ACUSON X150 ULTRASOUND SYSTEM

K070576 · Siemens Medical Solutions USA, Inc. · IYN · Mar 26, 2007 · Radiology

Device Facts

• Record ID: K070576
• Device Name: ACUSON X150 ULTRASOUND SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYN · Radiology
• Decision Date: Mar 26, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Acuson X150 is a diagnostic ultrasound system for clinical imaging and fluid flow analysis. It processes acoustic signals received via various transducers (phased, convex, linear arrays) to produce real-time B-mode, M-mode, Pulsed Wave Doppler, Color Doppler, and Amplitude Doppler images. Used in clinical settings by healthcare professionals for anatomical measurement and diagnostic analysis. The system supports advanced imaging modes including Ensemble tissue harmonic imaging, 3D imaging, and SieScape panoramic imaging. Output is displayed on the system monitor for physician interpretation to aid in clinical decision-making and patient diagnosis.

Clinical Evidence

Bench testing only. The device was verified and validated according to the company's design control process, including compliance with safety standards (UL 60601-1, IEC 60601-2-37, ISO 10993-1). No clinical data was required for this 510(k) submission.

Technological Characteristics

Diagnostic ultrasound system utilizing pulsed echo and pulsed Doppler imaging. Supports multiple transducer types (phased, convex, linear). Complies with IEC 60601-1, IEC 60601-2-37, and ISO 10993-1 for biocompatibility. Features include tissue harmonic imaging, 3D imaging, and panoramic imaging. Energy source is electrical; connectivity and software architecture details are not specified beyond standard diagnostic ultrasound functionality.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in patients of all ages (neonatal to adult) across abdominal, cardiac, vascular, musculoskeletal, OB/GYN, and small parts applications. Contraindications are not specified.

Regulatory Classification

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.

Predicate Devices

• Siemens Sonoline G40 ultrasound system

Submission Summary (Full Text)

{0}------------------------------------------------

K070576

# SECTION 11

## 510(k) Summary Prepared February 22, 2007

MAR 2 6 2007

| Sponsor: | Siemens Medical Solutions USA, Inc.,<br>Ultrasound Division<br>1230 Shorebird Way<br>P.O. Box 7393<br>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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

{5}------------------------------------------------

## 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(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<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | N | N | N | | BMDC | Note 2,3 |
| Small Organ<br>(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<br>Conventional | | N | N | N | N | N | N | | BMDC | Note 2,3 |
| Musculo-skeletal<br>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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

{6}------------------------------------------------

## 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<br>(Specify) | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|--------------------|-----------------------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | | Combined<br>(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<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3 |
| Small Organ<br>(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<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

{7}------------------------------------------------

# 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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

{8}------------------------------------------------

#### 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Intraoperative<br>(Note 6) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Small Organ<br>(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<br>Conventional | | P | P | P | | P | P | | BMDC | Note 2,3 |
| Musculo-skeletal<br>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

(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 17 of 51

{9}------------------------------------------------

#### 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

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

#### 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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

#### 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)

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

#### 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<br>(Note 6) | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | BMDC | Note 2,3 | |
| Small Organ<br>(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<br>Conventional | | | | | | | | | |
| Musculo-skeletal<br>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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3 | |
| Intraoperative<br>(Note 6) | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3 | |
| Small Organ<br>(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<br>Conventional | | P | P | P | | P | P | | BMDC | Note 2,3 | |
| Musculo-skeletal<br>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)