Diagnostic imaging or fluid flow analysis of the human body as follows: General Radiology, Fetal, Abdominal, Intracperative, 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.

Device Description

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

AI/ML Overview

This Siemens Acuson X300 Diagnostic Ultrasound System 510(k) submission does not contain information about acceptance criteria or a study proving the device meets said criteria. This document is a summary of safety and effectiveness, focused on establishing substantial equivalence to predicate devices and detailing the intended uses for various transducers. It does not include specific performance metrics, clinical study design, or results that would typically be found in a study demonstrating adherence to acceptance criteria.

The provided text lists the product safety standards the device has been designed to meet:

UL 60601-1, Safety Requirements for Medical Equipment
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
AIUM/NEMA, 1998, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound
93/42/EEC Medical Devices Directive
Safety and EMC Requirements for Medical Equipment (EN 60601-1, EN 60601-1-1, EN 60601-1-2)
IEC 61157 Declaration of Acoustic Power
ISO 10993 Biocompatibility

However, it does not provide any acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, or specificity) or reported device performance against such criteria. The document states that the device has been designed to meet these standards, but it does not present data from a study demonstrating active compliance or performance metrics.

Therefore, I cannot populate the requested table or answer most of the other questions, as the information is not present within this 510(k) summary. A 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results and acceptance criteria for performance. For clinical effectiveness data, one would typically look for a full clinical study report, which is not part of this summary document.

Here's a breakdown of why each specific point cannot be addressed:

A table of acceptance criteria and the reported device performance
- Reason Not Found: The document lists general safety and acoustic output standards but does not define specific performance acceptance criteria (e.g., image quality metrics, diagnostic accuracy thresholds) nor does it report any device performance against such metrics. It mentions that "analysis packages... provide information that is used for clinical diagnosis purposes" but provides no performance data for these.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Reason Not Found: There is no mention of a test set, clinical data, or studies that would involve a sample size. The submission focuses on device design and comparison to predicate devices, not clinical performance evaluation with a test set.
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)
- Reason Not Found: As no test set data is provided, there is no mention of experts or ground truth establishment.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Reason Not Found: No test set or related adjudication method is described.
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
- Reason Not Found: This document is about a diagnostic ultrasound system (hardware and general software capabilities), not an AI-assisted diagnostic tool. There is no mention of an MRMC study or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Reason Not Found: This is not an algorithm-only device; it's a general-purpose ultrasound system. No standalone algorithm performance is discussed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Reason Not Found: No ground truth information is provided, as clinical performance data is absent.
The sample size for the training set
- Reason Not Found: No training set or data used for training (e.g., for an AI algorithm) is mentioned in this submission.
How the ground truth for the training set was established
- Reason Not Found: As no training set is indicated, there's no information on how its ground truth would have been established.

In summary, this 510(k) submission establishes the substantial equivalence of the Siemens Acuson X300 Diagnostic Ultrasound System to existing predicate devices based on technological characteristics and intended uses. It does not provide the kind of detailed performance study data, acceptance criteria, or clinical validation results that would address the specific questions posed.

Summary

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

Siemens Acuson X300 Diagnostic Ultrasound Syste 510(k) Submission

510(K) SUMMARY

JUL 21 2006

Siemens Acuson X300 Diagnostic Ultrasound system

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.

1. Submitted By:

Siemens Medical Solutions USA, Inc., Ultrasound Division 1230 Shorebird Way Mountain View, California 94043

Contact Person: Sheila W. Pickering Requiatory Affairs Phone (650) 943 7187 Fax (6500 943 7053

Date Prepared: June 16, 2006

2. Proprietary Names:

Siemens Acuson X300™ Diagnostic Ultrasound System Sonoline Premier Plus Diagnostic Ultrasound System Sonavista X 300 Diagnostic Ultrasound System

Common/ Usual Name:

Diagnostic Ultrasound System with Accessories

Classification Name:

21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System Ultrasonic Pulsed Echo Imaging System Diagnostic Ultrasound Transducer

FR # 892.1550 FR # 892 1560 FR # 892.1570 Product Code 90-IYN Product Code 90-IYO Product Code 90-1TX

3. Predicate Device:

K050034, Antares Diagnostic Ultrasound System .
K052894, Sonoline G60 S Diagnostic Ultrasound System .
K043016, Sonoline Orchid Diagnostic Ultrasound System ●
. K042044, Acuson CV70 Cardiovascular System

Device Description: 4.

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

파 UL 60601-1, Safety Requirements for Medical Equipment
트 CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
AIUM/NEMA, 1998, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment

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

AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound l
이 93/42/EEC Medical Devices Directive
I Safety and EMC Requirements for Medical Equipment
- I EN 60601-1
- . EN 60601-1-1
- I EN 60601-1-2
. IEC 61157 Declaration of Acoustic Power
l ISO 10993 Biocompatibility

5. Intended Uses:

The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intracperative, 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.

6. Technological Comparison to Predicate Device:

The Siemens Acuson X300 is substantially equivalent to the Sonoline Antares (K050034), Sonoline G 60 S (K052894), Sonoline Orchid (K043016) and the Acuson CV70 (K042044), All systems transmit ultrasonic energy into patients, then perform post processing of to-ecoved echoes to generate on-screen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.

End of 510(k) Summary

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Image /page/2/Picture/1 description: The image shows a black and white logo. The logo consists of a circular border with text around the perimeter. Inside the circle, there is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 1 2006

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: K061946

Trade Name: ACUSON X300 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 6, 2006 Received: July 10, 2006

Dear Mr. Job:

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 C300 Diagnostic Ultrasound System, as described in your premarket notification:

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

	Transducer Model Number
P4-2	BE9-4	C8-5
CH5-2	CW2	8L3
VF10-5	CW5	10V4
L9-5	Acu Nav 8F	C7F2
EC9-4	Acu Nav 10F	EV9F4
EV9-4	V5Ms TEE	L13F5 3D/4D
VF13-5	4V1c
P8-4	VF13-5SP

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

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

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

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

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

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

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at (301) 594-1212.

Sincerely yours.

Nancy Baylor

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

Enclosure(s)

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

510(k) Number (if known):

K061946

Device Name:

ACUSON X300 Diagnostic Ultrasound Systems

Intended Use:

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

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

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

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)

Diagnostic Ultrasound Indications for Use Form

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices

510(k) Number

K061946

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

510(k) Number (if known):

K061946

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:

Clinical Application	Mode of Operation						Combined(Specify)
	A	B	M	PWD	CWD	ColorDoppler		AmplitudeDoppler	ColorVelocityImaging
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		N	N	N	N	N	N	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		N	N	N	N	N	N	BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared under K043016; E = added under Appendix E

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

Ensemble tissue harmonic imaging Note 2

3D imaging Note 3

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

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)

P. D. M. PETERSON

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

510(k) Number

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

510(k) Number (if known):

KD61946

CH5-2 Convex Array Transducer for use with: Device Name:

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		N	N	N		N	N		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		N	N	N		N	N		BMDC	Note 2.3.4.5.7.8.9
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared under K043016; 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 (Division Sign-Off)

Division of Reproductive, Abdominal,

and Radiological Devices

(

510(k) Number N050/1542

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

510(k) Number (if known):

K061946

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:

							Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		N	N	N		N	N		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 under K043016; 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)

(Division Sign-Off)

Division of Reproductive, Abdomit and Radiological De

510(k) Number

Kola 19

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

510(k) Number (if known):

K061946

Device Name:

L9-5 Linear Array Transducer for use with:

ACUSON X300 Diagnostic Ultrasound Systems

Intended Use:

Ultrasound 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		N	N	N		N	N		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 under K043016; E = added under Appendix E

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

Ensemble tissue harmonic imaging Note 2

3D imaqing Note 3

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 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 Devic

519(k) Number ...

K/Na 194

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

510(k) Number (if known):

K061946

Device Name:

Intended Use:

EC9-4 Convex Array Endocavity 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)		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		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 under K043016; 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)

(Division Sign-Off)

Division of Reproductive, Abdomina and Radiological Devices

510(k) Number

K061946

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

510(k) Number (if known):

Device Name:

Intended Use:

K D61946

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:

	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)		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		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 under K043016; 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)

(Division Sign-Off)

Divisi Reproductive, Abdominal and Ra cal Device

510(k)

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

510(k) Number @r known):

Device Name:

K061946

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		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		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 under K043016; 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

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)

(Division Sign-Off)
Division of Reproductive, Abdominal

Division of Reproductive, Abdominal, and Radiological Device

510(k) Number_

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

510(k) Number (if known):

K061946

P8-4 Phase Array 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:

		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		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
Transurethrai
Intravascular
Peripheral vessel		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared under K043016(P7-4); 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)

Y. Yamazak

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

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

510(k) Number (if known):

K061946

Device Name:

Intended Use:

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

BE9-4 Convex Array Transducer for use with:

	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)		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		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 under K043016; 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

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

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

510(k) Number (if known):

K061746

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:

	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 under K001400; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic Imaging

Note 3 3D imaging

B&W SieScape panoramic imaging Note 4

Note 5 Power SieScape panoramic Imaging

For example: abdominal, vascular Note 6
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)

D. Lawrence Harrington

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

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

510(k) Number (if known):

K061946

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:

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 under K023720; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic Imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

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 Size: 080

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

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

510(k) Number (if known):

Device Name:

Intended Use:

K061746

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:

Clinical Application	Mode of Operation
----------------------	-------------------

	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (Specify)	Other (Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Note 6)
Intraoperative Neurological
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 Conventional
Musculo-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 under K042593; 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

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)

limitation

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

510(k) Number K961946

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

510(k) Number (if known):

Device Name:

06194

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		BMDC	Note 2,3,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular		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		BMDC	Note 2,3,7,8,9,10

N = new indication; P = previously cleared under K033650; 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

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular 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)

Prescription Use (Per 21 CFR 801.109)

J. Henry Carpenter

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

5.10(k) Number K0619

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

510(k) Number (if known):

Device Name:

K061946

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:

Clinical Application	Mode of Operation
	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
Transesophageal		P	P	P	P	P	P		BMDC	Note 2,3,7,8,9
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared under K022567; 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

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 Sign-Off)
Division of Reproductive, Abdominai,
and Radiological Devices
510(k) Number KDe 1946

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

061946

510(k) Number @r 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		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,9
Adult Cephalic		N	N	N	N	N	N		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 under K022567; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

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,

Radiological Devices
510(k) Number K061946

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

510(k) Number (if known):

K061946

Device Name:

Intended Use:

VF13-5SP 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
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		N	N	N		N	N		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 under K023720; 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

B&W SieScape panoramic Imaging Note 4

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)

S. Vinton, C. Douglas

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

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

510(k) Number (if known):

K061946

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		N	N	N		N	N		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
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,9
Adult Cephalic		N	N	N		N	N		BMDC	Note 2,3,4,5,7,8,9
Cardiac		N	N	N		N	N		BMDC	Note 2,3,4,5,7,8,9
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		N	N	N		N	N		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P
Musculo-skeletalSuperficial		N	N	N		N	N

N = new indication; P = previously cleared under K020353; 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

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 Koce 1946

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

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
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		N	N	N		N	N		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		N	N	N		N	N		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		N	N	N		N	N		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		N	N	N		N	N		BMDC	Note 2,3,4,5,7,8,9
Other (specify)

061946

8L3 Linear "Regel" Transducer for use with :

N = new indication; P = previously cleared under K020353(5.0L45); 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)

1 11/2 2 .. " . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

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

510(k) Number (if known):

K061746

Device Name:

10V4 Phased Array Neonatal High Frequency 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 2,3,4,5,7,8,9
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		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,9
Laparoscopic
Musculo-skeletalConventional		N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,9
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared under K022567; E = added under Appendix E

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

Ensemble tissue harmonic imaging Note 2

3D imaqing 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)

L
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061946

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

510(k) Number (if known):

K 1061946

Device Name:

Intended Use:

C7F2 Curved array mechanical 3D/4D 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		N	N	N		N	N		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 under K023720; 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

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

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)

D'Alembert

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Device

510(k) Number -

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

510(k) Number (if known):

K061946

Device Name:

Intended Use:

EV9F4 Curved array mechanical 3D/4D 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		N	N	N		N	N		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 under K050034; 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

Contrast agent imaging Note 7

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 Sign-Off)
Division of Reproductive, Abdominal.
and Radiological Devices
510(k) Number, K061946

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

K061946

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 under K023720(C7F2 Wobbler) and K043016(VF13-5 Linear);

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

B&W SieScape panoramic Imaging Note 4

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

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)

Imerse 202-762

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

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.