ACUSON X150 ULTRASOUND SYSTEM

• K Number: K070576
• Device Name: ACUSON X150 ULTRASOUND SYSTEM
• Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Date Cleared: 2007-03-26 ( 26 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The Siemens Acuson X150 ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculosketal, Great Vessel, 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: Ophthalmic, Fetal, Abdominal, Intraoperative (abdominal, vascular), Intraoperative Neurological, 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 has been designed to meet the following product safety standards: UL 60601-1, Safety Requirements for Medical Equipment; IEC 60601-2-37 Diagnostic Ultrasound Safety Standards; CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment; AIUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment; AIUM/NEMA UD-2, 1998 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.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, and the description focuses on standard ultrasound technology and safety standards.

Therapeutic

No
The device is described as an "ultrasound imaging system" intended for "clinical diagnosis purposes" and "Diagnostic imaging or fluid flow analysis," indicating its use for diagnostic rather than therapeutic applications.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the system provides "analysis packages that provide information that is used for clinical diagnosis purposes" and is used for "Diagnostic imaging or fluid flow analysis."

SaMD (Software as a Medical Device)

No

The device description explicitly refers to the "Siemens Acuson X150 ultrasound imaging system," which is a hardware system, and lists compliance with hardware safety standards (UL 60601-1, IEC 60601-2-37, etc.).

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 derived from the human body (like blood, urine, tissue) in vitro (outside the body). The Acuson X150 is an ultrasound system that performs imaging in vivo (within the body) by transmitting and receiving sound waves.
• The Intended Use/Indications for Use clearly describe imaging applications on the human body. All the listed applications (Abdominal, Cardiac, Vascular, etc.) involve directly imaging internal structures of a living patient.
• The Device Description focuses on safety standards related to medical equipment used on patients. These standards (UL 60601-1, IEC 60601-2-37, etc.) are for devices that interact directly with the human body, not for laboratory testing of specimens.

Therefore, the Siemens Acuson X150 is a diagnostic imaging device, but it does not fit the definition of 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: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculosketal, Great Vessel, 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.

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

90-IYN, 90-IYO, 90-ITX

Device Description

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

• UL 60601-1, Safety Requirements for Medical Equipment
• IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
• CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
• AIUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• AIUM/NEMA UD-2, 1998 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

Mentions image processing

Diagnostic imaging or fluid flow analysis of the human body

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculosketal, Great Vessel, Peripheral Vascular, Fetal, Pediatric, Small Organ (e.g., breast, testes, thyroid, penis, prostate), Transrectal, Transvaginal, Peripheral vessel

Indicated Patient Age Range

Neonatal/Adult Cephalic, Fetal, Pediatric

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 X150 modifications are verified and validated according to the company's design control process.

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.

Siemens Sonoline G40 ultrasound system.

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

K070576

SECTION 11

510(k) Summary Prepared February 22, 2007

MAR 2 6 2007

| Sponsor: | Siemens Medical Solutions USA, Inc.,
Ultrasound Division
1230 Shorebird Way
P.O. Box 7393
Mountain View, California 94039-7393 |

----------	--------------------------------------------------------------------------------------------------------------------------------------------

Contact Person:	Sheila W. Pickering
	Telephone:	[phone]
	Fax:	[phone]

• Submission Date: February 16, 2007
  Device Name: Acuson X150 Ultrasound System

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-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 Ultrasound system is substantially equivalent to the Siemens Sonoline G40 ultrasound system.

B. Device Description:

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

• 이 UL 60601-1, Safety Requirements for Medical Equipment
• IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
• 이 CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
• AIUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound
• 93/42/EEC Medical Devices Directive
• 를 Safety and EMC Requirements for Medical Equipment
  • 에 EN/IEC 60601-1
  • EN/IEC 60601-1-1
  • 마 EN/IEC 60601-1-2
• 트 IEC 1157 Declaration of Acoustic Power
• 트 ISO 10993-1 Biocompatibility

1

Siemens Acuson X150 5 10(k) Notification CONFIDENTIAL

C. Intended Use

The Siemens Acuson X150 ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculosketal, Great Vessel, and Peripheral Vascular applications.

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 X150 modifications are verified and validated according to the company's design control process.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the top. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sheila W. Pickering, Ph.D. Senior Director of Regulatory Affaris Siemens Medical Solutions USA, Inc. Ultrasound Division 1230 Shorebird Way, P.O. Box 7393 MOUNTAIN VIEW CA 94039-7393

MAR 2 6 2007

Re: K070576

Trade Name: Acuson X150 Ultrasound Imaging System Regulation Number: 21 CFR §892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Product Code: IYN Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: IYO Regulation Number: 21 CFR §892.1570 Regulation Name: Diagnostic ultrasonic transducer Product Code: ITX Regulatory Class: II Dated: February 22, 2007 Received: February 28, 2007

Dear Dr. Pickering:

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 Ultrasound Imaging System, as described in your premarket notification:

Transducer Model Numbers P4-2 CH5-2 VF10-5 EC9-4 EV9-4 VF13-5 P8-4 1 0-5

3

Page 2 - Dr. Sheila Pickering

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 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 [phone]. 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 [phone] or [phone] 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 Ewa Czerska. M.D. at [phone],

Sincerely yours,

Daniel le Lyman

N
DE

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

4

SECTION 7

Intended Use of the Device

510(k) Number (if known):

Device Name: Acuson X150 Ultrasound Imaging System

Indications For Use:

The Siemens Acuson X150 ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, 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.

David A. Seaymon

Division Sign-Off Division of Reproductive, Abdomina and Radiological Devices

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

ACUSON X150 Diagnostic Ultrasound System

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		N	N	N	N	N	N		BMDC	Note 2,3
Abdominal		N	N	N	N	N	N		BMDC	Note 2,3
Intraoperative
(Note 6)
Intraoperative
Neurological
Pediatric		N	N	N	N	N	N		BMDC	Note 2,3
Small Organ
(Note 1)		N	N	N	N	N	N		BMDC	Note 2,3
Neonatal Cephalic		N	N	N	N	N	N		BMDC	Note 3
Adult Cephalic		N	N	N	N	N	N		BMDC	Note 2
Cardiac		N	N	N	N	N	N		BMDC	Note 2,3
Transesophageal
Transrectal		N	N	N	N	N	N		BMDC	Note 2,3
Transvaginal		N	N	N	N	N	N		BMDC	Note 2,3
Transurethral
Intravascular
Peripheral vessel		N	N	N	N	N	N		BMDC	Note 2,3
Laparoscopic
Musculo-skeletal
Conventional		N	N	N	N	N	N		BMDC	Note 2,3
Musculo-skeletal
Superficial		N	N	N	N	N	N		BMDC	Note 2,3
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.

• 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

Daniel h. Larson

(Division Sign Division of Reproductive. and Radiological Devic 510(k) Nu

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Diagnostic Ultrasound Indications for Use Form

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:

| Clinical Application | Mode of Operation | | | | | | | | Other
(Specify) | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|--------------------|-----------------------|
| | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | | Combined
(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; 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
• Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

David A. Wagner
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070

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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:

	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		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 FDA; 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

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Doinh h. Sagnon
(Division Sign-Off)

Division of Reproductive, Ab and Radiological Device 510(k) Numbe

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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	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 FDA; 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

Note 7 Contrast agent imaging

David he. Sigman

---

(Division Sign-Off)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Page 17 of 51

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Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

Intended Use:

EC9-4 Convex Array Endocavity 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		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 FDA; E = added under Appendix E

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

• 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: abdominal, vascular
• Note 7 Contrast agent imaging

David R. Ingram

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

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

Prescription Use (Per 21 CFR 801.109)

Page 18 of 51

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Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

Intended Use:

EV9-4 Convex 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 Color Clinical Application Color Amplitude Combined Other B PWD CWD A M Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic P P P P P BMDC Note 2,3 Fetal Abdominal Intraoperative (Note 6) Intraoperative Neurological Pediatric Small Organ (Note 1) Neonatal Cephalic Adult Cephalic Cardiac Transesophageal P Transrectal P P P P BMDC Note 2,3 P P P P P BMDC Transvaginal Note 2,3 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

• 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

David R. Ingram

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

,但

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Diagnostic Ultrasound Indications for Use Form

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 Color Clinical Application Amplitude Color Combined Other B M PWD CWD Velocity A Doppler Doppler (Specify) (Specify) Imaging Ophthalmic Fetal Abdominal Intraoperative (Note 6) Intraoperative Neurological p P Pediatric b P P BMDC Note 2,3 P P P Small Organ P b BMDC Note 2,3 (Note 1) P P BMDC Neonatal Cephalic b b b Note 2,3 Adult Cephalic Cardiac Transesophageal Transrectal Transvaginal Transurethral Intravascular P P P Peripheral vessel P P BMDC Note 2,3 Laparoscopic P P Musculo-skeletal P P P BMDC Note 2,3 Conventional Musculo-skeletal P P P P P BMDC Note 2,3 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.

Note 2 Ensemble tissue harmonic imaging

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

David R. Hysom

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

P8-4 Phase Array Transducer for use with: ACUSON X150 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as

Intended Use:

follows: Mode of Operation Color Clinical Application Color Amplitude Combined Other B PWD CWD A M Velocity Doppler Doppler (Specify) (Specify) Imaging

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
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; 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

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

Daniel R. Syverson

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

13

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

L9-5 Linear 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	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 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

David h. Logem

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)