ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO

• K Number: K071289
• Device Name: ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
• Manufacturer: SHIMADZU MEDICAL SYSTEMS
• Date Cleared: 2008-01-09 ( 246 days)
• Product Code: ITX , IYN , IYO
• Regulation Number: 892.1570
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K061643
• Predicate For: N/A

Intended Use

Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional, Transrectal.

Device Description

The SDU-1200Pro is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 1.5 to 15 MHz. It has B mode, M mode, Pulsed Doppler mode, Continuous Doppler mode, Real time 3D mode, Color mode, or in a combination of modes.

AI/ML Overview

The provided document is a 510(k) summary for the SHIMADZU MEDICAL SYSTEMS SDU-1200Pro Ultrasound Imaging System. It outlines the device's intended use and compliance with safety standards. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of diagnostic accuracy or reader performance.

The document primarily focuses on:

• Device Description: A mobile diagnostic ultrasound system with various probes and imaging modes (B mode, M mode, Pulsed Doppler, Continuous Doppler, Real-time 3D, Color mode).
• Intended Use/Indications for Use: A list of clinical applications for which the device is intended (Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial, Musculo-skeletal Conventional, Transrectal). These are "previously cleared by FDA" (indicated by 'P' in the tables) or "new indication" (indicated by 'N').
• Safety Considerations: Compliance with international and national safety and acoustic output standards (IEC 60601-1, UL60601-1:2003, AIUM NEMA UD2, AIUM 1998, AIUM NEMA UD3).
• Substantial Equivalence: A claim that the device is substantially equivalent to a predicate device (Shimadzu SDU-1200Pro K061643), which is the basis for 510(k) clearance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment, as these details are not present in the provided text.

Specifically, the following information is missing from the document:

1. A table of acceptance criteria and the reported device performance: The document only lists intended uses and safety standards. There are no quantitative performance metrics (e.g., sensitivity, specificity, accuracy for a particular clinical task) or acceptance criteria for such metrics.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This is an ultrasound imaging system, not an AI-assisted diagnostic device, and no such study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical imaging device, not an algorithm.
7. The type of ground truth used: Not applicable, as no performance study is described.
8. The sample size for the training set: Not applicable, as no algorithm training is mentioned.
9. How the ground truth for the training set was established: Not applicable.

Summary

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K071289
pg. 1 of 2

JAN

!

9 2008

510(k) Summary

1.0 SUBMITTER INFORMATION

SHIMADZU MEDICAL SYSTEMS 1.1 Submitter: 20101 South Vermont Ave. Torrance, CA 90502-1328 PH: 310-217-8855 FX: 310-217-8869

1.2 Contact: Don Karle

1.3 Date: April 25, 2007

2.0 DEVICE NAME

2.1 Proprietary Name:	SDU-1200Pro
2.2 Common Name:	Ultrasound Imaging System
2.3 Classification:	Ultrasonic Pulsed Doppler Imaging SystemFR # 892.1550, Product Code 90-IYNUltrasonic Pulsed Echo Imaging SystemFR # 892.1560, Product Code 90-IYODiagnostic Ultrasound TransducerFR # 892.1570, Product Code 90-ITX
2.4 Predicate Device:	Shimadzu SDU-1200Pro (K061643, Jul./27/06)

3.0 DEVICE DESCRIPTION

The SDU-1200Pro is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 1.5 to 15 MHz. It has B mode, M mode, Pulsed Doppler mode, Continuous Doppler mode, Real time 3D mode, Color mode, or in a combination of modes.

4.0 INTENDED USE

The SDU-1200Pro is intended for the following applications:

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Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional.

5.0 SAFETY CONSIDERATIONS

SDU-1200Pro has been designed to meet the following voluntary and measurement standards:

• . IEC 60601-1 Safety of Medical Electric Equipment
• UL60601-1:2003 Medical Electrical Equipment Part I : General Requirements ● for Safety
• AIUM NEMA UD2 Acoustic Output Measurement Standard for Diagnostic . Ultrasound Equipment
• Acoustic Output Measurement and Labeling Standard for Diagnostic . Ultrasound Equipment Revision 1 (AIUM 1998)
• AIUM NEMA UD3 Standard for Real-time Display of Thermal and Mechanical . Acoustic Output Indices on Diagnostic Ultrasound Equipment

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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 arranged in a circular pattern around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with a serpent entwined around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 9 2008

Mr. Don Karle Manager, Customer Service Shimadzu Medical Systems USA 20101 South Vermont Avenue TORRANCE CA 90502

Re: K071289

Trade/Device Name: Diagnostic Ultrasound System SDU-1200Pro, system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: December 18, 2007 Received: December 19, 2007

Dear Mr. Karle:

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 Diagnostic Ultrasound System SDU-1200Pro, system, as described in your premarket notification:

Transducer Model Number

L040-075U	VA13R-035U	VA40R-035VNU	EC10R-065VPU
L040-120U	VA13R-050U	VA57R-0375WU	S011-050U
L040-120HU	VA20R-035U	VA57R-0375HU	S017-035U
L070-075U	VA40R-035U	TV11R-055U	S020-025U
L072-050U	VA40R-035HU	UB10R-065U
VA11R-055U	VA40R-035VPU	EC11R-055U

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

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

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

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

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

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

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

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If you have any questions regarding the content of this letter, please contact Lauren Hefner at [phone].

Sincerely yours,

Noyn Th Whay

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

.

Enclosure(s)

1

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Ultrasound Device Indications Statement Page 1 of 23

K071289 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1200Pro, system

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging	Other(Specify)***
Ophthalmic
Fetal		P	P	P		P	P	P	P	P	N
Abdominal		P	P	P		P	P	P	P	P	N
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *		P	P	P		P	P	P	P	P
NeonatalCephalic
Adult Cephalic
Cardiac		P	P	P		P	P	P	P	P
Transesophageal
Transrectal		P	P	P		P	P	P	P	P	N
Transvaginal		P	P	P		P	P	P	P	P	N
Transurethral
Intravascular
Peripheral Vascular		P	P	P		P	P	P	P	P
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P	P	P	P
Musculo-skeletalSuperficial		P	P	P		P	P	P	P	P
Other (Specify)

Mode of Operation

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

Other Indications or Modes:

• Thyroid, Testicles, Breast

** B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M).

*** Real time 3D

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

Thhan

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

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Ultrasound Device Indications Statement Page 2 of _ 23

071280 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1200Pro, L040-075U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmoniCImaging	Other(Specify)***
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *		P	P	P		P	P	P	P	P
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P	P		P	P	P	P	P
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P	P	P	P
Musculo-skeletalSuperficial		P	P	P		P	P	P	P	P
Other (Specify)

Mode of Oneration

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

Other Indications or Modes:

• Thyroid, Testicles, Breast

** B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)

*** Real time 3D

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

JWhay

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

Division of Reproductive, Abdomina Radiological Devices 510(k) Number

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Ultrasound Device Indications Statement

Page 3 of 23

011289 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1200Pro, L040-120U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging	Other(Specify)***
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *	P	P	P	P		P	P	P	P	P
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P		P	P	P	P	P
Laparoscopic
Musculo-skeletalConventional	P	P	P	P		P	P	P	P	P
Musculo-skeletalSuperficial	P	P	P	P		P	P	P	P	P
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

• Thyroid, Testicles, Breast ** B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M) ***Real time 3D

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K071289

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Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 4 of 23

K071289 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1200Pro, L040-120HU

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging	Other(Specify) ***
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *		P	P	P		P	P	P	P	P
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P	P		P	P	P	P	P
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P	P	P	P
Musculo-skeletalSuperficial		P	P	P		P	P	P	P	P
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

• Thyroid, Testicles, Breast

** B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)

*** Real time 3D

Thang

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

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

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 5 of 23

K071289 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1200Pro, L070-075U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging	Other(Specify)***
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *		P	P	P		P	P	P	P	P
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P	P		P	P	P	P	P
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P	P	P	P
Musculo-skeletalSuperficial		P	P	P		P	P	P	P	P
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

• Thyroid, Testicles, Breast ** B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M) *** Real time 3D

TWhang

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

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

Ultrasound Device Indications Statement

Page 6 of 23

510(k) Number (if known) : k 071284

Device Name : Diagnostic Ultrasound System SDU-1200Pro, L072-050U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging	Other(Specify)***
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *	P	P	P	P		P	P	P	P	P
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P	P		P	P	P	P	P
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P	P	P	P
Musculo-skeletalSuperficial
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jwhg

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

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Ultrasound Device Indications Statement

Page 7 of 23

011280 510(k) Number (if known) : _ Device Name : Diagnostic Ultrasound System SDU-1200Pro, VA11R-055U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging	Other(Specify)***
Ophthalmic
Fetal		P	P	P		P	P	P	P	P
Abdominal		P	P	P		P	P	P	P	P
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric		P	P	P		P	P	P	P	P
Small Organ(Specify) *
NeonatalCephalic		P	P	P		P	P	P	P	P
Adult Cephalic		P	P	P		P	P	P	P	P
Cardiac		P	P	P		P	P	P	P	P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

** B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M)*** Real time 3D(Division Sign-Off)

Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K071289

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

Ultrasound Device Indications Statement

Page _ _ of 23

K611289 510(k) Number (if known) : _

Device Name : Diagnostic Ultrasound System SDU-1200Pro, VA13R-035U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging	Other(Specify)***
Ophthalmic
Fetal		P	P	P		P	P	P	P	P
Abdominal		P	P	P		P	P	P	P	P
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac		P	P	P		P	P	P	P	P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Others (Specify)

Mode of Oneration

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

Other Indications or Modes:

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Shhy
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K011289

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

Ultrasound Device Indications Statement

Page_9__ of_23

671289 510(k) Number (if known) : _

Device Name : Diagnostic Ultrasound System SDU-1200Pro, VA13R-050U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging	Other(Specify)***
Ophthalmic
Fetal		P	P	P		P	P	P	P	P
Abdominal		P	P	P		P	P	P	P	P
Intra-operative(Specify)
Neurological
Pediatric
Small Organ(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac		P	P	P		P	P	P	P	P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

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

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

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

.

Ultrasound Device Indications Statement Page 10 _of_23

510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1200Pro, VA20R-035U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging	Other(Specify)***
Ophthalmic
Fetal		P	P	P		P	P	P	P	P
Abdominal		P	P	P		P	P	P	P	P
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac		P	P	P		P	P	P	P	P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

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(Division Sign-Off ductive, Abdominal and Division of F Radiologica 510(k) Numbe

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

Ultrasound Device Indications Statement Page __ 11_ of _23

Page 11 of 23

510(k) Number (if known) :

Device Name : Djagnostic Ultrasound System SDU-1200Pro, VA40R-035U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging	Other(Specify)***
Ophthalmic
Fetal	P	P	P	P		P	P	P	P	P
Abdominal	P	P	P	P		P	P	P	P	P
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------LA SECREEMENT COLLEGE COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION CONNOME CARDSI IN LEASE SHOW SHOULD SECTION COLLECT----------------------------------------------** R/M R/PWD CRM/R/PWD CFM/R/CFM/A/		------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
2-45 1-84 4-4Page Part Part.A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A . A A	A 400 - 400 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 - 40 -
A . A . A . A		A MIN AR

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

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

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

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page _12 of __23 011280 510(k) Number (if known) : _

Device Name : Diagnostic Ultrasound System SDU-1200Pro, VA40R-035HU

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging	Other(Specify)***
Ophthalmic
Fetal		P	P	P		P	P	P	P	P
Abdominal		P	P	P		P	P	P	P	P
Intra-operative(Specify)
Intra-operative
Neurological
Pediatric
Small Organ(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Others (Specify)

Mode of Oneration

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

Other Indications or Modes:

** DAדז דאח/ דוCFM/R/PWD CEMB/CEM1

School Station And Advertising College of ChildrenCanada Children American Company of Children Company of Children Company of Children Company of Children Company of Children Company of Children Company of Children Company o1A PAGE A CALL CONTRACTOR COLLEGION------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Beach Autoand and see1999 CCarrer

Bearing Late & Life

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

(Division Sign-Off)

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

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

Prescription Use (Per 21 CFR 801.109)
Ultrasound Device Indications Statement Page 13 of 23

510(k) Number (if known):	K071289
---------------------------	---------

Device Name : Diagnostic Ultrasound System SDU-1200Pro, VA40R-035VPU

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging	Other(Specify)***
Ophthalmic
Fetal		N	N	N		N	N	N	N	N	N
Abdominal		N	N	N		N	N	N	N	N	N
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal
Superficial
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

			------------------------------------------------------------------------------------------------------------------------------------------------------------------------------1
** B/M.	.A. B/PWD, CFM(B)/PWD,CFM(B)/CFM(M)
		1

*** Real time 3D

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

Radiological Devices
510(k) Number K07

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

Ultrasound Device Indications Statement

Page 14 of _ 23

0-11-28 510(k) Number (if known) : __

Device Name : Diagnostic Ultrasound System SDU-1200Pro, VA40R-035VNU

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging	Other(Specify)***
Ophthalmic
Fetal		N	N	N		N	N	N	N	N	N
Abdominal		N	N	N		N	N	N	N	N	N
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Others (Specify)

Mode of Oneration

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

Other Indications or Modes:

The was read to the state of the states of the country of the country of the first and the county of the first of the first of the first and the first and the first and the fD /DITTY--------------------------------------------------------------------------------	ווייץ מקומע מעני מענעמעס ומעני
ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ.---------------------------------------------------------------------------------	------ANNUAL CO. MI AND AN AND AN AND OF ANTB LENGLE CONSULER-

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

(Division Sian-Off) Division of Reproductive, Abdominal a Radiological Devices 510(k) Number

JWhay

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

Ultrasound Device Indications Statement

Page __ 15_ of __ 23

011280 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1200Pro, VA57R-0375WU

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging	Other(Specify)***
Ophthalmic
Fetal		P	P	P		P	P	P	P	P
Abdominal		P	P	P		P	P	P	P	P
Intra-operative
(Specify)
Intra-operative
Neurological
Pediatric
Small Organ
(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

	** B/M, B/PWD, CFM(B)/PWD.CFM(B)/CFM(B)/CFM(M)
A montal de from the first for the first for the count of the country of the comments of theThe The The Court of Children Collection of the Collection Controlled of the Childrenריר - - - - - 1 -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

** Real time 3D

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

JWhang

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

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

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page_16_of_23

510(k) Number (if known) : Device Name : Diagnostic Ultrasound System SDU-1200Pro, VA57R-0375HU

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging	Other(Specify)***
Ophthalmic
Fetal		P	P	P		P	P	P	P	P
Abdominal		P	P	P		P	P	P	P	P
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Others (Specify)

Mode of Oneration

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

Other Indications or Modes:

** D Л /The IT: TT: 1 The 1 The 1 The 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1יווי ליינו והיות וחד מחוז גודות מחולA ARABLE------------------------------------------------------------------------------------------------------------------------------------------------------------------------------CONTRACTOR COLLEGION COLLEGIONAddress of the contribution of the company of the company of the company of the company of the company of the company of the company of the company of the company of the comp	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------1000 110 100---------
All add to100% 100%Company of Children-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	o------------------THE LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LE	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------1------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

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

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

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 17 of 23 1280 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1200Pro, TV11R-055U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging	Other(Specify)***
Ophthalmic
Fetal		P	P	P		P	P	P	P	P
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P	P		P	P	P	P	P
Transvaginal		P	P	P		P	P	P	P	P
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M)
-----------------------------------------

*** Real time 3D

Real time 3D

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

JWhan

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

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

Ultrasound Device Indications Statement

Page 18 of 23

510(k) Number (if known) : _

Device Name : Diagnostic Ultrasound System SDU-1200Pro, UB10R-065U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging	Other(Specify)***
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operative
Neurological
Pediatric
Small Organ
(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	P	P	P	P	P	P	P	P	P	P
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

** B/M, B/PWD, CFM(B)/PWD,CFM(B)/CFM(M) *** Real time 3D

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K071289

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

Ultrasound Device Indications Statement

Page 19 of 23

510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1200Pro, EC11R-055U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging	Other(Specify)***
Ophthalmic
Fetal		P	P	P		P	P	P	P	P
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P	P		P	P	P	P	P
Transvaginal		P	P	P		P	P	P	P	P
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

-----------------44 T. 12 8מיני מוני 1AA ChildrenCharacter Concession Call Cr. A 800 A 800 A 800 A 8000 A 8000 A 8000 A 8000 A 800 A 100 A 100 A 100 A 100 A 100 A 100 A 100 A 100 A 100 A 100 A 100 A 100 A 100 A 100 A 100 A	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ANNUAL A CANADA MARK A BELL A CO
4 - 1 - 1 -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Address Company Controllers ofAmadeSTATISTIC OF ACREEN OF CONSULTION OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHEARTH OF CHEARTH OF CHEARTH OF CHEARTH OF CHEARTH OF CHEARTH OF CHEARTH OF CHEARTH OF CHEARTH AAddress of Address And
commended to be annual a common of consideration of the	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

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

Ultrasound Device Indications Statement

Page 20 of 23

071289 510(k) Number (if known) : _

Device Name : Diagnostic Ultrasound System SDU-1200Pro, EC10R-065VPU

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging	Other(Specify)***
Ophthalmic
Fetal		N	N	N		N	N	N	N	N	N
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N		N	N	N	N	N	N
Transvaginal		N	N	N		N	N	N	N	N	N
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Others (Specify)

Mode of Oneration

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

Other Indications or Modes:

------- The Trial The Free States of American Comments of American Comments of American Comments of American Comments of American Comments of American Come of Comments of AmericanSep and State I100 - All All - All - All - Children - Charles - Charles - Career - Caracter - Caracter - Caracter - Caracter - Caracter - Caracter - Caracter - Caracter - Caracter - Caracte	1 4 40COSTS & CASS \ ITS ST TYS /Canada, N. come of1AND A CONSULTION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION CONTRACTOR COLLEGION CONTRA		--------------	SAR-LA-LA-A-A-Company Company CAS A Change Cat	AN - AN - Click 4
CARLAND COLLECTION------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------		CALLERYA Property of Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Childre	.	MARRA A LA PERSON	-----------
Company of Children Company of Children	Not and any annual resume of	I	--------------------------		.

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

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

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

Ultrasound Device Indications Statement

Page 21 of _ 23

117 KC 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1200Pro, S011-050U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging	Other(Specify)***
Ophthalmic
Fetal
Abdominal				P		P	P			P
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ(Specify) *
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	P	P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

** B/M, B/PWD, CFM(B)/PWD,CFM(B)/PWD,CFM(B)/CFM(M),B/CWD,CFM(B)/CWD

Harmonic Imaging *** Real time 3D

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jwhan

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

Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K071289

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

Ultrasound Device Indications Statement

Page 22 of _23

510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1200Pro, S017-035U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging	Other(Specify)***
Ophthalmic
Fetal
Abdominal				P		P	P			P
Intra-operative(Specify)
Intra-operative
Neurological
Pediatric
Small Organ
(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P	P	P	P	P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

**B/M	B/PWD
CFM(B)/PWD	CFM(B)/PWD
CFM(B)/CFM(M)	B/CWD
CFM(B)/CWD

Harmonic Imaging *** Real time 3D

JWhang

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

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

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page_23_of 23 671780

510(k) Number (if known) : Device Name : Diagnostic Ultrasound System SDU-1200Pro, S020-025U

Fill out one form for each ultrasound system or transducer.

Indications for use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging	Other(Specify)***
Ophthalmic
Fetal
Abdominal				P		P	P			P
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P	P	P	P	P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Others (Specify)

Mode of Operation

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

Other Indications or Modes:

** B/M, B/PWD, CFM(B)/PWD,CFM(B)/PWD,CFM(B)/CFM(M),B/CWD,CFM(B)/CWD

Harmonic Imaging

*** Real time 3D

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.