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 tables detailing specific applications and modes of operation for various transducers).

Device Description

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

UL 60601-1, Safety Requirements for Medical Equipment
I 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
1 AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
93/42/EEC Medical Devices Directive
. Safety and EMC Requirements for Medical Equipment
- 트 EN/IEC 60601-1
- 요 EN/IEC 60601-1-1
- 트 EN/IEC 60601-1-2
- 트 EN/EC 60601-1-4
이 EN/EC 60601-1-6
. EN/IEC 60601-2-18
피 EN/EC 60601-2-25
I IEC 61157 Declaration of Acoustic Power
ISO 10993-1 Biocompatibility

AI/ML Overview

The provided document is a 510(k) summary for the ACUSON X300™ Ultrasound System. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain information regarding acceptance criteria, device performance studies (like test set sample size, provenance, expert qualifications, or adjudication methods), MRMC studies, standalone algorithm performance, or details about the training set.

The "Performance Data" section (Section E) simply states: "The ACUSON X300 modifications are verified and validated according to the company's design control process." This is a general statement and does not provide the specific details requested in your prompt.

Therefore, I cannot provide the requested information from the given text.

In summary:

1. A table of acceptance criteria and the reported device performance: Not provided in the document.
2. Sample sized used for the test set and the data provenance: Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not provided in the document. This is a diagnostic ultrasound system, not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided in the document. This is a diagnostic ultrasound system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not provided in the document.
8. The sample size for the training set: Not provided in the document. This is a diagnostic ultrasound system, not an AI/ML model that undergoes "training."
9. How the ground truth for the training set was established: Not provided in the document.

Summary

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Siemens Medical Solutions USA, Inc. Ultrasound Division CONFIDENTIAL

APR 2 5 2008

K080760

ACUSON X300™ Ultrasound System Special 510(k) Submission

SECTION 12

510(k) Summary

Sponsor:	Siemens Medical Solutions USA, Inc.,Ultrasound Division1230 Shorebird WayMountain View, California 94043
Contact Person:	Martina VogtTelephone: (425) 557 1434Fax: (425) 391 9198
Submission Date:	March 14, 2008
Device Name:	ACUSON X300™ ultrasound systemSONOVISTA X300 ultrasound systemACUSON X300™ ultrasound system, premium edition
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-IYO
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-DQC

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 (K072676, K071036, K061946).

B. Device Description:

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

UL 60601-1, Safety Requirements for Medical Equipment
I 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
1 AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
93/42/EEC Medical Devices Directive
. Safety and EMC Requirements for Medical Equipment
- 트 EN/IEC 60601-1
- 요 EN/IEC 60601-1-1
- 트 EN/IEC 60601-1-2
- 트 EN/EC 60601-1-4

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이 EN/EC 60601-1-6
. EN/IEC 60601-2-18
피 EN/EC 60601-2-25
I IEC 61157 Declaration of Acoustic Power
ISO 10993-1 Biocompatibility

C. Intended Use

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/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" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with outstretched wings, symbolizing the department's mission to protect and promote the health and well-being of Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Martina Vogt Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. Ultrasound Division 1230 Shorebird Way MOUNTAIN VIEW CA 94043

APR 2 5 2008

Re: K080760

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 DQO Dated: March 14, 2008 Received: March 26, 2008

Dear Ms. Vogt:

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

C6-2 Convex Array SoundStar 10F P4-2 Phased Sector Array CH5-2 Convex Array VF10-5 Linear Array

L9-5 Linear Array EC9-4 Convex Array Endocavity EV9-4Convex Array VF13-5 Linear Array P8-4 Phased Array

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8L3 Linear "Regel" BE9-4 Convex Array CW2 Continuous Wave Doppler 10V4 Phased Array Neonatal High CW5 Continuous Wave Doppler Frequency C7F2 Curved Array AcuNav 8F Intracardiac EV9F4 Curved Array Mechanical 3D/4D AcuNav 10F IntraCardiac L13F5 3D/4D Mechanical Wobbler Linear V5Ms TEE 4V1c Phased Array VF8-3 Linear Array P5-1 Phased Array VF13-5SP Linear Array C8-5 Tightly Curved 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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.

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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

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

Sincerely yours,

Nancy C. Brogdon

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

510(k) Number (if known):

Device Name: _ACUSON X300 Diagnostic Ultrasound System

Indications For Use:

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

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

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arri Mr. Wry

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

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510(k) Number (if known):

Device Name:

ACUSON X300 Diagnostic Uitrasound Systems

Intended Use:

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

Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(Specify)	Other(Specify)
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
Intraoperative(Note 6)	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
IntraoperativeNeurological	P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,9
Pediatric	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Small Organ(Note 1)	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Neonatal Cephalic	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Adult Cephalic	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Cardiac	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Transesophageal	P	P	P	P	P	P	BMDC	Note 2,3,7,8,9
Transrectal	P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,9
Transvaginal	P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,9
Transurethral
Intravascular	P	P	P	P	P	P	BMDC	Note 2,3,7,8,9,10
Peripheral vessel	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Other (specify)	P	P	P	P	P	P	BMDC	Note 2,3,7,8,9,10

N = new indication; P = previously cleared by K072676; E = added under Appendix E

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 Note 4

Note 5 Power SieScape panoramic imaging

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

SieClear multi-view spatial compounding Note B

Tissue Equalization Technology Note 9

Note 10 Intracardiac imaging

(Division Sign-Off
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

Prescription Use (Per 21 CFR 801.109)

Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K08074

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510(k) Number (if known):

Device Name:

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

Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		N	N	N		N	N		BMDC	Note2,3,4,5,7,8,9
Abdominal		N	N	N		N	N		BMDC	Note2,3,4,5,7,8,9
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		N	N	N		N	N		BMDC	Note2,3,4,5,7,8,9
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N	N		N	N		BMDC	Note2,3,4,5,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		N	N	N		N	N		BMDC	Note2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletal(Conventional)		N	N	N		N	N		BMDC	Note2,3,4,5,7,8,9
Musculo-skeletal(Superficial)
Other (specify)

N = new indication; P = previously cleared by FDA; E = added under Appendix E

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 Note 7

Contrast agent imaging Note 8

SieClear multi-view spatial compounding Note 9

Tissue Equalization Technology

Note 10 Intracardiac imaging

(Division Sign-Off)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Ber 21 CER 801 1001

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

Section 6

Prescription Use (Per 21 CFR 801.109)

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510(k) Number (if known):

Device Name:

SoundStar 10F Transducer for use with:

Intended Use:

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

Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Amplitude Doppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N	N	N	N	N		BMDC	Note2,3,7,8,9,10
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular		N	N	N	N	N	N		BMDC	Note2,3,7,8,9,10
Peripheral vessel
Laparoscopic
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Other (intra-cardiac)		N	N	N	N	N	N		BMDC	Note2,3,7,8,9,10

N = new indication; P = previously cleared by FDA; E = added under Appendix E.

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

Ensemble tissue harmonic imaging Note 2

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 Contrast agent imaging

Note 8 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 9

Note 10 Intracardiac imaging

(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 K080 760 510(k) Number _

Section 6

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510(k) Number (if known):

Device Name:

Intended Use:

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

Mode of Operation Clinical Application Color Amplitude Color PWD Combined Other A B ખ CWD Velocity Doppler Doppler (Specify) (Specify) Imaging 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 Intraoperative (Note 6) Intraoperative Neurological Pediatric P P P P P P BMDC Note 2,3,4,5,7,8,9 Small Organ (Note 1) Neonatal Cephalic P P P P P P Note 2,3,4,5,7,8,9 BMDC Adult Cephalic P P P P P P BMDC Note 2,3,4,5,7,8,9 Cardiac P P P P P P BMDC Note 2,3,4,5,7,8,9 Transesophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel P p P P P P BMDC Note 2,3,4,5,7,8,9 Laparoscopic Musculo-skelatal Conventional Musculo-skeletal Superficial Other (specify)

N = new indication; P = previously cleared by K072676; E = added under Appendix E

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 Note 4

Note 5 Power SieScape panoramic imaging

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

SieClear multi-view spatial compounding Note 8

Note 9 Tissue Equalization Technology

Note 10 Intracardiac imaging

(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
Badiological Daui

Radiological Devices 510(k) Number

Section 6 Diagnostic Ultrasound Indications for Use Form

Pg. 6.4 of 6.29

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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	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined(Specify)	Other(Specify)
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
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional	P	P	P	P	P	BMDC	Note 2.3.4.5.7.8.9
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K072676; E = added under Appendix E

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

Power SieScape panoramic imaging Note 5

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

SieClear multi-view spatial compounding Note 8

Tissue Equalization Technology Note 9

Intracardiac imaging Note 10

(PLEASE DO NOT WRITE
Concu
(Division Sign-Off)
Division

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 of Reproductive, Abdominal and
Radiological Devices
510(k) Number K080760

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

510(k) Number (if known):

Device Name:

İntended 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:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
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
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Small Organ(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
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Other (specify)

N = new indication; P = previously cleared by K072676; E = added under Appendix E

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 Note 4

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

(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

Prescription Use (Per 21 CFR 801.109)

Radiological Devices
510(k) Number K080760

Section 6

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510(k) Number (if known):

Device Name:

L9-5 Linear Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

Intended Use:

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

							Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
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
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Small Organ(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
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Other (specify)

N = new indication; P = previously cleared by K072676; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

B&W SieScape panoramic imaging Note 4

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

SieClear multi-view spatial compounding Note 8

Tissue Equalization Technology Note 9

Note 10 Intracardiac imaging

(PLEASE DO NOT WRITE BELOW TH
Concurrence of CDRH

Prescription

(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 K080760
Section

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

510(k) Number (if known):

Device Name:

EC9-4 Convex Array Endocavity 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	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Abdominal
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric
Small Organ(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
Cardiac
Transesophageal
Transrectal	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Transvaginal	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K072676; E = added under Appendix E

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

Nota 2 Ensemble tissue harmonic imaging

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

SieClear multi-view spatial compounding Note 8

Tissue Equalization Technology Note 9
Note 10 Intracardiac imaging

(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 K080760

Prescription Use {Per 21 CFR 801.109}

Radiological Devices
(K) Number
K080760

Section 6

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

Siemens Medical Solutions USA, Inc. Ultrasound Division CONFIDENTIAL

ACUSON X300™ Ultrasound System Special 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

EV9-4 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:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Abdominal
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric
Small Organ(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
Cardiac
Transesophageal
Transrectal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Transvaginal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K072676; E = added under Appendix E

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

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

B&W SleScape panoramic imaging Note 4

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

SieClear multi-view spatial compounding Note 8

Tissue Equalization Technology Note 9
Note 10 Intracardiac imaging

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

Division of Reproductive. Abdominal a Radiological De 510(k) Number

Section 6

Prescription Use (Per 21 CFR 801.109)

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

510(k) Number (if known):

Device Name:

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

Intended Use:

							Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
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
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Small Organ(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
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Other (specify)

N = new indication; P = previously cleared by K072676; E = added under Appendix E

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

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

Note 8 SieClear multi-view spatial compounding

Note 9 Tissue Equalization Technology
Note 10 Intracardiac imaging

Horner Thayer

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

Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K080760

Prescription Use (Per 21 CFR 801.109)

cal Device
Number K080 760

Section 6

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

510(k) Number (if known):

Device Name:

Intended Use:

P8-4 Phased Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

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

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P		P		BMDC	Note 2,3,4,5,7,8,9
Abdominal		P	P	P	P		P		BMDC	Note 2,3,45,7,8,9
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P	P		P		BMDC	Note 2,3,4,5,7,8,9
Small Organ(Note 1)
Neonatal Cephalic		P	P	P	P		P		BMDC	Note 2,3,4,5,7,8,9
Adult Cephalic
Cardiac		P	P	P	P		P		BMDC	Note 2,3,4,5,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P		P		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		P	P	P	P		P		BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K072676; E = added under Appendix E

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

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaoing

Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Note 8 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 9
Note 10 Intracardiac imaging

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

(Divisio Division of Reproductive, Abdominal and Radiological Devic

Section 6

510(k) Number

Prescription Use (Per 21 CFR 801,109)

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

510(k) Number (if known):

Device Name:

Intended Use:

BE9-4 Convex Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Abdominal
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric
Small Organ(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
Cardiac
Transesophageal
Transrectal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Transvaginal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K072676; E = added under Appendix E

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

Ensemble tissue harmonic imaging Note 2

Nota 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 Note 8

Tissue Equalization Technology Note 9

Note 10 Intracardiac imaging

(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 K080760
Section 6 Diagnostic Ultrasound Indications for Use Form Pg. 6.12 of 6.29
Prescription Use (Per 21 CFR 801.109)

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

510(k) Number (if known):

Device Name:

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

Intended Use:

Mode of Operation Clinical Application Color Color Amplitude Combined Other A B M PWD CWD Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic Fetal P Abdominal P Intraoperative P (Note 6) Intraoperative Neurological Pediatric P Small Organ P (Note 1) Neonatal Cephalic P Adult Cephalic P Cardiac P Transesophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel P Laparoscopic Musculo-skeletal P Conventional Musculo-skeletal Superficial Other (specify)

N = new indication; P = previously cleared by K072676; E = added under Appendix E

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

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

Note 8 SieClear multi-vlew spatial compounding

Note 9 Tissue Equalization Technology

Note 10 Intracardiac imaging

(Division Sign-Off)

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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

Section 6

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

510(k) Number (if known):

Device Name:

CW5 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:

							Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal					P
Abdominal					P
Intraoperative(Note 6)					P
IntraoperativeNeurological
Pediatric					P
Small Organ(Note 1)					P
Neonatal Cephalic					P
Adult Cephalic					P
Cardiac					P
Transesophageal
Transrectal
Transvaginal
Transurethrai
Intravascular
Peripheral vessel					P
Laparoscopic
Musculo-skeletalConventional					P
Musculo-skeletalSuperficial
Other (specify)

= new indication; P = previously cleared by K072676; E = added under Appendix E

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

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaqino

Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

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

(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 K080760
Prescription Use (Per 21 CFR 801.109)

Section 6

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

510(k) Number (if known):

Device Name:

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

Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,10
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardlac		P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,10
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular		P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,10
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Intra-cardiac)		P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,10

N = new indication; P = previously cleared by K072676; E = added under Appendix E

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

Power SieScape panoramic imaging 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

Note 10 Intracardiac imaging

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

(Division Sign-

Prescription Use (Per 21 CFR 801.109)

Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K080760

Section 6

{21}------------------------------------------------

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:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,10
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMDC	Note 2,3,7,8,9, 10
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular		P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,10
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Intra-cardiac)		P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,10

N = new indication; P = previously cleared by K072676; E = added under Appendix E

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

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

Note 8 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 9

Note 10 Intracardiac imaging

(Division Sign-Off

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Gregoription Joo (Bor 31 CER 901 1001

Prescription Use (Per 21 CFR 801.109)

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

Section 6

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

510(k) Number (if known):

Device Name:

V5Ms TEE Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMDC	Note 2,3,7,8,9
Transesophageal		P	P	P	P	P	P		BMDC	Note 2,3,7,8,9
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K072676; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

3D imaging Note 3

Section 6

Note 4 B&W SieScape panoramic imaging

Note 2 Power SieScape panoramic imaging

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

Note 8 SieClear multi-view spatial compounding

Note 9 Tissue Equalization Technology

Note 10 Intracardiac imaging

(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 K080760

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

510(k) Number (if known):

Device Name:

4V1c Phased Array Transducer for use with : ACUSON X300 Diagnostic Ultrasound Systems

Intended Use:

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

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Abdominal	P	P	P	P	P	P	P	BMDC	Note 2,3,5,6,7,8,9
Intraoperative(Note 6)									Note 2,3,5,6,7,8,9
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Small Organ(Note 1)								BMDC	Note 2,3,4,5,7,8,9
Neonatal Cephalic	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Adult Cephalic	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Cardiac	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K072676; E = added under Appendix E

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

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6 Note 7

Contrast agent imaging

SieClear multi-view spatial compounding Note 8

Note 9 Tissue Equalization Technology

Note 10 Intracardiac imaging

A 12 A PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Reproductive, Abdominal and Radiological Devices

Prescription Use (Per 21 CFR 801.109)

Radiological Devices
510(k) Number K080760

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

510(k) Number (if known):

Device Name:

Intended Use:

ACUSON X30

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:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(Note 6)		P	P	P			P	P		BMDC	Note 2,3,4,5,7,8,9
IntraoperativeNeurological		P	P	P			P	P		BMDC	Note 2,3,4,5,7,8,9
Pediatric		P	P	P			P	P		BMDC	Note 2,3,4,5,7,8,9
Small Organ(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
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P			P	P		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		P	P	P			P	P		BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial		P	P	P			P	P		BMDC	Note 2,3,4,5,7,8,9
Other (specify)

N = new indication; P = previously cleared by K072676; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

3D imaging Note 3

Section 6

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging 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

Note 10 Intracardiac imaging

(Division Sign-Off) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Division of Reproductive, Abdominal and Concurrence of CDRH, Office of Device Evaluation (ODE)
Dedislegiael Dovings Prescription Use (Per 21 CFR 801.109)

Radiological Devices 510(k) Number _

1-800-4-MY-HOME®

{25}------------------------------------------------

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:

Mode of Operation Clinical Application Color Color Amplitude Combined Other A B M PWD CWD Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic Fetal P P P P P BMDC Note 2,3,4,5,7,8,9 Abdominal P p P P P BMDC Note 2,3,5,6,7,8,9 Intraoperative (Note 6) Intraoperative Neurological Pediatric P P P P P BMDC Note 2,3,4,5,7,8,9 Small Organ P P P P P BMDC Note 2,3,4,5,7,8,9 (Note 1) 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 Cardiac p P P P P BMDC Note 2,3,4,5,7,8,9 Transesophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel P P P P P BMDC Note 2,3,4,5,7,8,9 Laparoscopic Musculo-skeletal P P P P P BMDC Note 2,3,4,5,7,8,9 Conventional Musculo-skeletal P P P P P BMDC Note 2,3,4,5,7,8,9 Superficial Other (specify)

N = new indication; P = previously cleared by K072676; E = added under Appendix E

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

Contrast agent imaging Note 7

SieClear multi-view spatial compounding Note 8

Tissue Equalization Technology Note 9

Note 10 Intracardiac imaging

(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
K080760

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

510(k) Number (if known):

Device Name:

Intended Use:

8L3 Linear "Regel" Transducer for use with : ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

							Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
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
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Small Organ(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
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Other (specify)

N = new Indication; P = previously cleared by K072676; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

Note 8 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 9

Note 10 Intracardiac imaging

Haya N. Atter

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

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 1680 the

Prescription Use (Per 21 CFR 801.109)

Radiological Devices

(Division Sign-Off

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

510(k) Number (if known):

Device Name:

10V4 Phased Array Neonatal High Frequency Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

Intended Use:

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

							Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P		P		BMDC	Note 2,3,4,5,7,8,9
Abdominal		P	P	P	P		P		BMDC	Note 2,3,45,7,8,9
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P	P		P		BMDC	Note 2,3,4,5,7,8,9
Small Organ(Note 1)
Neonatal Cephalic		P	P	P	P		P		BMDC	Note 2,3,4,5,7,8,9
Adult Cephalic
Cardiac		P	P	P	P		P		BMDC	Note 2,3,4,5,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P		P		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		P	P	P	P		P		BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K072676; E = added under Appendix E

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

Division Sign-Off)
LEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Goneurrence of CDRH, Office of Device Evaluation (ODE)

Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K080760
Prescription Use (Per 21 CFR 801.109)
Diagnostic Ultrasound Indications for Use Form

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

510(k) Number (if known):

Device Name:

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:

Intended Use:

Mode of Operation Clinical Application Color Color Amplitude Combined A B PWD CWD Other M Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic Fetal P P P P P BMDC Note 2,3,4,5,7,8,9 Abdominal P P പ്ര P b BMDC Note 2,3,4,5,7,8,9 Intraoperative (Note 6) Intraoperative Neurological Pediatric P P P b P BMDC Note 2,3,4,5,7,8,9 Small Organ (Note 1) Neonatal Cephalic Adult Cephalic Cardiac P P P P P BMDC Note 2,3,4,5,7,8,9 Transesophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel P P P P P BMDC Note 2,3,4,5,7,8,9 Laparoscopic Musculo-skeletal P P P P P BMDC Conventional Note 2.3.4.5.7.8.9 Musculo-skeletal Superficial . Other (specify)

N = new indication; P = previously cleared by K072676; E = added under Appendix E

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

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

· SieClear multi-view spatial compounding Note 8

Note 9 Tissue Equalization Technology Note 10 Intracardiac imaging

(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)

510/k) Numb

Division of Reproductive, Abdominal and

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

510(k) Number (if known):

Device Name:

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

Intended Use:

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

							Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Abdominal
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric
Small Organ(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
Cardiac
Transesophageal
Transrectal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Transvaginal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K072676; E = added under Appendix E

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 SleScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Note 8 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 9

Note 10 Intracardiac imaging

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

Prescription Use (Per 21 CFR 801.109)

Division of Representa
Radiological Devices
510(k) Number

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

510(k) Number (if known):

Device Name:

Intended Use:

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

Intended Use:

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

										Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
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
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Small Organ(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
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Other (specify)

N = new indication; P = previously cleared by K072676; E = added under Appendix E

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

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

Contrast agent imaging Note 7

Note 8 SieClear multi-view spatial compounding

Note 9 Tissue Equalization Technology

Note 10 Intracardiac imaging

(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	K080760
Section 6

Prescription Use (Per 21 CFR 801.109)
Diagnostic Ultrasound Indications for Use Form	Pg. 6.25 of 6.2

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

510(k) Number (if known):

Device Name:

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

Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
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
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Small Organ(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
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Other (specify)

N = new indication; P = previously cleared by K072676; E = added under Appendix E

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

Note 7 Contrast agent imaging

SieClear multi-view spatial compounding Note B

Tissue Equalization Technology Note 9

Note 10 Intracardiac imaging

(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

Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K080760

Section 6

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

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:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
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
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Small Organ(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
Cardiac		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K072676; E = added under Appendix E

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

SieClear multi-view spatial compounding Note 8

Note 9 Tissue Equalization Technology

Note 10 Intracardiac imaging

(Division Sign-Off)
---------------------	--

(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	K080760
---------------	---------

Section 6 Diagnostic Ultrasound Indications for Use Form Pg. 6.27 of 6.29

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.