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

Device Description

The Siemens Acuson X300 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, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment; AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound; 93/42/EEC Medical Devices Directive; Safety and EMC Requirements for Medical Equipment EN/EC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2; IEC 61157 Declaration of Acoustic Power; ISO 10993-1 Biocompatibility.

AI/ML Overview

The Siemens ACUSON X300 Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with various transducers. The provided text is a 510(k) Summary and Indications for Use forms, primarily focusing on establishing substantial equivalence to a predicate device and outlining the range of applications for the system and its various transducers. There is no performance data regarding acceptance criteria for an AI/CADe device, and no study is described to prove a device meets acceptance criteria.

The document indicates that "The Acuson X300 modifications are verified and validated according to the company's design control process." However, it does not provide details of specific performance metrics, acceptance criteria, or the study conducted to demonstrate compliance for any AI/CADe functionality. The tables provided are "Indications for Use" forms, not performance tables.

Therefore, for aspects related to AI/CADe acceptance criteria and studies, the requested information is not available in the provided text.

Here's a breakdown of what can be inferred from the text regarding the device and its regulatory submission, but no AI/CADe-specific performance claims or studies are present:

1. A table of acceptance criteria and the reported device performance

This information is Not Available in the provided text for any AI/CADe device. The tables shown are "Indications for Use" forms, indicating the clinical applications and modes of operation for various transducers, not performance metrics or acceptance criteria for an AI/CADe system.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is Not Available in the provided text. The submission is for an ultrasound system and its transducers, and no specific test set details for AI/CADe performance are mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is Not Available in the provided text. No ground truth establishment related to AI/CADe performance is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is Not Available in the provided text. No adjudication method related to AI/CADe performance is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is Not Available in the provided text. The submission is for a diagnostic ultrasound system and its transducers, not explicitly for an AI-assisted diagnostic product. There are no mentions of MRMC studies or human reader improvement with AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is Not Available in the provided text. There is no mention of a standalone algorithm performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is Not Available in the provided text. No ground truth definition related to AI/CADe performance is provided.

8. The sample size for the training set

This information is Not Available in the provided text. No training set details for an AI/CADe system are mentioned.

9. How the ground truth for the training set was established

This information is Not Available in the provided text. No ground truth establishment for a training set is described.

Summary of Device and Safety Information (from the provided text):

Device Name: ACUSON X300™ Diagnostic Ultrasound System / SONOVISTA X300 Diagnostic Ultrasound System
Sponsor: Siemens Medical Solutions USA, Inc., Ultrasound Division
Submission Date: April 11, 2007
Regulatory Status: Substantially Equivalent to predicate device Siemens Acuson X300 ultrasound system (K061946). This is a 510(k) submission, not a new AI/CADe device seeking market authorization based on clinical performance.
Intended Use: Diagnostic imaging or fluid flow analysis of the human body for a wide range of clinical 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).
Transducers covered in this submission (as listed on Page 2 of the FDA letter):
- P4-2 Phased Sector Array
- CH5-2 Convex Array
- VF10-5 Linear Array
- L9-5 Linear Array
- EC9-4 Convex Array
- EV9-4 Convex Array
- VF13-5 Linear Array
- P8-4 Phased Array
- BE9-4 Convex Array
- CW2 Continuous Wave Doppler
- CW5 Continuous Wave Doppler
- Acu Nav 8F Intracardiac
- Acu Nav 10F Intracardiac
- V5Ms TEE
- 4V1c Phased Array
- VF13-5SP Linear Array
- C8-5 Tight Curved Array
- 8L3 Linear "Regel"
- 10V4 Phased Array Neonatal High Frequency
- C7F2 Curved Array Mechanical 3D/4D
- EV9F4 Curved Array Mechanical 3D/4D
- L13F5 3D/4D Mechanical Wobbler Linear
- VF8-3 Linear
Performance Data Mentioned: "The Acuson X300 modifications are verified and validated according to the company's design control process." The FDA letter also requests a post-clearance special report containing acoustic output measurements based on production line devices, referencing "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." This indicates a focus on physical and acoustic safety performance standards rather than AI/CADe diagnostic accuracy.
Safety Standards: The device has been designed to meet several safety standards including UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, 93/42/EEC Medical Devices Directive, EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2, IEC 61157, and ISO 10993-1.

The provided document describes the regulatory clearance for a diagnostic ultrasound system and its transducers, emphasizing its substantial equivalence to a previously cleared device and adherence to safety standards. It does not contain information about the performance or validation of an AI/CADe component.

Summary

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

SECTION 11

510(k) Summary

Sponsor:	Siemens Medical Solutions USA, Inc.,Ultrasound Division1230 Shorebird WayMountain View, California 94043	MAY 16 2007
Contact Person:	Martina Vogt
Telephone:	(425) 557 1434
Fax:	(425) 391 9198
Submission Date:	April 11, 2007
Device Name:	ACUSON X300™ Diagnostic Ultrasound SystemSONOVISTA X300 Diagnostic 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
Diagnostic Intravascular Catheter	FR # 870.1200	Product Code 74-DQO

A. Legally Marketed Predicate Devices

The Siemens Acuson X300 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 X300 ultrasound system (K061946).

B. Device Description:

The Siemens Acuson X300 has been designed to meet the following product safety standards:

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

{1}------------------------------------------------

유 IEC 61157 Declaration of Acoustic Power
ISO 10993-1 Biocompatibility

C. Intended Use

The Siemens Acuson X300 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 X300 modifications are verified and validated according to the company's design control process.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and formal nature.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

MAY 16 2007

Re: K071036

Trade Name: ACUSON X300 Diagnostic Ultrasound Systems Regulation Number: 21 CFR §892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX and DQO Dated: April 11, 2007 Received: April 16, 2007

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 X300 Diagnostic Ultrasound Systems, as described in your premarket notification:

Transducer Model Number

P4-2 Phased Sector Array CH5-2 Convex Array VF10-5 Linear Array L9-5 Linear Array EC9-4 Convex Array EV9-4 Convex Array VF13-5 Linear Array P8-4 Phased Array BE9-4 Convex Array CW2 Continuous Wave Doppler CW5 Continuous Wave Doppler Acu Nav 8F Intracardiac

Acu Nav 10F Intracardiac V5Ms TEE 4V1c Phased Array VF13-5SP Linear Array C8-5 Tight Curved Array 8L3 Linear "Regel" 10V4 Phased Array Neonatal High Frequency C7F2 Curved Array Mechanical 3D/4D EV9F4 Curved Array Mechanical 3D/4D L13F5 3D/4D Mechanical Wobbler Linear VF8-3 Linear

{3}------------------------------------------------

Page 2 - Ms. Martina Vogt

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your device is classified (dos are controls. Existing major regulations affecting your device It may be subject to sach as 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 I Tease be advised that I DTT official of our device complies with other requirements of the Act that I Drinas Intatutes and regulations administered by other Federal agencies. You must of any I coural statutes and regerments, including, but not limited to: registration and listing (21 comply with an the 10th 3 requirements, More, and manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping I ms device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested information, merculing acounts of the Center's September 30, 1997 "Information for Manufacturers In Appendix U, (encrosou) of the Senter tic Ultrasound Systems and Transducers." If the special Secking Manching Cloudins unaceptable values (e.g., acoustic output greater than approved report is incomplete or comains anaooopation faract (organisation units which as a result may be considered adulterated or misbranded.

The special report should réference the manufacturer's 510(k) number. It should be clearly and The special report should be submitted in designitted 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 This letter will anow you to begin marketing your device to a legally marketed notification. The I Driving of succion 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 If you dosire specific advision at (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Oremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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

{4}------------------------------------------------

Page 3 – Ms. Martina Vogt

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

Sincerely yours,

Nancy C Brogdon
Nancy C. Brogdon

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

Enclosures

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

510(k) Number (if known):

ACUSON X300 Diagnostic Ultrasound Systems

Device Name:

Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Intraoperative(Note 6)		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
IntraoperativeNeurological		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Pediatric		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Small Organ(Note 1)		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Adult Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Cardiac		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Transesophageal		P	P	P	P	P	P		BMDC	Note 2,3,7,8,9
Transrectal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Transvaginal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Transurethral
Intravascular		P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,10
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Other (specify)		P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,10

N = new indication; P = previously cleared by FDA (K061946); E = added under Appendix E

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

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

B&W SieScape panoramic imaging Note 4

Note 5 Power SieScape panoramic imaging

For example: abdominal, vascular Note 6

Note 7 , Contrast agent imaging

SieClear multi-view spatial compounding Note 8

Note 9 Tissue Equalization Technology

Note 10 Intracardiac imaging

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

Concurrence of CDRH, Office of Device Evaluation (ODE)	Nancy C Brogdon
Prescription Use (Per 21 CFR 801.109) (Division Sign-Off)	Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K071036

Pg. 6.2 of 6.25Diagnostic Ultrasound Indications for Use Form

Pg. 6.2 of 6.25

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

510(k) Number (if known):

Device Name:

P4-2 Phased Sector Array Transducer for use with: ACUSON X300 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3,5,6,7,8,9
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Small Organ(Note 1)
Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Adult Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Cardiac		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA (K061946); E = added under Appendix E

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

Noțe 2 Ensemble tissue harmonic imaging

3D imaqing Note 3

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

SieClear multi-view spatial compounding Note 8

Note 9 Tissue Equalization Technology

Note 10 Intracardiac imaging

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE 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 K071036

Diagnostic Ultrasound Indications for Use Form

Pg. 6.3 of

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

510(k) Number (if known):

Device Name:

Intended Use:

CH5-2 Convex Array Transducer for use with: ACUSON X300 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA (K061946); 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

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 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 9

Note 10 Intracardiac imaging

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAC 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 K071036

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

510(k) Number (if known):

Device Name:

Intended Use:

VF10-5 Linear Array Transducer for use with: ACUSON X300 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Other (specify)

N = new indication; P = previously cleared by FDA (K061946); 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

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

SieClear multi-view spatial compounding Note 8

Tissue Equalization Technology Note 9

Note 10 Intracardiac imaging

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

Nancy C. Broydon

Prescription Use (Per 21 CFR 801.109)

D
(Division Sign-Oft)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K071036

Diagnostic Ultrasound Indications for Use Form

Pg. 6.5 of 6.25

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

510(k) Number (if known):

Device Name:

Intended Use:

L9-5 Linear Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2.3.4.5.7.8.9
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Other (specify)

N = new indication; P = previously cleared by FDA (K061946); 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

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular
Note 7 Contrast agent imaging

SieClear multi-view spatial compounding Note 8

Tissue Equalization Technology Note 9

Note 10 Intracardiac 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)

(ODE)
Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K071036

g. 6.6 of 6.25

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

510(k) Number (if known):

Device Name:

Intended Use:

EC9-4 Convex Array Endocavity Transducer for use with: ACUSON X300 Diagnostic Uitrasound 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 Velocity A M Doppler Doppler (Specify) (Specify) Imaging Ophthalmic P P P P P BMDC Note 2,3,4,5,7,8,9 Fetal Abdominal Intraoperative (Note 6) Intraoperative Neurological Pediatric Small Organ P P P P P BMDC Note 2,3,4,5,7,8,9 (Note 1) P P Neonatal Cephalic P P P BMDC Note 2,3,4,5,7,8,9 Adult Cephalic Cardiac Transesophageal P P BMDC Note 2,3,4,5,7,8,9 Transrectal P P P Transvaginal P P P P P BMDC Note 2,3,4,5,7,8,9 Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal Conventional Musculo-skeletal Superficial Other (specify)

N = new indication; P = previously cleared by FDA (K061946); 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

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

SieClear multi-view spatial compounding Note 8

Note 9 Tissue Equalization Technology

Note 10 Intracardiac imaging

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

DE)
Nancy Broadon

Prescription Use (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form

Pg. 6.7 of 6.25

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

510(k) Number (if known):

Device Name:

EV9-4 Convex Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Intended Use:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Abdominal
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Transvaginal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA (K061946); 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

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

Contrast agent imaging Note 7

SieClear multi-view spatial compounding Note 8

Note 9 Tissue Equalization Technology

Note 10 Intracardiac imaging

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

Prescription Use (Per 21 CFR 801.109)

Nancy brogdon

ictive. Abdominal, and 510(k) Num

Section 6

Diagnostic Ultrasound Indications for Use Form

Pg. 6.8 of 6.25

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

510(k) Number (if known): .

Device Name:

Intended Use:

VF13-5 Linear Array Transducer for use with: ACUSON X300 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2.3.4.5.7.8.9
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Other (specify)

N = new indication; P = previously cleared by FDA (K061946); 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

B&W SieScape panoramic imaging Note 4

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Contrast agent imaging Note 7

SieClear multi-view spatial compounding Note 8

Note 9 Tissue Equalization Technology

Note 10 Intracardiac imaging

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off)

BrogdonPrescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K071036

{13}------------------------------------------------

510(k) Number (if known):

Device Name:

Intended Use:

P8-4 Phase Array Transducer for use with: ACUSON X300 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3,45,7,8,9
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Small Organ(Note 1)
Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA (K061946); 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
Power SieScape panoramic imaging Note 5
For example: abdominal, vascular Note 6
Note 7 Contrast agent imaging
Note 8 SieClear multi-view spatial compounding
Note 9 Tissue Equalization Technology

Note 10 Intracardiac 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 Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K071036

Diagnostic Ultrasound Indications for Use Form

Pg. 6.10 of 6.25

{14}------------------------------------------------

510(k) Number (if known):

Device Name:

Intended Use:

BE9-4 Convex Array Transducer for use with: ACUSON X300 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Abdominal
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Transvaginal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA (K061946); 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 SieClear multi-view spatial compounding

Note 9 Tissue Equalization Technology

Note 10 Intracardiac 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)

Nancy C. Hogdon

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

Section 6

{15}------------------------------------------------

510(k) Number (if known):

Device Name:

Intended Use:

CW2 Continuous Wave Doppler Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal					P
Abdominal					P
Intraoperative(Note 6)					P
IntraoperativeNeurological
Pediatric					P
Small Organ(Note 1)					P
Neonatal Cephalic					P
Adult Cephalic					P
Cardiac					P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel					P
Laparoscopic
Musculo-skeletalConventional					P
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA (K061946); 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

Contrast agent imaging Note 7

Note 8 SieClear multi-view spatial compounding

Note 9 Tissue Equalization Technology

Note 10 Intracardiac 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)

Nancy C Brogdon

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

Section 6

Diagnostic Ultrasound Indications for Use Form

Pg. 6.12 of 6.25

{16}------------------------------------------------

510(k) Number (if known):

Device Name:

Intended Use:

CW5Continuous Wave Doppler Transducer for use with: ACUSON X300 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal					P
Abdominal					P
Intraoperative(Note 6)					P
IntraoperativeNeurological
Pediatric					P
Small Organ(Note 1)					P
Neonatal Cephalic					P
Adult Cephalic					P
Cardiac					P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel					P
Laparoscopic
Musculo-skeletalConventional					P
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA (K061946); 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
B&W SieScape panoramic imaging Note 4
Note 5 Power SieScape panoramic imaging
For example: abdominal, vascular Note 6
Note 7 Contrast agent imaging
SieClear multi-view spatial compounding Note 8
Tissue Equalization Technology Note 9
Note 10 Intracardiac 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 Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number
K071036

V an

Diagnostic Ultrasound Indications for Use Form

Pg. 6.13 of 6.25

{17}------------------------------------------------

510(k) Number (if known):

Device Name:

Intended Use:

Acu Nav 8F Intracardiac Transducer for use with : ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P		BMDC	Note 2,3,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular	P	P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,10
Peripheral vessel
Laparoscopic
Musculo-skeletal
ConventionalMusculo-skeletal
Superficial
Other (Intra-cardiac)	P	P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,10

N = new indication; P = previously cleared by FDA (K061946); 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

Note 6 For example: abdominal, vascular

Contrast agent imaging Note 7

Note 8 SieClear multi-view spatial compounding

Note 9 Tissue Equalization Technology

Note 10 Intracardiac imaging

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

Concurrence of CDRH, Office of Device Evaluation (ODE)	Muat
--------------------------------------------------------	------

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K071036

{18}------------------------------------------------

510(k) Number (if known):

Device Name:

Intended Use:

Acu Nav 10F Intracardiac Transducer for use with : ACUSON X300 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P		BMDC	Note 2,3,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular	P	P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,10
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Intra-cardiac)	P	P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,10

N = new indication; P = previously cleared by FDA (K061946); E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaqing

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 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 9

Note 10 Intracardiac imaging

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

Prescription Use (Per 21 CFR 801.109)

Nancy Modon

(Division Sign-Off)

Division of Reproductive, Abdominal, and
Radiological Devices

Pg. 6.15 of 6.25

510(k) Number

{19}------------------------------------------------

510(k) Number (if known):

Device Name:

Intended Use:

V5Ms TEE Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Mode of Operation Color Clinical Application Amplitude Combined Color Other B PWD CWD Velocity A M Doppler Doppler (Specify) (Specify) Imaging Ophthalmic Fetal Abdominal Intraoperative (Note 6) Intraoperative Neurological Pediatric Small Organ (Note 1) Neonatal Cephalic Adult Cephalic Cardiac P P P P P P BMDC Note 2,3,7,8,9 Transesophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal Conventional Musculo-skeletal Superficial Other (specify)

N = new indication; P = previously cleared by FDA (K061946); E = added under Appendix E

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

Ensemble tissue harmonic imaging Note 2

3D imaging Note 3

Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

SieClear multi-view spatial compounding Note 8

Note 9 Tissue Equalization Technology

Note 10 Intracardiac 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)

Nancy Brogdon

oductive. Abdominal, a 510(k) Number

Section 6

Diagnostic Ultrasound Indications for Use Form

Pg. 6.16 of 6.25

{20}------------------------------------------------

510(k) Number (if known):

Device Name:

Intended Use:

4V1c Phased Array Transducer for use with : ACUSON X300 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3,5,6,7,8,9
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Small Organ(Note 1)
Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Adult Cephalic		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Cardiac		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA (K061946); 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

SieClear multi-view spatial compounding Note 8

Tissue Equalization Technology Note 9

Note 10 Intracardiac imaging

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

Prescription Use (Per 21 CFR 801.109)

Sign-off vragen

(Division Sign-Off)

Division of Reproductive Abd

Division of Reproductive. Abdominal. Raciological Device 510(k) Number

Diagnostic Ultrasound Indications for Use Form

Pg. 6.17 of 6.

{21}------------------------------------------------

510(k) Number (if known):

Device Name:

VF13-5SP Linear array Transducer for use with : ACUSON X300 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(Note 6)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
IntraoperativeNeurological		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Other (specify)

N = new indication; P = previously cleared by FDA (K061946); 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

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

SieClear multi-view spatial compounding Note 8

Note 9 Tissue Equalization Technology

Note 10 Intracardiac imaging

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

Concurrence of CDRH, Office of Device Evaluation (ODE)	Nancyc broodon
Prescription Use (Per 21 CFR 801.109)	(Division Sign-Off)
	Division of Reproductive, Abdominal, and
	Radiological Devices
510(k) Number	R071036

Section 6 Diagnostic Ultrasound Indications for Use Form Pg. 6.18 of 6.25

{22}------------------------------------------------

510(k) Number (if known):

Device Name:

Intended Use:

C8-5 Tight Curved Array Transducer for use with: ACUSON X300 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Abdominal		P	P	P		P	P		BMDC	Note 2,3,5,6,7,8,9
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Adult Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Cardiac		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Other (specify)

N = new indication; P = previously cleared by FDA (K061946); 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
Note 8 SieClear multi-view spatial compounding
Note 9 Tissue Equalization Technology
Note 10 Intracardiac 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)

Nanay C. bradon

(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K071036

Pg. 6.19 or 6.25

{23}------------------------------------------------

510(k) Number (if known):

Device Name:

Intended Use:

8L3 Linear "Regel" Transducer for use with : ACUSON X300 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 A B PWD CWD Velocity M Doppler Doppler (Specify) (Specify) Imaging Ophthalmic Fetal P P P P P BMDC Note 2,3,4,5,7,8,9 P p Abdominal P P P BMDC Note 2,3,4,5,7,8,9 Intraoperative (Note 6) Intraoperative Neurological Pediatric P P P P P BMDC Note 2,3,4,5,7,8,9 Small Organ P P P P P BMDC Note 2,3,4,5,7,8,9 (Note 1) P P P Neonatal Cephalic P P BMDC Note 2,3,4,5,7,8,9 Adult Cephalic Cardiac Transesophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel P P P P P BMDC Note 2,3,4,5,7,8,9 Laparoscopic Musculo-skeletal P P P P P BMDC Note 2,3,4,5,7,8,9 Conventional Musculo-skeletal P P P P P BMDC Note 2,3,4,5,7,8,9 Superficial

N = new indication; P = previously cleared by FDA (K061946); 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

Other (specify)

Note 4 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 5
For example: abdominal, vascular Note 6
Note 7 Contrast agent imaqing
SieClear multi-view spatial compounding Note 8
Tissue Equalization Technology Note 9
Note 10 Intracardiac 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)

Nancy C. Hoagdon

of Reproductive, Abdominal, a 510(k) Numbe

Pg. 6.20 of 6.25

{24}------------------------------------------------

510(k) Number (if known):

Device Name:

Intended Use:

10V4 Phased Array Neonatal High Frequency Transducer for use with: ACUSON X300 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 A B PWD CWD M Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic P P P Fetal P P P BMDC Note 2,3,4,5,7,8,9 P Abdominal P P b P P BMDC Note 2,3,45,7,8,9 Intraoperative (Note 6) Intraoperative Neurological Pediatric P P P P P P BMDC Note 2,3,4,5,7,8,9 Small Organ (Note 1) P P P Neonatal Cephalic P P P BMDC Note 2,3,4,5,7,8,9 Adult Cephalic Cardiac P P P P P P BMDC Note 2,3,4,5,7,8,9 Transesophageal Transrectal Transvaginal Transurethral Intravascular P Peripheral vessel P P P P P BMDC Note 2,3,4,5,7,8,9 Laparoscopic Musculo-skeletal P P P P P P BMDC Note 2,3,4,5,7,8,9 Conventional Musculo-skeletal Superficial Other (specify)

N = new indication; P = previously cleared by FDA (K061946); 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
B&W SieScape panoramic imaging Note 4
Note 5 Power SieScape panoramic imaging
For example: abdominal, vascular Note 6
Note 7 Contrast agent imaging
SieClear multi-view spatial compounding Note 8
Tissue Equalization Technology Note 9
Note 10 Intracardiac 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)

Nancy C. Brogdon

(Division Sign-pm)

Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K071036

Pg. 6.21 of 6.25

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510(k) Number (if known):

Device Name:

C7F2 Curved array mechanical 3D/4D Transducer for use with : ACUSON X300 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA (K061946); 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

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 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 9

Note 10 Intracardiac 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)

Nancy Chuyalon
Division Sign-Off

oductive. Abdominal, 510(k

Pg. 6.22 of 6.2

{26}------------------------------------------------

510(k) Number (if known):

Device Name:

Intended Use:

EV9F4 Curved array mechanical 3D/4D Transducer for use with : ACUSON X300 Diagnostic Uitrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Abdominal
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Transvaginal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA (K061946); 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

SieClear multi-view spatial compounding Note 8

Tissue Equalization Technology Note 9

Note 10 Intracardiac 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)

Nancy C. Hogdon

ductive, Abdominal, a Radi

{27}------------------------------------------------

510(k) Number (if known):

Device Name:

Intended Use:

L13F5 3D/4D mechanical wobbler linear transducer for use with: ACUSON X300 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Other (specify)

N = new indication; P = previously cleared by FDA (K061946); E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaqing

Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

SieClear multi-view spatial compounding Note 8

Tissue Equalization Technology Note 9

Note 10 Intracardiac 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)

Nancy Brogdon

oductive, Abdominal, and Divis 510(k) Number

Section 6

Diagnostic Ultrasound Indications for Use Form

Pp. 624

{28}------------------------------------------------

510(k) Number (if known):

Device Name:

Intended Use:

VF8-3 linear transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation						Combined(Specify)
	A	B	M	PWD	CWD	ColorDoppler		AmplitudeDoppler	ColorVelocityImaging
Ophthalmic
Fetal		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8,9
Abdominal		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8,9
Intraoperative(Note 6)
IntraoperativeNeurological
Pediatric		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8,9
Small Organ(Note 1)		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8,9
Neonatal Cephalic		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8,9
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8,9
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

Note 8 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 9

Note 10 Intracardiac imaging

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
	Nancy C. Brogdon
Prescription Use (Per 21 CFR 801.109)	(Division Sign-Off)
	Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K071036

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.