Predicate Devices

K052894, K040060, K033196, K050240, K043016

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML algorithms in medical imaging.

Therapeutic

No
The device is described as an "Ultrasound imaging" device used for "fluid flow analysis," indicating its purpose is diagnostic, not therapeutic.

Diagnostic

Yes

The 'Device Description' explicitly states that the device meets safety standards for 'Diagnostic Ultrasound Safety Standards' and references 'Diagnostic Ultrasound Equipment'. The 'Intended Use / Indications for Use' also describes its use for 'Ultrasound imaging' across various anatomical sites, which is inherently a diagnostic capability.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions meeting multiple hardware safety standards (UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, etc.) and refers to an "ultrasound system" (Siemens Acuson X500 and Siemens Sonoline G60S), which are hardware devices. The intended use also describes ultrasound imaging, which requires hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states the device is an "Ultrasound imaging or fluid flow analysis of the human body". This is an in vivo (within the living body) imaging technique, not an in vitro (in glass/outside the body) test.
Intended Use: The intended use lists various anatomical sites for imaging and fluid flow analysis within the body.
Device Description: The safety standards listed are for medical equipment used on patients, not for laboratory diagnostic equipment.

Therefore, the Siemens Acuson X500, as described, is a diagnostic ultrasound system used for imaging the human body directly, which falls under the category of medical devices but not specifically In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Siemens Acuson X500 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 Musculoskeletat, Great Vessel, and Peripheral Vascular applications.

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

For the Siemens Acuson X500 Ultrasound System:
Clinical Applications: Fetal, Abdominal, Intraoperative (Note 6), Intraoperative Neurological, Pediatric, Small Organ (Note 1), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral vessel, Laparoscopic, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial).
Modes of Operation: A, B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging. Combined (BMDC). Other (Note 2,3,4,5,7).

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
Note 8 Virtual Format

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

90-IYN, 90-IYO, 90-ITX

Device Description

The Siemens Acuson X500 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

Ensemble tissue harmonic imaging, 3D imaging, B&W SieScape panoramic imaging, Power SieScape panoramic imaging, SieClear multi-view spatial compounding, Tissue Equalization Technology, 3-Scape real-time 3D imaging, Virtual Format.

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 Musculoskeletat, Great Vessel, Peripheral Vascular, Fetal, Transrectal, Transvaginal, Breast, Testes, Thyroid, Penis, Prostate.

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 X500 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.

K052894, K040060, K033196, K050240, K043016

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

Kobl980

SECTION 11 510(k) Summary

| 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: (650) 943 7187 | |
| | Fax: (650) 943 7053 | |
| Submission Date: | July 11, 2006 | |
| Device Name: | Siemens Acuson X500 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 X500 Ultrasound system is substantially equivalent to the Siemens Sonoline G60S ultrasound system.

B. Device Description:

The Siemens Acuson X500 has been designed to meet the following product safety standards:

트 UL 60601-1, Safety Requirements for Medical Equipment
이 IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
요 CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
트 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
이 93/42/EEC Medical Devices Directive
t Safety and EMC Requirements for Medical Equipment
- 트 EN/IEC ୧୦୧01 - I
- . EN/IEC 60601-1-1
- 트 EN/IEC 60601-1-2
트 IEC 1157 Declaration of Acoustic Power
l ISO 10993-1 Biocompatibility

1

C. Intended Use

The Siemens Acuson X500 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 Musculoskeletat, 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 X500 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 Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 7 2006

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

Re: K061980

Trade Name: Siemens Acuson X500TM Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 11, 2006 Received: July 17, 2006

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 Siemens Acuson X500™ Ultrasound System, as described in your premarket notification:

Image /page/2/Picture/11 description: The image is a black and white circular logo for the FDA Centennial. The logo includes the letters "FDA" in a bold, stylized font, with the word "Centennial" written in cursive underneath. The years "1906 - 2006" are displayed above the FDA letters. The logo is surrounded by text that curves along the circle's edge, and there are three stars below the word "Centennial".

Protecting and Promoting Public Health

3

Transducer Model Number

C5-2 Convex Array
C6-2 Convex Array
C8-5 Convex Array
5.0C50+ Convex Array
C6-3 3D Mechanically Driven 3D Convex
Array
EV9-4 Convex Array Endovaginal
Endo-VII Mechanical Sector Endovaginal
Endo-V 3D Mechanical Sector Endovaginal
Ec9-4 Convex Array Endovaginal
BE9-4 Convex Array Endocavity
5.0L45 Linear Array
7.5L70 Linear Array
LB5-2 Linear Array
L10-5 Linear Array

VF13-5 Linear Array VF13-5SP Linear Array 7.5L50I Linear Array 7.5L50Q Linear Array 8L3 Linear Array C7F2 Curved Array Mechanical 3D LAP8-4 Laparoscopic P4-2 Phased Sector Array 5.0P10 Phased Array MPT7-4 Phased Sector Array TEE CW2 CW5 P9-4 Phased Sector Array CH5-2 Convex 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 (OS) 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:

4

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 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 Ralph Shuping at (301) 594-1212.

Sincerely yours,

David h. Syzmm

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

Enclosure(s)

5

Diagnostic Ultrasound Indications for Use Form

Kob 11720

510(k) Number (if known):

Device Name:

SIEMENS ACUSON X500™ Ultrasound System

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		P	P	P	P	P	P	BMDC	Note 2,3,4,5
Abdominal		P	P	P	P	P	P	BMDC	Note 2,3,4,5
Intraoperative (Note 6)		P	P	P		P	P	BMDC	Note 3
Intraoperative Neurological		P	P	P		P	P	BMDC	Note 2,3
Pediatric		P	P	P	P	P	P	BMDC	Note 2,3,4,5
Small Organ (Note 1)		P	P	P	P	P	P	BMDC	Note 2,3,4,5
Neonatal Cephalic		P	P	P	P	P	P	BMDC	Note 2,3
Adult Cephalic		P	P	P	P	P	P	BMDC	Note 2
Cardiac		P	P	P	P	P	P	BMDC	Note 2,7
Transesophageal		P	P	P	P	P	P	BMDC	Note 2,3,7
Transrectal		P	P	P		P	P	BMDC	Note 2,3,4,5
Transvaginal		P	P	P		P	P	BMDC	Note 2,3,4,5
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P	BMDC	Note 2,3,4,5
Laparoscopic		P	P	P		P	P	BMDC	Note 3
Musculo-skeletal (Conventional)		P	P	P	P	P	P	BMDC	Note 2,3,4,5
Musculo-skeletal (Superficial)		P	P	P	P	P	P	BMDC	Note 2,3,4,5
Other (specify)

P = previously cleared by the FDA under # K052894) 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

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

Note 8 Virtual Format

productive

6

Diagnostic Ultrasound Indications for Use Form

Koblito

510(k) Number (if known):

Device Name:

Intended Use:

C5-2 Convex Array Transducer for use with: SIEMENS ACUSON X500 Ultrasound System 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		P	P	P		P	P	BMDC	Note 2,3,4,5,
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5,
Intraoperative Abdominal
Intraoperative Neurological
Pediatric		P	P	P		P	P	BMDC	Note 2,3,4,5,
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note 2,3,4,5,
Laparoscopic
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Other (Specify)

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

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

Ensemble tissue harmonic imaging Note 2

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
Note 8 Virtual format

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

Daniel A. Hagerman

(Division Sign-Off) Division of Reproductive. Abde and Radiological Devic 510(k) Number _

7

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Koleli To

Device Name:

C6-2 Convex Array Transducer for use with:

SIEMENS ACUSON X500 Ultrasound System

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		P	P	P		P	P	BMDC	Note
2,3,4,5,7
Abdominal		P	P	P		P	P	BMDC	Note
2,3,4,5,7
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric		P	P	P		P	P	BMDC	Note
2,3,4,5,7
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note
2,3,4,5,7
Laparoscopic
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Other (specify)

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

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

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

Note 8 Virtual format

David R. Lessem

(Division Sign-Off) Division of Reproductive, Abd and Radiological Devic 510(k) Number

Page 32 of 68

8

Diagnostic Ultrasound Indications for Use Form

KU61420 510(k) Number (if known):

Device Name:

Intended Use:

C8-5 Convex Array Transducer for use with: SIEMENS ACUSON X500 Ultrasound System 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 3,4,5
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric		P	P	P		P	P	BMDC	Note 3,4,5
Small Organ (Note 1)		P	P	P		P	P	BMDC	Note 3,4,5
Neonatal Cephalic		P	P	P		P	P	BMDC	Note 3,4,5
Adult Cephalic
Cardiac		E	E	E		E	E	BMDC	Note 3,4,5,7
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal (Conventional)		P	P	P		P	P	BMDC	Note 3,4,5
Musculo-skeletal (Superficial)		E	E	E		E	E	BMDC	Note 3,4,5
Other (specify)

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

Note I 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

Note 5 Power SieScape panoramic imaging

For example: abdominal, vascular Note 6 Note 7

Contrast agent imaging

Note 8 Virtual format

David La Heyman

(Division Sign-Off) Division of Reproductive, A and Radiological Devic 510(k) Number

9

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known).

1661980 5.0C50+ Convex Array Transducer for use with: Device Name:

SIEMENS ACUSON X500 Ultrasound System

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		P	P	P	P	P	P	BMDC	Note 3,4,5
Abdominal		P	P	P	P	P	P	BMDC	Note 3,4,5
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric		P	P	P	P	P	P	BMDC	Note 3,4,5
Small Organ (Note 1)		P	P	P	P	P	P	BMDC	Note 3,4,5
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P	BMDC	Note 3,4,5
Laparoscopic
Musculo-skeletal (Conventional)		E	E	E	E	E	E	BMDC	Note 3,4,5
Musculo-skeletal (Superficial)		E	E	E	E	E	E	BMDC	Note 3,4,5
Other (specify)

P = previously cleared by the FDA under # K040060; 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

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

Contrast agent imaging Note 7

Note 8 Virtual Format
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lyman

(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number_

10

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):	K061150
Device Name:	C6-3 3D Mechanically Driven 3D Convex Array Transducer for use with:
SIEMENS ACUSON X500 Ultrasound System
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		P	P	P		P	P	BMDC	Note 2,3,4,5
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric		P	P	P		P	P	BMDC	Note 2,3,4,5
Small Organ (Note 1)
Neonatal Cephalic		E	E	E		E	E	BMDC	Note 2,3,4,5
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Other (specify)

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

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

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 Note 8 Virtual format

Daniel A. Lynn

(Division Sign-Off) Division of Reproductive, Ab and Radiological Device 510(k) Number

11

Diagnostic Ultrasound Indications for Use Form

14061960

510(k) Number (if known):

Device Name:

Intended Use:

EV9-4 Convex Array Endovaginal Transducer for use with: SIEMENS ACUSON X500 Ultrasound System 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		P	P	P		P	P	BMDC	Note 2,3,4,5
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 2,3,4,5
Transvaginal		P	P	P		P	P	BMDC	Note 2,3,4,5
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Other (specify)

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

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

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

Note 8 Virtual format
(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)

Elmer A. Larson

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

Page 36 of 68

12

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

1661180

Device Name:

Intended Use:

Endo-VII Mechanical Sector Endovaginal Transducer for use with: SIEMENS ACUSON X500 Ultrasound System 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		P	P				BM	Note 3
Abdominal
Intraoperative Abdominal
Intraoperative Neurological
Pediatric
Small Organ (Note 1)
Neonatal Cephalic		P	P				BM	Note 3
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P				BM	Note 3
Transvaginal		P	P				BM	Note 3
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

Note l 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

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging
Note 8 Virtual format

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

David R. Lygren

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

13

Diagnostic Ultrasound Indications for Use Form

Kobigro 510(k) Number (if known):

Device Name:

Intended Use:

Endo-V 3D Mechanical Sector Endovaginal Transducer for use with: SIEMENS ACUSON X500 Ultrasound System 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		P	P				BM	Note 3
Abdominal
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric
Small Organ (Note 1)
Neonatal Cephalic		P	P				BM	Note 3
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P				BM	Note 3
Transvaginal		P	P				BM	Note 3
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Other (specify)

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

Note I 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

Note 8 Virtual format

David Lynn

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

Page 38 of 68

14

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

11:01750

EC9-4 Convex Array Endovaginal Transducer for use with: Device Name: SIEMENS ACUSON X500 Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as Intended Use: 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 2,3,4,5
Abdominal
Intraoperative Abdominal
Intraoperative Neurological
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P	P		P	P	BMDC	Note 2,3,4,5
Transvaginal		P	P	P		P	P	BMDC	Note 2,3,4,5
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

Note l 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
Note 8 Virtual format

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

David A. Ingram

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

15

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

11061982

Device Name:

Intended Use:

BE9-4 Convex Array Endocavity Transducer for use with: SIEMENS ACUSON X500 Ultrasound System 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		P	P	P		P	P	BMDC	Note 2,3,4,5
Abdominal
Intraoperative Abdominal
Intraoperative Neurological
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P	P		P	P	BMDC	Note 2,3,4,5
Transvaginal		P	P	P		P	P	BMDC	Note 2,3,4,5
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

Note l 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
Note 8 Virtual format

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

David Bro. Lyman

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

16

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

5.0L45 Linear Array Transducer for use with:

061960

SIEMENS ACUSON X500 Ultrasound System

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	P	BMDC	Note 2,3,4,5
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric		P	P	P	P	P	P	BMDC	Note 2,3,4,5
Small Organ (Note 1)		P	P	P	P	P	P	BMDC	Note 2,3,4,5
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P	BMDC	Note 2,3,4,5
Laparoscopic
Musculo-skeletal (Conventional)		P	P	P	P	P	P	BMDC	Note 2,3,4,5
Musculo-skeletal (Superficial)
Other (specify)

P = previously cleared by the FDA under # K040060; 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

Note 8 Virtual format

David A. Segerson

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

Page 41 of 68

17

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

7.5L70 Linear Array Transducer for use with:

= 61980

SIEMENS ACUSON X500 Ultrasound System

Ultrasound imaging or fluid flow analysis of the human body as Intended Use: 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 3,4,5
Small Organ (Note 1)		P	P	P		P	P	BMDC	Note 3,4,5
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		E	E	E		E	E	BMDC	Note 3,4,5
Laparoscopic
Musculo-skeletal (Conventional)		P	P	P		P	P	BMDC	Note 3,4,5
Musculo-skeletal (Superficial)		P	P	P		P	P	BMDC	Note 3,4,5
Other (specify)

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

Note l 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

Note 7 Contrast agent imaging

Note 8 Virtual format

David A. Syme

(Division Sign-Off Division of Reproductive. Abd Page 42 of 68and Radiological Devices 510(k) Numbe

18

Diagnostic Ultrasound Indications for Use Form

follows:

510(k) Number (if known):	K e 6 1120
Device Name:	LB5-2 Linear Array Transducer for use with:
Intended Use:	SIEMENS ACUSON X500 Ultrasound System
	Ultrasound imaging or fluid flow analysis of the human body as

	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 4,5
Abdominal		P	P	P		P	P	BMDC	Note 4,5
Intraoperative Abdominal
Intraoperative Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

Note I 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

David A. Leggett

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

Page 43 of 68

19

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Collico

Device Name:

L10-5 Linear Array Transducer for use with:

SIEMENS ACUSON X500 Ultrasound System

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
2,3,4,5,8
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric		P	P	P		P	P	BMDC	Note
2,3,4,5,8
Small Organ (Note 1)		P	P	P		P	P	BMDC	Note
2,3,4,5,8
Neonatal Cephalic		P	P	P		P	P	BMDC	Note
2,3,4,5,8
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note
2,3,4,5,8
Laparoscopic
Musculo-skeletal (Conventional)		P	P	P		P	P	BMDC	Note
2,3,4,5,8
Musculo-skeletal (Superficial)		P	P	P		P	P	BMDC	Note
2,3,4,5,8
Other (specify)

P = previously cleared by the FDA under # K040060; 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 Contrast agent imaging

Note 7 Note 8 Virtual format

Prescription Use (Per 21 CFR 801.109)

David A. Symm

Page 44 of 68

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

20

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known).

K. 61706

Device Name:

VF13-5 Linear Array Transducer for use with:

SIEMENS ACUSON X500 Ultrasound System

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
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric		P	P	P	P	P	P	BMDC	Note 3,4,5,8
Small Organ (Note 1)		P	P	P	P	P	P	BMDC	Note 3,4,5,8
Neonatal Cephalic		P	P	P	P	P	P	BMDC	Note 3,4,5,8
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P	BMDC	Note 3,4,5,8
Laparoscopic
Musculo-skeletal (Conventional)		P	P	P	P	P	P	BMDC	Note 3,4,5,8
Musculo-skeletal (Superficial)		P	P	P	P	P	P	BMDC	Note 3,4,5,8
Other (specify)

P = previously cleared by the FDA under # K040060; 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

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Note 8 Virtual format

David A. Syzmm

(Division Sign Division of Reproductive, A and Radiological Devices 510(k) Numb

Page 45 of 68

21

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

16 - 619 70

Device Name:

VF13-5SP Linear Array Transducer for use with:

SIEMENS ACUSON X500 Ultrasound System

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
Intraoperative (Note 6)		P	P	P		P	P	BMDC	Note 3,4,5,8
Intraoperative Neurological		P	P	P		P	P	BMDC	Note 3,4,5,8
Pediatric		P	P	P		P	P	BMDC	Note 3,4,5,8
Small Organ (Note 1)		P	P	P		P	P	BMDC	Note 3,4,5,8
Neonatal Cephalic		P	P	P		P	P	BMDC	Note 3,4,5,8
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note 3,4,5,8
Laparoscopic
Musculo-skeletal Conventional		P	P	P		P	P	BMDC	Note 3,4,5,8
Musculo-skeletal Superficial		P	P	P		P	P	BMDC	Note 3,4,5,8
Other (specify)

P = previously cleared by the FDA under # K040060; 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

Note 5 Power SieScape panoramic imaging

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

Note 8 Virtual format

(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)

Daniel h. Lyman

Page 46 of 68

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

22

Intended Use:

Diagnostic Ultrasound Indications for Use Form

X 661 150 510(k) Number (if known): Device Name:

7.5L50I Linear Array Transducer for use with: SIEMENS ACUSON X500 Ultrasound System 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 3,4,5
Intraoperative (Note 6)		P	P	P		P	P	BMDC	Note 3,4,5
Intraoperative Neurological
Pediatric
Small Organ (Note 1)		P	P	P		P	P	BMDC	Note 3,4,5
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note 3,4,5
Laparoscopic
Musculo-skeletal Conventional		P	P	P		P	P	BMDC	Note 3.4,5
Musculo-skeletal Superficial
Other (specify)

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

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

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
Note 8 Virtual format

(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)

David A. Symon

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

Page 47 of 68

23

Diagnostic Ultrasound Indications for Use Form

follows:

510(k) Number (if known):	K061780
Device Name:	7.5L50Q Linear Array Transducer for use with:
	SIEMENS ACUSON X500 Ultrasound System ·
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as

	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 3,4,5
Intraoperative (Note 6)		P	P	P		P	P	BMDC	Note 3,4,5
Intraoperative Neurological
Pediatric
Small Organ (Note 1)		P	P	P		P	P	BMDC	Note 3,4,5
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note 3,4,5
Laparoscopic
Musculo-skeletal (Conventional)		P	P	P		P	P	BMDC	Note 3,4,5
Musculo-skeletal (Superficial)
Other (specify)

P = previously cleared by the FDA under # K040060; E = added under Appendix E. .

Note l 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

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Note 8 Virtual format

David A. Bergman

(Divesion Sign-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Page 48 of 68

24

Diagnostic Ultrasound Indications for Use Form

1061980 510(k) Number (if known):

Device Name:

8L3 Linear Array Transducer for use with:

Siemens Acuson X500 Ultrasound System

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	N	N	N	N	N	N	N	BMDC	Note 2,3,4,5,8
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,8
Small Organ (Note 1)	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,8
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,8
Laparoscopic
Musculo-skeletal (Conventional)	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,8
Musculo-skeletal (Superficial)
Other (specify)

P = previously cleared by the FDA under # K040060; 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 SicScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Note 8 Virtual format

David B. Heyman

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

Page 49 of 68

25

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Kiiro

Device Name:

C7F2 Curved array mechanical 3D transducer for use with

Siemens Acuson X500 Ultrasound System

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		N	N	N		N	N	BMDC	Note 2,3,4,5,7
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5,7
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric		P	P	P		P	P	BMDC	Note 2,3,4,5,7
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note 2,3,4,5,7
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,7
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K033196; E = added under Appendix E

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding Note 3
Tissue Equalization Technology Note 4
3-Scape real-time 3D imaging Note 5
B&W SieScape panoramic imaging Note 7

(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)

David R. Ingram

Page 50 of 68

(Division Sian-Off) Division of Reproductive, Abd anc Badiological Devices 5 | (Xk) Number

26

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):	K061980
Device Name:	LAP8-4 Laparoscopic Transducer for use with:
SIEMENS ACUSON X500 Ultrasound System
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
Intraoperative (Note 6)		P	P	P		P	P	BMDC	Note 3,4,5
Intraoperative Neurological
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic		P	P	P		P	P	BMDC	Note 3,4,5
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Other (specify)

P = previously cleared by the FDA under # K040060; 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

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

Virtual format Note 8

David R. Sgammo

Page 51 of 68

(Division Sign-Off) Division of Reproductive. Abdom and Radiological Devices 510(k) Number

27

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Ke 61 14 82.

Device Name:

P4-2 Phased Sector Array Transducer for use with:

SIEMENS ACUSON X500 Ultrasound System

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		P	P	P	P	P	P	BMDC
Abdominal		P	P	P	P	P	P	BMDC	Note 2,3
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric		P	P	P	P	P	P	BMDC
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 2,3,7
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal (Conventional)
Musculo-skelctal (Superficial)
Other (specify)

P = previously cleared by the FDA under # K040060; E = added under Appendix E.

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

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

Note 8 Virtual format

David A. Sycom

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061980

Page 52 of 68

28

Diagnostic Ultrasound Indications for Use Form

| 510(k) Number (if

known):	K-61170
Device Name:	5.0P10 Phased Sector Array Transducer for use with:

SIEMENS ACUSON X500 Ultrasound System

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								BMDC	Note 2
Fetal	P	P	P	P	P	P	P	BMDC	Note 2
Abdominal	P	P	P	P	P	P	P	BMDC	Note 2
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	BMDC	Note 2
Small Organ (Note 1)
Neonatal Cephalic	P	P	P	P	P	P	P	BMDC	Note 2
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	BMDC	Note 2,7
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skelctal (Conventional)
Musculo-skeletal (Superficial)
Other (specify)

P = previously cleared by the FDA under # K040060; 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

Contrast agent imaging Note 7

Virtual format Note 8

Daniel R. Lyman

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices Page 53 of 68 1 Olki Number __

29

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

11 261150

Device Name:

MPT7-4 Phased Sector Array TEE Transducer for use with:

SIEMENS ACUSON X500 Ultrasound System

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
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal		P	P	P	P	P	P	BMDC	Note 2,3,7
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Other (specify)

P = previously cleared by the FDA under # K040060; 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

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

Note 8 Virtual format

(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)

David A. Seymour

I hunsion Sion - Off) Devision of Reproductive. ann Badinlouical Devi 5 € 5K) (wiender

Page 54 of 68

30

Diagnostic Ultrasound Indications for Use Form

Kobla VC 510(k) Number (if known):

Device Name:

CW2 Continuous Wave Doppler Transducer for use with:

SIEMENS ACUSON X500 Ultrasound System

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
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac					P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Other (specify)

P = previously cleared by the FDA under # K040060; 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
Note 8 Virtual format

(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)

David A. Severson

(Division Sign-Off) Division of Reproductive, and Redusingical Don ないと思います。この時はない

Page 55 of 68

31

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known): Device Name:

Koc 1970

CW5 Continuous Wave Doppler Transducer for use with:

SIEMENS ACUSON X500 Ultrasound System

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
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophagcal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel					P
Laparoscopic
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Other (specify)

P = previously cleared by the FDA under # K040060; 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

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging
Note 8 Virtual format

01.109)
David R. Lynn
(Division Sign-Off)

Division of Reproductive An and Radiological Device 51 Wirl Number

Page 56 of 68

32

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Kols1480

Device Name:

P9-4 Phased Sector Array Transducer for use with:

SIEMENS ACUSON X500 Ultrasound System

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		P	P	P	P	P	P	BMDC	Note 2
Abdominal		P	P	P	P	P	P	BMDC	Note 2
Intraoperative (Note 6)
Intraoperative Neurological		P	P	P		P	P	BMDC	Note 2
Pediatric		P	P	P	P	P	P	BMDC	Note 2
Small Organ (Note 1)		P	P	P	P	P	P
Neonatal Cephalic		P	P	P	P	P	P	BMDC	Note 2
Adult Cephalic		P	P	P	P	P	P
Cardiac		P	P	P	P	P	P	BMDC	Note 2,7
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P	BMDC	Note 2
Laparoscopic
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Other (specify)

P = previously cleared by the FDA under # K050240; E = added under Appendix E.

Note I 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

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Note 8 Virtual format

Daniel R. Lypman

(Division Sion-Off) vision of Reproductive. Abdo o Radiological Devic E 1 (1/k) Niember

Page 57 of 68

33

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known): Device Name:

Kel. 980

CH5-2 Convex Array Transducer for use with:

SIEMENS ACUSON X500 Ultrasound System

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		P	P	P		P	P	BMDC	Note
2,3,7,8
Fetal		P	P	P		P	P	BMDC	Note
2,3,7,8
Abdominal		P	P	P		P	P	BMDC	Note
2,3,7,8
Intraoperative (Note 6)
Intraoperative Neurological
Pediatric		P	P	P		P	P	BMDC	Note
2,3,7,8
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note
2,3,7,8
Laparoscopic
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Other (specify)

P = previously cleared by the FDA under # K043016; E = added under Appendix E.

Note I 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

Note 5 Power SieScape panoramic imaging

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

Note 8 Virtual format

David A. Syammen

Page 58 of 68

(Division Sian-Off Division of Reproductive, Abde and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________