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, Transrectal, Peripheral Vascular, Musculo-skeletal Conventional, and Musculo-skeletal Superficial.

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, Color mode, or in a combination of modes.

AI/ML Overview

The provided document is a 510(k) Summary for the SHIMADZU SDU-1200Pro Ultrasound Imaging System. It describes the device, its intended use, and indicates that it has been determined substantially equivalent to a predicate device. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical performance studies of AI-based devices.

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, Color mode, etc.).
Intended Use/Indications for Use: A comprehensive list of clinical applications for which the SDU-1200Pro and its various transducers are intended (e.g., Fetal, Abdominal, Pediatric, Cardiac, Peripheral Vascular), and the specific imaging modes available for each application (marked with 'N' for new indication in this submission).
Safety Considerations: Compliance with voluntary and measurement standards like IEC 60601-1, UL60601-1, AIUM NEMA UD2, and AIUM NEMA UD3.
Substantial Equivalence: FDA's determination that the device is substantially equivalent to the predicate device, Shimadzu SDU-2200 (K003514).

Therefore, based solely on the provided text, I cannot complete a table of acceptance criteria and reported device performance or answer most of the specific questions about clinical studies, ground truth, and sample sizes. This type of detailed performance data is typically found in the full 510(k) submission, not necessarily in the publicly available summary or Indications for Use statement.

Here's a breakdown of what can and cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not describe specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy values) or reported performance metrics from a study. The FDA clearance is based on substantial equivalence to a predicate device, meaning its performance characteristics are deemed similar enough to an already cleared device, rather than requiring new, specific performance targets to be met via a clinical study with detailed metrics.

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

Cannot be provided. The document does not mention any test set, sample size, or data provenance for performance evaluation.

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)

Cannot be provided. The document does not mention ground truth establishment or expert involvement for a clinical study.

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

Cannot be provided. The document does not mention any adjudication method for a test set.

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

Cannot be provided. The SDU-1200Pro is a diagnostic ultrasound system (hardware and software for image generation), not an AI-assisted diagnostic software. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be applicable or described for this type of device.

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

Cannot be provided. This is not an AI-algorithm-only device. It is a diagnostic ultrasound system.

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

Cannot be provided. No clinical study or ground truth information is presented in the document.

8. The sample size for the training set

Cannot be provided. As this is not an AI-based device, there is no mention of a training set.

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

Cannot be provided. As this is not an AI-based device, there is no mention of a training set or its ground truth.

Summary of what the document does provide regarding device clearance:

The SDU-1200Pro was cleared through the 510(k) pathway based on substantial equivalence to the predicate device, Shimadzu SDU-2200 (K003514). This means the FDA determined that the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. This typically involves demonstrating that the device has the same intended use, technological characteristics, and similar performance to the predicate, or that any differences do not raise new safety or effectiveness concerns. The provided document details the broad clinical applications and imaging modes for which the device and its various transducers are cleared. It also lists compliance with relevant safety and acoustic output standards.

In essence, the document confirms regulatory clearance for a diagnostic ultrasound system based on substantial equivalence, but it does not contain the kind of clinical study details usually associated with novel AI device performance evaluation.

Summary

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

K061643

510(k) Summary

1.0 SUBMITTER INFORMATION

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

1.2 Contact: Randal Walker

MAR. 1 7.2006 1.3 Date:

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-2200 (K003514, Feb./12/01)

3.0 DEVICE DESCRIPTION

4.0 INTENDED USE

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

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

Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Muscular, 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

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

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem that resembles an eagle or bird-like figure with stylized wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 27 2006

Mr. Randal Walker National Service Manager Shimadzu Medical Systems 20101 South Vermont Avenue TORRANCE CA 90502-1328

Re: K061643

Trade Name: SDU-1200Pro Diagnostic Ultrasound System Regulation Number: 21 CFR 89.1550 Regulation Name: Ultrasonic pulsed doppler imaging 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: IYN, IYO, and ITX Dated: March 17, 2006 Received: June 13, 2006

Dear Mr. Walker:

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

Image /page/2/Picture/11 description: The image is a circular logo with the letters "FDA" in the center. The letters are stylized and bold. Above the letters "FDA" are the letters "Est. 1906". Below the letters "FDA" is the word "Centennial". The logo is surrounded by a dotted border.

Jing Puttic . Health

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

Transducer Model Number

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

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

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

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

If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at (301) 594-1212.

Sincerely yours.

Nancy C Bugdon

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 20

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

Prescription Use

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061643

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

Ultrasound Device Indications Statement Page 2 _of_20

510(k) Number (if known) : ___________________________________________________________________________________________________________________________________________________

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) *	N	N	N	N	N	N	N	N
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	N	N	N	N	N	N	N	N
Laparoscopic
Musculo-skeletalConventional	N	N	N	N	N	N	N	N
Musculo-skeletalSuperficial	N	N	N	N	N	N	N	N
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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

cscription Use

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061643

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

Ultrasound Device Indications Statement Page 3 of _ 20

510(k) Number (if known) : _ 上ひん 1 6 43
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	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *	N	N	N	N	N	N	N	N	N
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N	N	N	N	N	N
Laparoscopic
Musculo-skeletalConventional		N	N	N	N	N	N	N	N
Musculo-skeletalSuperficial		N	N	N	N	N	N	N	N
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)

(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)

Y. Marquez
(Division Sign-Off)

Division of Reproductive, Abdominal, and Padiological Devices 5 13(x) Number _______________________________________________________________________________________________________________________________________________________________

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

Ultrasound Device Indications Statement Page _4 of_20

510(k) Number (if known) : _ 1 0 6 l 6 4 3 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:

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) *		N	N	N		N	N	N	N	N
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N	N	N	N
Laparoscopic
Musculo-skeletalConventional		N	N	N		N	N	N	N	N
Musculo-skeletalSuperficial		N	N	N		N	N	N	N	N
Others (Specify)

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)

prescription Use

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K061643

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

Ultrasound Device Indications Statement Page_5 of 20

6061643 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	B	M	PWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *	N	N	N	N	N	N	N	N
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	N	N	N	N	N	N	N	N
Laparoscopic
Musculo-skeletalConventional	N	N	N	N	N	N	N	N
Musculo-skeletalSuperficial	N	N	N	N	N	N	N	N
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)

REVISED FINAL

V. Larry C. Bearden

(Division Sign-Off) Division of Reproductive, Abdon and Radiological Devices 51(Xk) Number

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

Ultrasound Device Indications Statement Page_6 of 20

K061643 510(k) Number (if known) : 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
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *	N	N	N	N	N	N	N	N	N	N
NeonatalCephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N
Laparoscopic
Musculo-skeletalConventional	N	N	N	N	N	N	N	N	N	N
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)

Janay Prather

(Division Sign-Off) Division of Reproductive, Abdominal, and Padiological Devices 51 (1) Number

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

Ultrasound Device Indications Statement Page _7 _of 20

510(k) Number (if known) : ___________________________________________________________________________________________________________________________________________________

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	N	N	N	N	N	N	N	N
Abdominal	N	N	N	N	N	N	N	N
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric	N	N	N	N	N	N	N	N
Small Organ(Specify) *
NeonatalCephalic	N	N	N	N	N	N	N	N
Adult Cephalic	N	N	N	N	N	N	N	N
Cardiac	N	N	N	N	N	N	N	N
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)

$\checkmark$

Trusion Sign-Off & Reproductive, A olonica Devi 11 81 17100

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

Ultrasound Device Indications Statement Page_8 20 of

12061643 510(k) Number (if known) : _ Device Name : Diagnostic Ultrasound System SDU-1200Pro, VA13K-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	N	N	N	N	N	N	N	N
Abdominal	N	N	N	N	N	N	N	N
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac	N	N	N	N	N	N	N	N
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
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)

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

Yancy C. Morgan

on of Reproductive. Abdominal P ... Choose Device

: : : : : : :

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

Ultrasound Device Indications Statement Page 9 20 of

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	B	M	PWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging
Ophthalmic
Fetal	N	N	N	N	N	N	N	N
Abdominal	N	N	N	N	N	N	N	N
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
NeonatalCephalic
Adult Cephalic
Cardiac	N	N	N	N	N	N	N	N
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)

7 Nancy C. Beaton
Sign-Off

f Reproductive, Abdominal,
Radiological Devices K061643
Number

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

Ultrasound Device Indications Statement Page_10 of 20

12061643 510(k) Number (if known) : _

5 Fo(x) Namber (1) laromic 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	B	M	PWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging
Ophthalmic
Fetal	N	N	N	N	N	N	N	N
Abdominal	N	N	N	N	N	N	N	N
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac	N	N	N	N	N	N	N	N
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)

Nancy C. Ferguson
(Person Sign Off)
(Person's Legal Name - Terminal
Employee ID: 406643

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

Ultrasound Device Indications Statement Page _ 1 l of 20

KO61643 510(k) Number (if known) : _ Device Name : Diagnostic 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:

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
Abdominal		N	N	N		N	N	N	N	N
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
NeonatalCephalic
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)

J Dwayne Heaton
Division Sign-Off

Division Sign-Off)

L
Dusien af Reproductive, Abdominal,

٠٩٤٠٠
Ser

RO61643

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

Ultrasound Device Indications Statement Page of 20

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	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging
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:

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

Lacey (radion

no sinn Sinn Mit of Reproductive, Abdomina . minomasi De SE . THEIR

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

Ultrasound Device Indications Statement Page 13 of 20

1061 510(k) Number (if known) : Device Name : Diagnostic Ultrasound System SDU-1200Pro, VA57R-0375WU

ce Name : Diagnostic Ultrasound System DDC-1200110, 71497R 09179 Rev

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	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)

) January (neider

vision Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061643

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

Ultrasound Device Indications Statement Page _14_of_20

12061643 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	B	M	PWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging
Ophthalmic
Fetal	N	N	N	N	N	N	N	N
Abdominal	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)

Description Use

Aarici Broglioni

vision Sion-Off on of Reproductive, Abdomi adinlogical Device 1 : 12 : 32 : 1963 :

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

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page_15 of 20

KB6164 510(k) Number (if known) : _ 910(K) Namoor (111210"). 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:

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
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
NeonatalCephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N		N	N	N	N	N
Transvaginal		N	N	N		N	N	N	N	N
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)

Prescription Use

Jancy Cileari
Division Sign-Off

Reproductive, Abdomina (admingical Devices inde Nomber ..

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

Ultrasound Device Indications Statement Page _16 _of_20

510(k) Number (if known) : _ K 0 b 1 6 4 3 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	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	N	N	N	N	N	N	N	N
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)

(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)

Harry Crighton

Division Sign Off
Division of Reproductive, Abdominal,
and Radiological Devices
Safety Number
2061643

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

Ultrasound Device Indications Statement Page 17 of 20

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:

Mode of Operation

Clinical Application	B	M	PWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging
Ophthalmic
Fetal	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
Transvaginal	N	N	N	N	N	N	N	N
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)

(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)

S. Lacey C. Hopton

Liver, Other

Non-Invasive, Abdominal,

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

Ultrasound Device Indications Statement Page _ 18 of 20

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:

Mode of Operation

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) **	TissueHarmonicImaging
Ophthalmic
Fetal
Abdominal				N		N	N			N
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric	N	N	N	N	N	N	N	N	N	N
Small Organ(Specify) *
NeonatalCephalic
Adult Cephalic
Cardiac	N	N	N	N	N	N	N	N	N	N
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)/PWD,CFM(B)/CFM(M),B/CWD,CFM(B)/CWD Harmonic Imaging

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

Prescription Use

Stacey L. McAlister
Permission Sign-Off

on on Reproductive, abdomina Gological Desices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Ultrasound Device Indications Statement Page 19 of 20

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	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)**	TissueHarmonicImaging
Ophthalmic
Fetal
Abdominal			N	N	N	N			N
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac	N	N	N	N	N	N	N	N	N
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)/PWD,CFM(B)/CFM(M),B/CWD,CFM(B)/CWD Harmonic 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)

Henry C. Newton

LL061643

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

Ultrasound Device Indications Statement Page 20 of 20

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:

Mode of Operation

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

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

Prescription Use

(Division Sign-Off)

Division of Reproductive. Abdom and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.