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

AI/ML Overview

The Siemens ACUSON X300™ Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system.

Here's an analysis based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the typical sense of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for a particular clinical application. Instead, it demonstrates compliance with recognized product safety and acoustic output standards. The "device performance" reported is the meeting of these standards, which serves as the acceptance criteria for regulatory approval.

Feature/Standard	Acceptance Criteria	Reported Device Performance/Status
Product Safety Standards	Compliance with listed safety standards	Met: The Acuson X300 has been designed to meet and is verified/validated according to the company's design control process for the following: - 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
Substantial Equivalence (Intended Use)	Equivalent to legally marketed predicate devices	Met: The submission device is substantially equivalent to the predicate with regard to intended use. The intended use includes applications such as 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 measurement of anatomical structures and analysis packages for clinical diagnosis. This is largely based on "P = previously cleared by K090276" for various modes and applications across numerous transducers.
Substantial Equivalence (Technological Characteristics)	Equivalent to legally marketed predicate devices	Met: The submission device is substantially equivalent to the predicate with regard to technological characteristics. The document lists "Acuson X300 modifications are verified and validated according to the company's design control process." The predicate devices mentioned are other Siemens Acuson ultrasound systems: Siemens Acuson X300 (K090276, K071036, K061946), Siemens Acuson X500™ (K061980), and ACUSON X150 (K081121).
New Indication (P4-2 Litho Phased Sector Array - Abdominal)	The Abdominal application for this transducer is cleared.	Met: For the P4-2 Litho Phased Sector Array Transducer, the "Abdominal" application is marked with "N" for new indication, meaning it was newly cleared (N) for this specific application with this transducer, in various modes (B, M, PWD, Color Doppler, Amplitude Doppler, Combined BMDC). This implies the performance for this new indication on this transducer met the necessary safety and efficacy for clearance.
New Indication (BP9-4 Convex Array - Small Organ & Trans-rectal)	The Small Organ and Trans-rectal applications for this transducer are cleared.	Met: For the BP9-4 Convex Array Transducer, "Small Organ" and "Trans-rectal" applications are marked with "N" for new indication, meaning they were newly cleared (N) for this specific application with this transducer, in various modes (A, B, M, PWD, Color Doppler, Amplitude Doppler, Combined BMDC). This implies the performance for these new indications on this transducer met the necessary safety and efficacy for clearance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe specific clinical test set sizes, data provenance, or study types (retrospective/prospective) in the context of typical clinical performance studies for AI/CAD devices. The submission primarily focuses on substantial equivalence to predicate devices and compliance with recognized safety and performance standards for diagnostic ultrasound systems. The "Performance Data" section states: "The Acuson X300 modifications are verified and validated according to the company's design control process." This indicates internal testing and validation against engineering specifications and regulatory standards rather than a clinical trial with a "test set" in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the summary. As the submission relies on demonstrating substantial equivalence to predicate devices and compliance with general standards, a specific "ground truth" establishment process by external experts, as might be required for a novel AI/CAD device, is not detailed. The "ground truth" for compliance testing would be defined by the technical specifications of the standards themselves.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Given the nature of the submission (demonstrating compliance with technical standards and substantial equivalence), a formal adjudication method for clinical test interpretations is not described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not mentioned or indicated in this 510(k) summary. This submission predates the widespread regulatory requirements for performance studies of AI/CAD-enabled devices that would typically necessitate such studies. The device is a diagnostic ultrasound system, not an AI/CAD product.

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

A standalone performance study for an algorithm was not mentioned or indicated. The device is a complete ultrasound system, and the submission addresses its overall safety and performance as a diagnostic imaging tool.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the new indications (Abdominal for P4-2 Litho, Small Organ and Trans-rectal for BP9-4), the "ground truth" would be the established diagnostic capabilities of comparable ultrasound systems for those applications, as demonstrated through predicate device equivalency and adherence to established medical imaging principles and performance standards (e.g., image quality, penetration, resolution, Doppler accuracy). The document does not specify a separate clinical "ground truth" generation process.

8. The sample size for the training set

This information is not applicable / not provided. The ACUSON X300 is a diagnostic ultrasound system, and the submission focuses on its hardware and software functionality and compliance with performance standards. The concept of a "training set" is typically relevant for machine learning or AI-driven devices, which this submission does not describe.

9. How the ground truth for the training set was established

This information is not applicable / not provided for the reasons stated above.

Summary

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K093531

ACUSON X300 ™ Diagnostic Ultrasound System 510(k) Submission

510(k) Summary

Sponsor:	Siemens Medical Solutions, Inc.,Ultrasound Division1230 Shorebird WayMountain View, California 94043
Contact Person:	Shelly PearceTelephone: (650) 694-5988Fax: (650) 694-5580
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 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 (301) 796-6242.

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 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(Track1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic	P	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Fetal	P	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Abdominal	P	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Intra-operative(Note 6)	P	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Intra-operative(Neuro)	P	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
Fetal	Laparoscopic	P	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Pediatric	P	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
Imaging& Other	SmallOrgan(Note 1)	P	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Neonatal Cephalic	P	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Adult Cephalic	P	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Trans-rectal	P	P	P	P		P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Trans-vaginal	P	P	P	P		P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Trans-urethral	P	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Trans-esoph.(non-Card.)	P	P	P	P		P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Musculo-skel.(Convent.)	P	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Musculo-skel.(Superfic)	P	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Intra -vascular	P	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Other(Specify)	P	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Cardiac Adult	P	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11,12
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Intra-vascular(Cardiac)	P	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Trans-esophageal(Cardiac)	P	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Intra-Cardiac	P	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Other (Specify)	P	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
PeripheralVessel	Peripheral vessel	P	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11,12
	Other (Specify)	P	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11

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 1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal	P	P	P	P	P	P	P		BMDC	Note2,3,5,6,7,8,9,11
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
Imaging& Other	SmallOrgan(Note 1)
	Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Adult Cephalic		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	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	Note2,3,4,5,7,8,9,11
Cardiac	Cardiac Pediatric		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardlac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
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( Track1Only)	Specific(Tracks1& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fatal	Pediatric		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
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	Note2.3.4.5.7.8.9,11
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardlac Adult		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
Cardlac	Cardiac Pedlatric		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
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

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)

(Division Sign-Off)

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

Page 40 of 1531

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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:

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 1Only)	Specific(Tracks1& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	SmallOrgan(Note 1)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Neonatal Cephalic		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Musculo-skel.(Superfic)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric										Note 12
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11,12
	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 1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	SmallOrgan(Note 1)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Neonatal Cephalic		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Musculo-skel.(Superfic)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric										Note 12
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-Cardaic
	Other (Specify)
PeripheralVessel	Peripheral vessel		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11,12
	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 1Only)	Specific(Tracks1& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	PediatricSmallOrgan(Note 1)	P	P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Neonatal Cephalic	P	P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Adult Cephalic
	Trans-rectal	P	P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Trans-vaginal	P	P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	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)
PeripheralVessel	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(Track1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric
	SmallOrgan(Note 1)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Neonatal Cephalic		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Adult Cephalic
	Trans-rectal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Trans-vaginal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	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 1Only)	Specific(Tracks1i& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-operative(Note 6)									-
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	SmallOrgan(Note 1)		P	P	P		P	P		BMDC	Note2.3,4.5,7,8,9,11
	Neonatal Cephalic		P	P	P		P	P		BMDC	Note2.3,4,5,7,8,9,11
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Musculo-skel.(Superfic)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-vascular
	Other(Specify)
Cardiac	Cardiac Adult										Note 12
	Cardiac Pediatric
	Intra-vascular.(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11,12
	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 1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal		P	P	P	P	P	P		BMDC	Note2,3,5,6,7,8,9,11
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
Imaging& Other	SmallOrgan(Note 1)
	Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent)		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
Cardiac	Cardiac Pediatric		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel .		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
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 1Only)	Specific(Tracks1& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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 1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal					P
	Abdominal					P
	Intra-operative(Note 6)					P
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& 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-vascularOther
	(Specify)
	Cardiac Adult					P
Cardiac	Cardiac Pediatric					P
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	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 1Only)	Specific(Tracks 1& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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:

. . ..

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( Track1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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	Note2,3,7,8,9,10,11
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	Note2,3,7,8,9,10,11
	Other(Specify)
	Cardiac Adult		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
Cardiac	Cardiac Pediatric		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	Intra-vascular(Cardiac)		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	Trans-esophageal(Cardiac)
	Intra-cardiac		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	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 1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pedlatric		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	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	Note2,3,7,8,9,10,11
	Other(Specify)
	Cardlac Adult		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
Cardiac	Cardiac Pediatric		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	Intra-vascular(Cardiac)		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	Trans-esophageal(Cardlac)
	Intra-cardiac		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	Other (Specify)
PeripheralVessel	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:

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 1Only)	Specific(Tracks1I& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric
	SmallOrgan(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
Cardiac	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)
PeripheralVessel	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(Track1Only)	Specific(Tracks 11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9, 11
	Abdominal		P	P	P,	P	P	P		BMDC	Note2,3,5,6,7,8,9,11
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric		P	P	P	P	P	P		BMDC	Note2,3,5,6,7,8,9,11
Imaging& Other	Small Organ(Note 1)
	Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note2.3,5,6,7,8,9,11
	Adult Cephalic		P	P	P	P	P	P		BMDC	Note2,3,5,6,7,8,9, 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	Note2,3,5,6,7,8,9, 11
Cardiac	Cardiac Pediatric		P	P	P	P	P	P		BMDC	Note2,3,5,6,7,8,9, 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( Track1Only)	Specific(Tracks 1& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Note 6)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-operative(Neuro)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9.11
	Laparoscopic
Fetal	Pediatric		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9.11
Imaging& Other	SmallOrgan(Note 1)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Neonatal Cephalic		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9.11
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9.11
	Musculo-skel.(Superfic)		P	P	P		P	P		BMDC .	Note2,3,4,5,7,8,9.11
	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	Note2,3,4,5,7,8,9,11,12
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

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 1Only)	Specific(Tracks 11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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
FetalImaging& 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)
PeripheralVessel	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( Track1Only)	Specific(Tracks1& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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 1Only)	Specific(Tracks 1& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
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	Note2,3,4,5,7,8,9,11
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
Cardiac	Cardiac Pediatric		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
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:

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 1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging& Other	SmallOrgan(Note 1)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Neonatal Cephalic		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Adult Cephalic
	Trans-rectal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Trans-vaginal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	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)

Aopui in Wz
(Division Sign-Off)

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(Track1Only)	Specific(Tracks 1& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
Imaging& Other	SmallOrgan(Note 1)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Neonatal Cephalic		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Musculo-skel.(Superfic)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	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	Note2,3,4,5,7,8,9,11,12
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)

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(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(Track1Only)	Specific(Tracks11&3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
Imaging& Other	SmallOrgan(Note 1)
	Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Adult Cephalic		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	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	Note2,3,4,5,7,8,9,11
Cardiac	Cardiac Pediatric		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardlac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
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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Division of Reproductive, Abdominal, and Radiological Devic

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(Track1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	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	Note2,3,4,5,7,8,9,11
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
Cardiac	Cardiac Adult		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
Cardlac	Cardiac Pediatric		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	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 1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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	Note2,3,7,8,9,10,11
	Other(Specify)
	Cardiac Adult		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
Cardiac	Cardiac Pediatric		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	Intra-vascular(Cardiac)		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	Trans-esophageal(Cardiac)
	intra-cardiac		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	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(Track1Only)	Specific(Tracks1& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal	P	P	P	P	P	P	P		BMDC	Note2,3,5,6,7,8,9,11
	Intra-operative(Note 6)
	Intra-operative(Neuro)	P	P	P		P		P		BMDC	Note2,3,4,5,7,8,9,11
	Laparoscopic
FetalImaging& Other	Pediatric	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	SmallOrgan(Note 1)
	Neonatal Cephalic	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	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	Note2,3,4,5,7,8,9,11
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other(Cardiac Neonatal)	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
PeripheralVessel	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

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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(Track1Only)	Specific(Tracks 1& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal		N	N	N		N	N		BMDC	Note2,3,4,5,7,8,9, 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 1Only)	Specific(Tracks 1& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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	Note2,3,4,5,7,8,9,11
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N	N		N	N		BMDC	Note2,3,4,5,7,8,9,11
	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

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.