The G20 ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Fetal, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Pediatric, 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 G20 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. lts function is to acquire primary or secondary harmonic ultrasound echo data and display it in: B-Mode, M-Mode, a combination of modes, 3D imaging or Harmonic Imaging on a CRT display.

AI/ML Overview

The provided document is a 510(K) summary for the Siemens SONOLINE G20 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a predicate device for safety and effectiveness, rather than establishing performance against specific, quantitative acceptance criteria through new clinical efficacy studies.

Therefore, the document does not contain the following information:

A table of acceptance criteria and the reported device performance: This submission relies on demonstrating equivalence to predicate devices, not on a new set of performance metrics.
Sample size used for the test set and the data provenance: Clinical performance studies with test sets are not described.
Number of experts used to establish the ground truth for the test set and their qualifications: As no specific test set is described, this information is absent.
Adjudication method for the test set: Not applicable as there is no described test set requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: No such study is mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a diagnostic ultrasound system, not an AI algorithm.
The type of ground truth used: No ground truth establishment for a new performance study is described.
The sample size for the training set: Not applicable as this is not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable.

The document primarily focuses on:

Intended Use: The G20 ultrasound imaging system is intended for numerous applications including General Radiology, Abdominal, Fetal, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Pediatric, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular. It also provides measurement of anatomical structures and analysis packages for clinical diagnosis.
Technological Comparison to Predicate Device: The device is deemed substantially equivalent to the SONOLINE Adara (K946179) and other SONOLINE G20/G50/G60 S systems (K042833, K040502, K020353). The basis for this equivalence is that "All systems transmit ultrasonic energy into patients, then perform post processing of received 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."
Compliance with Safety Standards: The device has been designed to meet several product safety standards, including UL 60601-1, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, IEC 61157, and ISO 10993. This compliance demonstrates that the device functions safely and effectively within established industry benchmarks, which serves as a form of acceptance criteria for the safety aspects of the device.

In summary, this 510(k) submission establishes the safety and effectiveness of the G20 Diagnostic Ultrasound System by demonstrating its substantial equivalence to previously cleared predicate devices and its adherence to relevant safety and performance standards. It does not present new clinical study data with specific acceptance criteria and performance metrics for an AI/ML-based device.

Summary

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K071314

G20 Diagnostic Ultrasound System
510(k) Submission

510(K) SUMMARY

MAY 2 2 2007

G20 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, CA 94043

Contact Person:

Martina Vogt Regulatory Affairs

Phone: (425) 557-1434 FAX: (425) 391-9198

Date Prepared:

May 2, 2007

2. Proprietary Name:

SONOLINE G20™ Diagnostic Ultrasound System

Common/ Usual Name:

Diagnostic Ultrasound System with Accessories

Classification Name: CED 000 4000

21 CFR 892.1550
Ultrasonic Pulsed Doppler Imaging System	FR # 892.1550	Product Code 90-IYN
Ultrasonic Pulsed Echo Imaging System	FR # 892.1560	Product Code 90-IYC
Diagnostic Ultrasound Transducer	FR # 892.1570	Product Code 90-ITX

3. Predicate Device:

K042833, 10/27/2004, SONOLINE G20 Diagnostic Ultrasound System K040502, 03/09/2004, SONOLINE G20 Diagnostic Ultrasound System K020353, 02/13/2002, SONOLINE G50 & G60 S Diagnostic Ultrasound Systems K946179, 10/03/1995, marketed as SONOLINE Adara Diagnostic Ultrasound System

4. Device Description:

The G20, has been designed to meet the following product safety standards:

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

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Safety and EMC Requirements for Medical Equipment
- I EN 60601-1
- 트 EN 60601-1-1
- I EN 60601-1-2
- I EN 60601-2-37
월 IEC 61157 Declaration of Acoustic Power
이 ISO 10993 Biocompatibility

5. Intended Uses:

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 G20 is substantially equivalent to the SONOLINE Adara, cleared via K946179, the SONOLINE G50/G60 S, cleared via K020353, the SONOLINE G20, cleared via K040502 and the SONOLINE G20, cleared via K042833. All systems transmit ultrasonic energy into patients, then perform post processing of received 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 the logo for the Department of Health & Human Services (HHS). The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles a human figure embracing a bird, which is a common representation of health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

MAY 2 2 2007

Re: K071314

Trade Name: SONOLINE G20™ Diagnostic Ultrasound Systems 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: May 9, 2007 Received: May 10, 2007

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 SONOLINE G20™ Diagnostic Ultrasound Systems, as described in your premarket notification:

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Transducer Model Number

C5-2 Convex Array L10-5 Linear Array EV9-4 Convex Array 7.5L75S Linear Array EC9-4 Convex Array C4-2 Convex Array C8-5 Convex Array BE9-4 Biplane Endocavity C6-F3 Convex Array Mechanically Driven 3D EV8F5 Mechanical Sector Endocavity 3D 3.5C40S Convex Array 5.0C40S Convex Array Endo PII Mechanical Sector Biplane endo-cavity Endo VII Mechanical Sector Endovaginal

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

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

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

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

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

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

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

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

Sincerely yours,

Nancy C Brogdon

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

Enclosure(s)

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510(k) Number (if known):	K071314	Page 1 of 1
Device Name:	SONOLINE G20™ Diagnostic Ultrasound System
Indications for Use:

The G20™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, 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.

(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)	✓	OR	Over-the-Counter-Use(Optional Format 1-2-96)
------------------------------------------	---	----	--------------------------------------------------

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510(k) Number (if known):

Device Name: Intended Use:

SONOLINE G20™ 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						BM	Note 2,3
Abdominal		P	P						BM	Note 2,3
Intraoperative(Note 6)		P	P						BM	Note 3
IntraoperativeNeurological		P	P						BM	Note 3
Pediatric		P	P						BM	Note 2,3
Small Organ(Note 1)		P	P						BM	Note 2,3
Neonatal Cephalic		P	P						BM	Note 3
Adult Cephalic		P	P						BM	Note 2
Cardiac		P	P						BM	Note 2
Transesophageal		P	P						BM	Note 2,3
Transrectal		P	P						BM	Note 2,3
Transvaginal		P	P						BM	Note 2,3
Transurethral
Intravascular
Peripheral vessel		P	P						BM	Note 2,3
Laparoscopic		P	P						BM	Note 3
Musculo-skeletalConventional		P	P						BM	Note 2,3
Musculo-skeletalSuperficial		P	P						BM	Note 2,3
Other (specify)

N = new indication; P = previously cleared by FDA with K042833; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Nancyc Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number 1207/3/4

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

510(k) Number (if known):

Device Name:

Intended Use:

C5-2 Convex Array Transducer for use with: SONOLINE G20™ 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						BM	Note 2,3
Abdominal		P	P						BM	Note 2,3
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P						BM	Note 2,3
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P						BM	Note 2,3
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Specify)

N = new indication; P = previously cleared by FDA with K04283; 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

Nancy C Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
2071314

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

510(k) Number (if known):

Device Name:

Intended Use:

L10-5 Linear Array Transducer for use with: SONOLINE G20™ Diagnostic Ultrasound Systems Ultrasound imaging or fluid flow analysis of the human body as follows:

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

N = new indication; P = previously cleared by FDA with K042833; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

Nancy bragdon

(Division Sign-O Division of Reproduct and Radiological Devices 510(k) Number

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

510(k) Number (if known):

Device Name:

Intended Use:

EV9-4 Convex Array Transducer for use with: SONOLINE G20™ Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P						BM	Note 3
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P						BM	Note 3
Transvaginal		P	P						BM	Note 3
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA with K042833; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

Nancy C Broadon

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

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

510(k) Number (if known):

Device Name:

Intended Use:

7.5L75S Linear Array Transducer for use with: SONOLINE G20™ Diagnostic Uitrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

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

N = new indication; P = previously cleared by FDA with K042833; 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

Nancy Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K071314

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

510(k) Number (if known):

Device Name:

Intended Use:

EC9-4 Convex Array Endocavity Transducer for use with: SONOLINE G20™ 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						BM	Note 3
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P						BM	Note 3
Transvaginal		P	P						BM	Note 3
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA with K042833; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproduc and Radiological Devices 510(k) Number ___

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

510(k) Number (if known):

Device Name:

Intended Use:

C4-2 Convex Array Transducer for use with: SONOLINE G20™ 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						BM
Abdominal		P	P						BM	Note 2,3
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P						BM
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic		P	P						BM	Note 2,3
Cardiac		P	P						BM	Note 2,3
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA with K04283; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging
3D imaging Note 3
B&W SieScape panoramic imaging Note 4

Note 5 Power SieScape panoramic imaging

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

Nancy C. Brogdon

(Division Sign-O Division of Reproductive, Abdor and Radiological Devic 510(k) Number _

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

510(k) Number (if known):

Device Name:

Intended Use:

C8-5 Convex Array Transducer for use with: SONOLINE G20™ 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		P	P						BM	Note 3
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P						BM	Note 3
Small Organ(Note 1)		P	P						BM	Note 3
Neonatal Cephalic		P	P						BM	Note 3
Adult Cephalic
Cardiac		P	P						BM	Note 3
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional		P	P						BM	Note 3
Musculo-skeletalSuperficial		P	P						BM	Note 3
Other (specify)

N = new indication; P = previously cleared by FDA with K042833; E = added under Appendix E

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

Ensemble tissue harmonic imaging Note 2
Note 3 3D imaqing

Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

Nancy Broadon
Division Sign-Off

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices ு ப்ருடு Number _____________________________________________________________________________________________________________________________________________________________

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

510(k) Number (if known):

Device Name:

BE9-4 Biplane Endocavity Transducer for use with: SONOLINE G20™ 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						BM	Note 3
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P						BM	Note 3
Transvaginal		P	P						BM	Note 3
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA with K042833; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging
Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Nancy C. Snowdon

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

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

510(k) Number (if known):

Device Name:

Intended Use:

C6F3 Convex Array Mechanically Driven, 3D Transducer for use with: SONOLINE G20™ 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						BM	Note 2,3
Abdominal		P	P						BM	Note 2,3
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P						BM	Note 2,3
Small Organ(Note 1)
Neonatal Cephalic		P	P						BM	Note 2,3
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA with K04283; E = added under Appendix E

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

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Nancy C. Brogdon

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

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

510(k) Number (if known):

Device Name:

Intended Use:

EV8F5 Mechanical Sector Endovaginal 3D Transducer for use with: SONOLINE G20™ 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						BM	Note 3
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)
Neonatal Cephalic		P	P						BM	Note 3
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P						BM	Note 3
Transvaginal		P	P						BM	Note 3
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA with K042833; 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

Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K0713/4

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

510(k) Number (if known):

Device Name:

3.5C40S Convex Array Transducer for use with: SONOLINE G20™ 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						BM	Note 2,3
Abdominal		P	P						BM	Note 2,3
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P						BM	Note 2,3
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P						BM	Note 2,3
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA with K04283; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging
3D imaging Note 3
Note 4 B&W SieScape panoramic imaging

Note 5 Power SieScape panoramic imaging

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Nancy Brogdon

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

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

510(k) Number (if known):

Device Name:

5.0C40S Convex Array Transducer for use with: SONOLINE G20™ 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						BM	Note 2,3
Abdominal		P	P						BM	Note 2,3
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P						BM	Note 2,3
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P						BM	Note 2,3
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA with K04283; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

Nancy C Brogdon

(Division Sign-Off) Division of Reproduct tive, Abdon and Radiological Devices 510(k) Number __

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

510(k) Number (if known):

Device Name:

Endo PIt Mechanical Sector Biplane Endo-cavity Transducer for use with: SONOLINE G20™ 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						BM	Note 2,3
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P						BM	Note 2,3
Transvaginal		P	P						BM	Note 2,3
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA with K042833 and K946179; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Nancy C Broadon

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

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

510(k) Number (if known):

Device Name:

Endo VII Mechanical Sector Endovaginal Transducer for use with: SONOLINE G20™ 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						BM	Note 2,3
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)
Neonatal Cephalic		P	P						BM	Note 2,3
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P						BM	Note 2,3
Transvaginal		P	P						BM	Note 2,3
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA with K042833; E = added under Appendix E

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

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

Note 7 Contrast agent imaging

Nancy Brogdon
(Division Sign-Off)

Division of Reproductiv and Radiological Devices 5 ! ((k) Number __

Regulation Number and Section

N/A