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.
Mode of Operation: A, B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M), B/CWD, CFM(B)/CWD), Tissue Harmonic Imaging.

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, or in a combination of modes.

AI/ML Overview

The provided text is a 510(k) summary for the SHIMADZU MEDICAL SYSTEMS SDU-2200Pro Ultrasound Imaging System. This document outlines the device's intended use and compliance with safety standards, but it does not contain information about acceptance criteria for performance, a study proving device performance against acceptance criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for such a study.

The tables within the document (pages 5-20) are "Ultrasound Device Indications Statements" for various transducers. These tables indicate whether certain imaging modes (such as B-mode, M-mode, PWD, CWD, Color Doppler, Power Doppler, Color Velocity Imaging, Combined modes, and Tissue Harmonic Imaging) are "new indications" (N) for specific clinical applications (e.g., Fetal, Abdominal, Pediatric, Small Organ, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal). This is a statement of intended use and cleared functionalities, not a performance study result.

The 510(k) process is primarily a premarket notification demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new performance studies with specific acceptance criteria that would typically be described in an efficacy trial.

Therefore, based solely on the provided text, the requested information cannot be fully extracted.

Here's a breakdown of what can be inferred or what is explicitly missing:

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

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a specific clinical task. The acceptance criteria for 510(k) clearance generally revolve around compliance with recognized safety and performance standards (like IEC 60601-1, AIUM NEMA UD2, UD3) and demonstrating substantial equivalence to a predicate device in terms of intended use, technology, and safety/effectiveness.
Reported Device Performance: No quantitative performance data (e.g., sensitivity, specificity, accuracy, image quality scores) is provided in the document. The "performance" described is in terms of the range of clinical applications and imaging modes supported by the device and its various transducers, which were deemed "substantially equivalent" to the predicate device (Shimadzu SDU-2200, K003514).

2. Sample size used for the test set and the data provenance:

Sample Size: Not mentioned.
Data Provenance: Not mentioned; it's implicit that any comparative data would have been from internal testing or comparison with the predicate device, but no specifics are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

4. Adjudication method for the test set:

Adjudication Method: Not mentioned.

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:

MRMC Study: No MRMC study is mentioned. This device is an ultrasound imaging system, not an AI-assisted diagnostic tool as described in the context of improving human reader performance.

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

Standalone Performance: Not applicable for this device as it's an imaging system, not an algorithm being tested for standalone diagnostic performance.

7. The type of ground truth used:

Type of Ground Truth: Not applicable, as no performance study requiring ground truth is described.

8. The sample size for the training set:

Training Set Sample Size: Not applicable, as this is an ultrasound imaging system, not an AI model requiring a training set.

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

Ground Truth for Training Set: Not applicable.

Summary of available information related to "acceptance criteria" and "study":

The acceptance criteria for this 510(k) clearance are primarily based on:

Safety Compliance: Adherence to voluntary and measurement standards like IEC 60601-1, UL60601-1:2003, AIUM NEMA UD2, and AIUM NEMA UD3. The document explicitly states the device "has been designed to meet" these standards.
Substantial Equivalence: The FDA's determination that the SDU-2200Pro is "substantially equivalent" to a legally marketed predicate device (Shimadzu SDU-2200, K003514) for the stated indications for use. This means it has similar intended use, technological characteristics, and raises no new questions of safety and effectiveness.

The "study" or evidence provided to meet these criteria is the submission package itself, which typically includes:

Comparison of technological characteristics to the predicate device.
Documentation of compliance with safety standards and acoustic output measurements.
Statement of intended use (as seen in the tables from pages 5-20).

There is no detailed clinical performance study with specific quantitative acceptance criteria or results presented in this 510(k) summary. This is typical for traditional hardware medical devices demonstrating substantial equivalence, as extensive clinical trials with performance metrics are often not required unless significant new technological features or intended uses are introduced that raise new safety or effectiveness concerns.

Summary

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

K061637

JUL 25 2006

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

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 logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 25 2006

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

Re: K061637

Trade Name: Diagnostic Ultrasound System SDU-2200Pro, System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging 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 Diagnostic Ultrasound System SDU-2200Pro, System, as described in your premarket notification:

Image /page/2/Picture/11 description: The image shows a circular logo with the letters "FDA" in the center. Below the letters, the word "Centennial" is written. The logo is surrounded by a dotted border. The text is in black and white.

noting Public 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-0375HU
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, (cnclosed) 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

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

Page 3 - Mr. Walker

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. Ingdon

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

Enclosure(s)

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

Page_1 of 20 Ultrasound Device Indications Statement

K061637 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
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
Neonatal
Cephalic
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)

(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)

Yancy Ingram

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

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

Ultrasound Device Indications Statement Page 2 of _ 20

510(k) Number (if known) :

JTO(K) 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) *	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

One (open);
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)

$\checkmark$

Prescription Use _ (Per 21 CFR 801.109)

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

and Radiological Devi 510(k) Number

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

Ultrasound Device Indications Statement Page _3 _of_20

510(k) Number (if known): K061637

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-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)

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

Vision Sign Off

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

Prescription Use (Per 21 CFR 801.109)

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

Ultrasound Device Indications Statement Page 4 _of 20

06165 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:

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)

(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)

(Division Sign-Off)

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

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

Ultrasound Device Indications Statement Page 5 of _ 20

510(k) Number (if known): [K061637](https://510k.innolitics.com/search/K061637)
Device Name: Diagnostic Ultrasound System SDU-2200Pro, L070-075U

vice Name : Diagnostic Ultrasound System SDO-2200Pro, L070-0730

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)

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)

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

Radiological Devices
510(k) Number K061637

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

Ultrasound Device Indications Statement Page 6 of _ of _ 20

510(k) Number (if known): K061637
Device Name: Diagnostic Ultrasound System SDU-2200Pro, L072-050U

ice Name : Diagnostic Ultrasound System SDO-2200110, L072-0900

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) *	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
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)

i/hancy C. Mcclellan

(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number K061637

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

Ultrasound Device Indications Statement Page 7 of _ 20

K06163 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:

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	N	N	N	N		N	N	N	N	N
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric	N	N	N	N		N	N	N	N	N
Small Organ(Specify) *
Neonatal	N	N	N	N		N	N	N	N	N
Cephalic
Adult Cephalic	N	N	N	N		N	N	N	N	N
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 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 L (Por 21 CFR 801.109)

(Division Sign-Off)

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

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

Ultrasound Device Indications Statement Page _ 8 _of_20

510(k) Number (if known): K061637
Device Name : Diagnostic Ultrasound System SDU-2200Pro, VA13R-035U

Diagnostic Ultrasound System DDQ-2200/10, YHJR-055

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		N	N	N		N	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
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)

(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)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061637

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

Ultrasound Device Indications Statement Page _9 of_20

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	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)

(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)

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

510(k) Number

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

Ultrasound Device Indications Statement Page _10_of_20

1406163 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
Ophthalmic
Fetal	N	N	N	N	N	N	N	N
Abdominal	N	N	N	N	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
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)

(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)

(Division Sign-Off) Division of Reproductive, A5dominal and Radiological De 510(k) Number

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

Ultrasound Device Indications Statement Page _ 11_ of _ 20

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:

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)

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

Planley Haughen
Division Sign Off

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominai,
and Radiological Devices,
510(k) Number K06/637

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

Ultrasound Device Indications Statement Page _ 12 _ of 20

510(k) Number (if known) : K061637

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:

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

(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)

(Division Sign-Off) Division of Reproductive. Al-dominal and Radiological Device

510(k) Number K061637

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

Ultrasound Device Indications Statement Page _ 13_ of _ 20

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:

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)

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

L. Homburger

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

Prescription Use
(Per 21 CFR 801.109)

Radiological Devices.

510(k) Number K061637

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

Ultrasound Device Indications Statement Page 14 of 20

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	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)

(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)

Ylvestigation

(Division Sign-Off) Division of Reproductive, Andominal, and Radiological Dev 510(k) Number

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

Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page _ 15 of 20

510(k) Number (if known) : Device Name : Diagnostic Ultrasound System SDU-2200Pro, TVIIR-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	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
Transvaginal	N	N	N	N	N	N	N	N
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)

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

Y. Nani Nadrn
(Division Sign-Off)

Prescription Use Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominai.
and Radiological Devices
510(k) Number K061637

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

Ultrasound Device Indications Statement Page 16 of 20

510(k) Number (if known) : K061637

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	N	N	N	N	N	N	N	N
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
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)

Division Sign-Off

Reproductive, Abdoming ogical Dev

Prescription Use (Per 21 CFR 801.109)

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

Ultrasound Device Indications Statement Page _ 17 _ of _ 20

Kob1637 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:

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) *
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)

(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)

Location of the

(Division Sign-Off Division of Reproductive, Abdominal, and Radiological I 10(k) summer

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

Ultrasound Device Indications Statement Page 18 of 20

K 061634 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			N		N	N			N
Intra-operative
(Specify)
Intra-operative
Neurological
Pediatric	N	N	N	N	N	N	N	N	N
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)

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

Harmonic Imaging

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

scription else

Jancy C. Herglin
(Division Sigh-Off)

Division of Reproductive. At and Radioiogical Devi

510(k) Number

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

Ultrasound Device Indications Statement Page 19 of 20

510(k) Number (if known) : Device Name : Diagnostic Ultrasound System SDU-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			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 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

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

7 Huang Chih-lun

(Division Sign-Off) Division of Reproductive, At dominal and Radiological Devic 510(k) Number

Prescription Use (Per 21 CFR 801.109)

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

Ultrasound Device Indications Statement Page _20_of_20

0616 510(k) Number (if known) : Device Name : Diagnostic Ultrasound System SDU-2200Pro, 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				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	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)/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)

i 10(k) Number

Prescription Use
(Per 21 CFR 801.109)

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

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.