N		Note: 10,12,13,14
Cardiac	Cardiac Pediatric	N	N	N	N	N		Note: 10,12,13,14
	Trans-esophageal (Cardiac)Other (Fetal Echo)
PeripheralVessel	Peripheral vessel
	Cerebral Vascular

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

{31}------------------------------------------------

System:

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

	Clinical Application						Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, 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
	Other: Urology
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral	Peripheral vessel	N	N	N		N		Note: 1,2,3
Vessel	Cerebral Vascular	N	N	N		N		Note: 1,2,3
	N= new indication P= previously clearedAdditional Comments:*Color Doppler includes Color Amplitude DopplerNote 9: Color Power Angio (CPA)
								Note:5,6,8,9,10,11,12,13,17Note: 5,6,8,9,10,11,12,13

*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

{32}------------------------------------------------

agnostic ultrasound indications for use statemen

System:Intended Use:	Affiniti 70/50/30 Diagnostic Ultrasound SystemsDiagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation (*includes simultaneous B-mode)

General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P	P	P	Note: 1,3	Note: 5,6,7,8,9,10,12,13,17
	Abdominal	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,11,12,13,15,16,17
	Intra-operative (Cardiac)	P	P	P	P	P	Note: 1,3	Note: 5,8,10,12,13
	Intra-operative (Vascular)	P	P	P	P	P	Note: 1,3	Note: 5,8,10,12,13
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Small Organ (breast, thyroid, testicle)	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,11,12,13,15,17
	Neonatal Cephalic	P	P	P	P	P	Note: 1,3	Note: 5,8,9,10,12,13
	Adult Cephalic	P	P	P	P	P	Note: 1,3	Note: 8,10,12,13
	Trans-rectal	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Trans-vaginal	P	P	P	P	P	Note: 1,3	Note: 5,6,7,8,9,10,12,13,15,17
	Trans-urethral
	Trans-esoph. (non-Cardiac)	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Musculo-skel. (Conventional)	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Musculo-skel. (Superficial)	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Intra-luminal
	Other: GYN	P	P	P	P	P		Note: 5,6,7,8,9,10,11,12,13,15,17
	Other: Urology	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,11,12,13,15,17
	Cardiac Adult	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14
Cardiac	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
PeripheralVessel	Peripheral vessel	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Cerebral Vascular	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
E = added via Appendix E, N= new indication, P= previously clearedAdditional Comments:

Additional Comments:
*Color Doppler includes Color Amplitude Doppler
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 9: Color Power Angio (CPA)
Note 2: Combined modes include: B+M+Color	Note 10: Harmonic Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 11: Contrast Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 12: 3D/4D Imaging
Note 5: SonoCT	Note 13: XRES
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)
Previous Submission: K163120 EPIQ/Affiniti	Note:17 PercuNav

{33}------------------------------------------------

Affiniti 70 Diagnostic ULTRASOUND INDICATIONS FOR USE STATEMENT

CS-1
CS-1
DiaEnostic ultrasound Systems
DiaEnostic ultrasound imaging or fluid flow analysis of the human bod

System:
Transducer:
Intended Use

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

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:	Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic	P	P	P	P	P	Note: 1,3	Note: 5,6,7,8,9,10,12,13,17
	Fetal / OB	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,11,12,13,15,16,17
	Abdominal	P	P	P	P	P	Note: 1,3	Note: 5,6,7,8,9,10,12,13,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note: 1,3	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)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN	P	P	P	P	P	Note: 1,3	Note: 5,6,7,8, 9,10,12,13,17
	Other: Urology	P	P	P	P	P	Note: 1,3	Note: 5,6,8, 9,10,12,13,17
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P	P	P	Note: 1,3	Note: 5,6,10,12,13
PeripheralVessel	Peripheral Vessel
	Cerebral Vascular

E = added via Appendix E, 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 FPIO/Affiniti

{34}------------------------------------------------

System:
Transducer:
Intended Use

.....

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(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P	P	P	Note: 1,3	Note: 5,6,7,8,9,10,12,13
	Abdominal	P	P	P	P	P	Note: 1,3	Note: 5,6, 8,9,10,11,12,13,15
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Small Organ (breast, thyroid, 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	P	Note: 1,3	Note: 5,6,7,8, 9,10,12,13
	Other: Urology	P	P	P	P	P	Note: 1,3	Note: 5,6,8, 9,10,12,13
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P	P	P	Note: 1,3	Note: 5,6,10,12,13
PeripheralVessel	Peripheral Vessel
	Cerebral Vascular

E = added via Appendix E, 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
Previous Submission: K163120 EPIQ/Affiniti

{35}------------------------------------------------

്കുന്നു. അവലംബം പ്രസ്കാരിയോടിന് ആയാം

Affiniti 70/50/30 Diagnostic Ultrasound Systems
C8-5
Diagnostic ultrasound imaging or fluid flow analysis

System:
Transducer:
Intended Use

follo t nalvsis

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:	Mode of Operation (*includes simultaneous B-mode)
Clinical Application	General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging & Other	Fetal / OB	Abdominal	P	P	P	P	P	Note: 1,3	Note: 5,6, 8,9,,12,13
		Intra-operative (Cardiac)
		Intra-operative (Vascular)
		Laparoscopic
		Pediatric	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,12,13
		Small Organ (breast, thyroid, testicle)
		Neonatal Cephalic	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,12,13
		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)
PeripheralVessel		Peripheral vessel	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,12,13
		Cerebral Vascular	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,12,13

added via Appendix E, 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
Previous Submission: K163120 EPIQ/Affiniti

{36}------------------------------------------------

Affiniti 70 Diagnostic Ultrasound Systems

C9-2
Diagnostic ultrasound imaging or fluid flow

System:
Transducer:
Intended Use

follo નું ત cis

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(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Abdominal	P	P	P		P	Note: 1,3	Note: 5,6, 8,9,10,11,12,13.17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,3	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: 1,3	Note: 5,6,8,9,10,12,13,17
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P		P	Note: 1,3	Note: 5.6,10,12,13
PeripheralVessel	Peripheral vessel
	Cerebral Vascular
E = added via Appendix E

E-added via Appendix

= = added diaded the 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

{37}------------------------------------------------

	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(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
	Ophthalmic	Ophthalmic
		Fetal / OB	P	P		P	P	Note: 1,3	Note: 5,6,7,8,9,10,12,13
		Abdominal
		Intra-operative (Cardiac)
		Intra-operative (Vascular)
Fetal Imaging& Other		Laparoscopic
		Pediatric
		Small Organ (breast, thyroid, testicle)
		Neonatal Cephalic
		Adult Cephalic
		Trans-rectal
		Trans-vaginal	P	P		P	P	Note: 1,3	Note: 5,6,7, 8,10,12,13, 15
		Trans-urethral
		Trans-esoph. (non-Cardiac)
		Musculo-skel. (Conventional)
		Musculo-skel. (Superficial)
		Intra-luminal
		Other: GYN	P		P		P	Note: 1,3	Note:5,6,7,8,9,10,11,12,13,15
		Other: Urology	P	P	P		P	Note: 1,3	Note: 5,6,7,8,9,10,12,13,15
		Cardiac Adult
Cardiac		Cardiac Pediatric
		Trans-esophageal (Cardiac)
		Other (Fetal Echo)	P	P	P		P	Note: 1,3	Note: 5,6,8,10,12,13
PeripheralVessel		Peripheral vessel
		Cerebral Vascular
	P = added via Appendix E, N= new indication. P= previously cleared

Affiniti 70 Diagnostic Ultrasound Systems
C10-3v
Di System:
Transducer:

E = added via Appendix E, N= new indication. P= previo

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
Previous Submission: K163120 EPIQ/Affiniti

{38}------------------------------------------------

diagnostic ultrasound indications for use statement

System:
Transducer:
Intended Use:

Affiniti 70/50/30 Diagnostic Ultrasound Systems
3D9-3v
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
		B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
General(Track I only)	Specific(Tracks I & III)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal / OB	P	P	P		P	Note: 1,3	Note: 5,6,7,8,9,10,12,13
	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: 1,3	Note: 5,6,7,8,10,12,13
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN	P	P	P		P	Note: 1,3	Note: 5,6,7,8,9,10,12,13
	Other: Urology	P	P	P		P	Note: 1,3	Note: 5,6,7,8,9,10,12,13
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P		P	Note: 1,3	Note: 5,6,8,10,12,13
PeripheralVessel	Peripheral vessel
	Cerebral Vascular

E = added via Appendix E, 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
Previous Submission: K163120 EPIQ/Affiniti

{39}------------------------------------------------

144SUATA1900œPP Myt be the state of the state of the states of the states of the states of the states of the states of the station of the states of the states of the station of the station of10œI8œœI-------41
44

System:
Transducer:
Intended Use

follo alvsis fluid C9-4v
Diagnosti

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

E=added via Appendix.

E = added via Appendi
N= new indication

P= previously cleared

previously circulated

AMAwa wa	A 100 10 1141 10 00 00
11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/2017/11/2017/11/2017/11/2017/11/2017/11/2017/11/2019/11/2019/11/2019/11/2019/11/2019/11/2017/11/2017/11/2017/11/2017/11/2017/11/2	000 00 000 00000
	5

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CP
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;	Note 10: Harmonic Imagin
Note 2: Combined modes include: B+M+Cold	lote 11: Contrast Imagi
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+P\	Note 12: 3D/4D Imagin
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CW	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastograph
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver
Note 8: Panoramic Imaging
Previous Submission: K163120 EPIQ/Affini

{40}------------------------------------------------

System:
Transducer:
Intended Use

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

	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Clinical Application
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Fetal / OB	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P	P	P	Note: 1,3	Note: 5,6,7, 8,9,10,12,13,17
	Trans-vaginal	P	P	P	P	P	Note: 1,3	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
	Other: Urology	P	P	P	P	P	Note: 1,3	Note: 5,6,7,8,9,10,11,12,13,17
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P	P	P	Note: 1,3	Note: 5,6,8,10,12,13
PeripheralVessel	Peripheral Vessel
	Cerebral Vascular

added via Appendix E, 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

{41}------------------------------------------------

	Transducer: BP10-5ECIntended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application						Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P		P		P		Note: 1,3
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology	P	P	P		P		Note: 5,6,8,9,10,12,13
	Cardiac Adult
Cardiac	Cardiac Pediatric					P		Note: 5,6,8,9,10,12,13
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel
	Cerebral Vascular
	F= added via Appendix E, N= new indication, P= previously cleared

Affiniti 70/50 Diagnostic Ultrasound Systems

BP10-5ec System:
Transducer

ended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follo

E = added via Appendix E, N= new indication, P= previously cleared

Additional Comments

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
Previous Submission: K163120 EPIQ/Affiniti

{42}------------------------------------------------

Transducer:	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:		Mode of Operation (*includes simultaneous B-mode)
Clinical Application		B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
General(Track I only)	Specific(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, 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
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel
	Cerebral Vascular
								P

Affiniti 70/50/30 Diagnostic Ultrasound Systems
D2cwc System:
Transducer:

E = added via Appendix E, N= new indication, P= previously cleare

ANTC




AMM



(




(




ITIANI


ANIV
0

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
Previous Submission: K163120 EPIO/Affiniti

{43}------------------------------------------------

Affiniti 70/50 Diagnostic Ultrasound Systems

D2tcd

System:
Transducer:
Internationals durin

= body : alysis of the human fluid flo ii d in

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(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic			P
	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)
PeripheralVessel	Peripheral vessel
	Cerebral Vascular

E = added via Appendix E, 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
Previous Submission: K163120 EPIO/Affiniti

{44}------------------------------------------------

Affiniti 70/50 Diagnostic Ultrasound Systems

D5cwc
Diagnostic ultrasound imaging or fluid flow ana

System:
Transducer:
Intended Use

follo to lvsis

Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, 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
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel				P
	Cerebral Vascular				P

E = added via Appendix E, N= new indication, P= previously cleared

ments Additional

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
Previous Submission: K163120 EPIQ/Affiniti

{45}------------------------------------------------

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
General(Track I only)	Clinical ApplicationSpecific(Tracks I & III)	Mode of Operation (*includes simultaneous B-mode)				ColorDoppler*	Combined*(Spec.)	Other(Spec.)
		B	M	PWD	CWD
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P	P	P	Note: 1,3	Note: 5,6,7,8,9,10,12,13
	Abdominal	P	P	P	P	P	Note: 1,3	Note: 5,6, 8,9,10,11,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Small Organ (breast, thyroid, testicle)	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,11,12,13
	Neonatal Cephalic	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Musculo-skel. (Superficial)	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Cerebral Vascular	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,12,13
ded via Appendix E, N= new indication, P= previously cleare

Affiniti 70 Diagnostic Ultrasound Systems
L12-3 System:
Transducer:

b ﺭ ﺍﻟ 1ob

nal Co Additio

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
Previous Submission: K163120 EPIQ/Affiniti

{46}------------------------------------------------

System:	Affiniti 70/50/30 Diagnostic Ultrasound Systems
Transducer:	L12-4
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body

Transducer: L12-4Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
General(Track I only)	Clinical ApplicationSpecific(Tracks I & III)	Mode of Operation (*includes simultaneous B-mode)						Other(Spec.)
		B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,3	Note: 5,6,7,8,9,10,12,13
	Abdominal	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,11,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Pediatric	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Small Organ (breast, thyroid, testicle)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,11,12,13
	Neonatal Cephalic	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Cerebral Vascular	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13

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
Previous Submission: K163120 EPIQ/Affiniti

{47}------------------------------------------------

System:Transducer:Intended Use:	Affiniti 70/50/30 Diagnostic Ultrasound SystemsL12-5 50Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application						Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,3	Note: 5,6,7,8,9,10,12,13,17
	Abdominal	P	P	P		P	Note: 1,3	Note: 5,6, 8,9,10,12,13,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Small Organ (breast, thyroid,testicle)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,11,12,13,15,17
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Cerebral Vascular	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17

E = added via Appendix E, N= new indication, P= previously cleared

0Address the land to the been the been the beginner of the beginner of the bestille the bestille the bestille the bestille the bestille the bestille the bestille the bestille	:
10-0100
09	111
C	o

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

{48}------------------------------------------------

MA A2svstei119Inschiﻟﺘﺎﺭﻳﺨﺎ ﺍﻟﻤﺎﺿﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ.Diagnosti1EUf: 4. :ais1

tem

L15-7io
Diagnostic System:
Transducer:
Intended Use:

follo ರಕ -ho to nalvsis or fluid flo ui 7

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

E = added via appendix E,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
Previous Submission: K163120 EPIQ/Affiniti

{49}------------------------------------------------

diagnostic ultrasound indications for use statement

510(k) No: ___________________________________________________________________________________________________________________________________________________________________

Transducer:

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

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

Note 10: Harmonic Imaging Note 11: Contrast Imaging Note 16: ElastPQ (for Liver) Note 12: 3D/4D Imaging Note 15: Elastography Note 17: PercuNav Note 13: XRES Note 14: TDI Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD Note 4: Combined modes include: B+CWD; B+Color+CWD; Note 7: Infertility monitoring of follicle development Note 2: Combined modes include: B+M+Color Note 8: Panoramic Imaging
Previous Submission: K163120, EPIQAffiniti Note 6: Imaging for guidance of biopsy B+Amplitude+CWD Note 5: SonoCT

{50}------------------------------------------------

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

General(Track I only)	Specific(Tracks I & III)	Mode of Operation (*includes simultaneous B-mode)					Combined*(Spec.)	Other(Spec.)
		B	M	PWD	CWD	ColorDoppler*
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal	P	P	P		P	Note: 1,3	Note: 5,6, 8,9,10,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Pediatric	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Small Organ (breast, thyroid, testicle)	P	P	P		P	Note: 1,3	Note: 5,6,8,10,12,13
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Cerebral Vascular	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	F= added via Appendix F. N= new indication. P= previously cleared

Affiniti 70/50 Diagnostic Ultrasound Systems
L18-5 System:
Transducer:

E = added via Appendix E, N= new indication, P= previously cleared

dditio

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
Previous Submission: K163120 EPIQ/Affiniti

{51}------------------------------------------------

System:Transducer:Intended Use:	Affiniti 70 Diagnostic Ultrasound SystemsDiagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
General(Track I only)	Clinical Application	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Mode of Operation (includes simultaneous B-mode)Combined(Spec.)	Other(Spec.)
			Ophthalmic	Ophthalmic
	Fetal / OB		P	P			P	Note: 1,3	Note: 5,6, 8,9,10,12,13,17
	Abdominal		P	P	P		P	Note: 1,3	Note: 5,6, 8,9,10,12,13,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic		P	P	P		P	Note: 1,3	Note: 8,9,10,12,13,17
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult		P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14
Cardiac	Cardiac Pediatric		P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)

PeripheralVessel	Peripheral vessel
	Cerebral Vascular


E = added via Appendix E, N= new indication, P= previously clearedAdditional Comments:Color Doppler includes Color Amplitude DopplerNote 9: Color Power Angio (CPA)

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

{52}------------------------------------------------

System:
Transducer:
Intended Use

follo to alvsis

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:	Mode of Operation (*includes simultaneous B-mode)
Clinical Application	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
General(Track I only)	Ophthalmic
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal	P	P	P	P	P	Note: 1,3	Note: 5,6, 8,9,10,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	Note: 1,3	Note: 8,9,10,12,13
	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	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)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel
	Cerebral Vascular
E = added via Appendix E, 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
Previous Submission: K163120 EPIQ/Affiniti

{53}------------------------------------------------

Affiniti 70/50 Diagnostic Ultrasound Systems

S7-3t
Diagnostic ultrasound imaging or fluid flow ana

System:
Transducer:
Intended Use

ട് nalvsis

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:	Mode of Operation (*includes simultaneous B-mode)
Clinical Application		B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
General(Track I only)	Specific(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, 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
	Other: Urology
	Cardiac Adult	P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
Cardiac	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)
PeripheralVessel	Peripheral vessel
	Cerebral Vascular
	added via Appendix E, N= new indication, P= previously cleared

E = added via Appendix E, N= new indication, P= previou

Additional Comments

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
Previous Submission: K163120 EPIQ/Affiniti

{54}------------------------------------------------

Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Mode of Operation (*includes simultaneous B-mode)
Transducer	Clinical Application	General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
	Ophthalmic		Ophthalmic
	Fetal / OB			P	P	P	P	P	Note: 1,3	Note: 7,8,9,10,12,13
	Abdominal			P	P	P	P	P	Note: 1,3	Note: 8,9,10,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric			P	P	P	P	P	Note: 1,3	Note: 8,10,12,13
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic			P	P	P	P	P	Note: 1,3	Note: 8,10,12,13
	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			P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
Cardiac	Cardiac Pediatric			P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)			P	P	P	P	P	Note: 1,3	Note: 10,12,13
PeripheralVessel	Peripheral vessel
	Cerebral Vascular
F = added via Appendix F. N= new indication P= previously cleared

Affiniti 70/50/30 Diagnostic Ultrasound Systems

S8-3 System:
Transducer:

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

E = added via Appendix E,N= new indication, P= previously cleared

Addition:

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
Previous Submission: K163120 EPIQ/Affiniti

{55}------------------------------------------------

diagnostic ultrasound indications for use statement

Analysis of the human fluid film rupture of a micro-textured surface

Clinical Application						Mode of Operation (*includes simultaneous B-mode)
	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
General(Track I only)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
Fetal Imaging& Other	Pediatric
	Small Organ (breast, thyroid, 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
	Other: Urology
Cardiac	Cardiac Adult	P	P	P		P	Note: 1,2,3,4	Note: 10,,12,13,14
	Cardiac Pediatric	P	P	P		P	Note: 1,2,3,4	Note: 10,,12,13,14
	Trans-esophageal (Cardiac)	P	P	P		P	Note: 1,2,3,4	Note: 10,,12,13,14
	Other (Fetal Echo)
	Peripheral vessel
PeripheralVessel	Cerebral Vascular
	N= new indication P= previously clearedAdditional Comments:

Additional Comments:*Color Doppler includes Color Amplitude Doppler
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 9: Color Power Angio (CPA)
Note 2: Combined modes include: B+M+Color	Note 10: Harmonic Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 11: Contrast Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;B+Amplitude+CWD	Note 12: 3D/4D Imaging
Note 5: SonoCT	Note 13: XRES
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)
Previous Submission: K163120, EPIQ	Note 17: Percu Nav

{56}------------------------------------------------

diagnostic ultrasound indications for use statement

Affiniti 70/50 Diagnostic Ultrasound Systems

S12-4
Diagnostic ultrasound imaging or fluid flow ana

System:
Transducer:
Intended Use

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

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:	Mode of Operation (*includes simultaneous B-mode)
Clinical Application	General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal		P	P	P		P	Note: 1,3	Note: 8,9,10,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric		P	P	P		P	Note: 1,3	Note: 8,9,10,12,13
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic		P	P	P		P	Note: 1,3	Note: 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		P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel
	Cerebral Vascular

E = added via Appendix E, N= new indication, P= previously clearec

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
Previous Submission: K163120 EPIQ/Affiniti

{57}------------------------------------------------

Affiniti 70/50/30 Diagnostic Ultrasound Systems

V6-2
Diagnostic ultrasound imaging or fluid flow analysis of the l

System:
Transducer:
Intended Use:

human body as follow

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:		Mode of Operation (*includes simultaneous B-mode)
		B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
General(Track I only)	Specific(Tracks I & III)Clinical Application
Ophthalmic	Ophthalmic	P
	Fetal / OB	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, 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
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P		P	Note: 1,3	Note: 5,9,10,13
PeripheralVessel	Peripheral vessel
	Cerebral Vascular

E = added via Appendix E, N= new indication, P= previously c

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
Previous Submission: K163120 EPIQ/Affiniti

{58}------------------------------------------------

Affiniti 70/50 Diagnostic Ultrasound Systems

X7-2t
Diagnostic ultrasound imaging or fluid flow ana

System:
Transducer:
Intended Use

asound imaging or fluid flow analysis of the human body as follow

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:	Mode of Operation (*includes simultaneous B-mode)
	Clinical Application	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
General(Track I only)	Ophthalmic
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
Fetal Imaging& Other	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, 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
	Other: Urology
Cardiac	Cardiac Adult	P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
	Cardiac Pediatric
	Trans-esophageal (Cardiac)	P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
	Other (Fetal Echo)
PeripheralVessel	Peripheral vessel
	Cerebral Vascular
E = added via Appendix E, 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
Previous Submission: K163120 EPIQ/Affiniti

{59}------------------------------------------------

System:
Transducer:

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

	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)Clinical Application	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, testicle)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Neonatal Cephalic
	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 vessel	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
PeripheralVessel	Cerebral Vascular	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	= added via Appendix E. N= new indication, P= previously cleared

d pp

Additional Comments:
*Color Doppler includes Color Amplitude Doppler
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 9: Color Power Angio (CPA)
Note 2: Combined modes include: B+M+Color	Note 10: Harmonic Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 11: Contrast Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 12: 3D/4D Imaging
Note 5: SonoCT	Note 13: XRES
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)

{60}------------------------------------------------

510(k) Summary of Safety and Effectiveness

EPIQ and Affiniti Diagnostic Ultrasound Systems

This summary of safety and effectiveness information is submitted in accordance with 21CFR 8807.92

1. Submitter's name, address, telephone number, contact person. Philips Ultrasound, Inc. 22100 Bothell Everett Hwy Bothell, WA 98021-8431
  Maxs Newberry, Regulatory Affairs Engineer Contact person: Email: Maxs.newberry(@philips.com Tel: 360-581-2422 Fax: 425-487-8666

Date prepared: October 3, 2017

2. Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

Common/usual name: Diagnostic ultrasound system and transducers Proprietary name:

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

These devices are classified as follows:

Classification Name	21 CFR Section	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	IYO
Diagnostic Ultrasound Transducer	892.1570	ITX

As stated in 21 CFR, parts 892.1550, 892.1560, and 892.1570, each of these generic types of devices has been classified as Class II.

3. Substantially Equivalent Devices

Philips Ultrasound believes the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems are substantially equivalent to the following currently marketed devices:

{61}------------------------------------------------

Product		510(k)
Philips EPIQ Diagnostic UltrasoundSystem and Philips Affiniti DiagnosticUltrasound System	Primary PredicateDevice	K163120
Philips EchoNavigator	Predicate Device	K121781

4. Device Description

The removable transducers are connected to the system using a standard technology, multipin connectors.

5. Indications for 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 EPIO and Affiniti Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

6. Technological Comparison to Predicate Devices

The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems and the currently marketed and predicate device, Philips EPIQ Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System (K163120), employ the same fundamental scientific technology. The primary differences are the addition of the eL18-4 transducer to the EPIQ and Affiniti Diagnostic Ultrasound Systems, the addition of the XL14-3 and X8-2ti

{62}------------------------------------------------

transducers to the EPIQ Diagnostic Ultrasound System, and the addition of a new EchoNavigator mode that allows compatibility with the Philips EchoNavigator software tool.

A comparison of the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems to the currently marketed and predicate device, Philips EPIQ Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System, and Philips EchoNavigator is provided in Table 1 below:

Table 1
Comparison of the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems to thecurrently marketed and predicate device, Philips EPIQ Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System, and Philips EchoNavigator.
StandardFeature	PhilipsEchoNavigator(K121781)(Predicate device)	EPIQK163120 (PrimaryPredicate Device)	EPIQ 1.8(Proposed Device)	AffinitiK163120(PrimaryPredicateDevice)	Affiniti 1.8(ProposedDevice)
Indicationsfor Use	EchoNavigatorsupports theinterventionalist andsurgeon in treatmentswhere both live X-rayand live Echoguidance are used.The targeted patientpopulation consists ofpatients withcardiovasculardiseases requiringsuch a treatment.	Fetal/Obstetric,Abdominal,Intraoperative (Vascular),Intraoperative (Cardiac),Pediatric, Small Organ(Breast, Thyroid, Testicle),Cephalic (Neonatal),Cephalic (Adult),Transrectal, TransvaginalMusculoskeletal(Conventional),Musculoskeletal(Superficial)Gynecological, Other:Urology, Cardiac Adult, Cardiac Pediatric	Same as EPIQK163120 but withthe addition ofintegration withPhilipsEchoNavigator(K121781) softwaretool	Same as EPIQK163120	Same asEPIQK163120

	cardiovasculardiseases requiringsuch a treatment.	Transrectal, TransvaginalMusculoskeletal(Conventional),Musculoskeletal(Superficial)Gynecological, Other:Urology, Cardiac Adult,Cardiac Pediatric,Transesophageal(Cardiac),Cardiac other (Fetal),Peripheral Vessel,Cerebral Vascular,
Transducers	N/A	C5-1, C8-5, C9-2,C10-3v,C10-4ec, D2cwc, D5cwc,L12-3, L12-5 50, L15-7io,L18-5, S5-1, S7-3t, S8-3,S8-3t, S12-4, V6-2, X7-2t,X8-2t D2tcd, X5-1, X6-1,VL13-5, X7-2, 3D9-3v	Same as EPIQK163120 withaddition of eL18-4,XL14-3 and X8-2titransducers	3D9-3v, C5-1,C6-2, C8-5,C9-2, C9-4V, C10-3v, C10-4ec,D2cwc, D2tcd,D5cwc, BP10-5ec, L12-3, L12-4,L12-5, L15-7io,L18-5, S4-2, S5-1, S7-3t, S8-3,S12-4, V6-2,VL13-5, X7-2t	Same asAffinitiK163120with additionof the eL18-4 transducer

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Table 1 Comparison of the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems to the currently marketed and predicate device, Philips EPIQ Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System, and Philips EchoNavigator.

StandardFeature	PhilipsEchoNavigator(K121781)(Predicate device)	EPIQK163120 (PrimaryPredicate Device)	EPIQ 1.8(Proposed Device)	AffinitiK163120(PrimaryPredicateDevice)	Affiniti 1.8(ProposedDevice)
TransducerTypes	N/A	Phased array Linear array Curved array Pencil Probes Multi-planeTransesophageal Motorized arrays 3D Matrix Array	Same as EPIQK163120	Phased array Linear array Curvedarray PencilProbes Multi-planeTransesophageal Motorizedarrays	Same asAffinitiK163120
TransducerFrequency	N/A	1.0 - 18.0 MHz	Same	Same	Same
AcousticOutputDisplay &FDA Limits	N/A	IEC 62359ISPTA max=720mw/cm2MI max =1.9MI displayTI display	Same	Same	Same
ImagingMode	N/A	B mode, M mode, PWD,CWD, Color Doppler,Combined modes,	Same	Same	Same
Shear wave	N/A	ElastPQ	Same	Same	Same
Elastography	N/A	ElastQ Imaging	Same	NA	NA
# TransmitChannels	N/A	128	Same	Same	Same
# ReceiveChannels	N/A	256	Same	Same	Same
510(k) Track	N/A	Track 3	Same	Same	Same
ProductSafetyCertification	N/A	CSA InternationalIEC 60601-1C22.2 No. 60601-1ANSI/AAMI ES60601-1IEC 60601-2-37	Same	Same	Same
EMCCompliance	N/A	IEC 60601-1-2	Same	Same	Same
PatientContactMaterials	N/A		No changes from EPIQ K163120
StandardFeature	PhilipsEchoNavigator(K121781)(Predicate device)	EPIQK163120 (PrimaryPredicate Device)	EPIQ 1.8(Proposed Device)	AffinitiK163120(PramaryPredicateDevice)	Affiniti 1.8(ProposedDevice)
Accessories		Various hardcopy, recording and printing devices: video thermal printer, report printer, DVD, USB PercuNav Instruments Biopsy guides Footswitch	Addition of video switch for compatibility with EchoNavigator	Same	Same

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7. Safety Considerations

As a Track 3 ultrasound device, the subject EPIQ and Affiniti Diagnostic Ultrasound Systems are designed to comply with the acoustic output display requirements of IEC 60601-2-37 Ed 2.0 (Particular requirements for the basic safety and essential performance of ultrasonic medical and monitoring equipment) and IEC 62359, Ed 2.0 (Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields).

The subject EPIQ and Affiniti Diagnostic Ultrasound Systems comply with the referenced standard as well as the FDA ultrasound guidance document, Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, issued on September 9, 2008.

The system acoustic output limits are:

. Ispta.3 ≤ 720 MW/cm2
MI < 1.9 ●
. TI < 6.0

The system and transducers are compliant to:

IEC 60601-1: Medical electrical equipment. General requirements for basic ● safety and essential performance, 2005, Amendment 1, 2012
IEC 60601-1-2 Medical Electrical Equipment Part 1-2, General Requirements ● for Basic Safety and Essential Performance - Collateral Standard Electromagnetic Compatibility, 2007

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IEC 60601-1-6 Medical Electrical Equipment Part 1-6, General Requirements ● for Basic Safety and Essential Performance - Usability, 2010
. IEC 60601-2-37: Medical electrical equipment. Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, 2007
. IEC 62359. Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2010

8. Nonclinical Performance Data

Philips Ultrasound performed the following testing to ensure the safety and effectiveness of the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems:

IEC 60601-1: Medical electrical equipment. General requirements for basic safety and essential performance, 2005, Amendment 1, 2012
IEC 60601-1-2 Medical Electrical Equipment Part 1-2, General Requirements ● for Basic Safety and Essential Performance - Collateral Standard Electromagnetic Compatibility, 2007
IEC 60601-1-6 Medical Electrical Equipment Part 1-6, General Requirements ● for Basic Safety and Essential Performance - Usability, 2010
. IEC 60601-2-37: Medical electrical equipment. Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, 2007
ISO 10993: Biological evaluation of medical devices. .

The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems also comply with the FDA ultrasound specific guidance. Guidance for Industry and FDA Staff - Information for manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (September 9, 2008).

Non-Clinical verification testing has been performed to cover system level requirements and the risk control measures in Appendix M. Non-Clinical validation testing covered the intended use and commercial claims as well as usability testing with representative intended users.

All these tests were used to support substantial equivalence of the subject device and demonstrate that the proposed EPIO and Affiniti Diagnostic Ultrasound Systems:

comply with the aforementioned international and FDA-recognized consensus . standards and FDA ultrasound guidance document, and
meet the acceptance criteria and are adequate for their intended use. .

Therefore, the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems are substantially equivalent to the predicate EPIQ and Affiniti Diagnostic Ultrasound Systems in terms of safety and effectiveness.

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Ouality assurance measures applied to the system design and development include, but were not limited to:

o Risk Analysis
Product Specifications O
Design Reviews O
o Verification and Validation

9. Clinical Data

The proposed EPIO and Affiniti Diagnostic Ultrasound Systems did not require clinical studies since substantial equivalence to the currently marketed predicate devices. Philips EPIQ Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System, was demonstrated with the following attributes:

. Design features:
. Indication for use:
Fundamental scientific technology;
Non-clinical performance testing; and
. Safety and effectiveness.

10. Conclusion

The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems with EchoNavigator mode and the new eL18-4. XL14-3 and X8-2ti transducers are substantially equivalent with regards to safety and effectiveness to the currently marketed predicate devices, Philips EPIO Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System and Philips as follows :

The predicate device and the proposed EPIO and Affiniti Diagnostic Ultrasound . Systems are indicated for the diagnostic ultrasonic imaging and fluid flow analysis.
. The predicate device and the proposed EPIO and Affiniti Diagnostic Ultrasound Systems have the same gray-scale and Doppler capabilities.
The predicate device and the proposed EPIO and Affiniti Diagnostic Ultrasound Systems use essentially the same technologies for imaging. Doppler functions and signal processing.
The predicate device and the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems have acoustic output levels within the Track 3 FDA limits.
The predicate device and the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems are manufactured under equivalent quality systems.
The predicate device and the proposed EPIQ and Affiniti Diagnostic Ultrasound ● Systems are manufactured of materials with equivalent bio safety.
The predicate device and the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems are designed and manufactured to the same electrical and physical safety standards.

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514 Performance Standards

There are no Sec. 514 performance standards for the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems.

Prescription Status

The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems are prescription devices. The prescription device statement appears in the labeling.

Sterilization Sites

Not applicable. No components are supplied sterile.

Track

The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems are Track 3 systems.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.