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 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.

AI/ML Overview

This document is a 510(k) summary for the DUS-3000/DUS-3000Plus Digital Ultrasound Diagnostic Imaging System. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and outlining the intended uses.

Based on the provided text, there is no detailed information regarding acceptance criteria, specific device performance metrics for a study, or a study that proves the device meets specific acceptance criteria related to diagnostic accuracy.

The summary states: "Clinical testing is not required" and focuses on non-clinical tests for safety standards and comparison to a predicate device to establish substantial equivalence. Therefore, many of the requested details about a performance study with acceptance criteria cannot be extracted from this document.

However, I can extract the following based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative or qualitative acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, accuracy) are mentioned for the device. The document states that "clinical testing is not required" and instead relies on non-clinical testing for safety and demonstrating substantial equivalence to a predicate device.

The reported device "performance" is implicitly its adherence to various safety and general characteristics, as it is found substantially equivalent to the predicate.

Acceptance Criteria Category	Specific Criteria (Expected)	Reported Device Performance (Achieved)
Diagnostic Performance	(Not specified)	(Not applicable, no clinical testing required)
Electrical Safety	IEC 60601-1	Test conducted and met.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2	Test conducted and met.
Acoustic Output	Guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9 2008	Test conducted and met.
Biocompatibility	ISO 10993-1, ISO 10993-5, ISO 10993-10	Test conducted and met.
Substantial Equivalence	Similar technology, intended use, material, manufacturing, design, electrical classification, measurement mode, accuracy as predicate (EDAN Instruments DUS3/DUS6, K091680)	Verification and validation testing demonstrates substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Test Set): Not applicable, as no clinical performance study was conducted.
Data Provenance: Not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications

Not applicable, as no clinical performance study was conducted.

4. Adjudication Method for the Test Set

Not applicable, as no clinical performance study was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states "Clinical testing is not required."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Not applicable, as this device is a diagnostic ultrasound system, not an AI algorithm. It is a "Track 1 device" meaning it's a conventional medical device, not an AI/ML software as a medical device.

7. The Type of Ground Truth Used

Not applicable, as no clinical performance study was conducted. The "ground truth" for the submission's claims is adherence to safety standards and demonstration of substantial equivalence to a predicate device.

8. The Sample Size for the Training Set

Not applicable, as this device is a conventional diagnostic ultrasound system, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this device is a conventional diagnostic ultrasound system, not an AI/ML algorithm that requires a training set.

Summary

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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: 305-477-6331 Fax: 305-477-5351

Registration # 1066270

Official correspondent :

Jorge Millan, PhD Email: jmillan@hiatec.org 601 West 20 St Hialeah, FL 33010 Phone : (305) 925-1260

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

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Predicate Device:

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

Device Description:

Intended Use:

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
1. IEC 60601-1-2 Electromagnetic Compatibility

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1. Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9 2008
1. 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:

1Transducer 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 (301) 796-6881.

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:

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

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

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

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	ColorDoppler
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

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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

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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	ColorDoppler	Combined(Specify)	Other*(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
	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

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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	ColorDoppler	Combined(Specify)	Other*(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	ColorDoppler	Combined(Specify)	Other*(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

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
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.(b)
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.