ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System

• K Number: K152469
• Device Name: ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System
• Manufacturer: SIEMENS MEDICAL SOLUTIONS, INC., ULTRASOUND DIVISION
• Date Cleared: 2015-09-21 ( 21 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K141846 , K121699
• Predicate For: K161787 , K173957

Intended Use

For ACUSON NX3
The ACUSON NX3 ultrasound imaging system, is intended for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts(Small Organ), Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.

For ACUSON NX3 Elite
ACUSON NX3 Elite ultrasound imaging systems are intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Parts(Small Organ including intra-operative), Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular(including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. Note: This feature can be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular Medicine."

Device Description

The Siemens ACUSON NX3 Elite™ and ACUSON NX3™ Diagnostic Ultrasound Systems are multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Tissue Doppler Image, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.

AI/ML Overview

This document is a 510(k) premarket notification for the ACUSON NX3 Elite and ACUSON NX3 Diagnostic Ultrasound Systems by Siemens Medical Solutions USA, Inc. As such, it primarily focuses on establishing "substantial equivalence" to predicate devices rather than providing detailed acceptance criteria and performance studies in the way you might find for novel AI/ML devices.

Therefore, the information you requested regarding acceptance criteria and study details to prove the device meets them is largely based on demonstrating equivalence to existing, legally marketed ultrasound systems, and general safety and performance standards, rather than specific performance metrics for a new AI feature. The document explicitly states: "Since the ACUSON NX3 Elite™ and ACUSON NX3™ Diagnostic Ultrasound Systems use the same technology and principles as existing devices, clinical data is not required." This means there won't be a study demonstrating the device meets specific performance criteria in the sense of a new technology needing to prove its efficacy.

However, I can extract the information related to the device's characteristics and the basis for its clearance:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the document, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices (ACUSON X700™ Diagnostic Ultrasound System (K141846) and ACUSON X300™ Diagnostic Ultrasound System (K121699)) and adherence to recognized safety standards. The "reported device performance" is essentially that it functions similarly to the predicate devices across a range of applications and modes.

Feature / Characteristic	Predicate Device (ACUSON X300™ - K121699)	Predicate Device (ACUSON X700™ - K141846)	Submission Device (ACUSON NX3™)	Submission Device (ACUSON NX3 Elite™)	Implicit Acceptance Criteria (based on equivalence)	Reported Device Performance (based on equivalence)
Indications for Use (General)	Fetal, Abdominal, Intra-operative, Neonatal Cephalic, Small Organ, Pediatric, Adult Cephalic, Cardiac (Adult/Pediatric), Intracardiac, Trans-esophageal, Trans-rectal, Trans-vaginal, Peripheral vessel, Musculo-skeletal	Fetal, Abdominal, Intra-operative, Neonatal Cephalic, Small Organ, Pediatric, Adult Cephalic, Cardiac (Adult/Pediatric), Intracardiac, Trans-esophageal, Trans-rectal, Trans-vaginal, Peripheral vessel, Musculo-skeletal	Fetal, Abdominal, Small Organ, Pediatric, Adult Cephalic, Cardiac (Adult), Trans-rectal, Trans-vaginal, Peripheral vessel, Musculo-skeletal (some marked 'N' for new)	Fetal, Abdominal, Intra-operative, Neonatal Cephalic, Small Organ, Pediatric, Adult Cephalic, Cardiac (Adult/Pediatric), Trans-rectal, Trans-vaginal, Peripheral vessel, Musculo-skeletal (some marked 'N' for new)	Performance equivalent to predicates across all listed and new applications.	Device can perform all listed applications using various modes.
Center Frequencies (MHz)	2.0 - 11.0 MHz (some covered by K121699/K141846)	2.0 - 13.0 MHz (some covered by K121699/K141846)	2.0 - 11.0 MHz	2.0 - 13.0 MHz	Offer a comparable range of center frequencies for various applications.	The devices support frequencies within the established range of predicate devices.
Modes of Operation	B, M, PWD, CWD, SCW, CD, Amplitude Doppler, Directional Power Doppler, Combined (BM, BC, BCM, BCD), THI, AMM, Doppler Tissue Image, M-THI	B, M, PWD, CWD, SCW, CD, Amplitude Doppler, Directional Power Doppler, Combined (BM, BC, BCM, BCD), THI, AMM, Doppler Tissue Image, M-THI	B, M, PWD, SCW, CD, Amplitude Doppler, Directional Power Doppler, Combined (BM, BC, BCM, BCD), THI, AMM, Doppler Tissue Image, M-THI	B, M, PWD, CWD, SCW, CD, Amplitude Doppler, Directional Power Doppler, Combined (BM, BC, BCM, BCD), THI, AMM, Doppler Tissue Image, M-THI	Provide all standard ultrasound modes and functions found in predicates.	Device offers comprehensive set of diagnostic modes.
Features (e.g., SieClear, 3D/4D Imaging, Stress Echo, AHP)	Most listed features present in K121699 and/or K141846	Most listed features present in K121699 and/or K141846	Most listed features present (some marked with '-' indicating absence or different implementation)	Most listed features present (some marked with '√' indicating presence, 'N' for new)	Provide equivalent or enhanced features compared to predicates.	Device includes a variety of advanced imaging and analysis features.
Safety and EMC Requirements	Conforms to UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, IEC 62359, 93/42/EEC, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-1-6, IEC 62366, ISO 10993-1	Conforms to above standards	Conforms to above standards	Conforms to above standards	Meet all applicable medical device safety standards.	Devices undergone evaluation for acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety, and conform to listed standards.

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

• Sample Size: Not applicable in the context of efficacy studies for this type of 510(k). The clinical performance is inferred from the established safety and efficacy of the predicate devices. The document does mention "nonclinical tests" for safety and standards compliance, but does not provide specific sample sizes for these tests (e.g., number of units tested for electrical safety).
• Data Provenance: Not applicable. The FDA's basis for substantial equivalence for this diagnostic ultrasound system does not rely on a new clinical study with a specific test set. It relies on technological comparison to predicate devices and adherence to recognized performance standards. If clinical data were used from predicate devices, their provenance would be relevant, but this is not mentioned.

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

• Not applicable. No ground truth establishment by experts for a novel efficacy claim is described or needed for this 510(k) submission as it relies on substantial equivalence to existing technology. The "ground truth" for the predicate devices' efficacy would have been established historically through their own development and clearance processes.

4. Adjudication Method for the Test Set:

• Not applicable. There is no mention of a test set requiring adjudication in this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This document pertains to the clearance of a diagnostic ultrasound system and its transducers, which are imaging devices. It does not describe an AI-powered diagnostic algorithm or a clinical study that would involve human readers and AI assistance. The "Arterial Health Package (AHP) software" mentioned for the ACUSON NX3 Elite is described as providing "the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies," not as an AI requiring a MRMC study for improved human reading.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This is a 510(k) for an ultrasound imaging system, not a standalone algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• Not applicable for a new efficacy claim. For the purposes of this 510(k), the "ground truth" for demonstrating substantial equivalence is the comprehensive body of knowledge and regulatory clearance history associated with the predicate devices and general ultrasound technology, as well as adherence to established medical device safety and performance standards (e.g., IEC, ISO, AIUM/NEMA).

8. The Sample Size for the Training Set:

• Not applicable. This submission describes the clearance of an imaging hardware system, not a machine learning model that would require a training set.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. As there is no machine learning model or training set described in this 510(k) submission, this question is not relevant.

Summary

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

September 21, 2015

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

Re: K152469

Trade/Device Name: ACUSON NX3 Elite and ACUSON NX3 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, 2015 Received: August 31, 2015

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

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

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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

Sincerely yours,

Robert Odlo

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152469

Device Name

ACUSON NX3 Elite and ACUSON NX3 Diagnostic Ultrasound Systems

Indications for Use (Describe)

For ACUSON NX3

The ACUSON NX3 ultrasound imaging system, is intended for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts(Small Organ), Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.

For ACUSON NX3 Elite

ACUSON NX3 Elite ultrasound imaging systems are intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Organ including intra-operative), Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular(including Peripheral Vessel, intra-operative), Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. Note: This feature can be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular Medicine."

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Number (if known):

Device Name: Intended Use:

ACUSON NX3 Elite™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other(Track1Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10,12,14
	Abdominal	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10,15
	Intra-operative(Note 6)	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10
Imaging& Other	SmallOrgan(Note 1)	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10,17
	Neonatal Cephalic	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9
	Adult Cephalic	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,11
	Trans-rectal	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10
	Trans-vaginal	N	N	N	N	N	N	BMDC	Note 2,3,4,5,9,10,12,14,16
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10,11
	Musculo-skel.(Superfic)	N	N	N	N	N	N	BMDC	Note 2,3,4,9,10,11
	Intra -vascular
	Other(Specify)
	Cardiac Adult	N	N	N	N	N	N	BMDC	Note 2,7,8,9,13,
Cardiac	Cardiac Pediatric	N	N	N	N	N	N	BMDC	Note 2,3,4,6,8,9,13
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-Cardiac
	Other (Specify)
Peripheral	Peripheral vessel	N	N	N	N	N	N	BMDC	Note 2,3,4,6,9,10
Vessel	Other (Specify)

N = new indication; P = previously cleared

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

• Dynamic TCE Technology Note 2
• Note 3 SieClear
• Note 4 Advanced SieClear 3-Scape 3D Imaging
• Note 5 For example: abdominal, vascular Note 6
• Note 7 Stress Echo Imaging

Note 8 Axius Edge Assisted Ejection Fraction

Clarify Vascular Enhancement Technology Note 9

Note 10 SieScape Panoramic Imaging Note 11 syngo Arterial Health Package (AHP) (NX3 Elite only)

Note 12 syngo Auto OB Measurements

Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)

Note 14 syngo fourSight 4D imaging

Contrast Agent Imaging (NX3 Elite only) Note 15

syngo Auto follicle Note 16

eSie Touch (NX3 Elite only) Note 17

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

510(k)

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510(k) Number (if known):

Device Name: Intended Use:

ACUSON NX3TM Diagnostic Ultrasound System

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

Clinical Application		Mode of Operation
Other( Track 1Only)	Specific(Tracks11& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	BMDC	Note 2,3,4,5,6,9,10,12,14
	Abdominal	N	N	N		N	N	BMDC	Note 2,3,4,5,6,9,10
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric	N	N	N		N	N	BMDC	Note 2,3,4,5,6,9,10
Imaging& Other	SmallOrgan(Note 1)	N	N	N		N	N	BMDC	Note 2,3,4,5,6,9,10
	Neonatal Cephalic
	Adult Cephalic	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9
	Trans-rectal	N	N	N		N	N	BMDC	Note 2,3,4,5,6,9,10
	Trans-vaginal	N	N	N		N	N	BMDC	Note 2,3,4,5,9,10,12,16
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)	N	N	N		N	N	BMDC	Note 2,3,4,5,6,9,10
	Musculo-skel.(Superfic)	N	N	N		N	N	BMDC	Note 2,3,4,9,10
	Intra -vascular
	Other(Specify)
	Cardiac Adult	N	N	N		N	N	BMDC	Note 2,7,8,9
Cardiac	Cardiac Pediatric	N	N	N		N	N	BMDC	Note 2,7,8,9
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-Cardiac
	Other (Specify)
Peripheral	Peripheral vessel	N	N	N		N	N	BMDC	Note 2,3,4,5,6,9,10
Vessel	Other (Specify)

N = new indication; P = previously cleared

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Dynamic TCE Technology

• Note 2 Note 3 SieClear
• Advanced SieClear Note 4
• 3-Scape 3D Imaging Note 5
• For example: abdominal, vascular Note 6
• Stress Echo Imaging Note 7 Axius Edge Assisted Ejection Fraction Note 8
• Note 9 Clarify Vascular Enhancement Technology

Note 10 SieScape Panoramic Imaging

• syngo Arterial Health Package (AHP) (NX3 Elite only) Note 11
  Note 12 syngo Auto OB Measurements

Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)

Note 14 syngo fourSight 4D imaging

Contrast Agent Imaging (NX3 Elite only) Note 15

syngo Auto follicle Note 16

Note 17 eSie Touch (NX3 Elite only)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

510(k)_

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510(k) Number (if known):

CH5-2 Transducer for use with:

ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound Device Name: System Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other( Track1Only)	Specific(Tracks1l& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	BMDC	Note 2,3,4,5,6,9,10,12
	Abdominal	P	P	P		P	P	BMDC	Note 2,3,4,5,6,9,10,15,16
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P		P	P	BMDC	Note 2,3,4,5,6,9,10
Imaging& Other	SmallOrgan(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P	P	P		P	P	BMDC	Note 2,3,4,5,6,9,10
Vessel	Other (Specify)

N = new indication; P = previously cleared by K141846

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

• Dynamic TCE Technology Note 2
• SieClear Note 3 Note 4
• Advanced SieClear 3-Scape 3D Imaging Note 5
• For example: abdominal, vascular Note 6
• Stress Echo Imaging Note 7
• Axius Edge Assisted Ejection Fraction Note 8
• Clarify Vascular Enhancement Technology Note 9
• Note 10 SieScape Panoramic Imaging

Note 12 syngo Auto OB Measurements

Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)

• Note 14 syngo fourSight 4D imaging
• Note 15 Contrast Agent Imaging (NX3 Elite only) Note 16
• syngo Auto follicle Note 17 eSie Touch (NX3 Elite only)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

syngo Arterial Health Package (AHP) (NX3 Elite only) Note 11

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510(k) Number (if known):

Device Name:

VF10-5 Linear Array Transducer for use with: ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System

Intended Use:

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

Clinical Application		Mode of Operation
Other( Track 1Only)	Specific(Tracks1& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	BMDC	Note 2,3,4,9,10,16
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric	P	P	P		P	P	BMDC	Note 2,3,4,9,10
	SmallOrgan(Note 1)	P	P	P		P	P	BMDC	Note 2,3,4,9,10,17
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	P	BMDC	Note 2,3,4,9,10,11
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)	P	P	P		P	P	BMDC	Note 2,3,4,9,10
	Musculo-skel.(Superfic)	P	P	P		P	P	BMDC	Note 2,3,4,9,10
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	BMDC	Note 2,3,4,9,10

N = new indication; P = previously cleared K141846

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

• Dynamic TCE Technology Note 2
• Note 3 SieClear Advanced SieClear Note 4

3-Scape 3D Imaging Note 5

• Note 6 For example: abdominal, vascular
• Note 7 Stress Echo Imaging

Axius Edge Assisted Ejection Fraction Note 8

Note 9 Clarify Vascular Enhancement Technology

Note 10 SieScape Panoramic Imaging Note 11 syngo Arterial Health Package (AHP) (NX3 Elite only) Note 12 syngo Auto OB Measurements

syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only) Note 13

• syngo fourSight 4D imaging Note 14
  Contrast Agent Imaging (NX3 Elite only) Note 15

• Note 16 syngo Auto follicle

• Note 17 eSie Touch (NX3 Elite only)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

510(k)

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

510(k) Number (if known):

Device Name:

VF12-4 Linear Array Transducer for use with:

VF12-4 Linear Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System Intended Use:

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

Clinical Application		Mode of Operation
Other( Track 1Only)	Specific(Tracks1& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	BMDC	Note 2,3,4,9,10,16
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P	P	P	P	BMDC	Note 2,3,4,9,10
Imaging& Other	SmallOrgan(Note 1)	P	P	P	P	P	P	BMDC	Note 2,3,4,9,10,17
	Neonatal Cephalic- NX3 Elite only	P	P	P	P	P	P	BMDC	Note 2,3,4,9,10
	Adult Cephalic	P	P	P	P	P	P	BMDC	Note 2,3,4,9,10,11
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)	P	P	P	P	P	P	BMDC	Note 2,3,4,9,10
	Musculo-skel.(Superfic)	P	P	P	P	P	P	BMDC	Note 2,3,4,9,10
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	P	BMDC	Note 2,3,4,9,10
	Other (Specify)

N = new indication; P = previously cleared by K141846

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Dynamic TCE Technology Note 2

• Note 3 SieClear
  Advanced SieClear Note 4 3-Scape 3D Imaging Note 5

• Note 6 For example: abdominal, vascular

• Note 7 Stress Echo Imaging

Axius Edge Assisted Ejection Fraction Note 8

• Clarify Vascular Enhancement Technology Note 9
  SieScape Panoramic Imaging Note 10

Note 11 syngo Arterial Health Package (AHP) (NX3 Elite only)

Note 12 syngo Auto OB Measurements

Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)

syngo fourSight 4D imaging Note 14

Contrast Agent Imaging (NX3 Elite only) Note 15 Note 16 syngo Auto follicle

• Note 17 eSie Touch (NX3 Elite only)
  (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

510(k)_

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

510(k) Number (if known):

Device Name:

Intended Use:

EC10-5w Convex Array Transducer for use with: ACUSON NX3 Elite™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other( Track 1Only)	Specific(Tracks1& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10,12
	Abdominal
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric
	SmallOrgan(Note 1)	N	N	N	N	N	N	BMDC	Note 2,3,4,5,9,10
	Neonatal Cephalic	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6, 9,10
	Adult Cephalic
	Trans-rectal	N	N	N	N	N	N	BMDC	Note 2,3,4,5,9,10
	Trans-vaginal	N	N	N	N	N	N	BMDC	Note 2,3,4,5,9,10,12,16
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-Cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Dynamic TCE Technology Note 2 SieClear Note 3

• Advanced SieClear Note 4
• Note 5 3-Scape 3D Imaging
• Note 6 For example: abdominal, vascular

Note 7 Stress Echo Imaging

• Note 8 Axius Edge Assisted Ejection Fraction
  Note 9 Clarify Vascular Enhancement Technology

Note 10 SieScape Panoramic Imaging Note 11 syngo Arterial Health Package (AHP) (NX3 Elite only)

Note 12 syngo Auto OB Measurements

syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only) Note 13

Note 14 syngo fourSight 4D imaging

Note 15 Contrast Agent Imaging (NX3 Elite only)

Note 16 syngo Auto follicle

Note 17 eSie Touch (NX3 Elite only)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

510(k)

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

510(k) Number (if known):

Device Name:

EC9-4 Convex Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound

Intended Use:

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

Clinical Application		Mode of Operation
Other( Track 1Only)	Specific(Tracks1I& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	BMDC	Note 2,3,4,5,6,9,10,12
	Abdominal
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric
	SmallOrgan(Note 1)	P	P	P		P	P	BMDC	Note 2,3,4,5,9,10
	Neonatal Cephalic- NX3 Elite Only	P	P	P		P	P	BMDC	Note 2,3,4,5,6, 9,10
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	BMDC	Note 2,3,4,5,9,10
	Trans-vaginal	P	P	P		P	P	BMDC	Note 2,3,4,5,9,10,12,16
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-Cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared by K121699

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Dynamic TCE Technology

• Note 2 Note 3 SieClear
• Advanced SieClear Note 4
• 3-Scape 3D Imaging Note 5

For example: abdominal, vascular Note 6

• Note 7 Stress Echo Imaging
  Axius Edge Assisted Ejection Fraction Note 8

• Clarify Vascular Enhancement Technology Note 9

• SieScape Panoramic Imaging Note 10

Note 11 syngo Arterial Health Package (AHP) (NX3 Elite only)

Note 12 syngo Auto OB Measurements Note 13

syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only) Note 14 syngo fourSight 4D imaging

• Contrast Agent Imaging (NX3 Elite only) Note 15
• syngo Auto follicle Note 16
• Note 17 eSie Touch (NX3 Elite only)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

510(k)_

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

510(k) Number (if known):

CW2 Continuous Wave Doppler Transducer for use with: Device Name: ACUSON NX3 Elite™ Diagnostic Ultrasound System

Intended Use:

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

Clinical Application		Mode of Operation
Other( Track 1Only)	Specific(Tracks1& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric
	SmallOrgan(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared by K141846

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

• Note 2 Dynamic TCE Technology
• Note 3 SieClear Advanced SieClear Note 4
• 3-Scape 3D Imaging Note 5
• For example: abdominal, vascular Note 6
• Stress Echo Imaging Note 7
• Axius Edge Assisted Ejection Fraction Note 8
• Clarify Vascular Enhancement Technology Note 9
• SieScape Panoramic Imaging Note 10

syngo Arterial Health Package (AHP) (NX3 Elite only) Note 11

• Note 12 syngo Auto OB Measurements
• Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)
• Note 14 syngo fourSight 4D imaging
• Note 15 Contrast Agent Imaging (NX3 Elite only) Note 16
  • syngo Auto follicle
• Note 17 eSie Touch (NX3 Elite only)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

510(k) Number (if known):

CW5 Continuous Wave Doppler Transducer for use with: Device Name: ACUSON NX3 Elite™ Diagnostic Ultrasound System

Intended Use:

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

Clinical Application		Mode of Operation
Other(Track 1Only)	Specific(Tracks1I& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric
	SmallOrgan(Note 1)
	Neonatal Cephalic
	Adult Cephalic				P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult				P
Cardiac	Cardiac Pediatric				P
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared by K141846

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

• Note 2 Dynamic TCE Technology
• Note 3 SieClear Advanced SieClear Note 4
• 3-Scape 3D Imaging Note 5
• For example: abdominal, vascular Note 6
• Stress Echo Imaging Note 7
• Axius Edge Assisted Ejection Fraction Note 8
• Clarify Vascular Enhancement Technology Note 9
• SieScape Panoramic Imaging Note 10

Note 11 syngo Arterial Health Package (AHP) (NX3 Elite only)

• Note 12 syngo Auto OB Measurements
• Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)
• Note 14 syngo fourSight 4D imaging
• Note 15 Contrast Agent Imaging (NX3 Elite only) Note 16
  • syngo Auto follicle
• Note 17 eSie Touch (NX3 Elite only)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

510(k) Number (if known):

Device Name:

Intended Use:

P4-2 Phased Sector Array Transducer for use with:

P4-2 Phased Sector Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System

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

Clinical Application		Mode of Operation
Other( Track1Only)	Specific(Tracks1& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	BMDC	Note 2,9
	Abdominal	P	P	P		P	P	BMDC	Note 2,9,16
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P		P	P	BMDC	Note 2,9
Imaging& Other	SmallOrgan(Note 1)	P	P	P		P	P	BMDC	Note 2,9
	Neonatal Cephalic- NX3 Elite Only	P	P	P		P	P	BMDC	Note 2,9
	Adult Cephalic	P	P	P		P	P	BMDC	Note 2,9
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult	P	P	P	P	P	P	BMDC	Note 2,7,8,9,13
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	BMDC	Note 2,7,8,9,13
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared by K121699

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

• Note 2 Dynamic TCE Technology
• Note 3 SieClear
• Advanced SieClear Note 4
• 3-Scape 3D Imaging Note 5
• For example: abdominal, vascular Note 6 Note 7 Stress Echo Imaging
• Note 8 Axius Edge Assisted Ejection Fraction
• Note 9 Clarify Vascular Enhancement Technology
• Note 10 SieScape Panoramic Imaging
• Note 12 syngo Auto OB Measurements
• Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)
• Note 14 syngo fourSight 4D imaging
• Contrast Agent Imaging (NX3 Elite only) Note 15
• Note 16 syngo Auto follicle
• Note 17 eSie Touch (NX3 Elite only)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

510(k)_

syngo Arterial Health Package (AHP) (NX3 Elite only) Note 11

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

510(k) Number (if known):

Device Name:

VF16-5 Transducer for use with: ACUSON NX3 Elite™ Diagnostic Ultrasound System

Intended Use:

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

Clinical Application		Mode of Operation
Other( Track 1Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	BMDC	Note 2,3,4,9,10,16,17
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P		P	P	BMDC	Note 2,3,4,9,10
Imaging& Other	SmallOrgan(Note 1)	P	P	P		P	P	BMDC	Note 2,3,4,9,10,17
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	P	BMDC	Note 2,3,4,9,10,11
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)	P	P	P		P	P	BMDC	Note 2,3,4,9,10,17
	Musculo-skel.(Superfic)	P	P	P		P	P	BMDC	Note 2,3,4,9,10,17
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared by K141846

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

• Note 2 Dynamic TCE Technology
• Note 3 SieClear

Note 4 Advanced SieClear

• Note 5 3-Scape 3D Imaging
• Note 6 For example: abdominal, vascular

Note 7 Stress Echo Imaging

Note 8 Axius Edge Assisted Ejection Fraction Note 9 Clarify Vascular Enhancement Technology

Note 10 SieScape Panoramic Imaging Note 12 syngo Auto OB Measurements

Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)

syngo Arterial Health Package (AHP) (NX3 Elite only)

Note 14 syngo fourSight 4D imaging

Contrast Agent Imaging (NX3 Elite only) Note 15 Note 16 syngo Auto follicle

• Note 17 eSie Touch (NX3 Elite only)
  (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Note 11

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

510(k) Number (if known):

Device Name: Intended Use:

VF13-5sp Transducer for use with: ACUSON NX3 Elite™ Diagnostic Ultrasound System

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

Clinical Application		Mode of Operation
Other( Track 1Only)	Specific(Tracks1I& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Note 6)	P	P	P		P	P	BMDC	Note 2,3,4,9,10,16,17
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P		P	P	BMDC	Note 2,3,4,9,10
Imaging& Other	SmallOrgan(Note 1)	P	P	P		P	P	BMDC	Note 2,3,4,9,10,17
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	P	BMDC	Note 2,3,4,9,10,11
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)	P	P	P		P	P	BMDC	Note 2,3,4,9,10,17
	Musculo-skel.(Superfic)	P	P	P		P	P	BMDC	Note 2,3,4,9,10,17
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel(Note 1)	P	P	P		P	P		Note 2,3,4,9
Vessel	Other (Specify)

N = new indication; P = previously cleared by K121699

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

• Note 2 Dynamic TCE Technology
• Note 3 SieClear
• Advanced SieClear Note 4
• Note 5 3-Scape 3D Imaging Note 6 For example: abdominal, vascular
• Note 7 Stress Echo Imaging
• Axius Edge Assisted Ejection Fraction Note 8
• Clarify Vascular Enhancement Technology Note 9
• Note 10 SieScape Panoramic Imaging

Note 11 syngo Arterial Health Package (AHP) (NX3 Elite only)

Note 12 syngo Auto OB Measurements

Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)

• Note 14 syngo fourSight 4D imaging
• Note 15 Contrast Agent Imaging (NX3 Elite only)
• Note 16 syngo Auto follicle Note 17 eSie Touch (NX3 Elite only)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

510(k) Number (if known):

C8F3 Transducer for use with:

ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound Device Name: System Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other( Track 1Only)	Specific(Tracks1& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,9,10,12,14
	Abdominal	P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,9,10,14,16
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric
	SmallOrgan(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared by K141846

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

• Dynamic TCE Technology Note 2
• SieClear Note 3 Note 4
• Advanced SieClear 3-Scape 3D Imaging Note 5
• For example: abdominal, vascular Note 6
• Stress Echo Imaging Note 7
• Axius Edge Assisted Ejection Fraction Note 8
• Clarify Vascular Enhancement Technology Note 9
• Note 10 SieScape Panoramic Imaging

Note 12 syngo Auto OB Measurements

Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)

• Note 14 syngo fourSight 4D imaging
• Note 15 Contrast Agent Imaging (NX3 Elite only) Note 16
• syngo Auto follicle Note 17 eSie Touch (NX3 Elite only)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

syngo Arterial Health Package (AHP) (NX3 Elite only) Note 11

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

510(k) Number (if known):

Device Name:

C8-5 Transducer for use with: ACUSON NX3 Elite™ Diagnostic Ultrasound System

Intended Use:

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

Clinical Application		Mode of Operation
Other( Track 1Only)	Specific(Tracks1& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	BMDC	Note 2,3,4,5,6,9,10,16
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P		P	P	BMDC	Note 2,3,4,5,6,9,10
Imaging& Other	SmallOrgan(Note 1)
	Neonatal Cephalic	P	P	P		P	P	BMDC	Note 2,3,4,5,6,9,10
	Adult Cephalic	P	P	P		P	P	BMDC	Note 2,3,4,5,6,9,10
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric	P	P	P		P	P	BMDC	Note 2,3,4,5,6,9,10
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared by K141846

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

• Note 2 Dynamic TCE Technology
• Note 3 SieClear

Note 4 Advanced SieClear

• Note 5 3-Scape 3D Imaging For example: abdominal, vascular
  Note 6 Note 7 Stress Echo Imaging

Note 8

Axius Edge Assisted Ejection Fraction Note 9 Clarify Vascular Enhancement Technology

Note 10 SieScape Panoramic Imaging Note 11 syngo Arterial Health Package (AHP) (NX3 Elite only)

Note 12 syngo Auto OB Measurements

Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)

Note 14 syngo fourSight 4D imaging

• Contrast Agent Imaging (NX3 Elite only) Note 15
  Note 16 syngo Auto follicle

• Note 17 eSie Touch (NX3 Elite only)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

510(k) Number (if known):

Device Name:

P8-4 Transducer for use with: ACUSON NX3 Elite™ Diagnostic Ultrasound System

Intended Use:

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

Clinical Application		Mode of Operation
Other( Track 1Only)	Specific(Tracks1& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,9,10,16
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,9,10
Imaging& Other	SmallOrgan(Note 1)
	Neonatal Cephalic	P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,9,10
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric	P	P	P		P	P	BMDC	Note 2,3,4,5,6,9,10
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared by K141846

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

• Note 2 Dynamic TCE Technology
• Note 3 SieClear

Note 4 Advanced SieClear

• Note 5 3-Scape 3D Imaging
• Note 6 For example: abdominal, vascular

Note 7 Stress Echo Imaging Note 8

Axius Edge Assisted Ejection Fraction Note 9 Clarify Vascular Enhancement Technology

Note 10 SieScape Panoramic Imaging Note 11 syngo Arterial Health Package (AHP) (NX3 Elite only)

Note 12 syngo Auto OB Measurements

Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)

Note 14 syngo fourSight 4D imaging

• Contrast Agent Imaging (NX3 Elite only) Note 15
• Note 16 syngo Auto follicle
• Note 17 eSie Touch (NX3 Elite only)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summarv Prepared September 10, 2015

Sponsor:	Siemens Medical Solutions, Inc.,Ultrasound Division685 East Middlefield RoadMountain View, California 94043
----------	-------------------------------------------------------------------------------------------------------------------------

Manufacturing Facility

SIEMENS LTD SEOUL2nd -30 floor, 143, Sunhwan-ro,Jungwon-gu, Seongnam-si, Gyeonggi-do,Republic of Korea

Contact Person:	Shelly Pearce
	Telephone:	[phone]
	Fax:	[phone]
Device Name:	ACUSON NX2 EliteTM Diagnostic Ultrasound

• ACUSON NX3 Elite™ Diagnostic Ultrasound System Device Name: ACUSON NX3™ Diagnostic Ultrasound System
• Common Name: Diagnostic Ultrasound System with Accessories

Classification:

Regulatory Class: Review Category: Tier II Classification Panel: Radiology

Ultrasonic Pulsed Doppler Imaging System	FR # 892.1550	Product Code 90-IYN
Ultrasonic Pulsed Echo Imaging System	FR # 892.1560	Product Code 90-IYO
Diagnostic Ultrasound Transducer	FR # 892.1570	Product Code 90-ITX

A. Legally Marketed Predicate Devices

The ACUSON NX3 Elite™ Diagnostic Ultrasound System and ACUSON NX3™ Diagnostic Ultrasound System are multi-purpose diagnostic ultrasound systems with accessories and proprietary software, and are substantially equivalent to our current product. the ACUSON X700™ Diagnostic Ultrasound System (K141846) and ACUSON X300™ Diagnostic Ultrasound System (K121699).

B. Device Description:

The Siemens ACUSON NX3 Elite™ and ACUSON NX3™ Diagnostic Ultrasound Systems are multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Tissue Doppler Image, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.

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C. Intended Use

For ACUSON NX3

The ACUSON NX3 ultrasound imaging system, is intended for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts(Small Organ), Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.

For ACUSON NX3 Elite

ACUSON NX3 Elite ultrasound imaging systems are intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Parts(Small Organ including intra-operative), Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular(including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. Note: This feature can be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular Medicine."

D. Substantial Equivalence

The Siemens ACUSON NX3 Elite™ and ACUSON NX3™ Diagnostic Ultrasound Systems are multi-purpose diagnostic ultrasound systems with accessories and proprietary software, and are substantially equivalent to our current products, the Siemens ACUSON X700™ Diagnostic Ultrasound System (K141846), and ACUSON X300 ™ Diagnostic Ultrasound System (K121699). All systems transmit ultrasonic energy into patients, and then perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.

The submission devices are substantially equivalent to the predicate with regard to both intended use and technological characteristics.

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Siemens Medical Solutions USA, Inc. Ultrasound Division

ACUSON NX3 Elite™ and ACUSON NX3™ Diagnostic Ultrasound Systems 510(k) Submission

Feature /Characteristic	PredicateDeviceACUSONX300TM(K121699)	PredicateDeviceACUSONX700TM(K141846)	SubmissionDeviceACUSONNX3TM	SubmissionDeviceACUSON NX3EliteTM
	Indications for Use:
	Fetal Echo	√	√	√	√
	Abdominal	√	√	√	√
	Intra-operative	√	√	-	√
	NeonatalCephalic	√	√	-	√
	SmallOrgan(parts)	√	√	√	√
	Pediatric	√	√	√	√
	Adult Cephalic(Trans-cranial)	√	√	√	√
	Cardiac (Adult)	√	√	√	√
	Cardiac(Pediatric)	√	√	-	√
	Intracardiac	√	√	-	-
	Trans-esophageal	√	√	-	-
	Trans-rectal	√	√	√	√
	Trans-vaginal	√	√	√	√
	Peripheral vessel	√	√	√	√
	Musculo-skeletal(conventional)	√	√	√	√
	Musculo-skeletal(superficial)	√	√	√	√
Center FrequenciesSupported:
	2.0 MHz	√	√	√	√
	2.5 MHz	√	√	√	√
	3.0 MHz	√	√	√	√
	3.5 MHz	√	√	√	√
	4.0 MHz	√	√	√	√
	5.0 MHz	√	√	√	√
	5.5 MHz	√	√	√	√
	6.0 MHz	√	√	√	√
	6.5 MHz	√	√	√	√
	7.5 MHz	√	√	√	√
	8.0 MHz	√	√	√	√
	9.0 MHz	√	√	√	√
	10.0 MHz	√	√	√	√
	11.0 MHz	√	√	√	√
	12.0 MHz	-	√	-	√
	13.0 MHz	-	√	-	√
	Modes:
	B	√	√	√	√
	M	√	√	√	√
	PWD (PulsedWave Doppler)	√	√	√	√
Feature /Characteristic	PredicateDevice ACUSONX300™(K121699)	PredicateDevice ACUSONX700™(K141846)	SubmissionDevice ACUSONNX3™	SubmissionDevice ACUSON NX3Elite™
■ CWD (Continuous WaveDoppler)	√	√	-	√
■ SCW (SteerableCW)	√	√	√	√
■ CD (ColorDoppler)	√	√	√	√
■ AmplitudeDoppler(Power Doppler)	√	√	√	√
■ DirectionalPower Doppler	√	√	√	√
■ Combined (BM,BC, BCM, BCD)	√	√	√	√
■ THI (TissueHarmonic Imaging)	√	√	√	√
■ AMM (Anatomical M-mode)	√	√	√	√
■ Doppler TissueImage (Color, PW)	√	√	√	√
■ M-THI	√	√	√	√
Features:
■ Multi-View SpatialCompounding(SieClear)	√	√	√	√
■ AdvancedSieClear	-	√	√	√
■ DTCE (Dynamic TissueContrast Enhancement)	√	√	√	√
■ Tissue GrayscaleOptimization(TGO)	√	√	√	√
■ Dual-BeamProcessing	√	√	√	√
■ Quad-BeamProcessing	√	√	√	√
■ Clip Capture	√	√	√	√
■ 3D Imaging (3-Scape)	√	√	√	√
■ 3DMeasurements	√	√	√	√
■ 4D BasicImaging (fourSight4D)	√	√	√	√
■ Panoramic 2DImaging(SieScape)	√	√	√	√
■ Syngo Auto OB	√	√	√	√
■ Syngo AutoFollicle	-	√	√	√
Feature /Characteristic	PredicateDeviceACUSONX300TM(K121699)	PredicateDeviceACUSONX700TM(K141846)	SubmissionDeviceACUSONNX3TM	SubmissionDeviceACUSON NX3EliteTM
Cardiac Imagingphysiologicalsignal displaymultiplane TEEfourSight TEEImaging	√	√	-	-
Stress Echo	√	√	√	√
VascularEnhancement(Clarify VE)	√	√	√	√
Syngo VVI(Velocity VectorImage)	√	√	-	-
Auto Left Heart	√	√	-	√
Axius EF	√	√	√	√
Syngo AHP	√	√	-	√
Contrast AgentImage	√	√	-	√
DIMAQ	√	√	√	√
MultipleFrequencyImaging(MultiHertz)	√	√	√	√
syngo MitralValveAssessments(MVA)	√	√	-	-
IntracardiacEchocardiography(ICE) Imaging	√	√	-	-
DigitalArchitecture	√	√	√	√
Fully integratedDICOM	√	√	√	√
CARTOSOUNDTM Communication	√	√	-	-
Wireless	√	√	√	√
eSie Touch	-	√	-	√
Monitor: FPD	(17" FPD)	√ (20" FPD)	√ (21.5" FPD)	√ (21.5" FPD)
# Channels	128	128	64	64
Output DisplayStandard(Track 3)	√	√	√	√
Patient ContactMaterials	Tested to ISO10993-1	Tested to ISO10993-1	Tested to ISO10993-1	Tested to ISO10993-1

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Siemens Medical Solutions USA, Inc. Ultrasound Division

ACUSON NX3 Elite™ and ACUSON NX3™ Diagnostic Ultrasound Systems 510(k) Submission

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Siemens Medical Solutions USA, Inc. Ultrasound Division

ACUSON NX3 Elite™ and ACUSON NX3™ Diagnostic Ultrasound Systems 510(k) Submission

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E. A brief discussion of nonclinical tests submitted, referenced, or relied on in

the 510(k) for a determination of substantial equivalence

The devices have been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and have been found to conform with applicable medical device safety standards. The systems comply with the following voluntary standards:

• UL 60601-1, Safety Requirements for Medical Equipment .
• IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
• I CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
• AIUM/NEMA UD-3. Standard for Real Time Display of Thermal and Mechanical 트 Acoustic Output Indices on Diagnostic Ultrasound Equipment
• AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound ■
• IEC 62359, Test methods for the determination of thermal and mechanical indices
• 93/42/EEC Medical Devices Directive
• I Safety and EMC Requirements for Medical Equipment
  • IEC 60601-1 .
  • . IEC 60601-1-2
  • IEC 60601-2-18 .
  • IEC 60601-1-6
  • IEC 62366 ■
• ISO 10993-1 Biocompatibility .

F. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.

Since the ACUSON NX3 Elite™ and ACUSON NX3™ Diagnostic Ultrasound Systems use the same technology and principles as existing devices, clinical data is not required.

G. Summary

Intended uses and other kev features are consistent with traditional clinical practice and FDA quidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards. The products are designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound system has accumulated a long history of safe and effective performance. Therefore it is the opinion of Siemens Medical that the ACUSON NX3 Elite™ and ACUSON NX3 ™ Diagnostic Ultrasound Systems are substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

The ACUSON NX3 Elite™ and ACUSON NX3 ™ Diagnostic Ultrasound Systems are verified and validated according to the company's design control process.

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.