ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM

• K Number: K093531
• Device Name: ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer: SIEMENS MEDICAL SOLUTIONS, INC.
• Date Cleared: 2009-12-01 ( 15 days)
• Product Code: IYN DQO ITX IYO
• Regulation Number: 892.1550

Intended 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. Diagnostic imaging or fluid flow analysis of the human body as follows: (followed by a table listing specific clinical applications and modes of operation for various transducers)

Device Description

The Acuson X300 has been designed to meet the following product safety standards: - UL 60601-1, Safety Requirements for Medical Equipment - IEC 60601-2-37 Diagnostic Ultrasound Safety Standards - I CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment - AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment - AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound - 93/42/EEC Medical Devices Directive - Safety and EMC Requirements for Medical Equipment - EN/IEC 60601-1 - EN/IEC 60601-1-1 - EN/IEC 60601-1-2 - EN/IEC 60601-1-4 - EN/IEC 60601-1-6 - EN/IEC 60601-2-18 - EN/IEC 60601-2-25 - IEC 1157 Declaration of Acoustic Power - ISO 10993-1 Biocompatibility

Predicate Devices

K090276, K071036, K061946, K061980, K081121

Reference Devices

K090276,K071036,K061946,K061980,K081121

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.

Therapeutic

No
The intended use clearly states "Diagnostic imaging" and "measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes." It does not mention any therapeutic applications or interventions.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the system provides "analysis packages that provide information that is used for clinical diagnosis purposes" and mentions "Diagnostic imaging or fluid flow analysis." The "Device Description" also references "IEC 60601-2-37 Diagnostic Ultrasound Safety Standards" and "AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment" and "AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound", all of which refer to diagnostic ultrasound.

SaMD (Software as a Medical Device)

No

The device description explicitly refers to the "Siemens Acuson X300 ultrasound imaging system" and lists numerous hardware-related safety standards (UL, IEC, CSA, AIUM/NEMA, EN/IEC, ISO) that apply to physical medical equipment, not just software. The intended use also describes a physical ultrasound system with transducers.

IVD (In Vitro Diagnostic)

Based on the provided information, the Siemens Acuson X300 ultrasound imaging system is not an IVD (In Vitro Diagnostic) device.

Here's why:

• IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. The intended use and device description clearly state that the Acuson X300 is an ultrasound imaging system used for diagnostic imaging or fluid flow analysis of the human body. It directly interacts with the patient's body to generate images, rather than analyzing samples taken from the body.
• The listed applications are all related to imaging internal structures and processes within the living patient. These include various anatomical sites and clinical applications that are performed in vivo.
• The safety standards listed are for medical equipment and diagnostic ultrasound, not for in vitro diagnostic devices.

Therefore, the Siemens Acuson X300 is a medical imaging device, not an in vitro diagnostic device.

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.

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

Product codes

90-IYN, 90-IYO, 90-ITX, 74-DQ

Device Description

The Acuson X300 has been designed to meet the following product safety 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 Safety and EMC Requirements for Medical Equipment EN/IEC 60601-1 EN/IEC 60601-1-1 EN/IEC 60601-1-2 EN/IEC 60601-1-4 EN/IEC 60601-1-6 EN/IEC 60601-2-18 EN/IEC 60601-2-25 IEC 1157 Declaration of Acoustic Power ISO 10993-1 Biocompatibility

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, breast, testes, thyroid, penis, prostate

Indicated Patient Age Range

Neonatal, Pediatric, Adult

Intended User / Care Setting

Not Found

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)

The Acuson X300 modifications are verified and validated according to the company's design control process.

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

Not Found

Predicate Device(s)

K090276, K071036, K061946, K061980, K081121

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

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K093531

ACUSON X300 ™ Diagnostic Ultrasound System 510(k) Submission

510(k) Summary

| Sponsor: | Siemens Medical Solutions, Inc.,
Ultrasound Division
1230 Shorebird Way
Mountain View, California 94043 | | | | | | | | | | | DEC - 1 2009 |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------|---------------------|--|--|--|--|--|--|--|--|--|--------------|
| Contact Person: | Shelly Pearce
Telephone: [phone]
Fax: [phone] | | | | | | | | | | | |
| Submission Date: | October 06, 2009 | | | | | | | | | | | |
| Device Name: | ACUSON X300™ Diagnostic Ultrasound System | | | | | | | | | | | |
| Common Name: | Diagnostic Ultrasound System with Accessories | | | | | | | | | | | |
| Classification: | | | | | | | | | | | | |
| Regulatory Class: | II | | | | | | | | | | | |
| Review Category: | Tier II | | | | | | | | | | | |
| Classification Panel: | Radiology | | | | | | | | | | | |
| Ultrasonic Pulsed Doppler Imaging System | FR # 892.1550 | Product Code 90-IYN | | | | | | | | | | |

Ultrasonic Pulsed Doppler Imaging System	FR # 892.1550	Product Code 90-IYN
Ultrasonic Pulsed Echo Imaging System	FR # 892.1560	Product Code 90-IYO
Diagnostic Ultrasound Transducer	FR # 892.1570	Product Code 90-ITX
Diagnostic Intravascular Catheter	FR # 870.1200	Product Code 74-DQ

A. Legally Marketed Predicate Devices

The Siemens Acuson X300 ultrasound system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product, the Siemens Acuson X300 ultrasound system (K090276, K071036 and K061946) and the following:

• K061980, Siemens Acuson X500™ Ultrasound System ◆
• K081121, ACUSON X150 Ultrasound System ●
• · K090276, ACUSON X300™ Diagnostic Ultrasound System, Premium Edition

B. Device Description:

The Acuson X300 has been designed to meet the following product safety standards:

• UL 60601-1, Safety Requirements for Medical Equipment 트
• IEC 60601-2-37 Diagnostic Ultrasound Safety Standards 제
• I CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
• 로 AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• 트 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
  • « EN/IEC 60601-1

발

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• 트 EN/IEC 60601-1-1
• M EN/IEC 60601-1-2
• 내 EN/IEC 60601-1-4
• I EN/IEC 60601-1-6
• 피 EN/IEC 60601-2-18
• EN/IEC 60601-2-25 I
• IEC 1157 Declaration of Acoustic Power
• ISO 10993-1 Biocompatibility

C. Intended 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.

D. Substantial Equivalence

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

E. Performance Data

The Acuson X300 modifications are verified and validated according to the company's design control process.

X300 510{k} Submission

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, facing to the right.

Public Health Service

DEC - 1 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

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

Re: K093531

Trade/Device Name: ACUSON X300™ Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, and DOO Dated: November 13, 2009 Received: November 16, 2009

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

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

Transducer Model Number

P4-2 Phased Sector Array CH5-2 Convex Array VF10-5 Linear Array L9-5 Linear Array EC9-4 Convex Array

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EV9-4 Convex Array VF13-5 Linear Array P8-4 Phased Sector Array BE9-4 Convex Array CW2 Continuous Wave Doppler CW5-Continuous Wave Doppler AcuNav 8F Intracardiac AcuNav 10F Intracardiac V5Ms TEE 4V1c Phased Sector Array VF13-5SP Linear Array C8-5 Tightly Curved Array 8L3 Linear "Regel" 10V4 Phased Array C7F2 Curved Array Mechanical 3D/4D EV9F4 Curved Array Mechanical 3D/4D L13F5 3D/4D Mechanical Wobbler Linear VF8-3 Linear Array P5-1 Phased Array C6-2 Convex Array SoundStar 10F P9-4 Phased Array P4-2 Litho Phased Sector Array BP9-4 Convex Array

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please

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note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at [phone].

Sincerely yours,

hozu h. Why

5 Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Indications for Use Statement

63531 510(k) Number (if known):

Device Name:

ACUSON X300™ Diagnostic Ultrasound System

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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

X300 510(k) Submission

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ACUSON X300™ Diagnostic Ultrasound System SIO(k) Submission

Diagnostic Ultrasound Indications for Use Form

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	P	P	P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,9,11
	Fetal	P	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	P	BMDC	Note
2,3,4,5,7,8,9,11
	Intra-operative
(Note 6)	P	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	P	BMDC	Note
2,3,4,5,7,8,9,11
Fetal	Laparoscopic	P	P	P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,9,11
	Pediatric	P	P	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	P	P	BMDC	Note
2,3,4,5,7,8,9,11
	Neonatal Cephalic	P	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	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	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	P	BMDC	Note
2,3,4,5,7,8,9,11
	Musculo-skel.
(Superfic)	P	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	P	BMDC	Note
2,3,4,5,7,8,9,11
	Other
(Specify)	P	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	P	BMDC	Note
2,3,4,5,7,8,9,11,12
Cardiac	Cardiac Pediatric	P	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	P	BMDC	Note
2,3,4,5,7,8,9,11
	Trans-esophageal
(Cardiac)	P	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	P	BMDC	Note
2,3,4,5,7,8,9,11
	Other (Specify)	P	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	P	BMDC	Note
2,3,4,5,7,8,9,11,12
	Other (Specify)	P	P	P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,9,11

N = new indication; P = proviously cleared by K090276

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

Note 2 Ensemble tissue harmonic imaging Note 3

Note 3 SD Imaging
Note 4 PWM BioScanner

andramara
B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 4
Note 5

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imagi

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

Note 9 Tissue Equalization Technology

Note 10
Note 11 Intracardiac Imaging
Dynamic TCE

Note 12 AHP

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Aomr Mz Wz

(Division Si roductive, Abdominal and

Page 38 of 1531

510(k) Number

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ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

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
(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
2,3,5,6,7,8,9,11
	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		P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Adult Cephalic		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		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
(Cardlac)
	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)

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

Note 2

Note 3

Ensemble lissue hamonic imaging
JD imaging
B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging
For example: abdominal, vascular Note 5
Note 6

Note 6 For exemple: abdominal, vas
Note 7 Contrast agent imaging

Nole 7 Contrast agent imaging

SieClear multl-view spatial compounding
Tissue Equalization Technology Note 8
Note 9

Note 9 Tissue Equalization Technology
Note 10. Additional scans

Note 10 Intracardiac Imaging

Note 11 Dynamic TCE

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Aora M. Whay

(Division Sign-Division of Reproductive, Abdominal, and Radiological D

Page 39 of 1531

510(k) N

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ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

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		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
Fatal	Pediatric		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		BMDC	Note
2.3.4.5.7.8.9,11
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardlac Adult		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
Cardlac	Cardiac Pedlatric		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		BMDC	Note
2,3,4,5,7,8,9,11
Vessel	Other (Specify)

N = new indication; P = prevlously cleared by K090276

Note 1
Note 2 For example: breast, testes, thyrold, penls, prostate, atc.

Ensemble tissue harmonic imaging

Note 3

Note 4 Note 5

2008. Imaging manoramic imaging
      BBW Sging Siessape panoramic limaging
      B&Wer SiesScape panoramic limaging
      For example: abodominal, vascularing
      Contrast agent imaging Note 6

Note 7

Note 8 SieClear multi-view spatial compounding

Note 9 Tissue Equalization Technology
Intracardiac imaging

Note 10

Note 11 Dynamic TCE

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concence of CDRH, Office of Device Evaluation (ODE)
Concence of CDRH, Office of Device Evaluation (ODE)

.

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(Division Sign-Off)

productive. Abdominal. Division of Re and Radiological Dev 510(k) Numbe

Page 40 of 1531

9

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

r

Intended Use:

ASHOON XSAC Di ACUSON X300 Dlagnostic 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		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										Note 12
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11,12
	Other (Specify)
	N = new indication: P = previously cleared by K090278

For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 1

Note 2

Note 3
Note 4

Rule 4 DAW Seascapes panoramic image
Note 6 Penna-Olga 1x6 U

3D imaging
B&W SieScape panoramic imaging
Power SleScape panoramic imaging
For example: abdominal, wascular
For example: abdominal, vascular
Contrast agent imaging Note S Note B

Note 7

Note 8
Note 9 SleClear multi-view spatial compounding

Tissue Equalization Technology
Intracardiac imaging

Note 10

Note 11
Note 12 Dynamic TCE
AHP

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use (Per 21 CFR 801.109)

Ammal m. Why
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological De 510(k) Number

Page 41 of 1531

10

ACUSON X300m Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

Intended Use:

L.9-5 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
(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		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										Note 12
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-Cardaic
	Other (Specify)
Peripheral
Vessel	Peripheral vessel		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11,12
	Other (Specify)

N = new indication; P = previously cleared by K090276

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

Note 2 Ensemble tissue harmonic Imaging Note 3

Note 4
3D Imaging
B&W SieScape

3D imaging
B&W SieScape panoramic Imaging
Power SieScape panoramic Imaging Note 4
Note 5 Power SieScape panoramic Imaging
For example: abdominal, vascular

Nota 6

Note 7

Contrast agent imaging
SieClear multi-view spatlal compounding Note 8

Note 9
Note 10 Tissua Equalization Technology Intracardiac imaging

Note 11 Dynamic TCE

Note 12 AHP

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Aopai Th Way

(Division Si Division of Reproductive, Abdomina and Radiological Dev

Page 42 of 1531

510(k) Number

11

ACUSON X300™ Diagnostic Ultrasound System SIO(k) Submission

Dlagnostic Ultrasound Indications for Use Form

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
( 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
2,3,4,5,7,8,9,11
	Abdominal
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
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	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.)
	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)

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

• Note 2 Ensemble tissue harmonic imaging Note 3 3D imaging
• Note 4
• B&W SieScape panoramic imaging Note 5
• Power SieScape panoramic imaging Note f
• Note 7 Contrast agent imaging Note 8
• SieClear multi-view spatial compounding
  Tissue Equalization Technology
• Note 9 Note 10 Intracardiac imaging
• Nole 11 Dynamic TCE

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Lori M. Whay

(Divi Sign-Off Division of Reproductive, Abdominal, and Radiological De 510(k) Number

Page 43 of 1531

12

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

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
(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		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	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared by K090276

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Ensemble tissue harmonic imaging

Note 2
Note 3

3D imaging
B&W SieScape panoramic imaging Nole 4

Note 5 Power SieScape panoramic Imaging
For example: abdominal, vascular

Nota 6

Note 7
Note B

Contrast agent imaging
SieClear multi-view spatial compounding
Tissue Equalization Technology

Note 9
Note 10 Intracardiac imaging

Note 11 Dynamic TCE

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence Prescription Use (Per 21 CFR 801.109)

Tony M. Wieg

. .

(Division Reproductive, Abdominal, grid 510(k) N

Page 44 of 1531

13

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

VF13-5 Linear Array Transducer for use with:

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
(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		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										Note 12
	Cardiac Pediatric
	Intra-vascular.
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11,12
	Other (Specify)

N = new indication; P = previously cleared by K090276

Note 1 For example: breast, testes, thyrold, penis, prostate, etc. Ensemble tissue harmonic imaging

Note 2 Note 3

3D imaging
B&W SieScape panoramic imaging Note 4

Note 5
Note 6 Power SieScape panoramic imaging

For example: abdominal, vascular

Note 7 Contrast agent imaging Note 8

SleClear multi-view spatial compounding
Tissue Equalization Technology Note 9

Intracardiac Imaging

Note 10
Note 11 Dynamic TCE
AHP

Note 12

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evalualion (ODE)
Prescription Use (Per 21 CFFR 801, 109)

Aorall M. Whing

Abdominal oductive and Ra

Page 45 of 1531

510(k) Numbe

14

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

P8-4 Phased Sector Array Transducer for use with:

Intended Use:

ACUSON X300 Dlagnostic 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		BMDC	Note
2,3,4,5,7,8,9,11
	Abdominal		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	Pediatric		P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
Imaging
& Other	SmallOrgan
(Note 1)
	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)
	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 K090276

For example: breast, testes, thyrold, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 1

Note 2

Note 3 3D imaging Note 4

B&W SieScape panoramic imaging Note 5 Power SieScape panoramic Imaging

મગામ છ For example: abdominal, vascular

Note 7

Contrast agent Imaging
SieClear multl-view spatial compounding Note B

Nota 9 Tissue Equalization Technology

Note 10 Intracardiac Imaging

Nole 11 Dynamic TCE

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Aone h Wh

(Division S Division of Reproductive, Abdominal and Radiological Det

Page 46 of 1531

510(k) Number

gical Devices)
mber K09353/

15

ACUSON X300™ Diagnostic Ultrasound System S10(k) Submission

Diagnostic Ultrasound indications for Use Form

510(k) Number (if known):

Device Name:

ﺑ

Intended Use:

BE9-4 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
( 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
	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
	Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Adult Cephalic
	Trans-rectal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Trans-vaginal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new Indication; P = previously cleared by K090276

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

Note 2 Ensemble lissue harmonic imaging Note 3

Note 4

anomaging
B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular
Contrast agent imaging

Note 7

Note 8 SieClear multi-view spatial compounding Tissue Equalization Technology Note 9

Note 10 Intracardiac imaging

Note 11 Dynamic TCE

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

y m. Why

(Division Sign-G Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number

Page 47 of 1531

16

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

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
( 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
	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 K090276

For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue hamonic linaging Note 1

Note 2

Note 3
Note 4

• 3D imaging
  B&W SieScape panoramic Imaging
• Note 5
  Note 6 Power SieScape panoramic imaging
  For example: abdominal, vascular
• Note 7 Contrast agent imaging
• SteClear multi-view spatial compounding
  SieClear multi-view spatial compounding
  Tissue Equalization Technology Note 8
• Note 9 Intracardiac imaging
• Nole 10
  Note 11 Dynamic TCE

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Jorry M. Whing

(Division Sig Division of Reproductive, and Radiological 510(k) Number

Page 48 of 1531

17

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

.

Intended Use:

CW5 Continuous Wave Doppler 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
	Abdominal					P
	Intra-operative
(Note 6)					P
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric					P
Imaging
& Other	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	Peripheral vessel					P
Vessel	Other (Specify)

N = new indication; P = previously cleared by K090276

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

Ensemble tissue harmonic Imaging Note 2 Note 3

Note 4

3D imaging
B&W SieScape panoramic imaging
Power SieScape panoramic imaging Nole 5

Note 6
Note 7 For example: abdominal, vascular

Contrast agent imaging

Note 8 SleClear multi-vlew spatial compounding

Note 9 Tissue Equalization Technology
Intracardlac imaging Note 10

Note 10 Intracardiac TC
Note 11 Dynamic TCI

Note 11 Dynamic TCE

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of Device Evaluation (ODE). Prescription Use (Per 21 CFR 801.109)

Lora M. White

(Division Sign-Division of Reproductive, Abdomina and Radiological D 510(k) Number

18

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

51D(k) Number (if known):

Device Name: Intended Use:

1

. . ..

AcuNav 8F 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
( Track1
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
Felal	Pediatric	P	P	P	P	P	P	P		BMDC	Note
2,3,7,8,9,10,11
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
2,3,7,8,9,10,11
	Other
(Specify)
	Cardiac Adult		P	P	P	P	P	P		BMDC	Note
2,3,7,8,9,10,11
Cardiac	Cardiac Pediatric		P	P	P	P	P	P		BMDC	Note
2,3,7,8,9,10,11
	Intra-vascular
(Cardiac)		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		BMDC	Note
2,3,7,8,9,10,11
	Other (Specify)
Perpheral	Peripheral vessel
Vessel	Other (Specify)

indication; P = previously cleared by K090276 N = new

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

Note 2 Ensemble tissue harmonic imaging
3D imaging
B&W SieScape panoramic imaging
F Note 3

Nota 4

Note 5

Power SieScape panoramic imaging
For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

Note 8 SieClear multi-view spatial compounding
Tissue Equalization Technology

Note 9

Nota 10 Intracardiac imaging

Note 11 Dynamic TCE

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Arzui Th. Whz

Off) (Division (Division of Reproductive, Abdominal, and Radiological

Page 50 of 1531

510(k) Number

19

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

Intended Use:

ACHSON Yang Di ACUSON X300 Diagnostic Uitrasound 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
	Abdominal
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pedlatric		P	P	P	P	P	P		BMDC	Note
2,3,7,8,9,10,11
	SmallOrgan
(Note 1)
	Neonatal Caphalic
	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
2,3,7,8,9,10,11
	Other
(Specify)
	Cardlac Adult		P	P	P	P	P	P		BMDC	Note
2,3,7,8,9,10,11
Cardiac	Cardiac Pediatric		P	P	P	P	P	P		BMDC	Note
2,3,7,8,9,10,11
	Intra-vascular
(Cardiac)		P	P	P	P	P	P		BMDC	Note
2,3,7,8,9,10,11
	Trans-esophageal
(Cardlac)
	Intra-cardiac		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 K090276

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

Nole 2 Ensemble tissue harmonic imaging Note 3 3D imaging

Note 4

B&W SieScape panoramic Imaging
Power SieScape panoramic Imaging Note 5

Note 6 For example: abdominal, vascular

Note 7

Contrast agent Imaging
SleClear mulli-view spatial compounding Nole 8

Nole 9
Nole 10 Tissue Equalization Technology

Intracardiac imaging

Nole 11 Dynamic TCE

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Lova R. Wha

(Div Division o oroductive, Abdominal, and Radiological De

Page 51 of 1531

510(k) N

20

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

1

Intended Use:

V5Ms TEE 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
(Tracks1I& 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
	Other
(Specify)
Cardiac	Cardiac Adult		P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,11
	Cardiac Pedlatric		P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,11
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)		P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,11
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared by K090276

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

Note 2 Ensemble tissue harmonic Imaging

3D imaging Note 3 Note 4

B&W SieScape panoramIc imaging

Note 2 Power SieScape panoramic imaging
For example: abdominal, vascular

Nota 7 Contrast agent imaging

SieClear multi-view spatial compounding
Tissue Equalization Technology Note 8

• Note 9 Note 10
  Intracardiac imaging
  Dynamic TCE Note 11

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Usa (Per 21 CFR 801.109)

tomm why
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devi-510(k) Number

Page 52 of 1531

21

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

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:

Intended Use:

Clinical Application		Mode of Operation
Other
(Track1
Only)	Specific
(Tracks 11& 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
2,3,5,6,7,8,9,11
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric		P	P	P	P	P	P		BMDC	Note
2,3,5,6,7,8,9,11
Imaging
& Other	Small Organ
(Note 1)
	Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note
2.3,5,6,7,8,9,11
	Adult Cephalic		P	P	P	P	P	P		BMDC	Note
2,3,5,6,7,8,9, 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		BMDC	Note
2,3,5,6,7,8,9, 11
Cardiac	Cardiac Pediatric		P	P	P	P	P	P		BMDC	Note
2,3,5,6,7,8,9, 11
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel

N = new indication; P = previously cleared by K090276

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging

Nota 2 Note 3

3D imaging
B&W SieScape panoramic imaging Note 4

Note 5 Power SieScape panoramic imaging
For example: abdominal, vascular
Contrast agent imaging

Note 6

Note 7

Note A SieClear multi-view spatial compounding Tissue Equalization Technology
Intracardiac imaging Note 9

Note 10

Nota 11 Dynamic TCE

Note 12 AHP

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

lozu M. Wly

Division and Radiolo;

Page 53 of 1531

510(k) Number

X0935

22

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Prescription Use (Par 21 CFR 801.109)

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

Intended Use:

VF13-5SP 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
(Tracks 1& 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		BMDC	Note
2,3,4,5,7,8,9,11
	Intra-operative
(Neuro)		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9.11
	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										Note 12
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11,12
Vessel	Other (Specify)

N = new indication; P = previously cleared by K090276

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble lissue harmonic imaging

Note 2

3D imaging
B&W SieScape panoramic imaging Note 3
Note 4

Note 5

Power SieScape panoramic imaging
For example: abdominal, vascular
Contrast agent imaging Note 6

Note 7

Note 8
Note 9 SieClaar mobile spallal compounding
Tissue Equalization Technology
Intracardiac Imaging

Note 10

Note 11
Note 12 Dynamic TCE
AHP

.7

Note 12 AHP

---

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

Page 54 of 1531

23

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

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

Prescription Use (Per 21 CFR 801.109)

Diagnostic Ultrasound Indications for Use Form

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
( Track 1
Only)	Specific
(Tracks 11& 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		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		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		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Cardiac	Cardiac Pediatric		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		BMDC	Note 2,3,4,5,7,8,9
	Other (Specify)

ndication; P N = new = previously cleared by K090276

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic Imaging

Note 2 Note 3 3D imaging

Note 4

B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

Nole 7 Contrast agent imaging

Note 8 SieClear mull-vlew spatial compounding

Note 9 Tissue Equalization Tachnology

Nola 10 Intracardiac imaging

Note 11 Dynamic TCE

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Page 55 of 1531

Division of Reproductive, Abdomina and R

510(k) Number

24

ACUSON X300™ Diagnostic Ultrasound System 5 l 0(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

8L3 Linear "Regel" Transducer for use with: 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 Color Specific Color Amplitude Combined ( Track 1 A B M PWD CWD Other (Tracks11& 3) Velocity Only) Dogalar Doppler (Specify) (Specify) Imaging Ophthalmic Ophthalmic Fetal P P P P P BNDC 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 Pediatric P P P P P BMDC Note 2,3,4,5,7,8,9 Imaging SmallOrgan P P P P P & Other (Note 1) BMDC Note 2,3,4,5,7,8,9 Neonatal Ceohalic P P P P P BMDC Nole 2,3,4,5,7,8,9 Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoon. ン (non-Card.) Musculo-skel. P P P P P BMDC (Convent.) Note 2,3,4,5,7,8,9 Musculo-skel P P P P P BMDC Note 2,3,4,5,7,8,9 (Superfic) Intra-vascular Other (Specify) Cardiac Adult Note 12 Cardiac Cardiac Pediatric Intra-vascular (Cardiac) . Trans-esophageal (Cardiac) Intra-cardiac Other (Specify) Peripheral Peripheral vessel b p P P P Note BMDC 2,3,4,5,7,8,9,12 Vessel Other (Specify)

N = new Indication; P = previously cleared by K090276 Note 1 For example: breast, testes, thyrold, penis, prostate, etc.

Note 2 Ensemble tissue harmonic imaging

3D imaging Note 3

Note 4 B&W SieScape panoramic imaging

Note 5 Power SleScape panoramic imaging Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Note 8 SieClear multi-view spatial compounding

Note 9 Tissue Equalization Technology

Note 10 Intracardlac imaging

Note 1 1 Dynamic TCE Note 12 AHP

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

$\frac{\text{}}{\text{(Division Sign-Off)}}$

oductive, Abdominal and

510(k) Numbe

25

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

Intended Use:

10V4 Phased 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
	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)
	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)
	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 K090276

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

Note 2 Ensemble tissue harmonic imaging Note 3

3D imaging
B&W SieScape panoramic imaging Note 4

Note 5
Note 6 Power SieScape panoramic imaging
For example: abdominal, vascular

Note 6 For example: abdominal, vascular
Note 7 Gradient-recalled echo

Note 7
Note 8 Contrast agent imaging

• SleClear multi-view spallal compounding
  Tissue Equalization Technology Note 9
  Note 10

Intracardiac imaging
Dynamic TCE Note 11

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use (Per 21 CFR 801.109)

Aone In Why
(Division Sign-Off)

Division o Reproductive, Abdominal, and Radiological I 510(k) Number

Page 57 of 1531

26

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

In!ended Use:

C7F2 Curved Array Mechanical 3D/4D 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)
	Neonatal Cephalic
	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)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
Cardiac	Cardiac Pediatric		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		BMDC	Note
2,3,4,5,7,8,9,11
Vessel	Other (Specify)

N = new indication; P = previously cleared by K090276

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

Note 2 Ensemble tissue harmonic imaging

Note 3 Note 4

3D imaging
B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6
Note 7 For example: abdominal, vascular
Contrast agent imaging

Note 8 SieClear multi-view spatial compounding

Note 9

Tissue Equalization Technology
Intracardiac imaging Nota 10

Note 11 Dynamic TCE

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Division of Reproductive, Abdominal and Radiological Dev 510(k) Number

Page 58 of 1531

27

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name: Intended Use:

1

EV9F4 Curved Array Mechanical 3D/4D 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
(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		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)

N = new indication; P = previously cleared by K090276

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

Note 2 Ensemble tissue harmonic Imaging

3D imaging
B&W SieScape panoramic imaging Note 3 Note 4

Power SieScape panoramic imaging
For example: abdominal, vascular Note 5

Note 6

Note 7 Contrast agent Imaging

SieClear multi-view spatial compounding
Tissue Equalization Technology Note 8

Note 9 Note 10 Intracardiac imaging

Note 11 Dynamic TCE

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

(Division 9) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

Page 59 of 1531

28

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

Intended Use:

L13F5 3D/4D Mechanical Wobbler Linear Transducer for use with: 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 Color Specific Color Amplitude Combined Other ( Track 1 A B M PWD CWD Velocity (Tracks 11& 3) Dopple Doppler (Specify) Only) (Specify) Imaging Ophthalmic Ophthalmic Fetal P P P P P BMDC Note 2,3,4,5,7,8,9 Abdominal P P P പ്ര 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 BMDC Note 2,3,4,5,7,8,9 lmaging SmallOrgan P P P P P BMDC Note 2,3,4,5,7,8,9 & Other (Note 1) 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. P P P P P BMDC Note 2,3,4,5,7,8,9 (Convent.) Musculo-skel. P P P P BMDC P Note 2,3,4,5,7,8,9 (Superfic) Intra-vascular Other (Specify) Cardlac Adult Cardiac Cardlac Pediatric Intra-vascular (Cardiac) Trans-esophageal (Cardiac) Intra-cardiac Other (Specify) Peripheral Peripheral vessel p P P P P BMDC Note 2,3,4,5,7,8,9

Other (Specify) N = new indication; P = praviously cleared by K090276

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

Note 2 Ensemble tissue harmonic imaging

Vessel

Note 3

3D imaging
B&W SieScape panoramic imaging Note 4 Note 5

Power SleScape panoramic imaging Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Note 8 SieClear multi-view spatial compounding

Note 9 Tissue Equalization Technology

Note 10 Intracardiac imaging

Note 11 Dynamic TCE

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

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Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

Page 60 of 1531

29

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

Intended Use:

VFB-3 Linear Array Transducer for use with:
ACUSON X300 Dlagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
(Track1
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										Note 12
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11,12
Vessel	Other (Specify)

N = new indication; P = previously cleared by K090276

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

Note 2 Ensemble tissue harmonic imaging

Note 3

20 Imaging
B&W SieScape panoramic imaging
Power SieScape panoramic Imaging Note 4
Note 5

Note 6 For example: abdominal, vascular

Note 7

Contrast agent imaging
SieClear multi-view spatial compounding Note 8

Note 9 Tissue Equalization Technology

intracardiac imaging Note 10 Note 11 Dynamic TCE

Note 12 AHP

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use (Per 21 CFR 801.109)

Hone m Why

(Division Sign-C Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number _

K09353,

Page 61 of 1531

30

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

Intended Use:

P5-1 Phased 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
(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
2,3,4,5,7,8,9,11
	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		P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
	Adult Cephalic		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		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
(Cardlac)
	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 = prevlously cleared by K090276

For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 1

Note 2 Note 3

Note 4

B&W SieScape panoramic imaging Nole 5 Power SieScape panoramic imaging

For example: abdominal, vascular Note 6

Nota 7 Contrast agent imaging

Note 8 SieClear multi-view spatial compounding

Tissue Equalization Technology
Intracardiac imaging Note 9

Note 10

Note 11 Dynamic TCE

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

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Page 62 of 1531

510(k) Number

Devices:
K093531

31

ACUSON X300™ Diagnostic Ultrasound System 5!0(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

Intended Use:

C6-2 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
(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		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)
	Neonatal Cephalic
	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)
	Intra-vascular
	Other
(Specify)
Cardiac	Cardiac Adult		P	P	P		P	P		BMDC	Note
2,3,4,5,7,8,9,11
Cardlac	Cardiac Pediatric		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		BMDC	Note
2,3,4,5,7,8,9,11
	Other (Specify)

N = new Indication; P = previously cleared by K090276

Note 1
Note 2 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4

B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

Contrast agent imaging Note 7

Note 8 SteClear multi-view spatial compounding

Note 9 Tissue Equalization Technology Intracardiac imaging Note 10

Note 11 Dynamic TCE

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Page 63 of 1531

32

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

Intended Use:

SoundStar 10F Transducer for use with: ACUSON X300 Dlagnostic 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
	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
2,3,7,8,9,10,11
	Other
(Specify)
	Cardiac Adult		P	P	P	P	P	P		BMDC	Note
2,3,7,8,9,10,11
Cardiac	Cardiac Pediatric		P	P	P	P	P	P		BMDC	Note
2,3,7,8,9,10,11
	Intra-vascular
(Cardiac)		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		BMDC	Note
2,3,7,8,9,10,11
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared by K090276;

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

Note 2
Note 3 Ensemble tissue harmonic imaging 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5

Power SieScape panoramic imaging
For example: abdominal, vascular Note 6

Note 7
Note 8

Contrast agent imaging
SleClear mull-view spatial compounding

Note g Tissue Equalization Technology Note 10 Intracardiac imaging

Note 11 Dynamic TCE

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

---

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Device

510(k) Number

Page 64 of 1531

33

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

:

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

Intended Use:

P9-4 Phased 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	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		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)
	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.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
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
(Cardiac Neonatal)	P	P	P	P	P	P	P		BMDC	Note
2,3,4,5,7,8,9,11
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

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

For example: Breast, testies, unfroid.
Sinsemble tissue panomic imaging
BBW SleScape panoramic imaging
Frower SieScape panoramic imaging
Frower SieScape panoramic imaging

Note 2
Note 3

Note 4 R&W SlaS

Note 4
Note 5

Note 6
Note 7 For example: abdominal, vascular

Note 7 Contrast agent imaging
Note 8 Ct/Ct-like multi-site identified

Contrast agent imaging
SieClear mull-view spatial compounding Note 8 Note 9

Tissue Equalization Technology
Intracardlac Imaging Note 10

Note 11 Dynamic TCE

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 65 of 1531

Amy In Nha
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Device

510(k) Number

Number K093531

34

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name: Intended Use:

.

P4-2 Litho 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
(Track1
Only)	Specific
(Tracks 1& 3)	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal		N	N	N		N	N		BMDC	Note
2,3,4,5,7,8,9, 11
	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 Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other
(Cardiac Neonatal)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared by FDA

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

Note 2 Ensemble tissue harmonic imaging

Nota 3

3D imaging
B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 4
Note 5

For example: abdominal, vascular

Note 6
Note 7 Contrast agent imaging

SieClear multi-view spatial compounding Note 8

Tissue Equalization Technology Note 9

Note 10 Intracardiac imaging

Note 11 Dynamic TCE

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Aonm In Wlz
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Device

510(k) Number K093531

Page 66 of 1531

35

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

BP9-4 Convex Array Transducer for use with:

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
(Tracks 1& 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)	N	N	N	N		N	N		BMDC	Note
2,3,4,5,7,8,9,11
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N	N		N	N		BMDC	Note
2,3,4,5,7,8,9,11
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

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

Note 2 Ensemble tissue harmonic imaging Note 3 3D imaging
B&W SieScape panoramic imaging

Note 4

Note 5 Power SieScape panoramic imaging
For example: abdominal, vascular

Note 6

Note 7
Note 8 Contrast agent Imaging

SieClear multi-view spatial compounding Note 9 Tissue Equalization Technology

Note 10

Intracardiac imaging
Dynamic TCE Note 11

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Tonuiz Wly
(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devic 510(k) Number

Page 67 of 1531