ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100

K050510 · Shimadzu Medical Systems · IYN · Apr 1, 2005 · Radiology

Device Facts

• Record ID: K050510
• Device Name: ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
• Applicant: Shimadzu Medical Systems
• Product Code: IYN · Radiology
• Decision Date: Apr 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• 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 Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional.

Device Story

SDU-1100 is a mobile diagnostic ultrasound system utilizing linear, convex, and sector probes (2-15 MHz). Operates in B, M, Pulsed Doppler, Color, and combined modes. Used in clinical settings by healthcare professionals for diagnostic imaging. System processes acoustic echoes to generate real-time images and Doppler data for clinical assessment of anatomy and blood flow. Output displayed on-screen for physician interpretation to support clinical decision-making and patient diagnosis.

Clinical Evidence

Bench testing only. The device complies with IEC 60601-1 safety standards and AIUM/NEMA UD2/UD3 acoustic output measurement and labeling standards. No clinical data was required or provided for this 510(k) clearance.

Technological Characteristics

Mobile ultrasound system with linear, convex, and sector transducers (2-15 MHz). Modes: B, M, Pulsed Doppler, Color, Tissue Harmonic Imaging. Safety standards: IEC 60601-1, AIUM NEMA UD2, AIUM NEMA UD3. Connectivity: Standalone diagnostic system.

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/adult cephalic, cardiac, transrectal, transvaginal, peripheral vascular, and musculoskeletal (conventional/superficial) applications.

Regulatory Classification

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.

Predicate Devices

• GE Logiq 500 (K991611)

Submission Summary (Full Text)

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

K0505/0

### 510(k) Summary

# 1.0 SUBMITTER INFORMATION

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

Randal Walker 1.2 Contact:

- January 18, 2005 1.3 Date:
### 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: | GE Logiq 500 (K991611, 6/9/99) |

### 3.0 DEVICE DESCRIPTION

DE VICE DESCREF TTO!"
The SDU-1100 is a mobile diagnostic ultrasound system. This system has flat linear The SDO Trooms and sector probe with a frequency range of approximately 2 to 15 array, convox mode, M mode, Pulsed Doppler mode, Color mode, or in a combination of modes.

## 4.0 INTENDED USE

The SDU-1100 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-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}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 1 2005

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

Re: K050510

Trade Name: SDU-1100 (Echo View/Shimasonic) Diagnostic Ultrasound Device 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: January 18, 2005 Received: March 1, 2005

Dear Mr. Walker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the SDU-1100 (Echo View/Shimasonic) Diagnostic Ultrasound Device, as described in your premarket notification:

Transducer Model Number

| L040-075U | L072-050U |
|-----------|------------|
| L040-120U | VA13R-035U |
| L070-075U | VA13R-050U |

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

| VA20R-035U | VA57R-0375HU |
|--------------|--------------|
| VA40R-035U | TV11R-055U |
| VA40R-035HU | UB10R-065U |
| VA57R-0375WU | |

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your do received 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 r least of a 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 or uny 1 outher 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 forth in the quand byovisions (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 m rippendines of the counce 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 If you desire specific at not 10. Jose [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain

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

Page 2 - Mr.Walker

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

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely yours,

Nancy C. Brogdon

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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## Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement

Page 1 _ of _ 14

510(k) Number (if known) : 510(K) Namber (II known) : 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:

| Mode of Operation | | | | | | | | | | | |
|-------------------------------|---|---|---|-----|-----|---------------|---------------------------|------------------------|----------------------|-------------------------|-----------------|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify)** | Tissue Harmonic Imaging | 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) * | | 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-skeletal Conventional | | N | N | N | | N | N | N | N | N | |
| Musculo-skeletal Superficial | | 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

Nancy bradom
(Division Sign-Off)

Division of and Radiological Device 510(k) Number

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

### Prescription Use (Per 21 CFR 801.109) Page _2_ of _ 14 Ultrasound Device Indications Statement

510(k) Number (if known) : 510(K) Numoci (II 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) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-----------------------------------|--------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | N | N | N | | N | N | N | N | N | N |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | N | N | N | N |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | N | N | | N | N | N | N | N | N |
| Musculo-skeletal<br>Superficial | | N | 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

Vance Snagdon

(Division Sign-C Division of Reproductive, Abdon and Radiological Device 510(k) Number

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

### Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 3 _of _ 14

510(k) Number (if known) : 510(K) Number (II 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:

| 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) | |
| 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)

Conversion Algae

(Division Sign-Off)
Nancy Brandon

Division of Reproductive and Radiological Device 510(k) Number

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

### Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 4_of __ 14

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

| | | | | | | 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) | |
| 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<br>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) | | | | | | | | | | | | |

ode 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)

Criminology Class

✓

Nancy C. Brigdon

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

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

#### Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 5 of 14

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

| 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) | |
| 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 | | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | | |

Ennoration

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)

\$\checkmark\$

Nancy C. Bradden

(Division Sign-Off) Division of Reproductive, Abdon and Radiological Device 510jk) Number

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

#### Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 6 _ of _ 14

510(k) Number (if known) : 510(K) Number (11 Kilowil) ·
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:

| 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) |
| 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 | | | | | | | | | | | |
| Small Organ<br>(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<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)

Nancy C. Broadson

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

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

#### Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 7 _ of __ 14 _

510(k) Number (if known) : 310(K) 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:

| 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) |
| 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 | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | 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

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

Other Indications or Modes:

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

\/

Nancy Choadon

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

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

#### Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 8 of 14

510(k) Number (if known) : 510(K) Number (II Khown) ·
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:

| 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) | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | N | N | N | | |
| Abdominal | | N | N | N | | N | N | N | N | N | | |
| Intra-operative<br>(Specify) | | | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | | | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | 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) | | | | | | | | | | | | |

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)

Nancy C Hogdon
(Division Sign-Off)

Division of Reproductive, Abdon and Radiological Devices 5 10(k) Number

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

#### Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page 9 of _ 14

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

| Mode of Operation | | | | | | | | | | | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|--------------------|
| 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) |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | N | N | N | |
| Abdominal | | N | N | N | | N | N | N | N | N | |
| 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

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

Other Indications or Modes:

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

\$\checkmark\$

Nancy C. hogdon

(Division Sign Off) Division of Reproductive, Abdo and Radiological Devices 5 10(k) Number

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

#### Prescription Use (Per 21 CFR 801.109) Page _ 10_ of _ 14 Ultrasound Device Indications Statement

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

| Mode of Operation | | | | | | | | | | | |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|--------------------|
| 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) |
| 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 | | | | | | | | | | | |
| Small Organ | | | | | | | | | | | |
| (Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| 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)

Nancy C. Hogdon

(Division Sigh-Off) Division of Reproductive, Abdominal, ഒരു പ്രവേശ്വാcal Devices ി

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

#### Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page _ 11_ of _ 14

510(k) Number (if known) : 510(K) Number (11 Khowil) .
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:

| 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) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|--------------------------|-------------------------------|--------------------|
| | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | N | N | N | |
| Abdominal | | N | N | N | | N | N | N | N | N | |
| 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) | | | | | | | | | | | |

ode of Oneration

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

Other Indications or Modes:

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

\$\checkmark\$

Nancy L. Tharpion
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(K) Number K0505

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

#### Prescription Use (Per 21 CFR 801.109) Ultrasound Device Indications Statement Page _ 12_of __ 14__

510(k) Number (if known) : 510(K) Number (11 khowil) · Litrasound 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:

| Mode of Operation | | | | | | | | | | | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-------------------------|-------------------------------|--------------------|
| 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) |
| 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 | | | | | | | | | | | |
| Small Organ<br>(Specify) * | | | | | | | | | | | |
| Neonatal | | | | | | | | | | | |
| Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | |…