LogoFDA 510(k) Search
K Number
K081121
Device Name
MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM
Manufacturer
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
Date Cleared
2008-06-04

(44 days)

Product Code
IYOITXIYN
Regulation Number
892.1560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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. Diagnostic imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (abdominal, vascular), Pediatric, Small Organ (breast, testes, thyroid, penis, prostate, etc.), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral vessel, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
Device Description
The Siemens ACUSON X150 ultrasound system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software.
More Information

K070576

Not Found

No
The document does not mention AI, ML, deep learning, or any related terms, nor does it describe training or test sets which are typical for AI/ML development.

No
The device is described as a "diagnostic ultrasound system" and its intended uses are for "imaging" and "measurement of anatomical structures" for "clinical diagnosis purposes," not for treating conditions.

Yes
The "Device Description" explicitly states, "The Siemens ACUSON X150 ultrasound system is a multi-purpose diagnostic ultrasound system." Additionally, the "Intended Use / Indications for Use" section mentions that the system provides "analysis packages that provide information that is used for clinical diagnosis purposes."

No

The device description explicitly states it is a "multi-purpose diagnostic ultrasound system with accessories and proprietary software," indicating it includes hardware components in addition to software.

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

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The ACUSON X150 is an ultrasound imaging system. It uses sound waves to create images of internal body structures. This is an in vivo (within the living body) diagnostic method, not in vitro.
  • Intended Use: The intended use clearly describes imaging of various anatomical sites within the human body.
  • Device Description: The description confirms it's a diagnostic ultrasound system.

Therefore, the ACUSON X150 falls under the category of medical imaging devices, not in vitro diagnostics.

N/A

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.

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

90-ITX, 90-IYN, 90-IYO

Device Description

The Siemens ACUSON X150™ ultrasound system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product, the Siemens ACUSON X150 ultrasound system (K070576).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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

Indicated Patient Age Range

Neonatal, Pediatric, Adult

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 ACUSON 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.

K070576

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

§ 892.1560 Ultrasonic pulsed echo imaging system.

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

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K08//121

USON X150™ Ultrasound System Special 510(k) Submission

Product Code 90-ITX

JUN - 4 2008

Siemens Medical Solutions USA, Inc. Ultrasound Division CONFIDENTIAL

SECTION 12

510(k) Summary

Siemens Medical Solutions USA, Inc., Sponsor: Business Unit Ultrasound 1230 Shorebird Way Mountain View, California 94043 Contact Person: Martina Vogt Telephone: (425) 557 1434 (425) 391 9198 Fax: April 18, 2008 Submission Date: ACUSON X150TM Diagnostic Ultrasound System Device Name: SONOVISTA X150 Diagnostic Ultrasound System Common Name: Diagnostic Ultrasound System with Accessories Classification: II Regulatory Class: Review Category: Tier II Classification Panel: Radiology Ultrasonic Pulsed Doppler Imaging System FR # 892.1550 Product Code 90-IYN Ultrasonic Pulsed Echo Imaging System FR # 892.1560 Product Code 90-IYO

A. Legally Marketed Predicate Devices

Diagnostic Ultrasound Transducer

The Siemens ACUSON X150 ultrasound system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product, the Siemens ACUSON X150 ultrasound system (K070576).

FR # 892.1570

B, Device Description:

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

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

1

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

C. Intended Use

:

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.

D. Substantial Equivalence

The submission device is substantially equivalent to the predicate with regard to both intended use and technological characteristics.

E. Performance Data

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

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is simple and recognizable, representing the department's role in promoting health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 4 2008

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

Re: K081121

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

Dear Ms. Vogt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the ACUSON X150 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

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

3

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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain

4

other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Sundar Rajan at (240) 276-3666.

Sincerely yours,

Jozpu M. Whay

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

Enclosure(s)

5

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

Indications for Use

510(k) Number (if known):

Device Name: ACUSON X150 Diagnostic Ultrasound System

Indications For Use:

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

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

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

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

6

510(k) Number (if known):

Device Name: Intended Use:

ACUSON X150 Diagnostic Ultrasound System

Diagnostic imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalPPPPPPBMDCNote 2,3
AbdominalPPPPPPBMDCNote 2,3
Intraoperative
(Note 6)
Intraoperative
Neurological
PediatricPPPPPPBMDCNote 2,3
Small Organ
(Note 1)PPPPPPBMDCNote 2,3
Neonatal CephalicPPPPPPBMDCNote 3
Adult CephalicPPPPPPBMDCNote 2
CardiacPPPPPPBMDCNote 2,3
Transesophageal
TransrectalPPPPPBMDCNote 2,3
TransvaginalPPPPPBMDCNote 2,3
Transurethral
Intravascular
Peripheral vesselPPPPPPBMDCNote 2,3
Laparoscopic
Musculo-skeletal
ConventionalPPPPPPBMDCNote 2,3
Musculo-skeletal
SuperficialPPPPPPBMDCNote 2,3
Other (specify)

N = new indication; P = previously cleared by K070576; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

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

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

510(k) Nu

7

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 ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalPPPPPPBMDCNote 2,3
AbdominalPPPPPPBMDCNote 2,3
Intraoperative
(Note 6)
Intraoperative
Neurological
PediatricPPPPPPBMDCNote 2,3
Small Organ
(Note 1)
Neonatal Cephalic
Adult CephalicPPPPPPBMDCNote 2,3
CardiacPPPPPPBMDCNote 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; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

3D imaging Note 3

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
ision of Reproductive, Abdominal and
adiological Devices
510(k) Number K08112/

8

CH5-2 Convex Array Transducer for use with:

510(k) Number (if known):

Device Name:

Intended Use:

ACUSON X150 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalPPPPPBMDCNote 2,3
AbdominalPPPPPBMDCNote 2,3
Intraoperative
(Note 6)
Intraoperative
Neurological
PediatricPPPPPBMDCNote 2,3
Small Organ
(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPBMDCNote 2,3
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by K070576; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

(PLEASE DO NOT WRITE BELOW

Conc

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

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

510(k) NumberR1101
----------------------

Radiological Devices

9

Siemens Medical Solutions USA, Inc. Ultrasound Division CONFIDENTIAL

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

.

VF10-5 Linear Array Transducer for use with: ACUSON X150 Diagnostic Ultrasound Systems

Intended Use:

Diagnostic imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
Fetal
AbdominalPPPPPBMDCNote 2,3
Intraoperative
(Note 6)
Intraoperative
Neurological
PediatricPPPPPBMDCNote 2,3
Small Organ
(Note 1)PPPPPBMDCNote 2,3
Neonatal CephalicPPPPPBMDCNote 2,3
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPBMDCNote 2,3
Laparoscopic
Musculo-skeletal
ConventionalPPPPPBMDCNote 2,3
Musculo-skeletal
SuperficialPPPPPBMDCNote 2,3
Other (specify)

N = new indication; P = previously cleared by K070576; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

tony M. Why

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

10

510(k) Number (if known):

Device Name:

EC9-4 Convex Array Endocavity Transducer for use with: ACUSON X150 Diagnostic Ultrasound Systems

Intended Use:

Diagnostic imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalPPPPPBMDCNote 2,3
Abdominal
Intraoperative
(Note 6)
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
TransrectalPPPPPBMDCNote 2,3
TransvaginalPPPPPBMDCNote 2,3
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by K070576; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

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

Concur

Sign-Off

Prescription Use (Per 21 CFR 801.109)

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

11

Siemens Medical Solutions USA, Inc. Ultrasound Division CONFIDENTIAL

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

EV9-4 Convex Array Transducer for use with: ACUSON X150 Diagnostic Ultrasound Systems

Intended Use:

Diagnostic imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalPPPPPBMDCNote 2,3
Abdominal
Intraoperative
(Note 6)
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
TransrectalPPPPPBMDCNote 2,3
TransvaginalPPPPPBMDCNote 2,3
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by K070576; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801 109)

Division of Reproductive, Abdominal Radiological Device 510(k) Number

12

510(k) Number (if known):

Device Name:

Intended Use:

VF13-5 Linear Array Transducer for use with: ACUSON X150 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
(Note 6)
Intraoperative
Neurological
PediatricPPPPPPBMDCNote 2,3
Small Organ
(Note 1)PPPPPPBMDCNote 2,3
Neonatal CephalicPPPPPPBMDCNote 2,3
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPPBMDCNote 2,3
Laparoscopic
Musculo-skeletal
ConventionalPPPPPPBMDCNote 2,3
Musculo-skeletal
SuperficialPPPPPPBMDCNote 2,3
Other (specify)

N = new indication; P = previously cleared by K070576; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

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

13

510(k) Number (if known):

Device Name:

P8-4 Phase Array Transducer for use with: ACUSON X150 Diagnostic Ultrasound Systems

Intended Use:

Diagnostic imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalPPPPPPBMDCNote 2,3
AbdominalPPPPPPBMDCNote 2,3
Intraoperative
(Note 6)
Intraoperative
Neurological
PediatricPPPPPPBMDCNote 2,3
Small Organ
(Note 1)
Neonatal CephalicPPPPPPBMDCNote 2,3
Adult Cephalic
CardiacPPPPPPBMDCNote 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; E = added under Appendix E

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

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

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

14

510(k) Number (if known):

Device Name:

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

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
Fetal
AbdominalPPPPPBMDCNote 2,3
Intraoperative
(Note 6)
Intraoperative
Neurological
PediatricPPPPPBMDCNote 2,3
Small Organ
(Note 1)PPPPPBMDCNote 2,3
Neonatal CephalicPPPPPBMDCNote 2,3
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPBMDCNote 2,3
Laparoscopic
Musculo-skeletal
ConventionalPPPPPBMDCNote 2,3
Musculo-skeletal
SuperficialPPPPPBMDCNote 2,3
Other (specify)

N = new indication; P = previously cleared by K070576; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

3D imaging Note 3

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

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

15

510(k) Number (if known):

Device Name:

Intended Use:

P4-2 Litho Phased Sector Array Transducer for use with: ACUSON X150 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

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

N = new indication; P = previously cleared by FDA; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Amor herta

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

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

Prescription Use (Per 21 CFR 801.109)

Section 6