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 Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging on a Flat Panel Display.

AI/ML Overview

This Siemens ACUSON X150™ Diagnostic Ultrasound System 510(k) submission (K121646) is a special 510(k) for an update to an existing device (K081121). Special 510(k)s by definition do not require clinical performance data for substantial equivalence and focus on verification and validation of design control processes. Therefore, the information provided primarily pertains to the system's intended use and compliance with technical standards rather than a study demonstrating clinical performance or acceptance criteria in the traditional sense of a clinical trial for a novel device or AI algorithm.

However, based on the provided text, I can infer the "acceptance criteria" as the claimed functionalities and indicated uses of the device, and the "reported device performance" as the assertion that these functionalities are present and the device complies with safety standards.

Here's the breakdown of the information you requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a special 510(k) for an updated ultrasound system, "acceptance criteria" here refers to the device's ability to perform its stated diagnostic imaging and fluid flow analysis functions across various clinical applications and modes of operation, and its compliance with relevant safety and performance standards. The "reported device performance" is the manufacturer's assertion that the device meets these criteria through verification and validation efforts, as is typical for a special 510(k).

Acceptance Criteria (Stated Intended Use / Functionality)	Reported Device Performance (Manufacturer's Claim)
Multi-purpose diagnostic ultrasound system	Functions as described in B-Mode, Pulsed (PW) Doppler, Continuous (CW) Doppler, Color Doppler, Amplitude Doppler, combination modes, Harmonic Imaging, and 3D Imaging.
Supports various clinical 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.	System is intended for and supports these applications, as detailed in the "Indications for Use" tables for the main system and each transducer.
Provides measurement of anatomical structures.	System provides analysis packages for clinical diagnosis.
Performs fluid flow analysis of the human body.	Supported across various clinical applications as indicated in the tables.
Complies with acoustic output standards (AIUM/NEMA UD-3, UD-2, IEC 1157).	Device has been evaluated and found to conform with these standards.
Complies with biocompatibility standards (ISO 10993-1).	Device has been evaluated and found to conform with this standard; patient contact materials are unchanged.
Complies with cleaning and disinfection effectiveness.	Device has been evaluated and found to conform with effectiveness.
Complies with thermal, electrical, electromagnetic, and mechanical safety standards (UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, 93/42/EEC, EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2).	Device has been evaluated and found to conform with these standards; electrical and mechanical safety are unchanged.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not describe a clinical study with a "test set" in the sense of a dataset used to evaluate the performance of a novel algorithm or diagnostic metric. This submission is for an updated diagnostic ultrasound system and focuses on demonstrating substantial equivalence to a predicate device through engineering verification and validation. Therefore, there are no specific sample sizes for a 'test set' or data provenance mentioned in relation to real clinical data for performance evaluation in this 510(k) summary. The performance data section states, "The modifications to the Siemens ACUSON X150 Diagnostic Ultrasound System are verified and validated according to the company's design control process."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. As explained above, there is no "test set" or ground truth established by experts for a clinical performance study in this 510(k) summary. The evaluation focuses on technical and safety compliance.

4. Adjudication Method for the Test Set

Not applicable. No "test set" that would require an adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states that the submission device is "substantially equivalent to the predicate with regard to both intended use and technological characteristics," implying that a full MRMC comparative effectiveness study was not deemed necessary for this special 510(k) submission. No effect size of human readers improving with AI vs. without AI assistance is mentioned because this is not an AI/CAD device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not a submission for an algorithm or AI device; it is for a diagnostic ultrasound system. Therefore, standalone algorithm performance is not relevant or evaluated here.

7. The Type of Ground Truth Used

Not applicable in the context of clinical study ground truth (e.g., pathology, outcomes data). The "ground truth" for this submission is adherence to established engineering specifications, safety standards, and performance characteristics as verified through design control processes. The "Indications for Use" tables define the intended clinical applications and operating modes, which are part of the device's functional "ground truth."

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that would involve a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set mentioned, there is no description of how ground truth for it would be established.

Summary

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K121646

Siemens Medical Solutions USA, Inc. Ultrasound Division

ACUSON X150™ Diagnostic Ultrasound System Special 510(k) Submission

SECTION 12 510(k) Summarv

JUN 2 2 2012

1. Sponsor: Siemens Medical Solutions USA, Inc., Ultrasound Division 685 East Middlefield Road Mountain View, California 94043

2.	Contact Person:	Shelly Pearce
	Title:	Regulatory Affairs Specialist
	Telephone:	(650) 694 5988
	Fax:	(650) 694 5580

1. May 14, 2012 Submission Date:
ACUSON X150™ Diagnostic Ultrasound System Device Name: 4. SONOVISTA X150 Diagnostic Ultrasound System (K081121)
1. Common Name: Diagnostic Ultrasound System with Accessories

Classification:6.
Regulatory Class:	II
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

A. Legally Marketed Predicate Devices

The Siemens ACUSON X150 Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to the current product that is already cleared for USA distribution under the following 510(k) PreMarket Notification number:

. K081121, ACUSON X150™ Diagnostic Ultrasound System, SONOVISTA X150 Diagnostic Ultrasound System
K113179, ACUSON SC2000™ Diagnostic Ultrasound System
K101091, ZONARE z.one Ultra Ultra Ultrasoud System
e K113690, GE LOGIQ i, LOGIQ e, Vivid e
K014206, GE LogigBooK XP ●
. K101757, Sonosite M-turbo

B. Device Description:

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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 modifications to the Siemens ACUSON X150 Diagnostic Ultrasound System are verified and validated according to the company's design control process.

F. A brief discussion of nonclinical tests submitted, referenced, or relied on in

the 510(k) for a determination of substantial equivalence.

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary 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

IEC 1157 Declaration of Acoustic Power

ISO 10993-1 Biocompatibility

Cleared patient contact materials, electrical and mechanical safety are unchanged.

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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 a stylized symbol resembling a caduceus, with three curved lines representing the staff and a single line representing the snake.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

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

JUN 2 2 2012

Re: K121646 Trade/Device Name: ACUSON X150™ Diagnostic Ultrasound System SONOVISTA 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: June 4, 2012 Received: June 5, 2012

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 Amerodments, 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 I cacral controls provisions of the Act. The general controls provisions of the Act include the general of the our 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, SONOVISTA 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

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

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de vice is olashired (800 a0070) regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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 r lease be determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I cacial states and states and submited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fart 6077, mooning (21 CFR Part 820); and if applicable, the electronic form in the qualify by occhine (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket I 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 rr you dosite speerille ad resboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulation emations the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Joshua Nipper at (301) 796-6524.

Sincerely Yours,

Michael D. O'Hare Esq.

Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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SECTION 6 Indications for Use Forms

Indications for Use Statement

510(k) Number (if known):

ACUSON X150TM Diagnostic Ultrasound System Device Name: SONOVISTA X150 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)

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510(k) Number (if known):

ACUSON X150 Diagnostic Ultrasound System

Device Name: 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)		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; K081121 E = added under Appendix E

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

Ensemble tissue harmonic imaging Note 2

3D imaging Note 3

Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

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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; K081121 E = added under Appendix E

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

Ensemble tissue harmonic imaging Note 2

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

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

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Siemens Medical Solutions USA, Inc. Ultrasound Division

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

. CH5-2 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:

Clinical Application	B	M	PWD	ColorDoppler	AmplitudeDoppler	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; K081121 E = added under Appendix E

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

Ensemble tissue harmonic imaging Note 2

3D imaqinq Note 3

B&W SieScape panoramic imaging Note 4

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)

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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: ﺮ

	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; K081121 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

Contrast agent imaging Note 7

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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; K081121 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

Contrast agent imaging Note 7

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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; K081121 E = added under Appendix E

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

Ensemble tissue harmonic imaging Note 2

3D imaging Note 3

Note 4 B&W SieScape panoramic imaging

Note 5 · Power SieScape panoramic imaging

Note 6 For example: abdominai, vascular

Note 7 Contrast agent imaging

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510(k) Number (if known):

Device Name:

VF13-5 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
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; K081121 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

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

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Michael D. O'Hern

Division Sign-Off Office of In Vitro Diag

510(k) K121646.

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510(k) Number (if known):

Device Name:

Intended Use:

P8-4 Phase 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		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		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; K081121 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

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

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

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510(k) K121646

Page 9 of

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

510(k) Number (if known):

Device Name:

Intended Use:

L9-5 Linear Array Transducer for use with: ACUSON X150 Diagnostic Ultrasound Systems

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; K081121 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

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

h D Ohm
Division Sign Officer

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510(k) K121646

Page 10 of

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

510(k) Number (if known):

Device Name:

P4-2 Litho 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 FDA K070576, K081211

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

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

Contrast agent imaging Note 7

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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510(k)K121646

Page 11 of

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.