Diagnostic imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (abdominal, neurological), Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral vessel, Laparoscopic, Musculo-skeletal (Conventional, Superficial). 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 Ebisu is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in: B-Mode, M-Mode, a combination of modes, 3D imaging or Harmonic Imaging on a CRT display.

AI/ML Overview

The provided text is a 510(k) summary for the Ebisu Diagnostic Ultrasound System and subsequent FDA clearance letters for several transducers. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to performance standards, rather than presenting a performance study with acceptance criteria and results for a new AI-powered diagnostic device.

Therefore, many of the requested categories in the prompt (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, sample size for training set, ground truth for training set) are not applicable or not present in the provided document.

Instead, the document details safety and effectiveness standards the device is designed to meet and lists its intended uses by clinical application and mode of operation. The "acceptance criteria" here refer to these safety and performance standards and the "study" is the manufacturer's internal data and declarations that the device meets these standards, which are reviewed by the FDA for clearance.

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are generally adherence to recognized safety and performance standards for medical equipment and substantial equivalence to predicate devices. The "reported device performance" is the manufacturer's declaration and the FDA's concurrence that the device meets these standards and is substantially equivalent.

Acceptance Criteria (Standards Met)	Reported Device Performance (Manufacturer's Declaration/FDA Concurrence)
UL 2601-1, Safety Requirements for Medical Equipment	The Ebisu has been designed to meet these product safety standards.
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment	The Ebisu has been designed to meet these product safety standards.
AIUM/NEMA, 1998, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment	The Ebisu has been designed to meet these product safety standards.
AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound	The Ebisu has been designed to meet these product safety standards.
93/42/EEC Medical Devices Directive	The Ebisu has been designed to meet these product safety standards.
EN 60601-1, EN 60601-1-1, EN 60601-1-2 (Safety and EMC Requirements)	The Ebisu has been designed to meet these product safety standards.
IEC 1157 Declaration of Acoustic Power	The Ebisu has been designed to meet these product safety standards.
ISO 10993 Biocompatibility	The Ebisu has been designed to meet these product safety standards.
Substantial Equivalence to Predicate Devices (K020353, K946179)	FDA has determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use.
Compliance with General Controls of the Act (21 CFR Part 807, 801, 820, 1000-1050)	The device is subject to general controls provisions of the Act. For transducers, FDA requires a post-clearance special report including acoustic output measurements.

Intended Uses (Indications for Use for each transducer model listed in tables in pages 5-17):

The device performance is deemed acceptable if it can safely and effectively perform diagnostic imaging for the specified clinical applications (e.g., Fetal, Abdominal, Pediatric, Small Organ, Neonatal/Adult Cephalic, Cardiac, Vascular, Musculoskeletal) using the indicated modes of operation (e.g., B-Mode, M-Mode, PWD, CWD, Color Doppler, Combined BM, Tissue Harmonic Imaging, 3D imaging, B&W SieScape panoramic imaging).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. As this is a 510(k) for an ultrasound system based on substantial equivalence, detailed clinical study data with specific test sets and data provenance for performance metrics (as would be typical for an AI-powered diagnostic device) are not part of this submission type.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The substantial equivalence process relies on comparison to predicate devices, not on a new clinical study with expert-adjudicated ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. 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

An MRMC study was not mentioned or indicated in the document. The Ebisu Ultrasound system itself is a diagnostic imaging device, not an AI-assisted diagnostic software.

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

A standalone algorithm performance study was not mentioned or indicated in the document. The device is an ultrasound system that produces images for human interpretation, not an automated diagnostic algorithm operating without human intervention.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The concept of "ground truth" as it applies to performance studies for AI devices is not directly applicable here. The "truth" for this 510(k) submission relates to the device's ability to produce images and measurements comparable to predicate devices and to meet safety standards. Its effectiveness is based on its conventional diagnostic imaging capabilities, not on a specific diagnostic output requiring a ground truth for validation.

8. The sample size for the training set

This information is not applicable/not provided. The Ebisu is a hardware and software system for generating ultrasound images, not an AI model that undergoes a "training" phase in the described context. Its design and development would involve engineering benchmarks and testing, not machine learning training sets.

9. How the ground truth for the training set was established

This information is not applicable/not provided for the same reasons as point 8.

Summary

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

MAR - 9 2004

510(K) SUMMARY

Ebisu Diagnostic Ultrasound system

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

Submitted By: 1.

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

Contact Person:

Patrick J Lynch Regulatory Affairs

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

Date Prepared:

January 28, 2004

2. Proprietary Name:

Ebisu 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

3. Predicate Device:

K020353, 02/13/2002, cleared as Omnia X/XS, marketed as SONOLINE G50 & G60 S Diagnostic Ultrasound Systems

K946179, 10/03/1995, cleared as Prima, and marketed as SONOLINE Adara Diagnostic Ultrasound System

4. Device Description:

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

UL 2601-1, Safety Requirements for Medical Equipment
에 CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
AIUM/NEMA, 1998, Standard for Real Time Display of Thermal and Mechanical Acoustic 내 Output Indices on Diagnostic Ultrasound Equipment
l AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound

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

93/42/EEC Medical Devices Directive 트
Safety and EMC Requirements for Medical Equipment ■
- . EN 60601-1
- . EN 60601-1-1
- n EN 60601-1-2
IEC 1157 Declaration of Acoustic Power 重
ISO 10993 Biocompatibility 트

Intended Uses: 5.

Intentious oooo!
The Ebisu ultrasound imaging system is intended for the following applications: General The Eblog attacoche in Manage of the Scranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal, Superiicial 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: ર.

The Ebisu is substantially equivalent to the SONOLINE Adara, cleared via K946179, the The Eblad 16 Subted in any of a K020353, and some features of the GE LOGIQ 500, cleared OONOENE Group Crown transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.

End of 510(k) Summary

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 9 2004

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

Re: K040502

Trade Name: SONOLINE Ebisu Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYO and ITX Dated: February 24, 2004 Received: February 27, 2004

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the SONOLINE Ebisu Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

C5-2 Convex Array Transducer L10.5 Linear Array Transducer EV9-4 Convex Array Transducer

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

7.5L75S Linear Array Transducer EC9-4 Convex Array Endocavity Transducer C4-2 Convex Array Transducer C8-5 Convex Array Transducer BE9-4 Biplane Endocavity Transducer C6F3 Convex Array Mechanically Driven, 3D Transducer EV8F5 Mechanical Sector Endovaginal 3D Transducer 3.5C40S Convex Array Transducer 5.0C40S Convex Array Transducer

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

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

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

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

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

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

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

Page 3 - Mr. Job

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office 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) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act 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,

Nancy C Brogdon
Nancy C. Brogdon

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

Enclosure(s)

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

510(k) Number (if known):

SONOLINE Ebisu Diagnostic Ultrasound Systems

Device Name: Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P						BM	Note 2,3
Abdominal		P	P						BM	Note 2,3
Intraoperative(Note 6)		P	P						BM	Note 3
IntraoperativeNeurological		P	P						BM	Note 3
Pediatric		P	P						BM	Note 2,3
Small Organ(Note 1)		P	P						BM	Note 2,3
Neonatal Cephalic		P	P						BM	Note 3
Adult Cephalic		P	P						BM	Note 2
Cardiac		P	P						BM	Note 2
Transesophageal		P	P						BM	Note 2,3
Transrectal		P	P						BM	Note 2,3
Transvaginal		P	P						BM	Note 2,3
Transurethral
Intravascular
Peripheral vessel		P	P						BM	Note 2,3
Laparoscopic		P	P						BM	Note 3
Musculo-skeletalConventional		P	P						BM	Note 2,3
Musculo-skeletalSuperticial		P	P						BM	Note 2,3
Other (specify)

N = new indication; P = praviously cleared by FDA with K020353; E = added under Appendix E

For example: breast, testers, thyrold, penis, prostate, etc. Note 1

Ensemble tissue harmonic imaging Note 2

3D imaging Note 3

B&W SleScape panoramic imaging Note 4

Power SieScape panoramic imaging Note ર

For example: abdominal, vascular Note 6

Contrast agent imaging Note 7

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon

(Division Sign-Division of Reproduct ive. Al and Radiological Devices 510(k) Number

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

510(k) Number (if known):

Device Name:

C5-12 Convex Array Transducer for use with: SONOLINE Eblau Diagnostic Ultrasound Systems

Intended Use:

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

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

N = hew indication; P = prevlously claared by FDA with K020353; E = added under Appendix E

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

Ensemble tissue harmonic Imaging Note 2

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

Note 5 Power SieScape panoramic imaging

Note B For example: abdominal, vascular

Note 7 Contrast agent imaging

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon

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

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

510(k) Number (if known):

Device Name:

L10.5 Linear Array Transducer for use with: SONOLINE Ebisu Diagnostic Ultrasound Systems

Intended Use:

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						BM	Note 2,3
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P						BM	Note 2,3
Small Organ		P	P						BM	Note 2,3
Neonatal Cephalic		N	N						BM	Note 2,3
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P						BM	Note 2,3
Laparoscopic
Musculo-skeletalConventional		P	P						BM	Note 2.3
Musculo-skeletalSuperficial		P	P						BM	Note 2,3
Other (specify)

N = new indication; P = previously claared by FDA with K020353; E = added under Appendix E

For example: breast, testes, thyroid, penls, prostate, etc. Nole 1

Note 2 Ensemble tissue harmonic Imaging
Note 3 30 imaging
B&W SieScape panoramic imaging Nole 4

Note 5 Power SleScape panoramic imaging

For example: abdominal, vascular Note B

Note 7 Contrast agent imaging

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Broadon

(Division Sign-Off Division of Reproductive, Ab and Radiological Devices 5 (0(k) Number ---

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

510(k) Number (if known):

Device Name:

Intended Use:

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

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

N = new indication: P = previously cleared by FDA with K020353; 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 panoram c imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent Imaging Note 7

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C brydon

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

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

510(k) Number (it known):

Device Name:

Intended Use:

7,5L175S Linear Array Transducer for use with: SONOLINE Ebisu 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							Note 3
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P							Note 3
Small Organ(Note 1)		P	P							Note 3
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P							Note 3
Laparoscopic
Musculo-skeletalConventional		P	P							Note 3
Musculo-skeletalSuperficial		P	P							Note 3
Other (specify)

N = new indication; P = previously cleared by FDA with K946179; E = added under Appandix E

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

Note 2 Ensemble tissue harmonic imaging

30 imaging Note 3

B&W SieScape panoramic Imaging Note 4

Note 5 Power SleScape panoramic Imaging

For example: abdominal, vascular Note 6

Note 7 Contrast agent Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.108)

Nancy C. Brogdon

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

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

510(k) Number (if known):

EC9-4 Convex Array Endocavily Transducer for use with: Device Name: SONOLINE Ebisu Diagnostic Uitrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows: Intended Use:

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

N = new Indication: P = previously cleared by FDA with K020353; E = added under Appendix E

For example: breast, testers, thyrold, penis, prostate, elc. Note 1

Ensemble tissue harmonic imaging Note 2

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

Note 5 Power SieScape panoram c Imaging

For example: abdominal, vascular Note Б

Contrast agent imaging Note 7

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Beardon

(Division Sig Division of Reproductive, Abdo and Radiological Devices 510(k) Number _

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

510(k) Number (II known):

Device Name:

Intended Use:

C4-2 Convex Array Transducer for use with: SONOLINE Ebisu Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Mode of Operation Color Clinical Application Amplitude Combined Other Calor B M PWD CWD Velocity A (Specify) Doppler Doppler (Specify) Imaging Ophthalmic P P BM Felal Note 2,3 Abdominal P P BM Intraoperative Abdominal Intraoperative Neurological BM P P Pediatric Small Organ (Note 1) Naonatal Cephallo BM Note 2,3 P Adult Cephallc P P P BM Note 2,3 Cardiac Transesophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal Conventional Musculo-skeletal Superlicial Other (specify)

N = new indication; P = previously cleared by FDA with K962142; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

Note 3 30 imaging
B&W SieScape panoramic imaging Note 4

Note 5 Power SieScape panoramic imaging

For example: abdominal, vascular Note G

Note 7 Contrast agent Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Gordon

(Division Sig Division of Reproductive, Abdo and Radiological Devices 510(k) Number

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

510(k) Number (il known):

Davice Name:

Intended Use:

C8-5 Convex Array Transducer for use with: SONIOLINE Ebisu Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

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

N = new indication; P = previously cleared by FDA with K020353; E = added under Appendix E

Note t For example: breast, testes, thyrold, penis, prostate, etc.

Ensomble tissue harmonic imaging Nola 2

Note 3 3D imaging

Nole 4 B&W SieScape panoramic imaging

Power SleScape panoramic imaging Note 5

Note B For example: abdominal, vascular

Contrast agent imaging Note 7

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANDTHER PAGE: IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C bogdon

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

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

510(k) Number (if known):

Device Name:

BE9-4 Biplane Endocavity Transducer for use with: SONOLINE Ebisu Diagnostic Ultrasound Systems

Intended Use:

SONO-LINE Colsu Diagnestic on 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						BM	Note 3
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N						BM	Note 3
Transvaginal		N	N						BM	Note 3
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = prevlously cleared by FDA with K040060; 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, vuscular Note B

Contrast agent Imaging Note 7

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon

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

510(k) Number (if known):

Device Name:

Intended Use:

C6F3 Convex Array Mechanically Driven, 3D Transducer for use with: Cor 3 Ourvex Array lagnostic Ultrasound Systems SONOLINE Eblou Diagnostic of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P						BM	Note 2,3
Abdominal		P	P						BM	Note 2,3
IntraoperativeAbdominal
IntraoperativeNeurological									BM	Note 2,9
Pediatric		P	P
Small Organ(Note 1)
Neonatal Cephalic		P	P						BM	Note 2,3
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new Indication; P = previously cleared by FDA with K020353; E = added under Appendix E

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

Ensemble tissus harmonic imaging Note 2

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

Power SleScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent Imaging Note 7

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy Brogdon

(Division Sign Division of Reproductive, Abdominal, ana Radiological Devices 510(k) Number ___

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

510(k) Number (if known):

EV8F5 Mechanical Sector Endovaginal 3D Transducer for use with: Device Name: SONOLINE Ebisu Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows: Intended Use:

	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 = proviously cleared by FDA with K020353; E = added under Appendix E

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

Note 2 Ensemble tissue harmonic imaging

Note 3 3D imaging
.

B&W SieScape panoramic innaging Note 4

Note 5 Power SieScape panoramic imaging

For example; abdominal, vascular Note 8

Note 7 Contrast agent imaging

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Manaye Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K040502

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

510(k) Number (if known):

Device Name:

3.5C40S Convex Array Transducer for use with: SONOLINE Ebisu Diagnostic Ultrasound Systems

Intended Use:

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

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

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

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

Ensemble ilsoue harmonic imaging Note 2

30 imaoing Note 3
B&W SieScape panoramic Imaging Note 4

Note 5 Power SleScape panoramic imaging

For example: abdominal, vascular Note B

Note 7 Contrast agent imaging

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDAH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C Brogdon

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

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

:::

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

5.0C40S Convex Array Transducer for use with: 5.0C40S Conver Anajanostic Ultrasound Systems

Intended Use:

SONNEINE EBIGG Diagnoeller of the human body as follows:

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

Other (specify)
N = new indication: P = proviously cleared by FDA with K946179; E = added under Appendix E

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

Ensemble tissua harmonic Imaging Note 2

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

Power SieScape panoramic imaging Note 5

For example: abdominal, vascular Note 6

Contrast agent Imaging Note 7

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE.ON ANOTHER PAGE IF NEEDED)
THE CONTINUE CONSULTION Of ODEL Office of Device Evaluation (ODE) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C Brogdon

Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 5 10(k) Number ...............................................................................................................................................................

November 24, 2003

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.