Diagnostic imaging or fluid flow analysis of the human body as follows: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, 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 G50/G60 S are general purpose, mobile, software-controlled, diagnostic ultrasound systems with on-screen displays for thermal and mechanical indices related to potential bioeffect mechanisms. Their function is to acquire primary or secondary harmonic ultrasound echo data (CW) Doppler Mode, Continuous (CW) Doppler Mode, and display in in. D Mode, in Mode, it node, a combination of modes, or Harmonic Imaging, or 3D/4D imaging, on a CRT display.

AI/ML Overview

The provided text is a 510(k) summary for the SONOLINE G50/G60 Diagnostic Ultrasound Systems. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific performance acceptance criteria through clinical studies in the way a PMA (Premarket Approval) submission would.

Therefore, the document does not contain the detailed clinical study information you requested (e.g., sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details). The acceptance criteria for a 510(k) are typically based on demonstrating that the new device has the same intended use and similar technological characteristics as the legally marketed predicate device, or that any differences do not raise new questions of safety and effectiveness.

Based on the provided text, here's what can be extracted and what cannot:

Acceptance Criteria and Device Performance (as stated in the 510(k) Summary)

The acceptance criteria for this 510(k) submission are implicitly the demonstration of substantial equivalence to predicate devices. This is achieved by showing that the SONOLINE G50/G60 S systems perform similarly to already cleared devices and comply with relevant safety standards.

Acceptance Criteria (Implicit for 510(k) Substantial Equivalence)	Reported Device Performance (as stated)
Primary Function: Acquire primary or secondary harmonic ultrasound echo data mechanisms.	"Their function is to acquire primary or secondary harmonic ultrasound echo data mechanisms."
Display Modes: Operate in B Mode, M Mode, A Mode, Pulse Wave Doppler (PWD) Mode, Continuous Wave Doppler (CWD) Mode, and display in a combination of modes, or Harmonic Imaging, or 3D/4D imaging.	The device operates in B Mode, M Mode, A Mode, PWD, CWD, combination of modes, Harmonic Imaging, 3D/4D imaging, displayed on a CRT. Specific transducers also support Color Doppler, Amplitude Doppler, and Color Velocity Imaging (BMDC).
Intended Uses: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.	The system is intended for these applications (listed as "Intended Uses") and is considered substantially equivalent to predicate devices for these purposes.
Measurement and Analysis: Provide for measurement of anatomical structures and analysis packages for clinical diagnosis.	"The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes."
Safety and EMC Compliance: Meet specific product safety standards (UL 2601-1, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, 93/42/EEC Medical Devices Directive, EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2, IEC 1157, ISO 10993).	The G50/G60 S have been designed to meet these listed product safety standards.
Substantial Equivalence: Demonstrate substantial equivalence to predicate devices (K020353, K032111, K003125, K003525).	The document explicitly states: "The SONOLINE G50/G60 S are substantially equivalent to the SONOLINE G50 & G60 S, cleared via K020353; SONOLINE CV70, cleared via K032111; SONOLINE Elegra with Axius OB Calipers, cleared via K003125; and Medison Voluson 730, cleared via K003525."

Study Details Not Available in a 510(k) Summary

As explained, a 510(k) submission primarily relies on demonstrating equivalence to predicate devices, rather than new clinical effectiveness studies. Therefore, the following information is not provided within this document:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not described. The submission focuses on functional and technical equivalence, not patient study data for performance metrics.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not described. Ground truth establishment is typically part of a de novo or PMA clinical study, which is not the basis of this 510(k).
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not 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: Not applicable. This device is a diagnostic ultrasound system from 2003, and the document does not mention any AI components or MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an imaging system requiring human operation and interpretation, and the document does not describe standalone algorithmic performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not described.
The sample size for the training set: Not applicable, as this is related to AI/algorithm development, which isn't described for this device in this context.
How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) document is a regulatory submission for substantial equivalence of a diagnostic ultrasound system. It outlines the device's technical specifications, intended uses, and compliance with recognized safety standards to demonstrate that it is as safe and effective as pre-existing, legally marketed devices. It does not include new clinical study data with performance metrics against a defined truth set, which would be expected for novel devices or those requiring a higher level of evidence (e.g., PMA).

Summary

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K040060

SONOLINE G50/G60 Diagnostic Ultrasound Systems 510(k) Submission

510(K) SUMMARY

Sonoline G50™ and Sonoline G60 STM Diagnostic Ultrasound Systems

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

Submitted By: 1.

Siemens Medical Solutions USA, Inc., Ultrasound Division 22010 S.E. 51st Street Issaquah, WA 98029

Contact Person: Patrick J Lynch Requlatory Affairs

Phone: (425) 557-1825 FAX: (425) 391-9198

Date Prepared:

November 25, 2003

Proprietary Name: 2.

SONOLINE G50™ Ultrasound System and SONOLINE G60 S™ Ultrasound System

Common/ Usual Name:

Diagnostic Ultrasound System with Accessories

Classification Name:

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

Predicate Device: 3.

K020353, 2/13/2002, SONOLINE G50 and SONOLINE G60 S. K032111, 7/18/2003, ACUSON CV70 Cardiovascular System K003525, 11/22/2000, Medison Voluson 730 K00325, 11/22/2000, SONOLINE Elegra (with Axius™ Automated OB Calipers and 3D measurements)

4. Device Description:

The G50/G60 S are general purpose, mobile, software-controlled, diagnostic ultrasound systems with on-screen displays for thermal and mechanical indices related to potential bioeffect will on orean displays to n is to acquire primary or secondary harmonic ultrasound echo data mechanisms. "Their funotion is to acquire provinci (CW) Doppler Mode, Continuous (CW) Doppler Mode, and display in in. D Mode, in Mode, it node, a combination of modes, or Harmonic İmaging, or 3D/4D imaging, on a CRT display.

The G50/G60 S have been designed to meet the following product safety standards:

UL 2601-1, Safety Requirements for Medical Equipment l
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment ■

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AIUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and Mechanical D 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 I
- l EN/IEC 60601-1
- EN/IEC 60601-1-1
- 프 EN/IEC 60601-1-2
IEC 1157 Declaration of Acoustic Power .
트 ISO 10993 Biocompatibility

5. Intended Uses:

The G50/G60 S ultrasound imaging systems are intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, 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.

Technological Comparison to Predicate Device: 6.

The SONOLINE G50/G60 S are substantially equivalent to the SONOLINE G50 & G60 S, cleared via K020353; SONOLINE CV70, cleared via K032111; SONOLINE Elegra with Axius OB Calipers, cleared via K003125; and Medison Voluson 730, cleared via K003525. 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 seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, a staff with two snakes entwined around it, which is a common symbol associated with healthcare and medicine. The seal is in black and white.

'JAN 2 8 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K040060

Trade Name: SONOLINE G50/G60 S 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 systems Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: January 9, 2004 Received: January 13, 2004

Dcar Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device in onare for corrent 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 of or 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 I ms decentimation of but G50/G60 S Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

C5-2 Convex Array C6-2 Convex Array

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C8-5 Convex Array 5.0C50+ Convex Array C6-3 3D Mechanically Driven 3D Convex Array EV9-4 Convex Array Endovaginal Endo-VII Mechanical Sector Endovaginal Endo-V 3D Mechanical Sector Endovaginal EC9-4 Convex Array Endovaginal BE9-4 Convex Array Endocavity 5.0L45 Linear Array 7.5L70 Linear Array LB5-2 Linear Array L10-5 Linear Array VF13-5 Linear Array VF13-5SP Linear Array 7.5L50I Linear Array 7.5L50Q Lincar Array LAP8-4 Laparoscopic P4-2 Phased Sector Array 5.0P10 Phased Sector Array MPT7-4 Phased Sector Array Tee CW2 Continuous Wave Doppler CW5 Continuous Wave Doppler

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 or unry 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:

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

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

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed precticate 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 If you desire of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594promotes, please note the regulation entitled, "Misbranding by reference to premarket 4027. Thise new (21 CFR Part 807.97). Other general information on your responsibilities under the non may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Ermila Lynn...

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):

4 (SONOLINE G50/G60 S Family)

Device Name: Intended Use:

SONOLINE G50/G60 S 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	Color Velocity Imaging	Combined (Specify)	Other (Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Intraoperative(Note 6)		P	P	P		P	P		BMDC	Note 3
IntraoperativeNeurological		P	P	P		P	P		BMDC	Note 3
Pediatric		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Small Organ(Note 1)		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note 3
Adult Cephalic		P	P	P	P	P	P		BMDC	Note 2
Cardiac		P	P	P	P	P	P		BMDC	Note 2,7
Transesophageal		P	P	P	E	P	P		BMDC	Note 2,3,7
Transrectal		P	P	P		P	P		BMDC	Note 2,3,4,5
Transvaginal		P	P	P		P	P		BMDC	Note 2,3,4,5
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Laparoscopic		P	P	P		P	P		BMDC	Note 3
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 2,3,4,5
Other (specify)

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

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

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

David R. Lyons

(Division Sign-C Division Renronunting and Rac 510(k) Num

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

510(k) Number (if known): ###### (SONOLINE G50/G60 S Family)

Device Name:

Intended Use:

. C5-2 Convex Array Transducer for use with: SONOLINE G50/G60 S 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
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 2,3,4,5
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Specify)

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

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

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

Note 7 Contrast agent imaging

Daniel R. Seymm

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

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

510(k) Number (if known): ★GE0500 (SONOLINE G50/G60 S Family)

Device Name:

Intended Use:

C6-2 Convex Array Transducer for use with: SONOLINE G50/G60 S Diagnostic Ultrasound Systems Ultrasound imaging or fluid flow analysis of the human body as follows:

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

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

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

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

Daniel A. Segarra

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

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

510(k) Number (if known):

Device Name:

Intended Use:

C8-5 Convex Array Transducer for use with: SONOLINE G50/G60 S 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	P		P	P		BMDC	Note 3,4,5
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 3,4,5
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 3,4,5
Neonatal Cephalic		P	P	P		P	P		BMDC	Note 3,4,5
Adult Cephalic
Cardiac		E	E	E		E	E		BMDC	Note 3,4,5,7
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 3,4,5
Musculo-skeletalSuperficial		E	E	E		E	E		BMDC	Note 3,4,5
Other (specify)

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

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

Ensemble tissue harmonic imaging Note 2

3D imaging Note 3

Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

David A. Seymour

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

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

SONOLINE G50/G60 S Family) 510(k) Number (if known): 400

Device Name:

5.0C50+ Convex Array Transducer for use with: SONOLINE G50/G60 S 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 3,4,5
Abdominal		P	P	P	P	P	P		BMDC	Note 3,4,5
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		BMDC	Note 3,4,5
Small Organ(Note 1)		P	P	P	P	P	P		BMDC	Note 3,4,5
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 3,4,5
Laparoscopic
Musculo-skeletalConventional		E	E	E	E	E	E		BMDC	Note 3,4,5
Musculo-skeletalSuperficial		E	E	E	E	E	E		BMDC	Note 3,4,5
Other (specify)

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

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

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaqinq

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

David A. Ayres

(Division Sign - Off) Division of Reproductive, Abdom ano Radiological Devices 5 10(K) Number _______________________________________________________________________________________________________________________________________________________________

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

510(k) Number (if known): 4020050 (SONOLINE G50/G60 S Family)

Device Name:

Intended Use:

C6-3 3D Mechanically Driven 3D Convex_Array Transducer for use with: SONOLINE G50/G60 S 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
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMDC	Note 2,3,4,5
Small Organ(Note 1)
Neonatal Cephalic		E	E	E		E	E		BMDC	Note 2,3,4,5
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

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

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaqing

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

Daniel A. Ayres

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

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

ASECULE (SONOLINE G50/G60 S Family) 510(k) Number (if known):

Device Name:

Intended Use:

EV9-4 Convex Array Endovaginal Transducer for use with: SONOLINE G50/G60 S 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
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N		N	N		BMDC(N)	Note 2,3,4,5
Transvaginal		P	P	P		P	P		BMDC	Note 2,3,4,5
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

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

Ensemble tissue harmonic imaging Note 2
Note 3 3D imaqing

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

Daniel A. Lagom

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

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

REED (SONOLINE G50/G60 S Family) 510(k) Number (if known):

Device Name:

Intended Use:

Endo-VII Mechanical Sector Endovaginal Transducer for use with: SONOLINE G50/G60 S 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; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

3D imaging Note 3

Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

Daniel A. Legerem

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

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

Keeses (SONOLINE G50/G60 S Family) 510(k) Number (if known):

Device Name:

Intended Use:

Endo-V 3D Mechanical Sector Endovaginal Transducer for use with: SONOLINE G50/G60 S 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		N	N						BM(N)	Note 3
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N						BM(N)	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; E = added under Appendix E

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

Ensemble tissue harmonic imaging Note 2
Note 3 3D imaqing

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

David A. Lyman

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

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

1400000 (SONOLINE G50/G60 S Family) 510(k) Number (if known):

Device Name:

Intended Use:

EC9-4 Convex Array Endovaginal Transducer for use with: SONOLINE G50/G60 S 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
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P	P		P	P		BMDC	Note 2,3,4,5
Transvaginal		P	P	P		P	P		BMDC	Note 2,3,4,5
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

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

Note 2 Ensemble tissue harmonic imaging
3D imaging Note 3

B&W SieScape panoramic imaging Note 4

Note 5 Power SieScape panoramic imaging

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

David A. Lyman

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

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

K 510(k) Number (if known):

Device Name:

Intended Use:

BE9-4 Convex Array Endocavity Transducer for use with: SONOLINE G50/G60 S 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(N)	Note 2,3,4,5
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N		N	N		BMDC(N)	Note 2,3,4,5
Transvaginal		N	N	N		N	N		BMDC(N)	Note 2,3,4,5
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

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

Ensemble tissue harmonic imaging Note 2
Note 3 3D imaqinq

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

David br. Seymour

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

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

510(k) Number (if known):

42, 402008 (SONOLINE G50/G60 S Family) Norman

Device Name:

Intended Use:

5.0L45 Linear Array Transducer for use with: SONOLINE G50/G60 S 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	P	P	P	P		BMDC	Note 2,3,4,5
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		N	N	N	N	N	N		BMDC(N)	Note 2,3,4,5
Small Organ(Note 1)		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Laparoscopic
Musculo-skeletalConventional		P	P	P	P	P	P		BMDC	Note 2,3,4,5
Musculo-skeletalSuperficial
Other (specify)

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

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

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

Contrast agent imaging Note 7

David R. Segeen

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

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

MOLOSS (SONOLINE G50/G60 S Family) 510(k) Number (if known):

Device Name:

7.5L70 Linear Array Transducer for use with: SONOLINE G50/G60 S Diagnostic Ultrasound Systems

Intended Use:

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

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

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

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

Ensemble tissue harmonic imaging Note 2

3D imaging Note 3

Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

Damil A. Lynn
(Division Sign-Off)

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

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

#020050 (SONOLINE G50/G60 S Family) 510(k) Number (if known):

Device Name:

Intended Use:

LB5-2 Linear Array Transducer for use with: SONOLINE G50/G60 S 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 4,5
Abdominal		P	P	P		P	P		BMDC	Note 4,5
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
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; 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

Contrast agent imaging Note 7

David A. Ingram

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

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

KO20559 (SONOLINE G50/G60 S Family) 510(k) Number (if known):

Device Name:

Intended Use:

L10-5 Linear Array Transducer for use with: SONOLINE G50/G60 S Diagnostic Ultrasound Systems Ultrasound imaging or fluid flow analysis of the human body as follows:

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

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

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

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

David b. Seym

(Division Since Off) Division of Reproductive, Abdomin and Radinlogical Devices 5 1 (K) Number _______________________________________________________________________________________________________________________________________________________________

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

ഷോക്കും(SONOLINE G50/G60 S Family) 510(k) Number (if known):

Device Name:

Intended Use:

VF13-5 Linear Array Transducer for use with: SONOLINE G50/G60 S 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
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		BMDC	Note 3,4,5
Small Organ(Note 1)		P	P	P	P	P	P		BMDC	Note 3,4,5
Neonatal Cephalic		N	N	N	N	N	N		BMDC(N)	Note 3,4,5
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 3,4,5
Laparoscopic
Musculo-skeletalConventional		P	P	P	P	P	P		BMDC	Note 3,4,5
Musculo-skeletalSuperficial		P	P	P	P	P	P		BMDC	Note 3,4,5
Other (specify)

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

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

Note 2 Ensemble tissue harmonic imaging
3D imaging Note 3

Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

Dolmil A. Sagnan

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

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

KOLOSO (SONOLINE G50/G60 S Family) 510(k) Number (if known):

Device Name:

Intended Use:

VF13-5SP Linear Array Transducer for use with: SONOLINE G50/G60 S 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 3,4,5
IntraoperativeNeurological		P	P	P		P	P		BMDC	Note 3,4,5
Pediatric		P	P	P		P	P		BMDC	Note 3,4,5
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 3,4,5
Neonatal Cephalic		N	N	N		N	N		BMDC(N)	Note 3,4,5
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 3,4,5
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 3,4,5
Musculo-skeletalSuperficial		P	P	P		P	P		BMDC	Note 3,4,5
Other (specify)

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

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

Note 2 Ensemble tissue harmonic imaging
Note 3 3D imaging

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

David A. Seymore

(Division Sign-Off) Division of Reproductive, Abdom and Radielogical Devices 5 ! O(k) Number ______________________________________________________________________________________________________________________________________________________________

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

1992 142, Hozuse (SONOLINE G50/G60 S Family) 510(k) Number (if known):

Device Name:

Intended Use:

7.5L50l Linear Array Transducer for use with: SONOLINE G50/G60 S 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	P		P	P		BMDC	Note 3,4,5
Intraoperative(Note 6)		P	P	P		P	P		BMDC	Note 3,4,5
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 3,4,5
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 3,4,5
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 3,4,5
Musculo-skeletalSuperficial
Other (specify)

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

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

Ensemble tissue harmonic imaging Note 2
3D imaging Note 3

Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

Daniel Ch. Seymore

(Division Sian-Off) Division of Reproductive, Abdomin and Radiological Devices 519(k) Number __

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

1402142, NO20555 (SONOLINE G50/G60 S Family) 510(k) Number (if known):

Device Name:

Intended Use:

7.5L50Q Linear Array Transducer for use with: SONOLINE G50/G60 S 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	P		P	P		BMDC	Note 3,4,5
Intraoperative(Note 6)		P	P	P		P	P		BMDC	Note 3,4,5
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)		P	P	P		P	P		BMDC	Note 3,4,5
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMDC	Note 3,4,5
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 3,4,5
Musculo-skeletalSuperficial
Other (specify)

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

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

Ensemble tissue harmonic imaging Note 2
3D imaging Note 3

Note 4 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Note 7 Contrast agent imaging

Daniel A. Leymm

(Division Sign-Off) Division of Reproductive, Abdomin ano Radinlogical Devices 51(){k) Number ___

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

WOODS (SONOLINE G50/G60 S Family) 510(k) Number (if known):

Device Name:

Intended Use:

LAP8-4 Laparoscopic Transducer for use with: SONOLINE G50/G60 S 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 3,4,5
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic		P	P	P		P	P		BMDC	Note 3,4,5
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

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

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaqing

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

Daniel R. Lymn

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

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

142055 (SONOLINE G50/G60 S Family) 510(k) Number (if known):

Device Name:

Intended Use:

P4-2 Phased Sector Array Transducer for use with: SONOLINE G50/G60 S 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	N		BMDC(N)
Abdominal		P	P	P	P	P	P		BMDC	Note 2,3
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		N	N	N	N	N	N		BMDC(N)
Small Organ
Neonatal Cephalic
Adult Cephalic		P	P	P	P	P	P		BMDC	Note 2,3
Cardiac		P	P	P	P	P	P		BMDC	Note 2,3,7
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

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

Ensemble tissue harmonic imaging Note 2

Note 3 3D imaging

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

Note 6 For example: abdominal, vascular

Contrast agent imaging Note 7

Daniel R. Seymm

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

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

42, #000000 (SONOLINE G50/G60 S Family) 4000 510(k) Number (if known):

Device Name:

Intended Use:

5.0P10 Phased Sector Array Transducer for use with: SONOLINE G50/G60 S 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
Abdominal		P	P	P	P	P	P		BMDC	Note 2
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		BMDC	Note 2
Small Organ
Neonatal Cephalic		P	P	P	P	P	P		BMDC	Note 2
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMDC	Note 2,7
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

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

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

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

David R. Seymon

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

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

510(k) Number (if known):

****************************************************************************************************************************************************************************** (Sequoia) (Transducer cleared as TE-V5M)

Device Name:

Intended Use:

MPT7-4 Phased Sector Array TEE Transducer for use with: SONOLINE G50/G60 S Diagnostic Ultrasound Systems Ultrasound imaging or fluid flow analysis of the human body as follows:

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

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

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

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

David R. Leggmm

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

510(k) Number

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

WEBBER (SONOLINE G50/G60 S Family) 510(k) Number (if known):

Device Name:

Intended Use:

CW2 Continuous Wave Doppler Transducer for use with: SONOLINE G50/G60 S Diagnostic Ultrasound Systems Ultrasound imaging or fluid flow analysis of the human body as follows:

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

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

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

Ensemble tissue harmonic imaging Note 2
Note 3 3D imaqinq

B&W SieScape panoramic imaging Note 4

Power SieScape panoramic imaging Note 5

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

Daniel A. Legman

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

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

510(k) Number (if known):

Device Name:

Intended Use:

CW5 Continuous Wave Doppler Transducer for use with: SONOLINE G50/G60 S Diagnostic Ultrasound Systems Ultrasound imaging or fluid flow analysis of the human body as follows:

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

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

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

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

Daniel A. Lozano

(Division Sinn Off) Division of Reproductive, Abdom and Radiological Devices 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.