Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial. Small Organ (Specify): Thyroid, Testicles, Breast. Other (Specify): Real time 3D.

Device Description

The SDU-1100 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, Real time 3D mode, Color mode, or in a combination of modes.

AI/ML Overview

This document, K071291, is a 510(k) Summary for the SHIMADZU MEDICAL SYSTEMS SDU-1100 Ultrasound Imaging System. It describes the device, its intended use, and indicates which transducers support various clinical applications and operation modes. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a submission to the FDA for market clearance, stating the device's substantial equivalence to a predicate device. It lists standards the device has been designed to meet (IEC 60601-1, AIUM NEMA UD2, AIUM 1998, AIUM NEMA UD3) for safety and acoustic output, but these are design standards, not performance acceptance criteria against a specific clinical study.

Therefore, I cannot provide the requested information from the provided text. The document is primarily an "Indications for Use" statement and regulatory approval letter, not a clinical study report.

Summary

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

Image /page/0/Picture/0 description: The image shows handwritten text on a white background. The text at the top reads "K071291", and the text at the bottom reads "pg. 1 of 2". The handwriting is somewhat rough, but the characters are generally legible.

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

JAHI - C. 2

içi

1.2 Contact: Don Karle

1.3 Date: April 25, 2007

2.0 DEVICE NAME

2.1 Proprietary Name:	SDU-1100
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-1100 (K050510, 4/1/05)

3.0 DEVICE DESCRIPTION

4.0 INTENDED USE

The SDU-1100 is intended for the following applications:

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

K071291
pg.2 of 2

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

5.0 SAFETY CONSIDERATIONS

SDU-1100 has been designed to meet the following voluntary and measurement standards:

IEC 60601-1 Safety of Medical Electric Equipment .
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 & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines representing the wings and body.

Public Health Service

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: K071291

Trade/Device Name: Diagnostic Ultrasound System SDU-1100, 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-1100, system, as described in your premarket notification:

Transducer Model Number

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

{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,

Vorpi M. When
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

07/29) 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1100, 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
NeonatalCephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P
Transesophageal
Transrectal	P	P	P	P	P	P	P	P	N
Transvaginal	P	P	P	P	P	P	P	P	N
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P	P
Laparoscopic
Musculo-skeletalConventional	P	P	P	P	P	P	P	P
Musculo-skeletalSuperficial	P	P	P	P	P	P	P	P
Other (Specify)

of Onerotion Mode

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

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)

Thhay

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

Other Indications or Modes:

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

Ultrasound Device Indications Statement Page 2__ of 20

671291 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1100, 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
Neonatal
Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P	P
Laparoscopic
Musculo-skeletalConventional	P	P	P	P	P	P	P	P
Musculo-skeletalSuperficial	P	P	P	P	P	P	P	P
Other (Specify)

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

JWhay
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K071291

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

Ultrasound Device Indications Statement

Page _3_of_20

207129 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1100, 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)*	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
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

Jwhang

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

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

Ultrasound Device Indications Statement Page 4 of 20

0712al 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1100, 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)

*** Real time 3D

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

urrence of CDRH, Office of Device Evaluation (ODE)

Tzhag

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

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

Ultrasound Device Indications Statement

Page __ _ of _ 20

07129 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1100, 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) *	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 Overation

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

Jwha

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

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

Ultrasound Device Indications Statement Page _ 6 _ of _ 20

11.201

510(k) Number (if known) : Device Name : Diagnostic Ultrasound System SDU-1100, 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	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
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 __

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

Ultrasound Device Indications Statement

Page 7 of 20

510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1100, 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) *
NeonatalCephalic	N	N	N	N		N	N	N	N	N
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

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

Thhay

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

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

Ultrasound Device Indications Statement

Page 8_ of _ 20

K071291 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1100, VA13R-035U

Fill out one form for each ultrasound system or transducer.

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

Clinical Application	A	B	M	PWD	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-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:

חוות מ י****	דיי מחזרחו (נוזוג ויצר ריי/ 1733 / / Th /	September 19 to 10 to 10 to	Annual Property Ann
.100 Book Boom	ANNUAL IN AND ANNUAL FREE A BRANCH.	--------------------------------------	----

Whay

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

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

Ultrasound Device Indications Statement Page __ of __ 20

(07/291 510(k) Number (if known) : _

Device Name : Diagnostic Ultrasound System SDU-1100, 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-operativeNeurological
Pediatric
Small Organ(Specify) *
NeonatalCephalic
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

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

Dhhang

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

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

Ultrasound Device Indications Statement

Page 10 of __ 20 __

KD71291 510(k) Number (if known) : _

Device Name : Diagnostic Ultrasound System SDU-1100, 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	P	P	P	P	P	P	P	P
Abdominal	P	P	P	P	P	P	P	P
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify) *
Neonatal
Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Others (Specify)

Mode of Oneration

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

Other Indications or Modes:

** 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)

JWhan

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

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

Ultrasound Device Indications Statement

Page 11 20 of

510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1100, VA40R-035U

Fill out one form for each ultrasound system or transducer.

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

ClinicalApplication	A	B	M	PWD	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 Oneration

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)

DWhay

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

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

Ultrasound Device Indications Statement Page _ 12 _ of _ 20 _

67129 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1100, 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-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:

A-4-4-4-4-4-4-4-4-4-4------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------****month-TYTY TTA1/1/1/1/1/1/1/11/17 10:1/10/1/21 2008 11 11 11 11 11 11 11------------------------------------------------------------------------------------------------------------------------------------------------------------------------------1 00 Acres of	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Canada Caranter Color
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	---------------------------------------Carlos Children Charles	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Jhay

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

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

Ultrasound Device Indications Statement

Page _ 13_ of __ 20

હના ટેવ 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1100, VA40R-035VPU

Fill out one form for each ultrasound system or transducer.

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

ClinicalApplication	A	B	M	PWD	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

Thhay

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K071291

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

Ultrasound Device Indications Statement

Page _ 14_ of _ 20

0712a1 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1100, 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	B	M	PWD	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

Κοτ1291

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

Ultrasound Device Indications Statement Page _ 15 _ of 20

K071291 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1100, 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	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) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

Ultrasound Device Indications Statement Page _ 16_of_20

(07129) 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1100, 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:

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

Mode of Operation

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

Other Indications or Modes:

** 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)

JWhag

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

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

Ultrasound Device Indications Statement Page 17 of 20__

Page 17 of 20.

Korizal 510(k) Number (if known) : ر

Device Name : Diagnostic Ultrasound System SDU-1100, 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

Jwhay
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K071291

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

Ultrasound Device Indications Statement Page _18 _of_20

510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1100, 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-operative
Neurological
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 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

Jwhas
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K071291

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

Ultrasound Device Indications Statement

Page _19_of_20

Ko71291 510(k) Number (if known) : j

Device Name : Diagnostic Ultrasound System SDU-1100, ECI 1R-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-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

JWhay
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K071291

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

Ultrasound Device Indications Statement

Page 20 of 20

K071291 510(k) Number (if known) :

Device Name : Diagnostic Ultrasound System SDU-1100, 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:

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

Mode of Oneration

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

Other Indications or Modes:

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

JWhang

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

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

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