Predicate Devices

K020353, K032111, K003525, K00325

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, deep learning, or any related terms, and the description of the device's function focuses on standard ultrasound processing techniques.

Therapeutic

No
The primary function of this device, as described in its "Intended Use / Indications for Use," is "Diagnostic imaging or fluid flow analysis of the human body," and it aims to provide information "for clinical diagnosis purposes." It is explicitly stated as a "diagnostic ultrasound system." Therapeutic devices are designed to treat or alleviate medical conditions, which is not the stated purpose of this device.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic imaging or fluid flow analysis of the human body" and "for analysis packages that provide information that is used for clinical diagnosis purposes." The "Device Description" also refers to them as "diagnostic ultrasound systems."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "diagnostic ultrasound system," which inherently includes hardware components (transducer, processing unit, display, etc.) to acquire and process ultrasound data, even though it is software-controlled.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that this device is a diagnostic ultrasound system. Ultrasound systems use sound waves to create images of internal body structures. This is an in vivo (within the living body) diagnostic method, not an in vitro one.
Intended Use: The intended use describes imaging and analysis of the human body directly, not analysis of samples taken from the body.

Therefore, this device falls under the category of medical imaging devices, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Diagnostic imaging or fluid flow analysis of the human body as follows:
(This indication for use is repeated for each transducer type, with varying "clinical application" and "mode of operation" tables)

Product codes (comma separated list FDA assigned to the subject device)

90-IYN, 90-IYC, 90-ITX

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic Pulsed Doppler Imaging System, Ultrasonic Pulsed Echo Imaging System

Anatomical Site

Fetal, Abdominal, Intraoperative (Note 6), Intraoperative Neurological, Pediatric, Small Organ (Note 1 - e.g. breast, testes, thyroid, penis, prostate, etc.), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral vessel, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K020353, K032111, K003525, K00325 (Typo in document, presuming K003125)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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 ■

1

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

2

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

3

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)

5

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
Intraoperative
Neurological		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-skeletal
Conventional		P	P	P		P	P		BMDC	Note 2,3,4,5
Musculo-skeletal
Superficial		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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		Color
Doppler	P		BMDC	Note 2,3,4,5
Abdominal		P	P	P		Color
Doppler	P		BMDC	Note 2,3,4,5
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric		P	P	P		Color
Doppler	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		Color
Doppler	P		BMDC	Note 2,3,4,5
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal		P	P	P		P	P	BMDC	Note 3,4,5
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		P	P	P		P	P	BMDC	Note 3,4,5
Musculo-skeletal
Superficial		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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		E	E	E	E	E	E	BMDC	Note 3,4,5
Musculo-skeletal
Superficial		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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P				BM	Note 3
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P				BM	Note 3
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		N	N	N		N	N	BMDC(N)	Note 2,3,4,5
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal		P	P	P	P	P	P	BMDC	Note 2,3,4,5
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		P	P	P	P	P	P	BMDC	Note 2,3,4,5
Musculo-skeletal
Superficial
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		P	P	P		P	P	BMDC	Note 3,4,5
Musculo-skeletal
Superficial		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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5
Musculo-skeletal
Superficial		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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional		P	P	P	P	P	P	BMDC	Note 3,4,5
Musculo-skeletal
Superficial		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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
(note 6)		P	P	P		P	P	BMDC	Note 3,4,5
Intraoperative
Neurological		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-skeletal
Conventional		P	P	P		P	P	BMDC	Note 3,4,5
Musculo-skeletal
Superficial		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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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
Intraoperative
Neurological
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-skeletal
Conventional		P	P	P		P	P	BMDC	Note 3,4,5
Musculo-skeletal
Superficial
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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
Intraoperative
Neurological
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-skeletal
Conventional		P	P	P		P	P	BMDC	Note 3,4,5
Musculo-skeletal
Superficial
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
(Note 6)		P	P	P		P	P	BMDC	Note 3,4,5
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
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-skeletal
Conventional
Musculo-skeletal
Superficial
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac					P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel					P
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
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 _________