The Siemens ACUSON X150 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: Fetal, Abdominal, Intraoperative (abdominal, vascular), Pediatric, Small Organ (breast, testes, thyroid, penis, prostate, etc.), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral vessel, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial.

Device Description

The Siemens ACUSON X150 ultrasound system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software.

AI/ML Overview

The provided text is a 510(k) premarket notification for the ACUSON X150 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or statistical analyses common for novel device performance claims.

Therefore, the document does not contain the requested information regarding specific acceptance criteria, a study proving the device meets them, sample sizes (test or training), data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance details, or how ground truth was established for training data.

The document states:

"The ACUSON X150 modifications are verified and validated according to the company's design control process." (Section 12, E. Performance Data) This is a general statement about their internal quality system processes rather than a summary of specific performance study results.
The FDA's letter (K081121) confirms substantial equivalence to a predicate device, which inherently means that its performance is considered comparable and acceptable based on existing standards and the predicate's established safety and effectiveness.

The tables provided describe the intended use and available modes of operation for various transducers with the ACUSON X150 system, indicating which applications (e.g., Fetal, Abdominal, Cardiac) and modes (e.g., B-mode, M-mode, Color Doppler) were "previously cleared by K070576" (the predicate device) or are "new indications" (though for this submission, most are "P" indicating previously cleared). This is a functional description, not a performance evaluation against specific metrics.

Summary

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K08//121

USON X150™ Ultrasound System Special 510(k) Submission

Product Code 90-ITX

JUN - 4 2008

Siemens Medical Solutions USA, Inc. Ultrasound Division CONFIDENTIAL

SECTION 12 510(k) Summary

Siemens Medical Solutions USA, Inc., Sponsor: Business Unit Ultrasound 1230 Shorebird Way Mountain View, California 94043 Contact Person: Martina Vogt Telephone: (425) 557 1434 (425) 391 9198 Fax: April 18, 2008 Submission Date: ACUSON X150TM Diagnostic Ultrasound System Device Name: SONOVISTA X150 Diagnostic Ultrasound System Common Name: Diagnostic Ultrasound System with Accessories Classification: II Regulatory Class: 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

A. Legally Marketed Predicate Devices

Diagnostic Ultrasound Transducer

The Siemens ACUSON X150 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 X150 ultrasound system (K070576).

FR # 892.1570

B, Device Description:

The Siemens ACUSON X150 has been designed to meet the following product safety standards:

I UL 60601-1, Safety Requirements for Medical Equipment
I IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment 트
ど AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
트 ANJM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
트 93/42/EEC Medical Devices Directive
I Safety and EMC Requirements for Medical Equipment
- I EN/IEC 60601 - 1
- 트 EN/EC 60601-1-1
- l EN/IEC 60601-1-2
- 동 EN/IEC 60601-1-4
- EN/IEC 60601-1-6
- 피 EN/IEC 60601-2-18

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트 EN/EC 60601-2-25
미 IEC 61157 Declaration of Acoustic Power
트 ISO 10993-1 Biocompatibility
트 ISO 14971 Risk Management

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 X150 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 and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is simple and recognizable, representing the department's role in promoting health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 4 2008

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

Re: K081121

Trade/Device Name: ACUSON X150 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO and ITX Dated: April 18, 2008 Received: April 21, 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 X150 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

P4-2 Phased Sector Array CH5-2 Convex Array VF10-5 Linear Array EC9-4 Convex Array Endocavity EV9-4 Convex Array

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VF13-5 Linear Array P8-4 Phased Array L9-5 Linear Array P4-2 Litho Phased Sector 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.

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

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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 Sundar Rajan at (240) 276-3666.

Sincerely yours,

Jozpu M. Whay

ਿੰਗ 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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ACUSON X150"M Ultrasound System Special 510(k) Submission

Indications for Use

510(k) Number (if known):

Device Name: ACUSON X150 Diagnostic Ultrasound System

Indications For Use:

The Siemens Acuson X150 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

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

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

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

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510(k) Number (if known):

Device Name: Intended Use:

ACUSON X150 Diagnostic Ultrasound System

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
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		BMDC	Note 2,3
Small Organ(Note 1)		P	P	P	P	P	P		BMDC	Note 2,3
Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note 3
Adult Cephalic		P	P	P	P	P	P		BMDC	Note 2
Cardiac		P	P	P	P	P	P		BMDC	Note 2,3
Transesophageal
Transrectal		P	P	P		P	P		BMDC	Note 2,3
Transvaginal		P	P	P		P	P		BMDC	Note 2,3
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2,3
Laparoscopic
Musculo-skeletalConventional		P	P	P	P	P	P		BMDC	Note 2,3
Musculo-skeletalSuperficial		P	P	P	P	P	P		BMDC	Note 2,3
Other (specify)

N = new indication; P = previously cleared by K070576; 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

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
	Concurrence of CDRH, Office of Device Evaluation (ODE)
	6 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 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 1

Why
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices 1081121

510(k) Nu

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510(k) Number (if known):

Device Name:

P4-2 Phased Sector Array Transducer for use with: ACUSON X150 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	P		BMDC	Note 2,3
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		BMDC	Note 2,3
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic		P	P	P	P	P	P		BMDC	Note 2,3
Cardiac		P	P	P	P	P	P		BMDC	Note 2,3
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K070576; 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

Note 6 For example: abdominal, vascular

(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)
ision of Reproductive, Abdominal and
adiological Devices
510(k) Number K08112/

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CH5-2 Convex Array Transducer for use with:

510(k) Number (if known):

Device Name:

Intended Use:

ACUSON X150 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
Abdominal		P	P	P		P	P		BMDC	Note 2,3
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K070576; 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

(PLEASE DO NOT WRITE BELOW

Conc

(Division Sign-Off)
	Division of Reproductive, Abdominal and

OW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) currence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

510(k) Number	R1101
---------------	-------

Radiological Devices

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Siemens Medical Solutions USA, Inc. Ultrasound Division CONFIDENTIAL

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

VF10-5 Linear Array Transducer for use with: ACUSON X150 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		P	P	P		P	P		BMDC	Note 2,3
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3
Other (specify)

N = new indication; P = previously cleared by K070576; 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

tony M. Why

(Division Sign Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K081121

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

510(k) Number (if known):

Device Name:

EC9-4 Convex Array Endocavity Transducer for use with: ACUSON X150 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
Abdominal
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P	P		P	P		BMDC	Note 2,3
Transvaginal		P	P	P		P	P		BMDC	Note 2,3
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K070576; 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

Note 7 Contrast agent imaging

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

Concur

Sign-Off

Prescription Use (Per 21 CFR 801.109)

(Division Sign-On)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K08/12/

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

Siemens Medical Solutions USA, Inc. Ultrasound Division CONFIDENTIAL

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

EV9-4 Convex Array Transducer for use with: ACUSON X150 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
Abdominal
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P	P		P	P		BMDC	Note 2,3
Transvaginal		P	P	P		P	P		BMDC	Note 2,3
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K070576; 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

(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 Radiological Device 510(k) Number

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

510(k) Number (if known):

Device Name:

Intended Use:

VF13-5 Linear Array Transducer for use with: ACUSON X150 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)
IntraoperativeNeurological
Pediatric	P	P	P	P		P	P		BMDC	Note 2,3
Small Organ(Note 1)	P	P	P	P		P	P		BMDC	Note 2,3
Neonatal Cephalic	P	P	P	P		P	P		BMDC	Note 2,3
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P		P	P		BMDC	Note 2,3
Laparoscopic
Musculo-skeletalConventional	P	P	P	P		P	P		BMDC	Note 2,3
Musculo-skeletalSuperficial	P	P	P	P		P	P		BMDC	Note 2,3
Other (specify)

N = new indication; P = previously cleared by K070576; 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

(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 K081121

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

510(k) Number (if known):

Device Name:

P8-4 Phase Array Transducer for use with: ACUSON X150 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	P		BMDC	Note 2,3
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		BMDC	Note 2,3
Small Organ(Note 1)
Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note 2,3
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMDC	Note 2,3
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K070576; 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

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

(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 K081121

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

510(k) Number (if known):

Device Name:

L9-5 Lincar Array Transducer for use with: ACUSON X150 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
Abdominal		P	P	P		P	P		BMDC	Note 2,3
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3
Other (specify)

N = new indication; P = previously cleared by K070576; 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

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

(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

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

510(k) Number (if known):

Device Name:

Intended Use:

P4-2 Litho Phased Sector Array Transducer for use with: ACUSON X150 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 B A M PWD CWD Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic Fetal N N N N N N BMDC Note 2,3 Abdominal N N N N N BMDC N Note 2,3 Intraoperative (Note 6) Intraoperative Neurological Pediatric N N N N N N BMDC Note 2,3 Small Organ (Note 1) Neonatal Cephalic Adult Cephalic N N N N ત્વ N BMDC Note 2,3 Cardiac Note 2,3 N N N ત ત્વ N BMDC Transesophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal Conventional Musculo-skeletal Superficial Other (specify)

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

Note 7 Contrast agent imaging

Amor herta

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

Division of Reproductive, Abdominal an Radiological Devices 5(U(k) Number

Prescription Use (Per 21 CFR 801.109)

Section 6

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

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