ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100

K071291 · Shimadzu Medical Systems · ITX · Jan 9, 2008 · Radiology

Device Facts

• Record ID: K071291
• Device Name: ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
• Applicant: Shimadzu Medical Systems
• Product Code: ITX · Radiology
• Decision Date: Jan 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SDU-1100 is intended for the following applications: Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Fotal, Froundiac, Transvaginal, Peripheral Vascular, Muscular, Musculo-skeletal Superficial and Musculo-skeletal Conventional.

Device Story

SDU-1100 is a mobile diagnostic ultrasound system; utilizes flat linear array, convex linear, and sector probes (2-15 MHz). Operates in B-mode, M-mode, Pulsed Doppler, Real-time 3D, Color Doppler, and combined modes. Used in clinical settings by healthcare professionals for diagnostic imaging and Doppler analysis. System transforms acoustic echoes into visual images/signals for clinician interpretation; aids in clinical decision-making by providing anatomical and physiological visualization. Benefits include non-invasive diagnostic assessment of various body structures and vascular flow.

Clinical Evidence

Bench testing only. The device complies with IEC 60601-1 safety standards and AIUM/NEMA UD2 and UD3 acoustic output measurement and labeling standards.

Technological Characteristics

Mobile ultrasound system; flat linear, convex linear, and sector probes (2-15 MHz). Modes: B, M, Pulsed Doppler, Real-time 3D, Color Doppler. Complies with IEC 60601-1, AIUM NEMA UD2, and AIUM NEMA UD3 standards. Connectivity and software architecture details not specified.

Indications for Use

Indicated for diagnostic ultrasound imaging or Doppler analysis of the human body, including fetal, abdominal, pediatric, small organ (thyroid, testicles, breast), neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, peripheral vascular, and musculoskeletal (conventional and superficial) applications.

Regulatory Classification

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.

Predicate Devices

• Shimadzu SDU-1100 (K050510)

Submission Summary (Full Text)

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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 System<br>FR # 892.1550, Product Code 90-IYN<br>Ultrasonic Pulsed Echo Imaging System<br>FR # 892.1560, Product Code 90-IYO<br>Diagnostic Ultrasound Transducer<br>FR # 892.1570, Product Code 90-ITX |
| 2.4 Predicate Device: | Shimadzu SDU-1100 (K050510, 4/1/05) |

# 3.0 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.

#### 4.0 INTENDED USE

The SDU-1100 is intended for the following applications:

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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

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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 | |

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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

----

Sincerely yours,

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)

.

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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 | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify<br>***) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|---------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P | P | N |
| Abdominal | | P | P | P | | P | P | P | P | P | N |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | P | P | P | | P | P | P | P | P | |
| Neonatal<br>Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | | P | P | P | P | P | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | P | P | P | N |
| Transvaginal | | P | P | P | | P | P | P | P | P | N |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | P | P | P | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | P | P | P | |
| Musculo-skeletal<br>Superficial | | 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 | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)** | Tissue<br>Harmoni<br>c<br>Imaging | Other<br>(Specify)<br>*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-----------------------------------|---------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(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-skeletal<br>Conventional | | P | P | P | | P | P | P | P | P | |
| Musculo-skeletal<br>Superficial | | 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

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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 | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify)*** | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|-----------------------|--|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ<br>(Specify)* | | P | P | P | | P | P | P | P | P | | |
| Neonatal<br>Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | P | P | P | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | P | P | P | | |
| Musculo-skeletal<br>Superficial | | 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 | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) ** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify)<br>*** | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|---------------------------|--|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ<br>(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-skeletal<br>Conventional | | N | N | N | | N | N | N | N | N | | |
| Musculo-skeletal<br>Superficial | | 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 | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify)*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|-----------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(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-skeletal<br>Conventional | | P | P | P | | P | P | P | P | P | |
| Musculo-skeletal<br>Superficial | | 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 | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) ** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify)<br>*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|---------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(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-skeletal<br>Conventional | P | P | P | P | | P | P | P | P | P | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |

Mode of Operation

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

Other Indications or Modes:

* Thyroid, Testicles, Breast

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

*** Real time 3D

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

Radiological Devices
510(k) Number **__**

{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 | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify)<br>*** |
| Ophthalmic | | | | | | | | | | | |
| Fetal | N | N | N | N | | N | N | N | N | N | |
| Abdominal | N | N | N | N | | N | N | N | N | N | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | N | N | N | N | | N | N | N | N | N | |
| Small Organ<br>(Specify) * | | | | | | | | | | | |
| Neonatal<br>Cephalic | 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-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| 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 | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify)*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|-----------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | P | | P | P | P | P | P | |
| Abdominal | P | P | P | P | | P | P | P | P | P | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | P | P | P | P | | P | P | P | P | P | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| 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<br>**** | דיי מחזרחו (נוזוג ויצר ריי<br>/ 1733 / / Th / | September 19 to 10 to 10 to | Annual Property Ann |
|--------------------|-------------------------------------------------|----------------------------------------|---------------------|
| .<br>100 Book Boom | ANNUAL IN AND ANNUAL FREE A BRANCH<br>. | -------------------------------------- | ---- |

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 | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) ** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify)<br>*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|---------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P | P | |
| Abdominal | | P | P | P | | P | P | P | P | P | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | | P | P | P | P | P | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | |

Mode of Operation

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

Other Indications or Modes:

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

> (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 | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify)** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify)*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|-----------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | P | P | P | |
| Abdominal | | P | P | P | | P | P | P | P | P | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | | P | P | P | P | P | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| 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:

| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) ** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify)<br>*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|---------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | P | | P | P | P | P | P | |
| Abdominal | P | P | P | P | | P | P | P | P | P | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| 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:

| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) ** | Tissue<br>Harmonic<br>Imaging | Other<br>(Specify)<br>*** |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|---------------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | P | | P | P | P | P | P | |
| Abdominal | P | P | P | P | | P | P | P | P | P | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | |…