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

Device Description

The SDU-2200Pro is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, Pulsed Doppler mode, Continuous Doppler mode, Color mode, Real time 3D mode, or in a combination of modes.

AI/ML Overview

The provided document is a 510(k) summary for the Shimadzu SDU-2200Pro Diagnostic Ultrasound System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific performance acceptance criteria through clinical studies in the way you've outlined for AI/ML devices.

Therefore, the document does not contain information about:

Acceptance criteria in terms of measurable performance metrics (e.g., sensitivity, specificity, accuracy) for a specific diagnostic task.
A study conducted to prove the device meets acceptance criteria, as would be done for an AI/ML device.
Sample sizes used for test sets.
Data provenance (country of origin, retrospective/prospective).
Number of experts or their qualifications to establish ground truth for a test set.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human reader improvement with AI.
Standalone (algorithm only) performance studies.
The type of ground truth used (e.g., pathology, outcomes data).
Sample size for training sets.
How ground truth for training sets was established.

Instead, this document focuses on:

Device Description: A mobile diagnostic ultrasound system with various probes and imaging modes (B mode, M mode, Pulsed Doppler, Continuous Doppler, Color mode, Real-time 3D mode, or combinations).
Intended Use: Broad diagnostic ultrasound imaging and Doppler analysis for various clinical applications (Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial, Musculo-skeletal Conventional).
Safety Considerations: Compliance with international safety and acoustic output standards (IEC 60601-1, UL60601-1:2003, AIUM NEMA UD2, AIUM NEMA UD3).
Substantial Equivalence: The device is deemed substantially equivalent to a previously cleared predicate device (Shimadzu SDU-2200Pro, K061637). This typically means that the new device has the same intended use, technological characteristics, and safety and effectiveness profile as the predicate, or if it has different technological characteristics, these do not raise new questions of safety and effectiveness and the device is as safe and effective as the predicate.
Transducer Configurations: A list of various transducers and their specific cleared indications for use (marked 'P' for previously cleared or 'N' for new indications for that specific transducer model/application combination).

In summary, the provided text does not contain the information requested in your prompt regarding acceptance criteria and performance studies for an AI/ML device. It is a regulatory submission for a conventional ultrasound system demonstrating substantial equivalence based on its physical and functional characteristics and compliance with recognized standards.

Summary

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

K071287
pg. 1 of 2

510(k) Summary

1.0 SUBMITTER INFORMATION

JAN ー 9 2008

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-2200Pro
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-2200Pro (K061637, Jul./25/06)

3.0 DEVICE DESCRIPTION

4.0 INTENDED USE

The SDU-2200Pro is intended for the following applications:

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

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-2200Pro 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

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized caduceus, a symbol often associated with healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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: K071287

Trade/Device Name: Diagnostic Ultrasound System SDU-2200Pro, 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-2200Pro, 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

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

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.

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

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

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

Sincerely yours,

Norge M Whay
Nancy C. Brogdon

Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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

Ultrasound Device Indications Statement

Page_1_of_23

510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-2200Pro, 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	B	M	PWD	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
Neonatal
Cephalic
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

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

Ultrasound Device Indications Statement

Page _2 _ of _ 23

K07128 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-2200Pro, 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	B	M	PWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *	P	P	P	P	P	P	P	P
NeonatalCephalic
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 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

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

Ultrasound Device Indications Statement

Page 3 of 23

510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-2200Pro, 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	B	M	PWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operative
Neurological
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 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)

Thha

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

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

Ultrasound Device Indications Statement

Page 4 of 23

1071287 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-2200Pro, 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:

						Mode of Operation
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

(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
K071287

510(k) Number

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

Ultrasound Device Indications Statement Page _ 5__ of_ 23

107128 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-2200Pro, 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	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging
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
Superficial
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

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

Ultrasound Device Indications Statement

Page 6_ of __23

K67128 510(k) Number (if known) : _

Device Name : Diagnostic Ultrasound System SDU-2200Pro, 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	B	M	PWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging
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
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

Thha

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

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

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 7 _ of _ 23 407128. 510(k) Number (if known) : Device Name : Diagnostic Ultrasound System SDU-2200Pro, 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	B	M	PWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging
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	P	P	P	P	P	P	P	P
Small Organ(Specify) *
Neonatal	P	P	P	P	P	P	P	P
Cephalic
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

JWhan

(Division Sign-Off) Division of Reproductive. Abdomina Radiological Devices 510(k) Number

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

Ultrasound Device Indications Statement

Page_8 of 23

510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-2200Pro, 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	B	M	PWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging
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 B

Other Indications or Modes:

** 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)

(Division Sian-Off) Division of Reproductive. Abdominat Radiological Devices 510(k) Number

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

Ultrasound Device Indications Statement

Page 9 of 23

10-11-28 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-2200Pro, 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	B	M	PWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging
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	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

Real time 3D

JWhan

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

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

Ultrasound Device Indications Statement

Page 10 of _ 23

K01128 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-2200Pro, 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	B	M	PWD	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	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)/CFM(M) *** Real time 3D

$\mathcal{R}h$

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

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

Ultrasound Device Indications Statement

Page_11_of_23

510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-2200Pro, 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:

Mode of Operation
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 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

TWhay
(Division Sign-Off)

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

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

Ultrasound Device Indications Statement

Page _ 12_ of _ 23

1121128 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-2200Pro, 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	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging
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-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 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

(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 _

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

Ultrasound Device Indications Statement

Page __ 13_ of_ 23

510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-2200Pro, 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:

Mode of Operation
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 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 K071287

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

Ultrasound Device Indications Statement

Page 14 _of_23

510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-2200Pro, 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	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging	Other(Specify)***
Ophthalmic
Fetal	N	N	N	N	N	N	N	N	N	N
Abdominal	N	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 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

TWhay

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

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

Ultrasound Device Indications Statement

Page 15 23 nt

(071288 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-2200Pro, 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:

Mode of Operation
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)

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)	Company of the country of the country of the country of the county of the county of the county of the county of the county of the county of the county of the county of the co
Company of the production of the first of the country ofA*** Real time 3D

Sign-Off)

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

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

Ultrasound Device Indications Statement

Page 16 of 23

128 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-2200Pro, 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	B	M	PWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging
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:

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

Jwhay

(Division Sign-Off) ductive, Abdominal and Division of R Radiolog 510(K) Ni

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

Ultrasound Device Indications Statement Page _12 of __23 07128 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-2200Pro, 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	B	M	PWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging
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

Thhag

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

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

Ultrasound Device Indications Statement

07128 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-2200Pro, 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	B	M	PWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging
Ophthalmic
Fetal
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
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Others (Specify)

Mode of Oneration

Page _18 _ of _ 23

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

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

JWh

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

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

Ultrasound Device Indications Statement

Page_19 _ of _ 23

101128 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-2200Pro, 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:

Mode of Operation
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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

JWhz

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

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

Ultrasound Device Indications Statement

Page_20_of 23

221287 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-2200Pro, 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-operative
Neurological
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:

** 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)

Thang

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

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

Ultrasound Device Indications Statement

Page_21_of_23

510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-2200Pro, 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	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging
Ophthalmic
Fetal
Abdominal			P		P	P			P
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric	P	P	P	P	P	P	P		P
Small Organ(Specify)*
Neonatal
Cephalic
Adult Cephalic
Cardiac	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 Oneration

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

Other Indications or Modes:

** BM, B/PWD, CFM(B)/PWD,CFM(B)/PWD,CFM(B)/CFM(M),B/CWD,CFM(B)/CWD Harmonic Imaging

*** Real time 3D

JWhg

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

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

Ultrasound Device Indications Statement

Page 22 of 23

ી ( જિલ 510(k) Number (if known) : Device Name : Diagnostic Ultrasound System SDU-2200Pro, S017-035U

Device Name : Diagnostic Ultrasound System SDD-2200Pro, 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	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging
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
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)

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

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

Ultrasound Device Indications Statement Page _23_of_23

510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-2200Pro, $020-025U

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	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging
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
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)

JWh

(Division Sign-Off) Division of Reproductive, Abdominal a 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.