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.

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

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

Device Description

The Siemens ACUSON X300 Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppier Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.

AI/ML Overview

The provided text describes a Special 510(k) Submission for the ACUSON X300 Diagnostic Ultrasound System. This submission is for modifications to a previously cleared device, not for a new device requiring extensive clinical studies to establish safety and effectiveness from scratch. Therefore, the information typically found in such a study (like detailed acceptance criteria with performance values, sample sizes, ground truth establishment methods, or multi-reader multi-case studies) is not present in this document.

Instead, the submission focuses on substantial equivalence to predicate devices. This means the manufacturer demonstrates that the modified device performs as safely and effectively as a legally marketed device and does not raise new questions of safety or effectiveness. The performance data presented indicates nonclinical tests were performed.

Here's a breakdown of the available information regarding acceptance criteria and the "study" (nonclinical tests) that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that "The modifications to the Siemens ACUSON X300 Diagnostic Ultrasound System are verified and validated according to the company's design control process." It then lists the following voluntary standards that the system complies with. These standards implicitly serve as the acceptance criteria for the nonclinical performance of the device. The "reported device performance" is the statement of compliance with these standards.

Acceptance Criteria (Voluntary Standards)	Reported Device Performance
UL 60601-1, Safety Requirements for Medical Equipment	Conforms with applicable medical device safety standards
IEC 60601-2-37 Diagnostic Ultrasound Safety Standards	Conforms with applicable medical device safety standards
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment	Conforms with applicable medical device safety standards
AIUM/NEMA UD-3, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment	Conforms with applicable medical device safety standards; evaluated for acoustic output and thermal safety
AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound	Conforms with applicable medical device safety standards; evaluated for acoustic output
93/42/EEC Medical Devices Directive	Conforms with applicable medical device safety standards
EN/IEC 60601-1 (Safety and EMC Requirements for Medical Equipment)	Conforms with applicable medical device safety standards; evaluated for electrical and electromagnetic safety
EN/IEC 60601-1-1	Conforms with applicable medical device safety standards
EN/IEC 60601-1-2	Conforms with applicable medical device safety standards
IEC 1157 Declaration of Acoustic Power	Conforms with applicable medical device safety standards
ISO 10993-1 Biocompatibility	Conforms with applicable medical device safety standards; evaluated for biocompatibility; cleared patient contact materials are unchanged

2. Sample Size Used for the Test Set and Data Provenance:

The document does not describe a clinical test set with a specific sample size. The "tests" mentioned are nonclinical evaluations for safety and performance against established standards. There is no information provided about data provenance (e.g., country of origin, retrospective/prospective) because this submission relies on engineering verification and validation, and compliance with recognized standards, rather than new clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not applicable to the type of submission presented. The "ground truth" for nonclinical tests would be the specifications and requirements of the voluntary standards themselves, not expert consensus on medical images.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study involving human interpretation of medical results requiring adjudication. The compliance is determined by engineering testing and verification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed to demonstrate the clinical effectiveness of a new device or software feature, especially when involving AI, by comparing human reader performance with and without the aid of the device. This submission is for modifications to an existing ultrasound system, focusing on nonclinical performance relative to predicate devices.

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

Not explicitly stated as a "standalone" algorithm-only study in the context of AI performance. The document describes a diagnostic ultrasound system with various imaging modes and measurement packages. While these involve algorithms, the "performance data" mentioned refers to the system's compliance with safety and acoustic output standards, not a standalone evaluation of an AI algorithm's diagnostic accuracy. The Arterial Health Package (AHP) software is mentioned with its capability to measure Intima Media Thickness and reference normative tables, but no details of a standalone performance study for this software are provided in this summary.

7. The Type of Ground Truth Used:

For the nonclinical tests conducted, the "ground truth" is adherence to the specified voluntary standards (e.g., UL, IEC, AIUM/NEMA, ISO) for aspects like acoustic output, biocompatibility, electrical safety, etc. This is a form of standard-based ground truth rather than expert consensus, pathology, or outcomes data from patients.

8. The Sample Size for the Training Set:

Not applicable. The document does not describe any machine learning or AI models with training sets in the context of this 510(k) summary. The submission is for an ultrasound system, not for a new AI-based diagnostic algorithm requiring a specific training dataset.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as no training set for an AI model is described in this submission.

Summary

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ACUSON X300™ Diagnostic Ultrasound System Special 510(k) Submission

SECTION 12 510(k) Summary

JUN 2 2 2012

11.1. Sponsor: Siemens Medical Solutions USA, Inc., Ultrasound Division 685 East Middlefield Road Mountain View, California 94043
11.2. Contact Person: Shelly Pearce Title: Regulatory Affairs Specialist (650) 694 5988 Telephone: (650) 694 5580 Fax:

11.3. Submission Date: May 15, 2012

11.4. Device Name: ACUSON X300™ Diagnostic Ultrasound System SONOVISTA X300 Diagnostic Ultrasound System ACUSON X300 ™ Diagnostic Ultrasound System, premium edition (K090276, K093531)

11:5. Common Name: Diagnostic Ultrasound System with Accessories

11.6. Classification: Regulatory Class: ll Review Category: Tier II Radiology Classification Panel:

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-DQC

A. Legally Marketed Predicate Devices

The Siemens ACUSON X300 Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to the current product that is already cleared for USA distribution under the following 510(k) PreMarket Notification number:

K090276. K093531. ACUSON X300™ Diagnostic Ultrasound System, SONOVISTA . X300 Diagnostic Ultrasound System, ACUSON X300™ Diagnostic Ultrasound System, premium edition
K113179, ACUSON SC2000™ Diagnostic Ultrasound System .
K101091, ZONARE z.one Ultra Ultrasoud System .
K113690, GE LOGIQ i, LOGIQ e, Vivid e .
K014206, GE LogiqBooK XP .
. K101757, Sonosite M-turbo

B. Device Description:

The Siemens ACUSON X300 Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical

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

indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppier Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.

C. Intended Use

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

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 modifications to the Siemens ACUSON X300 Diagnostic Ultrasound System are verified and validated according to the company's design control process.

F. A brief discussion of nonclinical tests submitted, referenced, or relied on in

the 510(k) for a determination of substantial equivalence.

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary 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/IEC 60601-1

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EN/IEC 60601-1-1

EN/IEC 60601-1-2

IEC 1157 Declaration of Acoustic Power

ISO 10993-1 Biocompatibility

Cleared patient contact materials, electrical and mechanical safety are unchanged.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three abstract human profiles facing to the right, stacked on top of each other. The profiles are connected by a flowing line, creating a sense of unity and movement.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

JUN 2 2 2012

Siemens Medical Solutions USA, Inc. Ultrasound Group % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K121699

K121077
Trade/Device Name: ACUSON X300™ Diagnostic Ultrasound System; SONOVISTA X 300 Diagnostic Ultrasound Systems; ACUSON X300™ Diagnostic Ultrasound System, premium edition

Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, and DQO Dated: June 7, 2012 Received: June 8, 2012

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave leviewed your beenou broke is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the enclosure) to regally mankelou production Device Amendments, or to devices that have been May 26, 1970, the Chacement and of the Federal Food, Drug, and Cosmetic Act (Act). You reclassified in accordance with the provisions to the general controls provisions of the Act. The general may, therefore, thanket the device, basyon is month registration, listing of devices, good Controls provisions of the beling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with This determination of Salostantial System, SONOVISTA X 300 Diagnostic Ultrasound the ACUSON X 300 - Diagnostic Ultrasound System, premium edition, 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 Sector Array

BE 9-4 Convex Array CW2 Continuous Wave Doppler CW5 Continuous Wave Doppler AcuNav 8F Intracardiac AcuNav 10F Intracardiac V5Ms TEE 4V1c Phased Sector Array VF13-5SP Linear Array

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C8-5 Tightly Curved Array 8L3 Linear "Regel" 10V4 Phased Array C7F2 Curved Array Mechanical 3D/4D EV9F4 Curved Array Mechanical 3D/4D L13F5 3D/4D Mechanical Wobbler Linear VF8-3 Linear Array P5-1 Phased Array C6-2 Convex Array SoundStar 10F P9-4 Phased 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 Subled of Federal Regulations, Title 21, Parts 800 to 895. 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 I DA has made a deceminations administered by other Federal agencies. You must comply with all the I cocrar statutes and regulations as annot limited to: registration and listing (21 CFR Part 807); labeling (21 Act 3 requirements, morable wing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. This 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 go to 11 you desire specific advice for your er offices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Intip://www.ida.gov/Abouti Drivellers/Office of Compliance. Also, please note the regulation Devices and Radiological reallir o (SEPT Part 807.97). For questions regarding the reporting of referents in promote the MDR regulation (21 CFR Part 803), please go to regarding the reporting of daverse overse w/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Joshua Nipper at (301) 796-6524.

Sincerely Yours,

Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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SECTION 6 Indications for Use Forms

Indications for Use Statement

510(k) Number (if known):

Device Name:

ACUSON X300TM Diagnostic Ultrasound System SONOVISTA X300 Diagnostic Ultrasound System ACUSON X300™ Diagnostic Ultrasound System, premium edition

Indications For Use:

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

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

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Devices

510(k)K121699

Page 1 of

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510(k) Number (if known):

Device Name: Intended Use:

ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other(Track1Only)	Specific(Tracks 1& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-operative(Note 6)	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-operative(Neuro)	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Laparoscopic	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
FetalImaging& Other	Pediatric	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	SmallOrgan(Note 1)	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Neonatal Cephalic	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Adult Cephalic	P	P	P	P	P	P	P		BMDC	Note2.3.4.5.7.8.9,11
	Trans-rectal	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Trans-vaginal	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Trans-urethral
	Trans-esoph.(non-Card.)	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Musculo-skel.(Convent.)	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Musculo-skel.(Superfic)	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra -vascular	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Other(Specify)	P	P	P	P	P	P	P		BMDC	Note2.3.4.5.7.8.9.11
	Cardiac Adult	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-vascular(Cardiac)	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Trans-esophageal(Cardiac)	P	P	P	P	P	P	P		BMDC	Note2.3,4.5,7.8,9,11
	Intra-Cardiac	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7.8,9,11
	Other (Specify)	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
Peripheral	Peripheral vessel	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
Vessel	Other (Specify)	P	P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11

N = new indication; P = previously cleared by K080760; K090276

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

Note 3 3D imaging

3D imaging
Power SieScape panoramic imaging Note 5

Tissue Equalization Technology Note 9

Dynamic TCE Note 11

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

Note 2

Note 4

Note 6

Note 8

Note 10

Ensemble tissue harmonic imaging

B&W SieScape panoramic imaging

For example: abdominal, vascular

Intracardiac imaging

SieClear multi-view spatial compounding

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices
K121699

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Contrast agent imaging Note 7

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ACUSON X300™ Diagnostic Ultrasound System Special 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name: Intended Use:

P4-2 Phased Sector Array 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
Other( Track 1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal		P	P	P	P	P	P		BMDC	Note2,3,5,6,7,8,9,11
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	SmallOrgan(Note 1)
	Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Adult Cephalic		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult		P	P	P	P	P	P		BMDC	Note2.3.4.5.7.8,9.11
Cardiac	Cardiac Pediatric		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
Vessel	Other (Specify)

N = new indication; P = previously cleared by K080760

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

Note 3 3D imaging
Power SieScape panoramic imaging Note 5 Contrast agent imaging Note 7
Tissue Equalization Technology Note 9
Note 11 Dynamic TCE

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

Note 2 Note 4

Note 6

Note 8

Note 10

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office/of In Vitro Diagnostic Devices
KlAl699

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Ensemble tissue harmonic imaging

B&W SieScape panoramic imaging

For example: abdominal, vascular

Intracardiac imaging

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Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

CH5-2 Convex Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Intended Use:

Clinical Application Mode of Operation Color Other Color Amplitude Cambined Other Specific PWD CWD B M Velocity ( Track1 A Doppler Doppler (Specify) (Specify) (Tracks11& 3) Imaging Only) Ophthalmic Ophthalmic Note P P BMDC P P P Fetal 2.3.4.5.7,8.9.11 Note BMDC P P P P P Abdominal 2,3,4,5,7,8,9,11 Intra-operative (Note G) Intra-operative (Neuro) Laparoscopic Note P BMDC P P P P Pediatric Fetal 2,3,4,5,7,8,9,11 SmallOrgan Imaging & Other (Note 1) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Note Musculo-skel. P P P P P BMDC 2.3.4.5.7.8.9.11 . (Convent.) Musculo-skel. (Superfic) Intra-vascular Qther (Specify) Note P P BMDC P P P Cardiac Adult 2,3.4,5,7,8,9,11 Note P p P P BMDC P Cardiac Cardiac Pediatric 2,3,4,5,7,8,9,11 Intra-vascular (Carliac) Trans-esophageal (Cardiac) Intra-cardiac Other (Specify) Note P BMDC P P P Peripheral vessel P . 2,3,4,5,7,8,9,11 Peripheral Vessel Other (Specify)

N = new indication; P = previously cleared by K080760

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

Note 3 3D imaging
Note 5 Power SieScape panoramic imaging
Note 7 Contrast agent imaging
Tissue Equalization Technology Note 9

Note 11 Dynamic TCE

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices

510(k) K121699

Page 4 of

Note 4 Note 6
Note 2
For example: abdominal, vascular
SieClear multi-view spatial compounding Note 8
Note 10 Intracardiac imaging

Ensemble tissue harmonic imaging B&W SieScape panoramic imaging

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

510(k) Number (if known):

Device Name:

VF10-5 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:

Clinical Application	Mode of Operation
Other(Track1Only)	Specific(Tracks1& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9.11
Imaging& Other	SmallOrgan(Note 1)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Neonatal Cephalic		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Adult Cephalic
	Trans-rectai
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Musculo-skei.(Superfic)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9.11
Vessel	Other (Specify)

N = new indication; P = previously cleared by K080760

For example: breast, testes, thyroid, penis, prostate, etc. Note 2 Note 1
3D imaaina Note 3
Power SieScape panoramic imaging Note 5
Contrast agent imaging Note 7
Tissue Equalization Technology Note 9
Note 11 Dynamic TCE

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Note 4

Note 6

Note 8

Note 10

Division Sign-Off - Office of In-Vitro Diagnostic Devices

Kla1699
510(k)

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Intracardiac imaging

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Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

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

Intended Use:

Clinical Application Mode of Operation Other Color Specific Color Amplitude Combined Other A B M PWD CWD Velocity ( Track 1 (Tracks11& 3) Doppler Doppler (Specify) (Specify) Only) Imaging Ophthalmic Ophthalmic Note P P P P P BMDC Fetal 2,3,4,5,7,8,9,11 Note P P P P P BMDC Abdominal 2,3,4,5,7,8,9,11 Intra-operative (Note 6) Intra-operative (Neuro) Laparoscopic Note P P P BMDC Fetal Pediatric P P 2.3.4.5.7.8.9,11 · SmallOrgan Imaging Note P P P P P BMOC 2,3,4,5,7,8,9,11 & Other (Note 1) Note P Neonatal Cephalic P P P p BMDC 2,3,4,5,7,8,9,11 Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skel. Note P P P P P BMDC 2,3,4,5,7,8,9,11 (Convent.) Musculo-skel. Note P P P P BMDC P 2,3,4,5,7,8,9,11 (Superfic) Intra-vascular Other (Specify) Cardiac Adult Cardiac Cardiac Pediatric Intra-vascular (Cardiac) Trans-esophageal (Cardiac) Intra-Cardaic · Other (Specify) Note P P P BMDC Peripheral vessel P P Peripheral 2.3.4.5.7.8.9.11

Other (Specify) N = new indication; P = previously cleared by K080760

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

3D imaging Note 3
Power SieScape panoramic imaging Note 5 Contrast agent imaging

Note 7

Vessel

Tissue Equalization Technology Note 9 Dynamic TCE Note 11

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

Note 2

Note 4

Note 6

Note 8

Note 10

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices
510(k) K121699

Ensemble tissue harmonic imaging

B&W SieScape panoramic imaging

For example: abdominal, vascular

Intracardiac imaging

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

ACUSON X300™ Diagnostic Ultrasound System Special 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name: Intended Use: EC9-4 Convex Array 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 o

Clinical Application	Mode of Operation
Other(Track1Only)	Specific(Tracks 11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging& Other	SmallOrgan(Note 1)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Neonatal Cephalic		P	P	P		P	P		BMDC	Note2.3.4.5,7,8,9,11
	Adult Cephalic
	Trans-rectal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Trans-vaginal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8.9,11
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-Cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared by K080760

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

3D imaging Note 3
Power SieScape panoramic imaging Note 5
Note 7 Contrast agent imaging
Tissue Equalization Technology Note 9
Note 11 Dynamic TCE

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

Note 2

Note 4

Note G

Note 8

Nota 10

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices

510(k) K121699

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For example: abdominal, vascular

Intracardiac imaging

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

510(k) Number (if known):

Device Name:

EV9-4 Convex Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

Intended Use:

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

Clinical Application		Mode of Operation
Other(Track 1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging& Other	SmallOrgan(Note 1)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Neonatal Cephalic		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Adult Cephalic
	Trans-rectal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Trans-vaginal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent)
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	intra-Cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared by K080760

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

3D imaging Note 3
Power SieScape panoramic imaging Note 5
Contrast agent imaging
Tissue Equalization Technology Note 7
Note 9
Dynamic TCE Note 11
- (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

oncurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Note 2

Note 4

Note 6

Note 8

Note 10

Division Sign-Off - Office of In Vitro Diagnostic Devices
510(k) K121699

Page 8 of

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For example: abdominal, vascular

Intracardiac imaging

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

510(k) Number (if known):

Device Name:

VF13-5 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:

Clinical Application		Mode of Operation
Other(Track 1Only)	Specific(Tracks1 & 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	SmallOrgan(Note 1)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Neonatal Cephalic		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph,(non-Card.)
	Musculo-skel.(Convent)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Musculo-skel.(Superfic)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P	P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Other (Specify)

N = new indication; P = previously cleared by K080760

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

Note 3 3D imaging
Power SieScape panoramic imaging Note 5
Contrast agent imaging Note 7

Tissue Equalization Technology Note 9

Dynamic TCE Note 11
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Note 2

Note 4

Note 6

Note 8

Note 10

Ensemble tissue harmonic imaging

B&W SieScape panoramic imaging

For example: abdominal, vascular

Intracardiac imaging

Division Sign-Off - Office of in Vitro Diagnostic Devices

510(k) K121699

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

510(k) Number (if known):

Device Name:

P8-4 Phased Sector Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

Intended Use:

Other

( Track 1

Only) Ophthalmic

Diagnostic imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation Calor Specific Color Amplitude Combined Other CWD Velocity B M PWD A (Specify) (Tracks11& 3) Doppler Doppler (Specify) Imaging Ophthalmic

	Fetal	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Abdominal	P	P	P	P	P	P	BMDC	Note2,3,5,6,7,8,9,11
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
Imaging& Other	SmallOrgan(Note 1)
	Neonatal Cephalic	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent)	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P	P	P	P	P	P	BMDC	Note2,3,4,5,7,8,9,11
Vessel	Other (Specify)

N = new indication; P = previously cleared by K080760

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

Note 3 3D imaging
Power SieScape panoramic imaging Note 5

Contrast agent imaging Note 7 Tissue Equalization Technology Note 9

Dynamic TCE Note 11
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Note 2

Note 4

Note 6

Note 8

Note 10

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices
510(k) K121699

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510(k) Number (if known):

BE 9-4 Convex Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

Device Name: Intended Use:

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

Clinical Application		Mode of Operation
Other(Track 1Only)	Specific(Tracks1& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Abdominal
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging& Other	SmallOrgan(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
	Trans-rectal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Trans-vaginal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent)
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)
	N = new indication; P = previously cleared by K080760

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

3D imaging Note 3
Power SieScape panoramic imaging Note 5

Note 7 Contrast agent imaging

Tissue Equalization Technology Note 9

Note 11 Dynamic TCE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Note 2

Note 4

Note 6

Note 8

Note 10

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Olagnostic Devices

510(k) K121699

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For example: abdominal, vascular

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

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

CW2 Continuous Wave Doppler Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

Intended Use:

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

Clinical Application		Mode of Operation
Other( Track 1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal					P
	Abdominal					P
	Intra-operative(Note 6)					P
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric					P
Imaging& Other	SmallOrgan(Note 1)					P
	Neonatal Cephalic					P
	Adult Cephalic					P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)					P
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult					P
Cardiac	Cardiac Pediatric					P
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
Perpheral	Peripheral vessel					P
Vessel	Other (Specify)

N = new indication; P = previously cleared by K080760

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

Note 3 3D imaging
Power ŠieScape panoramic imaging Note 5
Contrast agent imaging Note 7 Tissue Equalization Technology
Note 9 Dynamic TCE Note 11

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

Note 2

Note 4

Note 6

Note 8

Note 10

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off / Office of In Vitro Diagnostic Devices
510(k) K121699

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For example: abdominal, vascular

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

510(k) Number (if known):

Device Name:

CW5 Continuous Wave Doppler Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

Intended Use:

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

Clinical Application		Mode of Operation
Other( Track 1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal					P
	Abdominal					P
	Intra-operative(Note 6)					P
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric					P
Imaging& Other	SmallOrgan(Note 1)					P
	Neonatal Cephalic					P
	Adult Cephalic					P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)					P
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult					P
Cardiac	Cardiac Pediatric					P
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-Cardiac
	Other (Specify)
Peripheral	Peripheral vessel					P
Vessel	Other (Specify)

N = new indication: P = previously cleared by K080760

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

3D imaging Note 3
Note 5 Power SieScape panoramic imaging
Note 7 Contrast agent imaging

Tissue Equalization Technology Note 9

Note 11 Dynamic TCE

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

Note 2

Note 4

Note 6

Note 8

Note 10

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices
510(k) K121699

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For example: abdominal, vascular

Intracardiac imaging

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

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

AcuNav 8F Intracardiac Transducer for use with:

Intended Use:

ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other(Track 1Only)	Specific(Tracks 11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
Imaging& Other	SmallOrgan(Note 1)										1
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)
	Musculo-skel.(Superfic)
	Intra-vascular		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	Other(Specify)
	Cardiac Adult		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
Cardiac	Cardiac Pediatric		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	Intra-vascular(Cardiac)		P	P	P	P	P	P		BMDC	Note2.3,7,8,9,10,11
	Trans-esophageal(Cardiac)
	Intra-cardiac		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication: P = previously cleared by K080760

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 3
3D imaging
Power SieScape panoramic imaging Note 5
Contrast agent imaging Note 7 Tissue Equalization Technology
Note 9 Note 11 Dynamic TCE

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

Note 2

Note 4

Note 6

Note 8

Note 10

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Concurrence of CDRH

Division Sign-Off - Office of In Vitro Diagnostic Devices

510(k): K121699

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For example: abdominal, vascular

Intracardiac imaging

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

510(k) Number (if known):

Device Name:

AcuNav 10F Intracardiac Transducer for use with:

Intended Use:

ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other( Track 1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	SmallOrgan(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)
	Musculo-skel.(Superfic)
	Intra-vascular		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	Other(Specify)
	Cardiac Adult		P	P	P	P	P	P		BMDC	Note2,3.7,8,9,10,11
Cardiac	Cardiac Pediatric		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	Intra-vascular(Cardiac)		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	Trans-esophageal(Cardiac)
	Intra-cardiac		P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared by K080760

For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 3 3D imaging
Note 5 Power SieScape panoramic imaging
Note 7 Contrast agent imaging Tissue Equalization Technology
Note.9 Note 11 Dynamic TCE

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

Note 2

Note 4

Note 6

Note 8

Note 10

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices

510(k) K121699

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

510(k) Number (if known):

Device Name:

V5Ms TEE Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

Intended Use:

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

Clinical Application		Mode of Operation
Other( Track 1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging& Other	SmallOrgan(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent)
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult	P	P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,11
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,11
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)	P	P	P	P	P	P	P		BMDC	Note 2,3,7,8,9,11
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared by K090276

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

3D imaging Note 3
Note 5 Power SieScape panoramic imaging
Note 7 Contrast agent imaging
Tissue Equalization Technology Note 9

Dynamic TCE Note 11

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

Note 2

Note 4

Note 6

Note 8

Note 10

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices

510(k) K121699

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

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

4V1c Phased Sector 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 Color Other Specific Color Amplitude Combined Other B PWD CWD Velocity { Track 1 A M (Tracks118 3) Doppler Doppler (Specify) (Specify) lmaging Only) Ophthalmic 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 Intra-operative (Note 6) Intra-operative (Neuro) Laparoscopic Fetal P P Note 2,3,4,5,7,8,9 P P P P BMDC Pediatric Imaging SmallOroan & Other (Note 1) P P P P P P BMDC Note 2,3,4,5,7,8,9 Neonatal Cephalic Note 2,3,4,5,7,8,9 P P P P a BMDC Adult Cephalic P Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skel. (Convent) Musculo-skel. (Superfic) Intra-vascular Other (Specify) P P BMDC Note 2,3,4,5,7,8,9 P P P Cardiac Adult P Cardiac Cardiac Pediatric P P P P P P BMDC Note 2,3,4,5,7,8,9 Intra-vascular (Cardiac) Trans-esophageal (Cardiac) Intra-cardiac Other (Specify) Note 2,3,4,5,7,8,9

N = new indication: P = previously cleared by K080760

Peripheral vessel

Other (Specify)

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

P P

Note 3 3D imaging
Peripheral

Vessel

Power SieScape panoramic imaging Note 5

Note 7 Contrast agent imaging

Note 8 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 9

Note 10 Intracardiac imaging

Dynamic TCE Note 11

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

Note 2

Note 4

Note 6

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BMDC

Ensemble tissue harmonic imaging

B&W SieScape panoramic imaging

For example: abdominal, vascular

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

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:

Clinical Application		Mode of Operation
Other( Track 1Only)	Specific(Tracks 1& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Note 6)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-operative(Neuro)		P	P	P		P	P		BMDC	Note2.3,4,5,7,8,9.11
	Laparoscopic
FetalImaging& Other	Pediatric		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9.11
	SmallOrgan(Note 1)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9.11
	Neonatal Cephalic		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9.11
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)		P	P	P		P	P		BMDC	Note2.3.4.5.7.8.9.11
	Musculo-skel.(Superfic)		P	P	P		P	P		BMDC	Note2,3.4,5.7,8.9.11
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9.11
	Other (Specify)

N = new indication; P = previously cleared by K080760

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

3D imaging
Power SieScape panoramic imaging Note 3
Note 5 Contrast agent imaging
Note 7

Note 9 Tissue Equalization Technology

Note 11
- Dynamic TCE

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Page 18 of

Intracardiac imaging Note 10

Note 2

Note 8

Note 4 B&W SieScape panoramic imaging Note 6 For example: abdominal, vascular

Ensemble tissue harmonic imaging

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

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

C8-5 Tightly Curved Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

Intended Use:

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

Clinical Application			Mode of Operation
Other(Track 1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	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
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	SmallOrgan(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
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Musculo-skel.(Superfic)	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Intra-vascular
	Other(Specify)
	Cardiac Adult	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Cardiac	Cardiac Pediatric	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Other (Specify)

N = new indication; P = previously cleared by K080760 ·

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

Note 3
3D imaging
Power SieScape panoramic imaging Note 5

Note 7 Contrast agent imaging

Note 9 Tissue Equalization Technology
Note 11

Dynamic TCE

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

Note 2

Note 4

Note 6

Note 8

Note 10

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Ensemble tissue harmonic imaging

B&W SieScape panoramic imaging

SieClear multi-view spatial compounding

For example: abdominal, vascular

Intracardiac imaging

2100

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

510(k) Number (if known):

Device Name:

8L3 Linear "Regel" Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

Intended Use:

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

Clinical Application		Mode of Operation
Other( Track 1Only)	Specific(Tracks1& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	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
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Imaging& Other	SmallOrgan(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
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skei.(Convent)	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Musculo-skel.(Superfic)	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Intra-vascuiar
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
Perpheral	Peripheral vessel	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Vessel	Other (Specify)

N = new indication; P = previously cleared by K080760
Note 1

Note 3 3D imaging

Note 5
: :

Power SieScape panoramic imaging Note 7 Contrast agent imaging

Note 9 Tissue Equalization Technology

Note 11 Dynamic TCE
Note 2 Ensemble tissue harmonic imaging

Note 4 B&W SieScape panoramic imaging

Note 6 For example: abdominal, vascular SieClear multi-view spatial compounding
Note 8 Note 10 Intracardiac imaging

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{25}------------------------------------------------

510(k) Number (if known);

Device Name:

10V4 Phased Array Transducer for use with; ACUSON X300 Diagnostic Ultrasound Systems

Intended Use:

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

Clinical Application		Mode of Operation								Combined(Specify)	Other(Specify)
Other( Track1Only)	Specific(Tracks 1 & 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
	Abdominal	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
	SmallOrgan(Note 1)
	Neonatal Cephalic	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,9
	Other (Specify)

N = new indication; P = previously cleared by K080760

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 3 3D imaging
Power SieScape panoramic imaging Note 5
Note 7 Contrast agent imaging
Tissue Equalization Technology Note 9
Dynamic TCE Note 11

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

Note 2

Note 4

Note 6

Note B

Note 10

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Page 21 of

Ensemble tissue harmonic imaging

B&W SieScape panoramic imaging

SieClear multi-view spatial compounding

For example: abdominal, vascular

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

510(k) Number (if known):

C7F2 Curved Array Mechanical 3D/4D Transducer for use with:

Device Name: Intended Use:

ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other(Track 1Only)	Specific(Tracks1& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal	P	P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric	P	P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	SmallOrgan(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)	P	P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult	P	P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
Cardiac	Cardiac Pediatric	P	P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P	P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Other (Specify)

N = new indication; P = previously cleared by K080760

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

Note 3 3D imaging

Note 5 Power SieScape panoramic imaging Note 7

Contrast agent imaging Tissue Equalization Technology Note 9

Dynamic TCE Note 11

Role #1: Dynamic

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Intracardiac imaging

Ensemble tissue harmonic imaging

B&W SieScape panoramic imaging

For example: abdominal, vascular

SieClear multi-view spatial compounding .

Note 2 Note 4 Note 6 Note 8 Note 10

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

510(k) Number (if known):

Device Name:

EV9F4 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:

Clinical Application		Mode of Operation
Other( Track 1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging& Other	SmallOrgan(Note 1)		P	P	P		P	P		BMDC	Note2.3,4,5,7,8,9,11
	Neonatal Cephalic		P	P	P		P	P		BMDC	Note2.3.4.5.7.8.9.11
	Adult Cephalic
	Trans-rectal		P	P	P		P	P		BMDC	Note2.3,4,5,7,8,9,11
	Trans-vaginal		p	P	P		ರ್ಥಿ	P		BMDC	Note2,3,4,5,7.8,9,11
	Trans-urethral
	Trans-esoph. ·(non-Card.)
	Musculo-skel.(Convent)
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripherai vessel
Vessel	Other (Specify)		1- - 1/ מחחרות - - - - -

indication; P = previously cleared by K080760

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
Note 11	Dynamic TCE

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Page 23 of

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

510(k) Number (if known):

Device Name:

L13F5 3D/4D Mechanica! Wobbler Linear Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

Intended Use:

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

Clinical Application		Mode of Operation
Other.(Track1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	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
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Imaging& Other	SmallOrgan(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
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent)	P	P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Musculo-skel,(Superfic)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3.4,5,7,8,9
Vessel	Other (Specify)

N = new indication; P = previously cleared by K080760

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

Note 3 3D imaging
Power SieScape panoramic imaging Note 5

Note 7 Contrast agent imaging

Note 9 Tissue Equalization Technology

Note 11 Dynamic TCE

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

Note 2

Note 4

Note 6

Note 8 Note 10

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Ensemble tissue harmonic imaging

B&W SieScape panoramic imaging

SieClear multi-view spatial compounding

For example: abdominal, vascular

{29}------------------------------------------------

510(k) Number (if known):

Device Name:

VF8-3 Linear Array Transducer for use with:

Intended Use:

ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other( Track 1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal		P	P	P		P	P		BMDC	Note2,3,4.5,7,8,9,11
	Intra-operative(Nota 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric		P	P	P		P	P		BMDC	Note2,3.4,5,7,8,9,11
Imaging& Other	SmallOrgan{Note 1)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Neonatal Cephalic		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent)		P	P	P		P	P		BMDC	Note2.3.4,5.7.8,9,11
	Musculo-skel.(Superfic)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify).
Peripheral	Peripheral vessel		P	P	P		P	P		BMDC	Note2,3.4,5,7,8,9,11
Vessel	Other (Specify)

N = new indication; P = previously cleared by K080760

Note ?Note 3Note 5Note 7Note 9Note 11	For example: breast, testes, thyroid, penis, prostate, etc.3D imagingPower SieScape panoramic imagingContrast agent imagingTissue Equalization TechnologyDynamic TCE	Note 2Note 4Note 6Note 8Note 10	Ensemble tissue harmonic imagingB&W SieScape panoramic imagingFor example: abdominal, vascularSieClear multi-view spatial compoundingIntracardiac imaging
-----------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-------------------------------------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Page 26 of _

Page. 6.25 of 6.29

{30}------------------------------------------------

510(k) Number (if known):

Device Name:

P5-1 Phased Array Transducer for use with:

Intended Use:

ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other( Track 1Only)	Specific(Tracks1& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	SmallOrgan(Note 1)
	Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Adult Cephalic		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
Cardiac	Cardiac Pediatric		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel		P	P	P	P	P	P		BMDC	Note2,3,4,5,7,8,9,11
	Other (Specify)

N = new indication; P = previously cleared by K080760

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. 3D imaging

Note 3
Note 5 Power SieScape panoramic imaging
Note 7 Contrast agent imaging Tissue Equalization Technology
Note 9 Note 11 Dynamic TCE

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

Nota 2

Note 4

Note 6

Note 8

Note 10

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of th Vitro Diagnostic Devices

510(k) K121699

Page 27 of

Ensemble tissue harmonic imaging

B&W SieScape panoramic imaging

For example: abdominal, vascular

Intracardiac imaging

SieClear multi-view spatial compounding

Page. 6.26 of 6.29

{31}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

C6-2 Convex Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

Intended Use:

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

Clinical Application		Mode of Operation
Other( Track 1Only)	Specific(Tracks11& 3)	A	в	M	PWD	CWD	ColorDoppler	Amplitude. Doppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
Imaging& Other	SmallOrgan(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skei.(Convent.)		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
Cardiac	Cardiac Pediatric		P	P	P		P	P		BMDC	Note2,3,4,5,7,8,9,11
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
Penpheral	Peripheral vessel		P	P	P		P	P		8MDC	Note2,3,4,5,7,8,9,11
Vessel	Other (Specify)

N = new indication; P = previously cleared by K080760

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

Note 3 3D imaging
Note 5 Power SieScape panoramic imaging
Note 7 Contrast agent imaging

Tissue Equalization Technology Note 9

Note 11 Dynamic TCE
Dynamic, OE

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

Note 2

Note 4

Note 6

Note 8 Note 10

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices
510(k)
Kla1699

Page 28 of

Ensemble tissue harmonic imaging

B&W SieScape panoramic imaging

For example: abdominal, vascular SieClear multi-view spatial compounding

{32}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

SoundStar 10F Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems

Intended Use:

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

Clinical Application		Mode of Operation
Other( Track 1Only)	Specific(Tracks 1 & 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging& Other	SmallOrgan(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)
	Musculo-skel.(Superfic)
	Intra-vascular	P	P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	Other(Specify)
	Cardiac Adult	P	P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	Intra-vascular(Cardiac)	P	P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	Trans-esophageal(Cardiac)
	Intra-cardiac	P	P	P	P	P	P	P		BMDC	Note2,3,7,8,9,10,11
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared by K080760;

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

Note 3 3D imaging
Note 5 Power SieScape panoramic imaging
Note 7 Contrast agent imaging

Note 9 Tissue Equalization Technology

Note 11 Dynamic TCE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Note 2

Note 4

Note 6

Note 8 Note 10

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices

510(k) K121699

Page 29 of

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B&W SieScape panoramic imaging

SieClear multi-view spatial compounding

For example: abdominal, vascular

{33}------------------------------------------------

510(k) Number (if known):

Device Name: Intended Use: P9-4 Phased Array 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
Other(Track 1Only)	Specific(Tracks11& 3)	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	N	N		BMDC	Note2,3,4,5,7,8,9,11
	Abdominal	N	N	N	N	N	N	N		BMDC	Note2,3,5,6,7,8,9,11
	Intra-operative(Note 6)
	Intra-operative(Neuro)	N	N	N	N		N	N		BMDC	Note2,3,4,5,7,8,9,11
	Laparoscopic
FetalImaging& Other	Pediatric	N	N	N	N	N	N	N		BMDC	Note2,3,4,5,7,8,9,11
	SmallOrgan(Note 1)	N	N	N	N	N	N	N		BMDC	Note2,3,4,5,7,8,9,11
	Neonatal Cephalic	N	N	N	N	N	N	N		BMDC	Note2,3,4,5,7,8,9,11
	Adult Cephalic	N	N	N	N	N	N	N		BMDC	Note2,3,4,5,7,8,9,11
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent)
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult	N	N	N	N	N	N	N		BMDC	Note2,3,4,5,7,8,9,11
Cardiac	Cardiac Pediatric	N	N	N	N	N	N	N		BMDC	Note2,3,4,5,7,8,9,11
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac										Note
	Other(Cardiac Neonatal)	N	N	N	N	N	N	N		BMDC	Note2,3,4,5,7,8,9,11
Peripheral	Peripheral vessel	N	N	N	N	N	N	N		BMDC	Note2,3,4,5,7,8,9,11
Vessel	Other (Specify)

N = new indication; P = previously cleared by FDA K090276

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

Note 3 3D imaging

o indiging
Power SieScape panoramic imaging
Contrast agent imaging Note 5 Note 7

Tissue Equalization Technology Note 9
Dynamic TCE Note 11

Note 11 Dynamic TCE

Note 2 Ensemble tissue hamonic imaging Note 4 B&W SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 8 SieClear multi-view spatial compounding

Note 10 Intracardiac imaging

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

itro Dia stic Devices of In Divis 51

Page 30 of

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.