Predicate Devices

K132654, K121699, K123001, K141846, K140318

Reference Devices

K071234, K080760, 121699, K072365, K102017, K113179, K132654, K093812, K081808, K070242, K111674

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the descriptions of the device and its functions do not mention any AI/ML capabilities.

Therapeutic

No

The device is an ultrasound imaging system intended for diagnostic purposes, such as visualizing anatomical structures and providing information for clinical diagnosis, rather than for treatment or therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the information provided by the system's analysis packages "is used for clinical diagnosis purposes" and "may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes." Additionally, the "Device Description" identifies them as "diagnostic ultrasound systems."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "multi-purpose mobile, software controlled diagnostic ultrasound systems" and describes its function as acquiring and displaying ultrasound echo data, which requires hardware components (transducers, processing units, display). While software is a key component, it is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that the Siemens Acuson X300 and SC2000 are ultrasound imaging systems. Their function is to acquire and display ultrasound echo data to visualize anatomical structures and provide measurements and analysis packages.
Intended Use: The intended uses listed are all related to imaging and visualization of internal structures and blood flow within the body. While the information derived from the imaging is used for clinical diagnosis, the device itself is not performing tests on in vitro samples.
Lack of IVD Language: The text does not mention any procedures involving the analysis of biological samples outside of the body.

Therefore, the device falls under the category of diagnostic imaging systems, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

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 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. This feature should 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 Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

The Acuson Acunav and Soundstar Ultrsound Catheter are intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal Intraoperative, Intraoperative, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX, OBJ

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, heart, cardiac valves, great vessels, carotid arteries, jugular veins, superficial and deep veins and arteries in the arms, legs and abdomen, brain

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal

Intended User / Care Setting

Physician / Clinical diagnosis purposes

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Since the modified devices use the same technology and principles as existing devices, clinical data is not required.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K132654, K121699, K123001, K141846, K140318

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K071234, K080760, 121699, K072365, K102017, K113179, K132654, K093812, K081808, K070242, K111674

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background.

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

September 9, 2014

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

Re: K142395

Trade/Device Name: SC2000/X300 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, OBJ Dated: August 21, 2014 Received: August 27, 2014

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.

This determination of substantial equivalence applies to the following transducers intended for use with the SC2000/X300 Diagnostic Ultrasound System, as described in your premarket notification:

	SC2000 Transducer Model Number
AcuNav 8F	Soundstar eco 8F		9L4
6C1HD	V5M		4V1c
8V3	CW2		4Z1c
AcuNav 10F	ACUSON AcuNav™ V 10F SoundStar 10F
V7M	10V4
	X300 Transducer Model Number
AcuNav 8F	Soundstar eco 8F	P4-2
CH5-2	VF10-5	I 9-5

1

EC9-4	EV9-4	VF13-5
P8-4	BE 9-4	CW2
CW5	AcuNav 10F	V5Ms
4V1c	VF13-5SP	C8-5
8L3	10V4	C7F2
EV9F4	L13F5	VF8-3
P5-1	C6-2	SoundStar 10F
P9-4

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 (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.

2

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,

Smh.7)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known): K142395

Device Name: ACUSON X300™ Diagnostic Ultrasound System SONOVISTA X300 Diagnostic Ultrasound System ACUSON X300 " Diagnostic Ultrasound System, premium edition

The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

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 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. This feature should 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 Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

The Acuson Acunav and Soundstar Ultrsound Catheter are intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

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

X Prescription Use (21 CFG 801 Subpart D)

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

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

FOR FDA USE ONLY

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

Page 1 of 31

4

510(k) Number (if known):

Device Name: Intended Use: ACUSON X300 Diagnostic Ultrasound Systems

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

Clinical Application		Mode of Operation
Other
(Track1
Only)	Specific
(Tracks11& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Abdominal	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-operative
(Note 6)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-operative
(Neuro)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	SmallOrgan
(Note 1)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Neonatal Cephalic	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Adult Cephalic	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Trans-rectal	P	P	P		P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Trans-vaginal	P	P	P		P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Trans-urethral
	Trans-esoph.
(non-Card.)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Musculo-skel.
(Convent.)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Musculo-skel.
(Superfic)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra -vascular	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Other
(Specify)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
Cardiac	Cardiac Adult	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Cardiac Pediatric	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-vascular
(Cardiac)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Trans-esophageal
(Cardiac)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-Cardiac	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Other (Specify)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Other (Specify)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11

N = new indication; P = previously cleared K080760, 121699

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

Note 3 3D imaging

Power SieScape panoramic imaging Note 5

Contrast agent imaging Note 7

Note 9 Tissue Equalization Technology

Note 11 Dynamic TCE Note 2 Ensemble tissue harmonic imaging

B&W SieScape panoramic imaging
For example: abdominal, vascular Note 4

Note 6

SieClear multi-view spatial compounding Note 8

Note 10 Intracardiac imaging

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

510(k)_

5

510(k) Number (if known):

AcuNav 8F Intracardiac Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

Device Name: Intended Use:

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

Clinical Application		Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric
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	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,16
	Other
(Specify)
Cardiac	Cardiac Adult	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,16
	Cardiac Pediatric	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,16
	Intra-vascular
(Cardiac)	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,16
	Trans-esophageal
(Cardiac)
	Intra-cardiac	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,16
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)
	N = new indication; P = previously cleared K080760, 121699

Note 1 state etc F olo: hr st testes thvroid i onic

Note 1	For example: breast, testes, thyroid, penis, prostate, etc.	Note 11	syngo Arterial Health Package (AHP)
Note 2	Dynamic TCE Technology	Note 12	syngo Auto OB Measurements
Note 3	SieClear	Note 13	syngo Auto Left Heart (Auto LH) Technology
Note 4	Advanced SieClear	Note 14	syngo Velocity Vector Imaging Technology
Note 5	3-Scape 3D Imaging	Note 15	CartoSound Communication
Note 6	For example: abdominal, vascular	Note 16	Intracardiac Echocardiography (ICE) Imaging
Note 7	Stress Echo Imaging	Note 17	syngo fourSight TEE View
Note 8	Axius Edge Assisted Ejection Fraction	Note 18	syngo Mitral Valve Assessment (MVA)
Note 9	Clarify Vascular Enhancement Technology	Note 19	syngo fourSight 4D imaging
Note 10	SieScape Panoramic Imaging	Note 20	Contrast Agent Imaging

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)__

6

510(k) Number (if known):

| Device Name: | Soundstar eco 8F Intracardiac Transducer for use with:
ACUSON X300 Diagnostic Ultrasound Systems |
|---------------|-----------------------------------------------------------------------------------------------------|
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows: |

Clinical Application			Mode of Operation
Other
( Track1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& 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	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,16
	Other
(Specify)
	Cardiac Adult	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,16
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,16
	Intra-vascular
(Cardiac)	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,16
	Trans-esophageal
(Cardiac)
	Intra-cardiac	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,16
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared K080760, 121699

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

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

syngo fourSight TEE View Note 17 Note 18 syngo Mitral Valve Assessment (MVA)

Note 19 syngo fourSinght 4D imaging Note 20 Contrast Agent Imaging

syngo Arterial Health Package (AHP)

syngo Auto Left Heart (Auto LH) Technology

Intracardiac Echocardiography (ICE) Imaging

syngo Velocity Vector Imaging Technology

syngo Auto OB Measurements

CartoSound Communication

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

Note 11

Note 12

Note 13

Note 14

Note 15

Note 16

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

510(k)_

7

510(k) Number (if known):

ACUSON X300 Diagnostic Ultrasound Systems

Device Name: Intended Use:

ACUSON X300 Diagnostic Ultrasound Systems

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

Clinical Application			Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks11& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Abdominal	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-operative
(Note 6)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-operative
(Neuro)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Laparoscopic	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
Fetal
Imaging
& Other	Pediatric	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	SmallOrgan
(Note 1)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Neonatal Cephalic	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Adult Cephalic	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Trans-rectal	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Trans-vaginal	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Trans-urethral	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Trans-esoph.
(non-Card.)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Musculo-skel.
(Convent.)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Musculo-skel.
(Superfic)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra -vascular	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Other
(Specify)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Cardiac Adult	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-vascular
(Cardiac)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Trans-esophageal
(Cardiac)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-Cardiac	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Other (Specify)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Other (Specify)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11

N = new indication; P = previously cleared by K080760, 121699

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

Note 3
Note 5 3D imaging

Power SieScape panoramic imaging Contrast agent imaging Note 7

Note 9 Tissue Equalization Technology

Note 11 Dynamic TCE

Note 2 Ensemble tissue harmonic imaging Note 4
Note 6 B&W SieScape panoramic imaging
For example: abdominal, vascular

te 6 For example: abdominal, vasc

Note 8 SieClear multi-view spatial compounding

Note 10 Intracardiac imaging

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

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Page 5 of 31

8

510(k) Number (if known):

Device Name:

Intended Use:

P4-2 Phased Sector Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks1& 3)		A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,9,11
	Abdominal		P	P	P	P	P	P	P	BMDC	Note
2,3,5,6,7,8,9,11
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric		P	P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,9,11
	SmallOrgan
(Note 1)
	Neonatal Cephalic		P	P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,9,11
	Adult Cephalic		P	P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,9,11
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
Cardiac	Cardiac Adult		P	P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,9,11
	Cardiac Pediatric		P	P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,9,11
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel		P	P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,9,11
	Other (Specify)

N = new indication; P = previously cleared by K080760, 121699

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

Note 3 3D imaging
Power SieScape panoramic imaging Note 5
Contrast agent imaging
Tissue Equalization Technology Note 7

Note 9

Note 11 Dynamic TCE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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510(k)_

Note 8
Note 10
For example: abdominal, vascular SieClear multi-view spatial compounding
Intracardiac imaging

10 Intracardiac imaging

Note 2 Ensemble tissue harmonic imaging Note 4 B&W SieScape panoramic imaging Note 6

9

510(k) Number (if known):

Device Name:

Intended Use:

CH5-2 Convex Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
(Track1
Only)	Specific
(Tracks1& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Abdominal	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
Imaging
& Other	SmallOrgan
(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	P	P		P	P		BMDC	Note
2.3.4.5.7.8.9,11
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
Cardiac	Cardiac Pediatric	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
Vessel	Other (Specify)

N = new indication; P = previously cleared by K080760, 121699

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

Note 3 3D imaging
Note 5 Power SieScape panoramic imaging

Contrast agent imaging
Tissue Equalization Technology Note 7

Note 9 Note 11 Dynamic TCE

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

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Page 7 of 31

Note 6 For example: abdominal, vascular Note 8

Note 10

For example: abdominal,
SieClear multi-view spatial

SieClear multi-view spa
a Intracardiac imaging

SieClear multi-view spatial compounding
Intracardiac imaging

Steclear multi-view sp
0 Intracardiac imaging

Note 2 Ensemble tissue harmonic imaging Note 4 B&W SieScape panoramic imaging

10

510(k) Number (if known):

Device Name:

Intended Use:

VF10-5 Linear Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
Other
(Track1
Only)	Specific
(Tracks1& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Abdominal		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	SmallOrgan
(Note 1)		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Neonatal Cephalic		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Musculo-skel.
(Superfic)		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-vascular
	Other
(Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Other (Specify)
	N = new indication; P = previously cleared by K080760, 121699

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

Note 3

3D imaging
Power SieScape panoramic imaging Note 5

Note 7 Contrast agent imaging

Note 9 Tissue Equalization Technology

Note 11 Dynamic TCE

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

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Page 8 of 31

Note 4 B&W SieScape panoramic imaging Note 6 For example: abdominal, vascular Note 8

Note 2

SieClear multi-view spatial compounding Note 10 Intracardiac imaging

Ensemble tissue harmonic imaging

11

510(k) Number (if known):

Device Name:

Intended Use:

L9-5 Linear Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
Other
(Track 1
Only)	Specific
(Tracks 1& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Abdominal		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
Imaging
& Other	SmallOrgan
(Note 1)		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Neonatal Cephalic		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Musculo-skel.
(Superfic)		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-Cardaic
	Other (Specify)
Peripheral	Peripheral vessel		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
Vessel	Other (Specify)

N = new indication; P = previously cleared by K080760, 121699

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

Note 3
3D imaging
Power SieScape panoramic imaging Note 5

Contrast agent imaging Note 7

Note 9 Tissue Equalization Technology

Dynamic TCE Note 11

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)_

Page 9 of 31

Note 4 B&W SieScape panoramic imaging Note 6

For example: abdominal, vascular

Ensemble tissue harmonic imaging

Note 8 SieClear multi-view spatial compounding

Note 10 Intracardiac imaging

Note 2

12

510(k) Number (if known):

Device Name: Intended Use:

EC9-4 Convex Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
(Track1
Only)	Specific
(Tracks1& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Abdominal
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
SmallOrgan
(Note 1)		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Neonatal Cephalic		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Adult Cephalic
	Trans-rectal		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Trans-vaginal		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	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
Vessel	Peripheral vessel
	Other (Specify)
	N = new indication; P = previously cleared by K080760, 121699

N = new indication, F = previously cleared by K060760, 121055

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

Note 3 3D imaging
Power SieScape panoramic imaging Note 5

Note 7 Contrast agent imaging Note 9 Tissue Equalization Technology

Note 11 Dynamic TCE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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510(k)_

Ensemble tissue harmonic imaging

B&W SieScape panoramic imaging

For example: abdominal, vascular
SieClear multi-view spatial compounding Intracardiac imaging Note 10
Note 2 Note 4 Note 6 Note 8

13

510(k) Number (if known):

Device Name:

Intended Use:

EV9-4 Convex Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
(Track1
Only)	Specific
(Tracks1 & 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Abdominal
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
	SmallOrgan
(Note 1)		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Neonatal Cephalic		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Adult Cephalic
	Trans-rectal		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Trans-vaginal		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	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
Vessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared by K080760, 121699

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

Note 3 3D imaging
Note 5 Power SieScape panoramic imaging
Note 7 Contrast agent imaging

Note 9 Tissue Equalization Technology

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

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Note 11

Page 11 OF 31

Intracardiac imaging

Note 2 Ensemble tissue harmonic imaging Note 4 B&W SieScape panoramic imaging

Note 6 For example: abdominal, vascular
SieClear multi-view spatial compounding

Note 8 Note 10

14

510(k) Number (if known):

| Device Name: | VF13-5 Linear Array Transducer for use with:
ACUSON X300 Diagnostic Ultrasound Systems |
|---------------|-------------------------------------------------------------------------------------------|
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows. |

Clinical Application			Mode of Operation
Other
(Track 1
Only)	Specific
(Tracks1& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Abdominal		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	SmallOrgan
(Note 1)		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Neonatal Cephalic		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Musculo-skel.
(Superfic)		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Other (Specify)
	N = new indication; P = previously cleared by K080760, 121699

For example: breast, testes, thyroid, penis, prostate, etc.
3D imaging Note 1

Note 3

Note 5 Power SieScape panoramic imaging
Note 2 Note 4 Note 6 Note 8
Note 10

Ensemble tissue harmonic imaging
B&W SieScape panoramic imaging

Intracardiac imaging

For example: abdominal, vascular

SieClear multi-view spatial compounding

Note 7 Contrast agent imaging Note 9 Tissue Equalization Technology

Note 11 Dynamic TCE

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

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510(k)_

Page 12 OF 31

15

510(k) Number (if known):

| Device Name: | P8-4 Phased Sector Array Transducer for use with:
ACUSON X300 Diagnostic Ultrasound Systems |
|---------------|------------------------------------------------------------------------------------------------|
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows: |

Clinical Application		Mode of Operation
Other
(Track 1
Only)	Specific
(Tracks1& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Abdominal	P	P	P	P	P	P	P		BMDC	Note
2,3,5,6,7,8,9,11
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	SmallOrgan
(Note 1)
	Neonatal Cephalic	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
Cardiac	Cardiac Adult	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Other (Specify)

N = new indication; P = previously cleared by K080760, 121699

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

3D imaging Note 3

Power SieScape panoramic imaging Note 5

Note 7 Contrast agent imaging

Tissue Equalization Technology Note 9

Note 11 Dynamic TCE Note 2 Ensemble tissue harmonic imaging

Note 4
Note 6 B&W SieScape panoramic imaging For example: abdominal, vascular

Note 8 SieClear multi-view spatial compounding

Intracardiac imaging Note 10

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

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16

510(k) Number (if known):

| Device Name: | BE 9-4 Convex Array Transducer for use with:
ACUSON X300 Diagnostic Ultrasound Systems |
|---------------|-------------------------------------------------------------------------------------------|
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows |

| Other
(Track1
Only) | Specific
(Tracks1& 3) | Mode of Operation | | | |-----------------------------|------------ | | Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | Ophthalmic | | Fetal | | Abdominal | | Intra-opera (Note 6) | | | | | | Intra-opera (Neuro) | | | | | | Laparoscopic | Fetal
Imaging
& Other | Pediatric | | | SmallOrgan< (Note 1) | | P | P | P | | | Neonatal Cephalic | | Adult Cephalic | | Trans-rectal | | Trans-vaginal | | Trans-urethral | | Trans-esoph (non-Card.) | | | | | | Musculo-ske (Convent.) | | | | | | Musculo-ske (Superfic) | | | | | | Intra-vascular | | Other
(Specify) | | Cardiac | Cardiac Adult | | Cardiac Pediatric | | Intra-vascu (Cardiac) | | | | | | Trans-esoph (Cardiac) | | | | | | | | Intra-cardiac | | Other (Specify) | Peripheral
Vessel | Peripheral vessel | | Other (Specify) | | | | | | |
-------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| A | B | M | PWD | CWD | Color
| | | | | | | | | | |
| | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| | | | | | | | | | |
tive
| | | | | | |
tive
| | | | | | |
| | | | | | | | | | |
| | | | | | | | | |
br/> | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| | | | | | | | | | |
| | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 |
| | | | | | | | | | |
.
| | | | | | |
l.
| | | | | | |
l.
| | | | | | |
| | | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
lar
| | | | | | |
ageal
| | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |

N = new indication; P = previously cleared by K080760, 121699

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

Note 3 3D imaging

Power SieScape panoramic imaging Note 5 Note 7

Contrast agent imaging
Tissue Equalization Technology Note 9

Note 11

Dynamic TCE

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

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Page 14 OF 31

Note 6 For example: abdominal, vascular Note 8 SieClear multi-view spatial compounding

Ensemble tissue harmonic imaging

B&W SieScape panoramic imaging

Intracardiac imaging Note 10

Note 2

Note 4

17

510(k) Number (if known):

| Device Name: | CW2 Continuous Wave Doppler Transducer for use with:
ACUSON X300 Diagnostic Ultrasound Systems |
|---------------|---------------------------------------------------------------------------------------------------|
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows: |

	Clinical Application		Mode of Operation
	Other
(Track1
Only)	Specific
(Tracks1& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic		Ophthalmic
		Fetal					P
		Abdominal					P
		Intra-operative
(Note 6)					P
		Intra-operative
(Neuro)
		Laparoscopic
Fetal
Imaging
& Other		Pediatric					P
		SmallOrgan
(Note 1)					P
		Neonatal Cephalic					P
		Adult Cephalic					P
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Trans-esoph.
(non-Card.)
		Musculo-skel.
(Convent.)					P
		Musculo-skel.
(Superfic)
		Intra-vascular
Other
		(Specify)
		Cardiac Adult					P
Cardiac		Cardiac Pediatric					P
		Intra-vascular
(Cardiac)
		Trans-esophageal
(Cardiac)
		Intra-cardiac
		Other (Specify)
Peripheral
Vessel		Peripheral vessel					P
		Other (Specify)

N = new indication; P = previously cleared by K080760, 121699

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

Note 3

3D imaging
Power SieScape panoramic imaging Note 5

Note 7 Contrast agent imaging

Note 9 Tissue Equalization Technology

Note 11 Dynamic TCE

Note 4	B&W SieScape panoramic imaging
Note 6	For example: abdominal, vascular

Ensemble tissue harmonic imaging

Note 6 Note 8 SieClear multi-view spatial compounding

Note 2

Note 10 Intracardiac imaging

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Page 15 OF 31

18

510(k) Number (if known):

CW5 Continuous Wave Doppler Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

Device Name: Intended Use:

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

Clinical Application	Mode of Operation
Other
(Track1
Only)	Specific
(Tracks1& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal					P
	Abdominal					P
Fetal
Imaging
& Other	Intra-operative
(Note 6)					P
	Intra-operative
(Neuro)
	Laparoscopic
	Pediatric					P
	SmallOrgan
(Note 1)					P
	Neonatal Cephalic					P
	Adult Cephalic					P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)					P
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
Cardiac	Cardiac Adult					P
	Cardiac Pediatric					P
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-Cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel					P
	Other (Specify)
	N = new indication; P = previously cleared by K080760, 121699

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

Note 3 3D imaging

Note 5 Power SieScape panoramic imaging

Note 7 Contrast agent imaging

Note 9 Tissue Equalization Technology

Note 11 Dynamic TCE

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Page 16 OF 31

Ensemble tissue harmonic imaging

Intracardiac imaging

Note 4 B&W SieScape panoramic imaging Note 6 For example: abdominal, vascular Note 8 SieClear multi-view spatial compounding

Note 2

Note 10

19

510(k) Number (if known):

Device Name:

Intended Use:

AcuNav 10F Intracardiac Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

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

Clinical Application		Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks1& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P	P	P	P	P	P	P		BMDC	Note
2,3,7,8,9,10,11
	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	P	P	P	P	P	P	P		BMDC	Note
2,3,7,8,9,10,11
	Other
(Specify)
	Cardiac Adult	P	P	P	P	P	P	P		BMDC	Note
2,3,7,8,9,10,11
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P		BMDC	Note
2,3,7,8,9,10,11
	Intra-vascular
(Cardiac)	P	P	P	P	P	P	P		BMDC	Note
2,3,7,8,9,10,11
	Trans-esophageal
(Cardiac)
	Intra-cardiac	P	P	P	P	P	P	P		BMDC	Note
2,3,7,8,9,10,11
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared by K080760, 121699

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

Note 3 3D imaqing Note 5

Power SieScape panoramic imaging Note 7 Contrast agent imaging

Note 9 Tissue Equalization Technology

Note 11 Dynamic TCE

((Please do not write below this line-continue on another Page if needed)

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Note 2 Ensemble tissue harmonic imaging Note 4 B&W SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 8 SieClear multi-view spatial compounding

Note 10 Intracardiac imaging

20

510(k) Number (if known):

| Device Name: | V5Ms TEE Transducer for use with:
ACUSON X300 Diagnostic Ultrasound Systems |
|---------------|--------------------------------------------------------------------------------|
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows: |

Clinical Application		Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks11& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric
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	Cardiac Adult	P	P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,11
	Cardiac Pediatric	P	P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,11
	Trans-esophageal
(Cardiac)	P	P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,11
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared by K090276

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

Note 3
3D imaging
Power SieScape panoramic imaging Note 5 Note 7 Contrast agent imaging
Note 9 Tissue Equalization Technology
Note 11 Dynamic TCE

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Page 18 OF 31

B&W SieScape panoramic imaging

SieClear multi-view spatial compounding

Note 2 Ensemble tissue harmonic imaging For example: abdominal, vascular

te 6 For example: abdominal, va

0 Cis-Clear multi-view spatial

Note 10 Intracardiac imaging

Note 4 Note 6 Note 8

21

510(k) Number (if known):

Device Name:

Intended Use:

4V1c Phased Sector Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks1& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
	Abdominal		P	P	P	P	P	P	BMDC	Note 2,3,5,6,7,8,9
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Imaging
& Other	SmallOrgan
(Note 1)
	Neonatal Cephalic		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
	Adult Cephalic		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
	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 2,3,4,5,7,8,9
Cardiac	Cardiac Pediatric		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Vessel	Other (Specify)

N = new indication; P = previously cleared by K080760, 121699

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

Note 3 3D imaging

Note 5 Power SieScape panoramic imaging

Note 7 Contrast agent imaging Note 8 SieClear multi-view spatial compounding

Note 9 Tissue Equalization Technology

Intracardiac imaging Note 10

Note 11 Dynamic TCE

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Page 19 OF 31

6 For example: abdominal, v

Note 2 Ensemble tissue harmonic imaging

e 4
B&W SieScape panoramic in
e 6
For example: abdominal, vas

te 4 B&W SieScape pane
ote 6 For example: abdom

Note 4 Note 6

B&W SieScape panoramic imaging For example: abdominal, vascular

22

510(k) Number (if known):

| Device Name: | VF13-5SP Linear Array Transducer for use with:
ACUSON X300 Diagnostic Ultrasound Systems |
|---------------|---------------------------------------------------------------------------------------------|
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows: |

Clinical Application			Mode of Operation
Other
(Track1
Only)	Specific
(Tracks1& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
(Note 6)	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-operative
(Neuro)	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9.11
	Laparoscopic
Fetal	Pediatric	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9.11
Imaging
& Other	SmallOrgan
(Note 1)	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9.11
	Neonatal Cephalic	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9.11
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9.11
	Musculo-skel.
(Superfic)	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9.11
	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	P		BMDC	Note
2,3,4,5,7,8,9.11
Vessel	Other (Specify)
	N = new indication; P = previously cleared by K080760, 121699

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

Note 3 3D imaging

Note 5 Power SieScape panoramic imaging
Note 2 Note 4 Note 6 Note 8
Note 10

Ensemble tissue harmonic imaging
B&W SieScape panoramic imaging

Intracardiac imaging

For example: abdominal, vascular

SieClear multi-view spatial compounding

Note 7 Contrast agent imaging Note 9 Tissue Equalization Technology

Note 11 Dynamic TCE

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Page 20 OF 31

23

510(k) Number (if known):

| Device Name: | C8-5 Tightly Curved Array Transducer for use with:
ACUSON X300 Diagnostic Ultrasound Systems |
|---------------|-------------------------------------------------------------------------------------------------|
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows: |

Clinical Application	Mode of Operation
Other
(Track1
Only)	Specific
(Tracks11& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P		BMDC	Note 2,3,4,5,7,8,9
	Abdominal	P	P	P		P	P	P		BMDC	Note 2,3,4,5,7,8,9
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P		P	P	P		BMDC	Note 2,3,4,5,7,8,9
Imaging
& Other	SmallOrgan
(Note 1)	P	P	P		P	P	P		BMDC	Note 2,3,4,5,7,8,9
	Neonatal Cephalic	P	P	P		P	P	P		BMDC	Note 2,3,4,5,7,8,9
	Adult Cephalic	P	P	P		P	P	P		BMDC	Note 2,3,4,5,7,8,9
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	P		P	P	P		BMDC	Note 2,3,4,5,7,8,9
	Musculo-skel.
(Superfic)	P	P	P		P	P	P		BMDC	Note 2,3,4,5,7,8,9
	Intra-vascular
	Other
(Specify)
	Cardiac Adult	P	P	P		P	P	P		BMDC	Note 2,3,4,5,7,8,9
Cardiac	Cardiac Pediatric	P	P	P		P	P	P		BMDC	Note 2,3,4,5,7,8,9
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	P		BMDC	Note 2,3,4,5,7,8,9
	Other (Specify)

N = new indication; P = previously cleared by K080760, 121699

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

Note 3 3D imaging
Power SieScape panoramic imaging
Contrast agent imaging
Tissue Equalization Technology Note 5
Note 7
Note 9
Note 11 Dynamic TCE

Note 2 Ensemble tissue harmonic imaging

Note 4 B&W SieScape panoramic imaging

For example: abdominal, vascular
SieClear multi-view spatial compounding Note 6

Intracardiac imaging

Note 8 Note 10

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Page 21 OF 31

24

510(k) Number (if known):

| Device Name: | 8L3 Linear "Regel" Transducer for use with:
ACUSON X300 Diagnostic Ultrasound Systems |
|---------------|------------------------------------------------------------------------------------------|
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows. |

Clinical Application	Mode of Operation
Other
(Track1
Only)	Specific
(Tracks1& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	SmallOrgan
(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Musculo-skel.
(Superfic)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)

Peripheral
Vessel	Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Other (Specify)

N = new indication; P = previously cleared by K080760, 121699

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

Note 3 3D imaging

Note 5 Power SieScape panoramic imaging

Contrast agent imaging
Tissue Equalization Technology Note 7

Note 9

Note 2 Ensemble tissue harmonic imaging

Note 4 B&W SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 8 SieClear multi-view spatial compounding

Intracardiac imaging Note 10

Note 11 Dynamic TCE

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

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Page 22 OF 31

25

510(k) Number (if known):

| Device Name: | 10V4 Phased Array Transducer for use with:
ACUSON X300 Diagnostic Ultrasound Systems |
|---------------|-----------------------------------------------------------------------------------------|
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows |

Clinical Application	Mode of Operation
Other
( Track1
Only)	Specific
(Tracks1& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
	Abdominal	P	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Imaging
& Other	SmallOrgan
(Note 1)
	Neonatal Cephalic	P	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult	P	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Vessel	Other (Specify)

N = new indication; P = previously cleared by K080760, 121699

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

3D imaging Note 3
Power SieScape panoramic imaging
Contrast agent imaging
Tissue Equalization Technology Note 5

Note 7

Note 9

Note 11 Dynamic TCE Note 2 Ensemble tissue harmonic imaging

Note 4 B&W SieScape panoramic imaging

For example: abdominal, vascular
SieClear multi-view spatial compounding Note 6

Note 8 Note 10 Intracardiac imaging

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Page 23 OF 31

26

510(k) Number (if known):

| Device Name: | C7F2 Curved Array Mechanical 3D/4D Transducer for use with:
ACUSON X300 Diagnostic Ultrasound Systems |
|---------------|----------------------------------------------------------------------------------------------------------|
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows: |

Clinical Application			Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks1I& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Abdominal	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
Imaging
& Other	SmallOrgan
(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
Cardiac	Cardiac Pediatric	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
Vessel	Other (Specify)

N = new indication; P = previously cleared by K080760, 121699

For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 3

3D imaging
Power SieScape panoramic imaging Note 5

Note 7 Contrast agent imaging Note 9 Tissue Equalization Technology

Note 9 Tissue Equalization Technique
Note 11 Dynamic TCE

Note 11 Dynamic TCE Note 8 SieClear multi-view spatial compounding

Note 2

Note 4

Note 6

Note 10 Intracardiac imaging

Ensemble tissue harmonic imaging

B&W SieScape panoramic imaging
For example: abdominal, vascular

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27

510(k) Number (if known):

EV9F4 Curved Array Mechanical 3D/4D Transducer for use with: Device Name: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows: Intended Use:

Clinical Application	Mode of Operation
Other
(Track1
Only)	Specific
(Tracks1& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Abdominal
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging
& Other	SmallOrgan
(Note 1)		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Neonatal Cephalic		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Adult Cephalic
	Trans-rectal		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Trans-vaginal		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	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)

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

Note 3 3D imaging

Note 5 Power SieScape panoramic imaging

Note 7 Contrast agent imaging

Tissue Equalization Technology Note 9

Note 11 Dynamic TCE

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Page 25 OF 31

Note 8 Note 10 Intracardiac imaging

Note 2 Note 4

Ensemble tissue harmonic imaging

B&W SieScape panoramic imaging

Note 6 For example: abdominal, vascular

3 SieClear Multi
10 Intracardiac im

SieClear multi-view spatial compounding

28

510(k) Number (if known):

L13F5 3D/4D Mechanical Wobbler Linear Transducer for use with: Device Name: ACUSON X300 Diagnostic Ultrasound Systems Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
(Track1
Only)	Specific
(Tracks1& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Abdominal	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	SmallOrgan
(Note 1)	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Neonatal Cephalic	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Musculo-skel.
(Superfic)	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Other (Specify)

N = new indication; P = previously cleared by K080760, 121699

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

Note 3 3D imaging
Power SieScape panoramic imaging
Contrast agent imaging Note 5

Note 7

Note 9 Tissue Equalization Technology

Note 11 Dynamic TCE Note 2 Ensemble tissue harmonic imaging

Note 4 B&W SieScape panoramic imaging

SieClear multi-view spatial compounding

Intracardiac imaging

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Note 6 For example: abdominal, vascular

Note 8

Note 10

29

510(k) Number (if known):

| Device Name: | VF8-3 Linear Array Transducer for use with:
ACUSON X300 Diagnostic Ultrasound Systems |
|---------------|------------------------------------------------------------------------------------------|
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows |

Clinical Application		Mode of Operation
Other
(Track1
Only)	Specific
(Tracks1 & 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Abdominal	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	SmallOrgan
(Note 1)	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Neonatal Cephalic	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Musculo-skel.
(Superfic)	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-vascular
	Other
(Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Other (Specify)

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

Note 1 Note 3 3D imaging

Note 5
Power SieScape panoramic imaging Note 7 Contrast agent imaging

Note 9 Tissue Equalization Technology

Note 11 Dynamic TCE

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510(k)_

Note 8 Note 10 Intracardiac imaging

B&W SieScape panoramic imaging

Ensemble tissue harmonic imaging

Note 6

For example: abdominal, vascular SieClear multi-view spatial compounding

SleClear multi-view sp
Intracardiac imaging

Note 2 Note 4

30

510(k) Number (if known):

| Device Name: | P5-1 Phased Array Transducer for use with:
ACUSON X300 Diagnostic Ultrasound Systems |
|---------------|-----------------------------------------------------------------------------------------|
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows: |

Clinical Application		Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks1I& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,9,11
	Abdominal	P	P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,9,11
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P	P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,9,11
	SmallOrgan
(Note 1)
	Neonatal Cephalic	P	P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,9,11
	Adult Cephalic	P	P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,9,11
	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	P	BMDC	Note
2,3,4,5,7,8,9,11
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,9,11
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,9,11
	Other (Specify)

N = new indication; P = previously cleared by K080760, 121699

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

Note 3
Note 5
3D imaging
Power SieScape panoramic imaging
C Note 7

Contrast agent imaging Note 9 Tissue Equalization Technology

Note 11 Dynamic TCE

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e 6 For example: abc

8
10
SieClear multi-view spa
Intracardiac imaging

Note 2 Ensemble tissue harmonic imaging

B&W SieScape panoramic imaging
For example: abdominal, vascular

SieClear multi-view spatial compounding

Note 10 Intracardiac imaging

ON ANOTHER PAGE

Note 4
Note 6 Note 8

31

510(k) Number (if known):

| Device Name: | C6-2 Convex Array Transducer for use with:
ACUSON X300 Diagnostic Ultrasound Systems |
|---------------|-----------------------------------------------------------------------------------------|
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows: |

Clinical Application		Mode of Operation
Other
(Track1
Only)	Specific
(Tracks1& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Abdominal	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	SmallOrgan
(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
Cardiac	Cardiac Adult	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Cardiac Pediatric	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Other (Specify)

N = new indication; P = previously cleared by K080760, 121699

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

Note 3

3D imaging
Power SieScape panoramic imaging Note 5

Note 7 Contrast agent imaging Tissue Equalization Technology

Note 9 Note 11 Dynamic TCE

Note 11 Dynamic TCL

Note 2 Ensemble tissue harmonic imaging Note 4 B&W SieScape panoramic imaging

Note 6 For example: abdominal, vascular

SieClear multi-view spatial compounding

Note 10 Intracardiac imaging

Note 8

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32

510(k) Number (if known):

| Device Name: | SoundStar 10F Transducer for use with:
ACUSON X300 Diagnostic Ultrasound Systems |
|---------------|-------------------------------------------------------------------------------------|
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows: |

Clinical Application		Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks1& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& 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	P	P	P	P	P	P	P		BMDC	Note
2,3,7,8,9,10,11
	Other
(Specify)
	Cardiac Adult	P	P	P	P	P	P	P		BMDC	Note
2,3,7,8,9,10,11
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P		BMDC	Note
2,3,7,8,9,10,11
	Intra-vascular
(Cardiac)	P	P	P	P	P	P	P		BMDC	Note
2,3,7,8,9,10,11
	Trans-esophageal
(Cardiac)
	Intra-cardiac	P	P	P	P	P	P	P		BMDC	Note
2,3,7,8,9,10,11
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)
N = new indication; P = previously cleared by K080760, 121699

non indication - 1 previously ordered by 10001-00/121000

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

Note 3 3D imaging
Note 5 Power SieScape panoramic imaging

Note 7 Contrast agent imaging

Tissue Equalization Technology Note 9

Note 11 Dynamic TCE Note 2 Ensemble tissue harmonic imaging Note 4

B&W SieScape panoramic imaging Note 6 For example: abdominal, vascular

Note 8 SieClear multi-view spatial compounding

Note 10 Intracardiac imaging

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33

510(k) Number (if known):

P9-4 Phased Array Transducer for use with:

Device Name: Intended Use:

ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
( Track1
Only)	Specific
(Tracks1& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Abdominal	P	P	P	P	P	P	P		BMDC	Note
2,3,5,6,7,8,9,11
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)	P	P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	SmallOrgan
(Note 1)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Neonatal Cephalic	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Adult Cephalic	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
Cardiac	Cardiac Adult	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Cardiac Pediatric	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other
(Cardiac Neonatal)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Other (Specify)

N = new indication; P = previously cleared by FDA 121699

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

Note 3 3D imaging

Power SieScape panoramic imaging Note 5

Note 7 Contrast agent imaging Note 9 Tissue Equalization Technology

Note 11 Dynamic TCE

Note 2 Ensemble tissue harmonic imaging

Note 4 B&W SieScape panoramic imaging Note 6 For example: abdominal, vascular

SieClear multi-view spatial compounding Note 8

Note 10 Intracardiac imaging

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34

Indications for Use

510(k) Number (if known):

ACUSON SC2000 Diagnostic Ultrasound System Device Name:

The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal Intraoperative, Intraoperative, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are:

Cardiac Imaging Applications and Analysis

The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiac patients creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

The system also supports catheters which are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.

The system transmits ultrasound energy from either a transthoracic or transesophageal approach in adult and pediatric patients; and from a transthoracic approach in neonatal and fetal cardiants creating 2D (B). 3D. M-Mode (M). Color Doppler (CD). Color Power Doppler (CPD). Pulsed Wave (PW) Dopler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Vascular Imaging Applications and Analysis

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and deep veins and arteries in the arms, legs and abdomen: and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Superficial Imaging Applications

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Dopler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

35

Intraoperative Imaging Applications

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B). Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during intraoperative procedures.

Transcranial Imaging Applications

The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence or absence of pathology.

The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Acuson Acunav and Soundstar Ultrsound Catheter are intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients

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

X Prescription Use (21 CFG 801 Subpart D)

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

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FOR FDA USE ONLY

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36

510(k) Number (if known):

Device Name:

Intended Use:

SC2000 Diagnostic Ultrasound System

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

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
3D | Other:
Real
Time
3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--------------|------------------------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | | P* | P | | P |
| Abdominal | P | P | P | P | P | P | P | | P* | P | | |
| Intraoperative
Abdominal | P | P | P | P | P | P | P | | P* | P | | |
| Intraoperative
Neurological | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P* | P | P | P |
| Small Organ
(specify) | | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | | P* | P | | |
| Cardiac | P | P | P | P | P | P | P | | P* | P | P | P |
| Trans-esophageal | P | P | P | P | P | P | | | P* | | P | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intra-Luminal | P | P | P | P | P | P | P | | P* | | | P |
| Peripheral Vessel | P | P | P | P | P | P | P | P | P* | P | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal
Conventional | P | P | P | P | P | P | P | | P* | P | | |
| Musculo-skeletal
Superficial | P | P | P | P | P | P | P | | P* | P | | |
| Other (Neonatal
Cardiac) | P | P | P | P | P | P | P | | P* | P | | |
| Other (Intra-
Cardiac) | P | P | | P | P | P | P | | P* | | | P |

N=new indication. P = Previously Cleared K072365, K102017, K113179, K132654

Additional Comments:

*Combinations include:

B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

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

510(k)_

37

510(k) Number (if known):

Device Name:

AcuNav 8F Intracardiac Transducer for use with:

Intended Use:

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

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
Real
Time
3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P* | | |
| Small Organ
(specify) ** | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | P | P | P | P | P | P | P | | P* | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intra-Luminal | P | P | P | P | P | P | P | | P* | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (Intra-
Cardiac) | P | P | P | P | P | P | P | | P* | | |

N=new indication. P = Previously Cleared K072365, K102017, K113179, K132654

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler

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

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38

510(k) Number (if known):

Device Name:

Intended Use:

Soundstar eco 8F Intracardiac Transducer for use with: ACUSON SC2000 Diagnostic Ultrasound Systems Ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
Real
Time
3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | P | P* | | |
| Small Organ
(specify) ** | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | P | P* | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intra-Luminal | | P | P | P | P | P | P | P | P* | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (Intra-
Cardiac) | | P | P | P | P | P | P | P | P* | | |

N=new indication. P = Previously Cleared

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler

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Page 5 of 18

39

510(k) Number (if known):

Device Name:

9L4

Indications for Use:

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

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(specify) | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vessel | P | P | P | P | | P | P | P | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | P | P | P | P | | P | P | P | P* | P |
| Musculo-skeletal
Superficial | P | P | P | P | | P | P | P | P* | P |
| Other (specify) | | | | | | | | | | |

N=new indication. P = Previously Cleared in 510(k) K072365, K102017, K113179, K132654

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)

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40

6C1HD

510(k) Number (if known):

Device Name:

Intended Use:

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

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P* | P |
| Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative
Abdominal | | P | P | P | P | P | P | | P* | P |
| Intraoperative | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P* | P |
| Small Organ
(specify) | | P | P | P | P | P | P | | P* | P |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vessel | | P | P | P | P | P | P | | P* | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other
(Abdominal
Vascular) | | P | P | P | P | P | P | | P* | P |

N=new indication. P = Previously Cleared in 510(k) K072365, K102017, K132654

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

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Page 8 of 18

41

510(k) Number (if known):

Device Name:

V5M

Intended Use:

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

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | | | P* | | P |
| Small Organ
(specify) | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | P | P | P | P | P | P | | | P* | | P |
| Trans-esophageal | P | P | P | P | P | P | | | P* | | P |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

N=new indication. P = Previously Cleared in 510(k) K072365, K102017, K113179, K132654

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

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Page 9 of 18

42

510(k) Number (if known):

Device Name:

4V1c

Intended Use:

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

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | | P * | P |
| Abdominal | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P * | P |
| Small Organ
(specify) | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | | P * | P |
| Cardiac | P | P | P | P | P | P | P | | P * | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Neonatal
Cardiac) | P | P | P | P | P | P | P | | P * | P |

N=new indication. Previously Cleared in 510(k) K072365, K102017, K113179, K132654

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

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43

510(k) Number (if known):

Device Name:

8V3

Intended Use:

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

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | P * | P |
| Abdominal | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P * | P |
| Small Organ
(specify) | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P * | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (Neonatal
Cardiac) | | P | P | P | P | P | P | | P * | P |

N=new indication. Previously Cleared in 510(k) K102017, K113179, K132654

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

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44

510(k) Number (if known):

Device Name:

CW2

Intended Use:

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

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | P | | | | | |
| Small Organ
(specify) | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | P | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral Vessel | | | | | P | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N=new indication. Previously Cleared in 510(k) K072365, K102017, K113179, K132654

Additional Comments:

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Page 12 of 18

45

510(k) Number (if known):

Device Name:

4Z1c

Intended Use:

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

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
Real
Time
3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | | | P* | P | P |
| Abdominal | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | | | P* | P | P |
| Small Organ
(specify) ** | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | | | P* | P | P |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

N=new indication. P = Previously Cleared in 510(k) K072365, K102017, K113179, K132654

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

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Page 13 of 18

46

510(k) Number (if known):

Device Name:

Intended Use:

AcuNav 10F Ultrasound Catheter

Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients as follows:

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
Real
Time
3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P* | | |
| Small Organ
(specify) ** | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | P | P | P | P | P | P | P | | P* | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intra-Luminal | P | P | P | P | P | P | P | | P* | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (Intra-
Cardiac) | P | P | P | P | P | P | P | | P* | | |

N=new indication. P = Previously Cleared in 510(k) K071234, K093812, K113179, K132654

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler

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47

510(k) Number (if known):

Device Name:

Intended Use:

ACUSON AcuNav™ V 10F Ultrasound Catheter

Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients as follows:

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
Real
Time
3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P* | | P |
| Small Organ
(specify) ** | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | P | P | P | P | P | P | P | | P* | | P |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intra-Luminal | P | P | P | P | P | P | P | | P* | | P |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (Intra-
Cardiac) | P | P | P | P | P | P | P | | P* | | P |

N=new indication. P = Previously Cleared in 510(k) K081808, K113179, K132654

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

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48

510(k) Number (if known):

Device Name:

Intended Use:

SoundStar 10F Ultrasound Catheter

Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart:

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
Real
Time
3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ
(specify) ** | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | P | P | P | P | P | P | P | | P* | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intra-Luminal | P | P | P | P | P | P | P | | P* | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (Intra-
Cardiac) | P | P | P | P | P | P | P | | P* | | |

N=new indication. P = Previously Cleared in 510(k) K070242, K113179, K132654

Additional Comments:

*Combinations include: B+M, B+PWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler

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510(k)

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49

510(k) Number (if known):

Device Name:

V7M

Intended Use:

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

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | Other:
3D |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | P | P | P | P | P | P | | P* | P | P |
| Intraoperative
Abdominal | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | | | P* | | P |
| Small Organ
(specify) | | | | | | | | | | | |
| Neonatal
Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | | | P* | | P |
| Trans-esophageal | | P | P | P | P | P | | | P* | | P |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

N=new indication. P = Previously Cleared in 510(k) K111674, K132654

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

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510(k) Number (if known):

Device Name:

10V4

Intended Use:

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

| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | |
|----------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--|
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | | P * | P | |
| Abdominal | P | P | P | P | P | P | P | | P * | P | |
| Intraoperative
Abdominal | P | P | P | P | P | P | P | | P * | P | |
| Intraoperative
Neurological | P | P | P | P | P | P | P | | P * | P | |
| Pediatric | P | P | P | P | P | P | P | | P * | P | |
| Small Organ
(specify) | | | | | | | | | | | |
| Neonatal
Cephalic
Adult Cephalic | | | | | | | | | | | |
| Cardiac | P | P | P | P | P | P | P | | P * | P | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | | |
| Peripheral Vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (Neonatal
Cardiac) | P | P | P | P | P | P | P | | P * | P | |

N=new indication. Previously Cleared in 510(k) K111674, K132654

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

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51

510(k) Summary Prepared August 19, 2014

| Sponsor: | Siemens Medical Solutions, Inc.,
Ultrasound Division
685 East Middlefield Road
Mountain View, California 94043 |
|------------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Shelly Pearce
Telephone: (650) 694-5988 |
| Submission Date: | August 7, 2014 |
| Device Name: | SC2000, X300 Diagnostic Ultrasound Systems |
| Common Name: | Diagnostic Ultrasound System with Accessories |

Classification:

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

Ultrasonic Pulsed Doppler Imaging System	CFR # 892.1550	Product Code 90-IYN
Ultrasonic Pulsed Echo Imaging System	CFR # 892.1560	Product Code 90-IYO
Diagnostic Intravascular Catheter	CFR # 870.1200	Product Code OBJ

A. Legally Marketed Predicate Devices

The device modifications described in this 510(k) are substantially equivalent to the company's own devices, previously cleared on K132654 (SC2000), K121699 (X3001 (X700), K141846 (X700). The catheter is substantially equivalent to K140318 (SSe8F), K071234 (AN8F).

B. Device Description:

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

52

C. Intended Use

SC2000 -

The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neonatal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are:

Cardiac Imaging Applications and Analysis

The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiac patients creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. The system also supports catheters which are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The system has Cardiac Measurements and Calculation Packages that provide information that may be used adiunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Vascular Imaging Applications and Analysis

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juqqular veins in the neck; superficial and deep veins and arteries in the arms and legs and abdomen; and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Superficial Imaging Applications

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

Intraoperative Imaging Applications

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during intraoperative procedures.

Transcranial Imaging Applications

The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous

53

Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence or absence of pathology. The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Acuson Acunav and Soundstar Ultrsound Catheter are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

X300:

The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

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. This feature should 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 Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

The Acuson Acunav and Soundstar Ultrsound Catheter are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

D. Substantial Equivalence

The device modifications described in this 510(k) are substantially equivalent to the company's own devices, previously cleared on K132654 (SC2000), K121699 (X300), K123001 (X700), K141846 (X700). The catheter is substantially equivalent to K140318 (SSe8F), K071234 (AN8F). The submission devices are substantially equivalent to the predicate devices with regard to both intended use and technological characteristics.

| Description | This
submission
(All
Devices) | Acuson
X700
K141846 | Acuson
SC2000 TM
K132654 | Acuson
X300 - K121699 /
X700 - K123001 |
|--------------------------------------------------|----------------------------------------|---------------------------|--------------------------------|----------------------------------------------|
| System: | | | | |
| Hardware Safety - EN60601-1 Certified | X | X | X | X |
| Acoustic Thermal Safety - EN60601-2-37 Certified | X | X | X | X |

54

| Medical device software - Software Life Cycle

Process - IEC 62304	X	X	X	X
Transducers:
As cleared in the device's previous 510(k)	X	X	X	X
AcuNav 8F Catheter	X	X	X	X
Soundstar eco 8F Catheter	X	X	X	X
Software Features
As cleared in the device's previous 510(k)	X	X	X	X

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 has 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
. CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment

AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic ■ Output Indices on Diagnostic Ultrasound Equipment

AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound .
93/42/EEC Medical Devices Directive ■
트 Safety and EMC Requirements for Medical Equipment
트 EN/IEC 60601-1
트 EN/IEC 60601-1-1
. EN/IEC 60601-1-2
EN/IEC 62304
EN/IEC 62366 트
트 EN/IEC 60601-2-18
EN/IEC 60601-2-25 트
ISO 10993-1 Biocompatibility ■

Cleared patient contact materials, electrical and mechanical safety are unchanged.

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

Since the modified devices use the same technology and principles as existing devices, clinical data is not required.

G. Summary

Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Requlation and ISO 13485:2003 quality system standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore it is the opinion of Siemens Medical that the modified devices are substantially equivalent with respect to safety and effectiveness to devices currently cleared for market. The modified devices are verified and validated according to the company's design control process.