Predicate Devices

K081121, K113179, K101091, K113690, K014206, K101757

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasound system and does not mention any AI or ML capabilities.

Therapeutic

No
The device is described as a "Diagnostic Ultrasound System" intended for "clinical diagnosis purposes" through "Diagnostic imaging or fluid flow analysis." Its function is to "acquire primary or secondary harmonic ultrasound echo data and display it," which are all characteristics of a diagnostic, not therapeutic, device.

Diagnostic

Yes

The "Intended Use / Indications for Use" section states that the system "provides information that is used for clinical diagnosis purposes" and supports "Diagnostic imaging". The "Device Description" also explicitly calls it a "Diagnostic Ultrasound System".

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "multi-purpose mobile, software controlled, diagnostic ultrasound system" and describes its function as acquiring and displaying ultrasound echo data, which inherently involves hardware components like transducers and display screens.

IVD (In Vitro Diagnostic)

Based on the provided information, the Siemens Acuson X150 ultrasound imaging system is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body. The Acuson X150 is an ultrasound system that uses sound waves to create images of the human body directly.
The intended use and device description clearly state that the system is for diagnostic imaging of the human body. It describes the various anatomical sites and applications for imaging, not for analyzing samples.
There is no mention of analyzing biological specimens or using reagents.

Therefore, the Siemens Acuson X150 is a diagnostic imaging device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Diagnostic imaging or fluid flow analysis of the human body.

Product codes (comma separated list FDA assigned to the subject device)

90-IYN, 90-IYO, 90-ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts (e.g., breast, testes, thyroid, penis, prostate), Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K081121, K113179, K101091, K113690, K014206, K101757

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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:

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.

1

C. Intended 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.

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.

2

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

3

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)

4

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 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 (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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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)
Intraoperative
Neurological
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-skeletal
Conventional		.P	P	P	P	P	P	BMDC	Note 2,3
Musculo-skeletal
Superficial		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

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

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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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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)
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
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

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

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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 | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | 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) | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| 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-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| 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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal		P	P	P		P	P	BMDC	Note 2,3
Intraoperative
(Note 6)
Intraoperative
Neurological
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-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2.3
Musculo-skeletal
Superficial		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

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

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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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3
Abdominal
Intraoperative
(Note 6)
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
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

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

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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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3
Abdominal
Intraoperative
(Note 6)
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
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

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

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510(k) K121646

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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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
(Note 6)
Intraoperative
Neurological
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-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3
Musculo-skeletal
Superficial		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)

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

Michael D. O'Hern

Division Sign-Off Office of In Vitro Diag

510(k) K121646.

Page 8 of

12

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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)
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
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)

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

Division Sign-Off

Office of In Vitro Diagnostic Devices

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal		P	P	P		P	P	BMDC	Note 2,3
Intraoperative
(Note 6)
Intraoperative
Neurological
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-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3
Musculo-skeletal
Superficial		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

on Sign-Off Office of In Vitro Diagnostic Devices

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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)
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
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)

Office of In Vitro Diagnostic Devices

510(k)K121646

Page 11 of