DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

K112022 · Advanced Instrumentations, Inc. · IYO · Sep 22, 2011 · Radiology

Device Facts

• Record ID: K112022
• Device Name: DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
• Applicant: Advanced Instrumentations, Inc.
• Product Code: IYO · Radiology
• Decision Date: Sep 22, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The DUS-3000/DUS-3000Plus Digital Ultrasonic Diagnostic Imaging System is intended for diagnostic ultrasound imaging analysis in gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The DUS-3000/DUS-3000Plus is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus; Abdomen; Pediatrics; Small Organ; Neonatal Cephalic; Cardiology; Peripheral Vessel; Musculo-skeleton (both Conventional and Superficial); Urology (including prostate); Transrectal and Transvaginal.

Device Story

Portable digital ultrasonic diagnostic imaging system; inputs ultrasound waves into body tissue via array of probes (linear, convex, micro-convex, transrectal, transvaginal); processes returned echo information; displays images in B-Mode, 2B-Mode, 4B-Mode, M-Mode, or combined B/M-Mode. Used in clinical settings (gynecology, obstetrics, ICU, ER) by physicians or qualified professionals. Output viewed on integrated monitor for diagnostic evaluation; aids clinical decision-making by providing real-time anatomical visualization. Benefits patient through non-invasive diagnostic imaging.

Clinical Evidence

No clinical data; bench testing only. Safety and performance verified via electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), acoustic output testing per FDA 2008 guidance, and biocompatibility (ISO 10993-1, -5, -10).

Technological Characteristics

Portable digital ultrasound system; frequency range 2.5MHz-10MHz; supports linear, convex, micro-convex, transrectal, and transvaginal probes. Software-controlled; B/M-mode imaging. Biocompatibility per ISO 10993. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid analysis in patients requiring evaluation of the fetus, abdomen, pediatrics, small organs, neonatal cephalic, cardiology, peripheral vessels, musculoskeletal (conventional and superficial), and urology (including prostate), via transrectal or transvaginal approaches.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• DUS3/DUS6 Digital Ultrasonic Diagnostic Imaging System (K091680)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

## Submitter

Advanced Instrumentations, Inc. 6800 N.W. 77th Court Miami, FI 33166 Telephone: [phone] Fax: [phone]

Registration # 1066270

## Official correspondent :

Jorge Millan, PhD Email: [e-mail] 601 West 20 St Hialeah, FL 33010 Phone : [phone]

Date Prepared:

July 13, 2011

## Device name and classification:

- DUS-3000/DUS-3000Plus Digital Ultrasonic . Device Name: Diagnostic Imaging System
- Classification Name: 892.1560 System, Imaging, Pulsed echo, Ultrasonic . Product code: IYO 892.1570 Transducer, Ultrasonic, Diagnostic Product code: |TX
- Regulatory Class: . II

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

## Predicate Device:

DUS3/DUS6 Digital Ultrasonic Diagnostic Imaging System. K091680 Manufacturer: EDAN Instruments

## Device Description:

The DUS-3000/DUS-3000Plus Digital Ultrasound Diagnostic Imaging System is a portable digital ultrasonic diagnostic BMV system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications.

It is designed to produce ultrasound waves into the body tissue and to present the returned echo information on the monitor. The resulting information is displayed in five display modes: B-Mode, 2B-Mode, 4B-Mode, M-Mode or the combined mode (i.e. B/M-Mode). This system controlled by software is a Track 1 device that employs an array of probes that include linear array, convex linear array, micro convex linear array, transrectal and transvaginal with a frequency range of approximately 2.5MHz-10MHz. The system consists of a main unit, a display and transducers.

### Intended Use:

The DUS-3000/DUS-3000Plus Digital Ultrasonic Diagnostic Imaging System is intended for diagnostic ultrasound imaging analysis in gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The DUS-3000/DUS-3000Plus is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus; Abdomen; Pediatrics; Small Organ; Neonatal Cephalic; Cardiology; Peripheral Vessel; Musculo-skeleton (both Conventional and Superficial); Urology (including prostate); Transrectal and Transvaginal.

## Effectiveness and Safety Contraindications:

### Clinical Test

Clinical testing is not required

## Non-clinical test:

The following safety standards are conducted on the subject device:

- 1. IEC 60601-1 Electrical Safety
- 2. IEC 60601-1-2 Electromagnetic Compatibility

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- 3. Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9 2008
- 4. ISO 10993-1, ISO 10993-5 and ISO 10993-10

## Comparison to the predicate device:

The subject device has similar technology characteristics and has the same intended use, same material components, same manufacturing process, same design principle, same electrical classification, same measurement mode and same accuracy as the predicate device.

### Substantially Equivalent Determination:

Verification and validation testing was done on the DUS 3000/DUS-3000Plus Digital Ultrasonic Diagnostic Imaging System. This premarket notification submission demonstrates that DUS-3000/DUS-3000Plus Digital Ultrasonic Diagnostic Imaging System is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows a logo with a circle on the left side and a stylized bird on the right side. The circle is made up of small dashes or lines, creating a dotted effect. The bird is depicted with three curved lines that suggest wings or feathers, giving it a sense of movement or flight. The logo appears to be simple and abstract, possibly representing freedom, nature, or a related concept.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Advanced Instrumentations. Inc. % Jorge Millan, Ph.D. Executive Director Hialeah Technology Center, Inc. 601 West 20 St HIALEAH FL 33010

SEEP 2222 2011 1

Re: Ki12022

Trade/Device Name: DUS-3000/DUS-3000Plus Digital Ultrasonic Diagnostic Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: September 13, 2011 Received: September 15, 2011

Dear Dr. Millan:

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 DUS-3000/DUS-3000Plus Digital Ultrasonic Diagnostic Imaging System, as described in your premarket notification:

| 1<br>Transducer Model Number | | |
|------------------------------|--|--|
| | | |

| DUS 3000 | DUS 3000 Plus |
|---------------|---------------|
| E613 | E611-1 |
| L743 | E741 |
| C321 | L741 |
| C363-1/C343-1 | C321-1 |
| | C361-1/C341 |

.
.

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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 895. 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 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.

ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safetv/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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

Sincerely Yours.

Mary Stotel

Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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#### Indications for Use

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

#### Device Name:

DUS-3000/DUS-3000Plus Digital Ultrasonic Diagnostic Imaging System

#### Indications for Use:

The DUS-3000/DUS-3000Plus Digital Ultrasonic Diagnostic Imaging System is intended for diagnostic ultrasound imaging analysis in gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The DUS-3000/DUS-3000Plus is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus; Abdomen; Pediatrics; Small Organ; Neonatal Cephalic; Cardiology; Peripheral Vessel; Musculo-skeleton (both Conventional and Superficial); Urology (including prostate); Transrectal and Transvaginal.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mun Srotyl
(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K112022

Page 1 of 1

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#### DUS 3000 Digital Ultrasonic Diagnostic Imaging System

Intended Use: Diagnostic Ultrasound imaging or fluid analysis of the human body as follows:

| Clinical Application | Mode of Operation | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
|---------------------------------|-------------------|---|---|-----|-----|------------------|-----------------------|---------------------|
| Ophthalmic | | | | | | | | |
| Fetal / Obstetrics | N | N | | | | N | | |
| Abdominal | N | N | | | | N | | |
| Intra-operative(Specify) | | | | | | | | |
| Intra-operative(Neurological) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | | | | N | | |
| Small Organ (Specify) | N | N | | | | N | | |
| Neonatal Cephalic | N | N | | | | N | | |
| Adult Cephalic | | | | | | | | |
| Transrectal | N | N | | | | N | | |
| Transvaginal | N | N | | | | N | | |
| Transurethral | | | | | | | | |
| Musculo-Skeletal (Conventional) | N | N | | | | N | | |
| Musculo-Skeletal (Superficiall) | N | N | | | | N | | |
| Intravascular | | | | | | | | |
| Other (specify) | | | | | | | | |
| Cardiac | N | N | | | | N | | |
| Intravascular | | | | | | | | |
| Peripheral vascular | N | N | | | | N | | |
| Other (specify) | | | | | | | | |

N = new indication xx- previously cleared by FDA: E – added under this appendix

Additional comments: Combined mode B + M

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

Concurrence of CDRH Office of Device Evaluation (ODE

Mary S. Patel
(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K112022

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

Digital Ultrasonic Diagnostic Imaging System 510k Submission

# Diagnostic Ultrasonic Indications for Use Form

### . DUS 3000 Plus with E613 Transducer

Intended Use: Diagnostic Ultrasound imaging or fluid analysis of the human body as follows:

| | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|-----|-----|---------------|--------------------|------------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative(Specify) | | | | | | | |
| Intra-operative(Neurological) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Transrectal | N | N | | | | N | |
| Transvaginal | N | N | | | | N | |
| Transurethral | | | | | | | |
| Musculo-Skeletal (Conventional) | | | | | | | |
| Musculo-Skeletal (Superficial) | | | | | | | |
| Intravascular | | | | | | | |
| Other (specify) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (specify) | | | | | | | |

N = new indication xx- previously cleared by FDA: E – added under this appendix

Additional comments: Combined mode B + M

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Mary S Potter
(Division Sign Off)

Office of Ir રાજ્યન

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### DUS_3000 Plus with L743 Transducer

Intended Use: Diagnostic Ultrasound imaging or fluid analysis of the human body as follows:

| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|-----|-----|---------------|--------------------|------------------|
| | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative(Specify) | | | | | | | |
| Intra-operative(Neurological) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Transrectal | N | N | | | | N | |
| Transvaginal | | | | | | | |
| Transurethral | | | | | | | |
| Musculo-Skeletal (Conventional) | | | | | | | |
| Musculo-Skeletal (Superficiall) | | | | | | | |
| Intravascular | | | | | | | |
| Other (specify) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (specify) | | | | | | | |

N = new indication xx- previously cleared by FDA: E – added under this appendix

Additional comments: Combined mode B + M

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

·

Concurrence of CDRH Office of Device Evaluation (ODE)

Mary S. Patel
(Division Sign-Off)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
6417677

510K. K112622

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

#### DUS 3000 Plus with L743 Transducer

Intended Use: Diagnostic Ultrasound imaging or fluid analysis of the human body as follows:

| | Mode of Operation | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|--|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) | |
| Ophthalmic | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | |
| Abdominal | | | | | | | | |
| Intra-operative(Specify) | | | | | | | | |
| Intra-operative(Neurological) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | | | | | | | | |
| Small Organ (Specify) | N | N | | | | N | | |
| Neonatal Cephalic | N | N | | | | N | | |
| Adult Cephalic | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Musculo-Skeletal (Conventional) | N | N | | | | N | | |
| Musculo-Skeletal (Superficial) | N | N | | | | N | | |
| Intravascular | | | | | | | | |
| Other (specify) | | | | | | | | |
| Cardiac | | | | | | | | |
| Intravascular | | | | | | | | |
| Peripheral vascular | N | N | | | | N | | |
| Other (specify) | | | | | | | | |

N = new indication xx- previously cleared by FDA: E ~ added under this appendix

Additional comments: Combined mode B + M

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Mury S. Pasto
(Director Sign Off)

luation and Safety

510K. 1112022

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#### DUS 3000 Plus with C321 Transducer

Intended Use: Diagnostic Ultrasound imaging or fluid analysis of the human body as follows:

| | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|-----|-----|---------------|--------------------|------------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | | | | | | | |
| Abdominal | N | N | | | | N | |
| Intra-operative(Specify) | | | | | | | |
| Intra-operative(Neurological) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | N | N | | | | N | |
| Small Organ (Specify) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Transrectal | | | | | | | |
| Transvaginal | | | | | | | |
| Transurethral | | | | | | | |
| Musculo-Skeletal (Conventional) | | | | | | | |
| Musculo-Skeletal (Superficiall) | | | | | | | |
| Intravascular | | | | | | | |
| Other (specify) | | | | | | | |
| Cardiac | N | N | | | | N | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (specify) | | | | | | | |

N = new indication xx- previously cleared by FDA: E – added under this appendix

Additional comments: Combined mode B + M

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Mery S. Postle
(Division Sign Off)

510K K112022

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

## DUS_3000 Plus with C363-1 /C343-1 Transducer

Intended Use: Diagnostic Ultrasound imaging or fluid analysis of the human body as follows:

| Clinical Application | Mode of Operation | | | | | | Other* (Specify) |
|---------------------------------|-------------------|---|-----|-----|---------------|--------------------|------------------|
| | B | M | PWD | CWD | Color Doppler | Combined (Specify) | |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | N | N | | | | N | |
| Abdominal | N | N | | | | N | |
| Intra-operative(Specify) | | | | | | | |
| Intra-operative(Neurological) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Transrectal | | | | | | | |
| Transvaginal | | | | | | | |
| Transurethral | | | | | | | |
| Musculo-Skeletal (Conventional) | | | | | | | |
| Musculo-Skeletal (Superficial) | | | | | | | |
| Intravascular | | | | | | | |
| Other (specify) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (specify) | | | | | | | |

N = new indication xx- previously cleared by FDA: E – added under this appendix

Additional comments: Combined mode B + M

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Mary S. Patil
(Division Sign-Off)

office of

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

#### DUS 3000 Plus Digital Ultrasonic Diagnostic Imaging System

Intended Use: Diagnostic Ultrasound imaging or fluid analysis of the human body as follows:

| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | N | N | | | | N | |
| Abdominal | N | N | | | | N | |
| Intra-operative(Specify) | | | | | | | |
| Intra-operative(Neurological) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | N | N | | | | N | |
| Small Organ (Specify) | N | N | | | | N | |
| Neonatal Cephalic | N | N | | | | N | |
| Adult Cephalic | | | | | | | |
| Transrectal | N | N | | | | N | |
| Transvaginal | N | N | | | | N | |
| Transurethral | | | | | | | |
| Musculo-Skeletal (Conventional) | N | N | | | | N | |
| Musculo-Skeletal (Superficial) | N | N | | | | N | |
| Intravascular | | | | | | | |
| Other (specify) | | | | | | | |
| Cardiac | N | N | | | | N | |
| Intravascular | | | | | | | |
| Peripheral vascular | N | N | | | | N | |
| Other (specify) | | | | | | | |

N = new indication xx- previously cleared by FDA: E - added under this appendix

Additional comments: Combined mode B + M

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Mary S Patel
(Division Sign Off)

Division of Office of In

510K K12022

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

#### DUS 3000 with E611-1 Transducer

Intended Use: Diagnostic Ultrasound imaging or fluid analysis of the human body as follows:

| | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|-----|-----|---------------|--------------------|------------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative(Specify) | | | | | | | |
| Intra-operative(Neurological) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Transrectal | N | N | | | | | |
| Transvaginal | N | N | | | | N | |
| Transurethral | | | | | | | |
| Musculo-Skeletal (Conventional) | | | | | | | |
| Musculo-Skeletal (Superficiall) | | | | | | | |
| Intravascular | | | | | | | |
| Other (specify) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (specify) | | | | | | | |

N = new indication xx- previously cleared by FDA: E – added under this appendix

Additional comments: Combined mode B + M

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Mary S. Postell
(Division Sign Off)

510K K112022

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

#### DUS 3000 with L741 Transducer

Intended Use: Diagnostic Ultrasound imaging or fluid analysis of the human body as follows:

| | Mode of Operation | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|---------|-----------|-----------|--|--|
| Clinical Application | B | M | PWD | CWD | Color | Combined | Other* | | |
| | | | | | Doppler | (Specify) | (Specify) | | |
| Ophthalmic | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intra-operative(Specify) | | | | | | | | | |
| Intra-operative(Neurological) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ (Specify) | N | N | | | | N | | | |
| Neonatal Cephalic | N | N | | | | N | | | |
| Adult Cephalic | | | | | | | | | |
| Transrectal | | | | | | | | | |
| Transvaginal | | | | | | | | | |
| Transurethral | | | | | | | | | |
| Musculo-Skeletal (Conventional) | N | N | | | | N | | | |
| Musculo-Skeletal (Superficial) | N | N | | | | N | | | |
| Intravascular | | | | | | | | | |
| Other (specify) | | | | | | | | | |
| Cardiac | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Peripheral vascular | N | N | | | | N | | | |
| Other (specify) | | | | | | | | | |

N = new indication xx- previously cleared by FDA: E — added under this appendix

Additional comments: Combined mode B - M

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

. Concurrence of CDRH Office of Device Evaluation (ODE)

Mary S. Postel
Division Sign-Off

Office of In

510K K112022

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

#### DUS 3000 with E741 Transducer

Intended Use: Diagnostic Ultrasound imaging or fluid analysis of the human body as follows:

| | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|-----|-----|---------------|--------------------|------------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative(Specify) | | | | | | | |
| Intra-operative(Neurological) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Transrectal | N | N | | | | N | |
| Transvaginal | | | | | | | |
| Transurethral | | | | | | | |
| Musculo-Skeletal (Conventional) | | | | | | | |
| Musculo-Skeletal (Superficiall) | | | | | | | |
| Intravascular | | | | | | | |
| Other (specify) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (specify) | | | | | | | |

N = new indication xx- previously cleared by FDA: E – added under this appendix

Additional comments: Combined mode B + M

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------and the control control consideration of the consisted

Mary S. Padle
(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K112022

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

Digital Ultrasonic Diagnostic Imaging System 510k Submission

## Diagnostic Ultrasonic Indications for Use Form

#### DUS 3000 with C321-1 Transducer

Intended Use: Diagnostic Ultrasound imaging or fluid analysis of the human body as follows:

| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|-----|-----|---------------|--------------------|------------------|
| | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | | | | | | | |
| Abdominal | N | N | | | | N | |
| Intra-operative(Specify) | | | | | | | |
| Intra-operative(Neurological) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | N | N | | | | N | |
| Small Organ (Specify) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Transrectal | | | | | | | |
| Transvaginal | | | | | | | |
| Transurethral | | | | | | | |
| Musculo-Skeletal (Conventional) | | | | | | | |
| Musculo-Skeletal (Superficiall) | | | | | | | |
| Intravascular | | | | | | | |
| Other (specify) | | | | | | | |
| Cardiac | N | N | | | | N | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (specify) | | | | | | | |

N = new indication xx- previously cleared by FDA: E – added under this appendix

Additional comments: Combined mode B + M

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Marn S. Postel
(Division Sign Off)

Office of I

510K K112022

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

#### DUS 3000 with C361-1/C341 Transducer

Intended Use: Diagnostic Ultrasound imaging or fluid analysis of the human body as follows:

| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | N | N | | | | N | |
| Abdominal | N | N | | | | N | |
| Intra-operative(Specify) | | | | | | | |
| Intra-operative(Neurological) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Transrectal | | | | | | | |
| Transvaginal | | | | | | | |
| Transurethral | | | | | | | |
| Musculo-Skeletal (Conventional) | | | | | | | |
| Musculo-Skeletal (Superficiall) | | | | | | | |
| Intravascular | | | | | | | |
| Other (specify) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (specify) | | | | | | | |

N = new indication xx- previously cleared by FDA: E – added under this appendix

Additional comments: Combined mode B + M

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Mary Scott

510K 112022

Office of In