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

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

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

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

AI/ML Overview

The provided 510(k) submission for the Siemens ACUSON X300 Diagnostic Ultrasound System does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria in the typical format of a clinical performance study with quantitative metrics (like sensitivity, specificity, or AUC) compared against a predefined threshold.

Instead, the submission primarily focuses on establishing substantial equivalence to legally marketed predicate devices, which is the primary pathway for 510(k) clearance. Substantial equivalence is demonstrated by showing that the new device has the same intended use and similar technological characteristics to the predicate device, or if there are differences, that these differences do not raise new questions of safety and effectiveness.

The "Performance Data" section (Section E) states: "The Acuson X300 modifications are verified and validated according to the company's design control process." This indicates that internal testing and verification/validation activities were performed to ensure the device functions as intended and meets its design specifications, but specific details of these tests, including acceptance criteria, sample sizes, ground truth establishment, or expert involvement, are not provided in this summary.

The document lists various product safety and biocompatibility standards that the device has been designed to meet. These standards themselves include acceptance criteria for their respective domains (e.g., electrical safety, acoustic output, biocompatibility). Compliance with these standards is a form of meeting acceptance criteria but doesn't involve clinical performance metrics in the way a comparative effectiveness study would.

The "Indications for Use Form" for the main system and each transducer lists the clinical applications and modes of operation ("P" for previously cleared, "N" for new indication). For the new indications, the assumption is that the new functionalities (like the Arterial Health Package) have been validated, but the details of this validation are not present in this document.

Therefore, based on the provided text, a table of acceptance criteria and reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, details of MRMC studies, or standalone algorithm performance, as requested in the input, cannot be extracted.

The document describes the intended use of the device for various applications and mentions the Arterial Health Package (AHP) software, which provides capabilities to measure Intima Media Thickness and reference normative tables "validated and published in peer-reviewed studies." This implies that the underlying science for AHP's clinical utility is derived from external, peer-reviewed research, rather than a de novo clinical study conducted for this specific 510(k) submission.

Summary of available information related to performance/validation:

Acceptance Criteria & Device Performance: Not explicitly stated as quantitative metrics against a specific threshold in this summary. The general acceptance criterion for a 510(k) is "substantial equivalence" to predicate devices, which implies similar safety and effectiveness.
Study Type: No specific clinical study is described in detail for performance evaluation of the ACUSON X300 or its specific new features (beyond stating "modifications are verified and validated according to the company's design control process"). The AHP software references "normative tables that have been validated and published in peer-reviewed studies," indicating reliance on existing scientific literature for its clinical basis, not a new study.
Sample Size (Test Set & Training Set): Not provided.
Data Provenance: Not provided.
Number of Experts/Qualifications (Test Set Ground Truth): Not provided.
Adjudication Method: Not provided.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No such study is mentioned.
Standalone Performance (Algorithm Only): Not mentioned, as this is an ultrasound system with associated software, not typically a standalone AI algorithm.
Type of Ground Truth: Not specified for any performance evaluation in this summary. For AHP, the ground truth for normative tables is implicitly from "peer-reviewed studies."
How Ground Truth for Training Set was Established: Not applicable as training set details are not provided.

Summary

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690776

Siemens Medical Solutions USA, Inc. Ultrasound Division

ACUSON X300 ™ Diagnostic Ultrasound System 510(k) Submission

FEB 1 9 2009

510(k) Summary

Siemens Medical Solutions, Inc., Sponsor: Ultrasound Division 1230 Shorebird Way Mountain View, California 94043

Contact Person: Shelly Pearce Telephone: (650) 694-5988 Fax: (650) 694-5580

January 6, 2009 Submission Date:

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

Diagnostic Ultrasound System with Accessories Common Name:

Classification:

Requlatory Class: 11 Review Category: Tier II Classification Panel: Radiology

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

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 (K080760, K071036 and K061946) and the following:

K050240, ACUSON CV70 Cardiovascular System .
K063085, ACUSON Sequoia Ultrasound System �
K071036, Acuson X300 Diagnostic Ultrasound System .
K080760, ACUSON X300™ Diagnostic Ultrasound System, premiunm edition .
K083149, Arterial Health Package (AHP) software ●

B. Device Description:

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

UL 60601-1, Safety Requirements for Medical Equipment 미
IEC 60601-2-37 Diagnostic Ultrasound Safety Standards I
8 CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment

{1}------------------------------------------------

B AJUM/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 1
93/42/EEC Medical Devices Directive E
1 Safety and EMC Requirements for Medical Equipment
- EN/IEC 60601-1 ■
- EN/IEC 60601-1-1 ■
- l EN/IEC 60601-1-2
- EN/IEC 60601-1-4 、『
- EN/IEC 60601-1-6 트
- 트 EN/IEC 60601-2-18
- 트 EN/IEC 60601-2-25
IEC 1157 Declaration of Acoustic Power 동
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.

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Image /page/2/Picture/0 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 an abstract image of an eagle with its wings spread.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

FEB 19 2009

Re: K090276

Trade/Device Name: Acuson X300 Diagnostic Ultrasound Systems :

Regulation Number: 21 CFR 892.1560

Regulation Name: Ultrasonic pulsed echo imaging system

Regulatory Class: II

Product Code: IYO, IYN, and ITX

Dated: February 3, 2009

Received: February 4, 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 missranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Acuson X300 Diagnostic Ultrasound Systems, 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 EV9-4 Convex Array

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VF13-5 Linear Array P8-4 Phased Sector Array BE 9-4 Convex Array CW2 Continuous Wave CW5 Continuous Wave 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

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 320); and ifrapplies ble, the electionic product radiation controll provisions (Sections 531-542 of the Prody 2F CFR 1000-1056.

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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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: :

100 - 100 -

11:11

Enclosure(s)

: 11 :

. . . . .

If you have any questions regarding the content of this letter, please contact Paul Hardy at (240) 276-3666.

. .;:' -

Sincerely yours,

Joaquín M. Thaz

Janine M. Morris رق Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

・

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Indications for Use Statement

510(k) Number (if known): Ko90276

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 (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-Off)

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

X300 510(k) Submission

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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:

ACUSON X300 Diagnostic Ultrasound Systems

ਾ | - | - |

・

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

Clinical Application	Specific(Tracks1 & 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
Fetal	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	Note2,3,4,5,7,8,9,11
	Intra-operative(Note 6)	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-operative(Neuro)LaparoscopicPediatric	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		BMDC	Note2,3,4,5,7,8,9,11
	Neonatal Cephalic	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		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
	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		BMDC	Note2,3,4,5,7,8,9,11
	Musculo-skel.(Superfic)	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		BMDC	Note2,3,4,5,7,8,9,11
	Other(Specify)	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
Cardiac	Cardiac Adult	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Cardiac Pediatric	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		BMDC	Note2,3,4,5,7,8,9,11
	Trans-esophageal(Cardiac)	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		BMDC	Note2,3,4,5,7,8,9,11
PeripheralVessel	Peripheral vessel	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		BMDC	Note2,3,4,5,7,8,9,11
N = new indication; P = previously cleared by K080760
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 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
Note 12	AHP
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	Note2,3,5,6,7,8,9,11
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric		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		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	Cardiac Adult		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	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)
PeripheralVessel	Peripheral vessel		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Other (Specify)

Radiological Devices 510(k) Number Kogo23

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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:

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

Note 2 Ensemble tissue harmonic imaging

Note 3

3D imaging
B&W SiaScape panoramic imaging Note 4

Nota 5 Power SieScape panoramic Imaging

Nota 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Nota 8 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 9

Note 10 Intracardiac imaging

Nota 11 Dynamic TCE . :

borny In When (B) EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use (Per 21 CFR 801.109)

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( 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)
	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
PeripheralVessel	Other (Specify)Peripheral vessel		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Other (Specify)
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	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
	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 K080760
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 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
Note 12	AHP

eviously cleared by K080760

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

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

Note 4 B&W SieScape panoramic Imaging

Note 5 Power SiaScape panoramic Imaging

Note 6 For example: abdominal, vascular Note 7

Contrast agent imaging

Nota A SieClaar 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)

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices EHA/JJ MI. A 507 24

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

Diagnostic Ultrasound Indications for Use Form

ਕੂੰ ਦੇ '' '' '

510(k) Number (if known):

Device Name:

Intended Use:

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

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

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

Intended Use:

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

cended use.

Clinical Application Mode of Operation Other Color Specific ( Track 1 Color Amplitude Combinad A Other B ખ PWD CWD (Tracks11& 3) Velocity Only) Doppler Doppler (Specify) (Specify) Imagino Ophthalmic Ophthalmic Fetal Nota P P P P P BMDC 2,3,4,5,7,8,3,11 Abdominas " P . P P . · Note P ප BMDC 2,3,4,5,7,8,9,11 Intra-operative (Note 6) Intra-operative (Neuro) Laparoscopic Fatal Pediatric P P P Note P P BMDC 2,3,4,5,7,8,9,11 Imaging SmallOrgan P P P Note P & Other P BMDC (Note 1) 2,3,4,5,7,8,9,11 Neonatal Cephalic P P P Note P P BMDC 2,3,4,5,7,8,9,11 Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skal. P P P Note P P (Convent) BMDC 2,3,4,5,7,8,9,11 Musculo-skal. P P P Note P P BMDC (Superfic) 2,3,4,5,7,8,9,11 Intra-vascular Other (Specify) Cardiac Adult Cardlac Cardlac Pediatric Note 12 Intra-vascular (Carrisc) . . . The Paramation (1) and 201 .. ・・・・・・ Cartistics ... . .. Intra-Cardaio . .. Other (Specify) Peripheral Peripheral vessel P P P Note P P BMDC 2,3,4,5,7,8,9,11,12 Vassel Other (Specify)

N = new Indication; P = previously cleared by K080760

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

Note 2 Ensemble tissue harmonic imaging

Note 3 3D Imaging

Note 4 B&W SieScape panoramic imaging

Nota 5 Power SieScape panoramic imaging

Nota 6 For example: abdominal, vascular Nota 7

Contrast agent imaging Note 8 SieClear multi-vlew spatial compounding

Nota 9 Tissue Equalization Technology

Nota 10 Intracardiac imaging

Note 11 Oynamic TCE

Note 12 AHP

(PLEASE OO 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}

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

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic 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(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
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	PediatricSmallOrgan(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)
PeripheralVessel	Peripheral vessel
	Other (Specify)

N = new allocation, R = previously captured by Robo/CO

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

Ensemble tissue harmonic imaging Note 2
3D imaging Note 3

B&W SieScape panoramic imaging Note 4

Power SleScape panoramic Imaging Note 5

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

Note 8 SleClear 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) Acurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

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

ACUSON X300m 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( 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(Nota 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)
PeripheralVessel	Peripheral vessel
	Other (Specify)

reviously cleared by K080760

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

Ensemble tissue harmonic imaging Nota 2

3D imaging Note 3

B&W SleScape panoramic Imaging Note 4

Power SieScape panomic Imaging Note 5

Note 6

Note 7 Contrast agent imaging

Note 8 SleClear 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)

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

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

.47

Diagnostic Ultrasound Indications for Use Form

香港

510(k) Number (if known):

VF13-5 Linear Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

.. .. ...

Device Name: Intended Use:

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

Clinical Application		Mode of Operation
Other(Track 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 5)
	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										Note 12
Cardiac	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
	Other (Specify)

Ensemble tissue harmonic imaging Note 2

Nota 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Nob 5 Power SieScape panoramic Imaging
Nota 6 For example: abdominal, vascular
Nota 7 Contrast agent imaging
Nota 8 SieClear multi-view spatial compounding

Nota 9 Tissue Equalization Technology

Note 10 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)

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

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

Intended Use:

P8-4 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(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)
	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.)	P	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	P		BMDC	Note2,3,4,5,7,8,9,11
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 (Specify)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Other (Specify)

N = new indication; P = previously cleared by K080760

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

Nota 2
Note 3 3D Imaging

Note 4 B&W SieScape panoramic imaging

Nate 5 Power SleScape panoramic Imaging Nate 6
For example: abdominal, vascular Note 7 Contrast agent Imaging
Nota 8 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 9
Intracardiac Imaging Note 10
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)

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

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

Intended Use:

BE 9-4 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 Color Specific Color Amplitude Other Combined I Track 1 A 8 M PWD CWD Velocity (Tracks11& 3) Doppler Doppler (Specify) (Specify) Only) Imaging Ophthalmic Ophthalmic Fetal p P p P P BMDC Note 2,3,4,5,7,8,9 + 제공 " : ... Abdominal . . .. :-Intra-operative (Note 6) Intra-operative (Neuro) Laparoscopic Fetal Pediatric Imaging SmallOrgan P P P P P BMDC Note 2,3,4,5,7,8,9 & Other (Nota 1) Neonatal Caphalic P P P P BMDC P 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-urethrai Trans-esoch. (non-Card.) Musculo-skel. (Convent) Musculo-skel. (Superfic) lutra-vascular Other (Specify) Cardlac Adult Cardiac Cardlac Pedlatric Intra-vascular : 1. : .. Clardisch .. ์ ที่การ ตรมน้ำสมุยละ ... 44. 4 Cardiacy " ... ' fitra-cardiac 11. 1 Other (Specify) Perioteral Peripheral vessel Vessel Other (Specify)

N = new indication; P = previously cleared by K080760

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

Note 2 Ensemble tissue harmonic imaging Note 3

Neds SO changing
And also SO changing

3D imaging
B&W SieScape panoramic imaging Note 4

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

Note 6 Nota 7
Contrast agent imaging Note 8 SteClear multi-view spatial compounding
Nota 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)

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

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

ACUSON X300m Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

・・

18 - 1 - 1 - 1 - 1 -

510(k) Number (if known):

CW2 Continuous Wave Dopplar Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

Device Name: Intended Use:

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

Other(Track1Only)	Specific(Tracks 1 & 3)	CWD
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-vascular
	Other(Specify)
	Cardiac Adult	P
Cardiac	Cardiac Pediatric	P
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral:Vessel	Peripheral vessel	P
	Other (Specify)
	N = new Indication; P = previously cleared by K080760

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

Note 2 Ensamble tissue harmonic imaging

3D imaging Note 3
2014 States panoramic imaging
Power SieScape panoramic imaging
For example: abdominal, vascular Note 4

Note 5

Note 6 Note 7 Contrast agent Imaging
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) Prescription Use (Per 21 CFR 801.109)

Aymith Wh

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

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

ﺮ ﺑﺎ - »

. . . . .

510(k) Number (if known):

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

Intended Use:

Device Name:

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
	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-vascular
	Other(Specify)
	Cardlac Adult					P
Cardiac	Cardiac Pediatric					P
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-Cardiac.
	Other (Specify)
PeripheralVessel	Peripheral vessel					P
	Other (Specify)
Note 1	N = new Indication; P = previously cleared by K080760
Note 2	For example: breast, testes, thyroid, penis, prostate, etc.
Note 3	Ensemble tissue harmonic Imaging
Note 4	3D Imaging
Note 5	B&W SieScape panoramic Imaging
Note 6	Power SieScape panoramic Imaging
Note 7	For example: abdominal, vascular
Note 8	Contrast agent imaging
Note 9	SleClear multi-view spatial compounding
Note 10	Tissue Equalization Technology
Note 11	Intracardiac imaging
	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 Devices 510(k) Number __

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

ﺔ ﺍﻟﻘ

Diagnostic Ultrasound Indications for Use Form

510(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(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
FetalImaging& Other	Pediatric	P	P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	SmallOrgan(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)
	Musculo-skel.(Superfic)
	Intra-vascular		P	P	P	P	P	P		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)		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	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 K080760

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

Nota 2 Ensemble tissue harmonic imaging
Note 3 3D imaging

Note 4 B&W SleScape panoramic imaging

Note 5 Power SieScape panoramic Imaging Note 6

For example: abdominal, vascular Note 7 Contrast agent imaging

Note 8
SieClear multi-view spatial compounding
Tissue Equalization Technology Note 9
Intracardiac imaging Note 10

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

Dynamic TCE

(PLEASE DO
Sign-Off)

Note 11

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

રીક

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

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

Intended Use:

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

Clinical Application		Mode of Operation
Other( 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		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)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared by K080760

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

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SleScape panoramic imaging

Note G For example: abdominal, vascular

Note 7 Contrast agent imaging

Note B SlaClear multi-vlew spatial compounding

Note 9 Tissue Equalization Technology

Note 10 Intracardiac imaging

Nota 11 Dynamic TCE

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

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

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

V5Ms TEE Transducer for use with:

Device Name: Intended Use:

ACUSON X300 Diagnostic Ultrasound Systems

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

Clinical Application		Mode of Operation
Other(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
FatalImaging& Other	Pediatric
	SmallOrgan(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult	P	P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,11
Cardiac	Cardiac Pediatric	P	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
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)

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

Note 2 Ensemble tissue harmonic imaging

3D imaging Note 3

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging Nort G 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)

(Division Sign-Off)

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

{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:

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	Note 2,3,4,5,7,8,9
	Abdominal		P	P	P	P	P	P		BMDC	Note 2,3,5,6,7,8,9
	Intra-operative(Note 5)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
	SmallOrgan(Note 1)
	Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
	Adult Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
Cardiac	Cardiac Adult		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
	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)
PeripheralVessel	Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
	Other (Specify)

Note t For example: breast, testas, thyroid, penis, prostate, etc.

Note 2 Ensemble tissue harmonic imaging

Note 3

3D imaging
B&W SleScape panoramic Imaging Note 4

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

Note 7 Contrast agent imaging

Nota 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)

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

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

VF13-5SP Linear Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

Device Name: Intended Use:

Diagnostic imaging or fluld 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)		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 K080760

Nota 1 For example: breast, testes, thyroid, penis, prostate, etc. Ensemble tissue harmonic knaging

Note 2 Note 3 3D Imaging
B&W SieScape panoramic imaging Note 4
Note 5 Power SieScape panoramic Imaging
Note 6 For example: abdominal, vascular
Contrast agent imaging Note 7
Note 8 SieClear multi-view spatial compounding
Tissue Equalization Technology
Nota 9
Note 10 Intracardiac imaging
Nota 11 Dynamic TCE
Note 12 AHP

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

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

ACUSON X300m Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name: Intended Use:

C8-5 Tightly Curved 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	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)

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

Note 2 Ensemble tissue harmonic imaging

Note 3

3D imaging
B&W SieScape panoramic Imaging
Power SieScape panoramic imaging
T Note 4

Note 5 Note 6 For example: abdominal, vascular

Nota 7 Contrast agent imaging

Nota 8 SleClear multi-view spatial compounding

Tissue Equalization Technology Nota 9

Note 10 Intracardiac Imaging

Note 11 Dynamic TCE
510(k) Number

(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

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

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

న్నారు.

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

8L3 Linear "Regel" Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

1999

Device Name: Intended Use:

Dlagnostic 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		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& 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
	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										Note 12
Cardiac	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
Peripheral	Peripheral vessel		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,12
Vessel	Other (Specify)
Note 1Note 2Note 3Note 4Note 5Note 6Note 7Note 8	N = new indication; P = previously cleared by K080760For example: breast, testes, thyroid, penis, prostate, etc.Ensemble tissue harmonic imaging3D ImagingB&W SleScape panoramic imagingPower SieScape panoramic ImagingFor example: abdominal, vascularContrast agent imaging
Note 9Note 10	SleClear multi-view spatial compoundingTissue Equalization TechnologyIntracardiac imaging
Note 11Note 12	Dynamic TCE
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
FetalImaging& Other	Pediatric		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
	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
	intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
	Other (Specify)

(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 K090276

{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:

N = new indication; P = previously cleared by K080760

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

Note 2 Ensemble tissua harmonic imaging

Note 3 3D imaging Note 4

B&W SieScape panoramic imaging Note 5

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

Note 7 Contrast agent Imaging
Note 8 SleClear 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)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K090276

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

Diagnostic Ultrasound Indications for Use Form

・・

510(k) Number (if known):

Device Name:

Intended 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(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
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 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)
PeripheralVessel	Peripheral vessel	P	P	P			P	P		BMDC	Note2,3,4,5,7,8,9,11
	Other (Specify)

N = new indication; P = proviously cleared by K080760

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 6 For example: abdomínai, vascular Note 7

Contrast agent imaging

Note B SteClear 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) m. h the Concurrence of CDRH. Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

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

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

EV9F4 Curved Array Mechanical 3D/4D Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

Device Name: Intended Use:

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

Intended Use.

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
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-esophagnal(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new Indication; P = previously cleared by K080760

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

Note 2 Note 3

3D imaging Note 4 B&W SieScape panoramic imaging

Power SleScape panoramic imaging Note 5
Note G For example: abdominal, vascular
Contrast agant imaging Note 7

Note 8 SieClear multi-view spatial compounding

Note 9 Tissue Equalization Technology

Intracardlac Imaging Note 10
Note 11 Oynamic TCE

EASE 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 Ko 90276

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

Diagnostic Ultrasound Indications for Use Form

ો હ

... ... ... .. .. .. .. ..

510(k) Number (if known):

L13F5 3D/4D Mechanical Wobbler Linear Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

Device Name: Intended Use:

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

Clinical Application		Mode of Operation
Other(Track 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	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
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Musculo-skel.(Superfic)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel		P	P						BMDC	Note 2,3,4,5,7,8,9
	Other (Specify)
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										Note 12
Cardiac	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 K080760Note 1 For example: breast, testes, thyroid, penis, prostate, etc.Note 2 Ensemble tissue harmonic imagingNote 3 3D ImagingNote 4 B&W SleScape panoramic imagingNote 5 Power SieScape panoramic imagingNote 6 For example: abdominal, vascularNote 7 Contrast agent imaging
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		P	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	P		BMDC	Note2,3,4,5,7,8,9,11
	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	Cardiac Adult		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Cardiac Pediatric		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Other (Specify)

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
For example: abdominal, vascular Note 4
Note 5 Note 6

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 Davice Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Atyen In Wh

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

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

な

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

VF8-3 Linear Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

ﺃ ،

ﻪ ، ،

Standard Form

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

Intended Use:

Note 9. Issue Equalization Technology
Note 10. Auto-calibration

Note 10
Note 11 Intracardiac imaging Dynamic TCE

Note 12 AHE
ra: ...

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

(Division Sign-Off)
	Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number	K090276

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

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:

N = new indication; P = previously cleared by K080760

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

Note 2 Ensemble tissue harmonic imaging

Note 3 30 imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic Imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging Nota 8

SleClear multi-view spatial compounding Tissue Equalization Tachnology Note 9

Note 10 Intracardiac imaging

Note 11 Dynamic TCE

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

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

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

C6-2 Convex Array Transducer for use with: ACUSON X300 Dlagnostic Ultrasound Systems

ﮯ ﮨﯿﺪ

Device Name: Intended Use:

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

Clinical Application		Mode of Operation
Other(Track 1Only)	Specific(Tracks1& 3)	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		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	P		BMDC	Note2,3,4,5,7,8,9,11
	Small Organ(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)	P	P	P	P		P	P		BMDC	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)
PeripheralVessel	Peripheral vessel	P	P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Other (Specify)

N = new indication; P = previously cleared by K080760

Note 1 For example: breast, testas, thyroid, penls, prostate, etc.

Nota 2 Ensemble tissue harmonic Imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging Note 6

Note 6 For example, abdominal
Note 7 Contrast agent imaging

Note 7
For example: abdominal, vascular
Contrast agent imaging
SieClear multi-view spattal compounding Note 8 Tissue Equalization Technology
Note 9 Note 10 intracardlac 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)

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

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

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

Device Name: Intended Use:

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

Clinical Application			Mode of Operation
Other(Track 1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Note O)		:						:
	Intra-operative(Nauro)		ﺎﺀ ﻣ
	Laparoscopic
Fetal	Pediatric
Imaging& Other	SmallOrgan{Noto 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	Nota2,3,7,8,9,10,11
	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	Nota2,3,7,8,9,10,11
	Intra-vascular(Cardlac)		P	P	P	p	P	P		BMDC	Note2,3,7,8,9,10,11
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Trans-esophagealCardlac)	:	ﺎ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -	12 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-	ﻴﻮﻧﺎ1	.		.
:	Intra-cardiac · J	:	P	ાં ર	" દ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	్లు భూమి:	产品广播-	رج. ←		BMDC: "	: Note Note : :2,3,7,8,9,10,11"
	Other (Specify)
· Peripheral	Peripheral vessel
Vessel	Other (Spacify)

N = new Indication; P = previously cleared by K080760;

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

Nata 2 Note 3

3D imaging Note 4
- B&W SieScape panoramic imaging
  Power SieScape panoramic imaging
  For example: abdominal, vascular
Note 5 Note 6
Note 7 Contrast agent imaging
Note 8 SieClear multi-view spatial compounding
Tissue Equalization Technology Nota 9
Note 10 Intracardiac imaging
Note 11 Dynamic TCE

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

(Division Sign Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K090276

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

ACUSON X300™ Diagnostic Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

P9-4 Phased Array Transducer for use with:

Device Name: -Intended Use:

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

Clinical Application		Mode of Operation
Other(Track 1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	N	N		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal	N	N	N	N	N	N	N		BMDC	Note2,3,5,6,7,8,9,11
	Intra-operative(Note 8)
	Intra-operative(Neuro)	N	N	N		N	N	N		BMDC	Note2,3,4,5,7,8,9,11
	Laparoscopic
FetalImaging& Other	Pediatric	N	N	N	N	N	N	N		BMDC	Note2,3,4,5,7,8,9,11
	SmallOrgan(Note 1)	N	N	N	N	N	N	N		BMDC	Note2,3,4,5,7,8,9,11
	Neonatal Cephalic	N	N	N	N	N	N	N		BMDC	Note2,3,4,5,7,8,9,11
	Adult Cephalic	N	N	N	N	N	N	N		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	N	N	N	N	N	N	N		BMDC	Note2,3,4,5,7,8,9,11
Cardiac	Cardiac Pediatric	N	N	N	N	N	N	N		BMDC	Note2,3,4,5,7,8,9,11
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other(Cardiac Neonatal)	N	N	N	N	N	N	N		BMDC	Note2,3,4,5,7,8,9,11
Peripheral	Peripheral vessel	N	N	N	N	N	N	N		BMDC	Note2,3,4,5,7,8,9,11
Vessel	Other (Specify)

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

Note 2 Ensemble tissue harmonic Imaging

Note 3 3D imaging

Note 4. B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic Imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

SieClear multi-view spatial compounding
Tissue Equalization Technology Note 8

Note 9
intracardiac Imaging Note 10

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)

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).