DUS-6000 Digital Ultrasonic Diagnostic Imaging System

• K Number: K172931
• Device Name: DUS-6000 Digital Ultrasonic Diagnostic Imaging System
• Manufacturer: Advanced Instrumentations, Inc.
• Date Cleared: 2017-12-01 ( 67 days)
• Product Code: IYO ITX
• Regulation Number: 892.1560

Intended Use

The DUS-6000 Digital Ultrasonic Diagnostic Imaging System is applicable for ultrasound evaluation in hospitals and clinics. It is intended for use in Abdominal, obstetric, gynecology, pediatrics, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial) and cardiac applications by or on the order of a physician or similarly qualified health care professional.

Device Description

The DUS-6000 Digital Ultrasonic Diagnostic Imaging System is a portable diagnostic ultrasound system, which applies advanced technologies such as Phased Inversion Harmonic Compound Imaging (eHCI), Double-Beam-Forming (D Beam), Speckle Resistance Imaging (eSRI), scan receiving aperture (SRA) and Spatial Compounding Imaging. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. It is intended for diagnostic ultrasound imaging analysis in hospitals and clinics. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor; the resulting information is displayed in the following display modes: BB/2B/4B-Mode, M-Mode, B+M Mode or PW Mode. Supported probe types include convex, linear, micro-convex, endocavity (transvaginal, endorectal) probes. The device can detect the probe automatically. The system consists of 7 major functional blocks, including a main unit, a display subsystem, a transducer and transceiver subsystem, digital beamformer, keyboard and power subsystem.

Predicate Devices

K131830

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description lists several advanced imaging technologies (eHCI, D Beam, eSRI, SRA, Spatial Compounding Imaging) but none are explicitly identified as AI or ML. The "Mentions AI, DNN, or ML" field is "Not Found".

Therapeutic

No
The device is described as a "Digital Ultrasonic Diagnostic Imaging System" and its intended use is for "ultrasound evaluation" and "diagnostic ultrasound imaging analysis." It produces images, but does not state any therapeutic function.

Diagnostic

Yes
The name of the device, "DUS-6000 Digital Ultrasonic Diagnostic Imaging System," explicitly states "Diagnostic." Furthermore, the "Intended Use / Indications for Use" section and the "Device Description" section both repeatedly state that the device is "intended for diagnostic ultrasound imaging analysis."

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including a main unit, display subsystem, transducer and transceiver subsystem, digital beamformer, keyboard, and power subsystem, in addition to various probes.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
• Device Function: The DUS-6000 Digital Ultrasonic Diagnostic Imaging System uses ultrasound waves to create images of internal body structures. It does not analyze samples taken from the body.
• Intended Use: The intended use clearly states it's for "ultrasound evaluation" and "diagnostic ultrasound imaging analysis" of various anatomical sites within the body.

Therefore, based on the provided information, the DUS-6000 is a diagnostic imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The DUS-6000 Digital Ultrasonic Diagnostic Imaging System is applicable for ultrasound evaluation in hospitals and clinics. It is intended for use in Abdominal, obstetric, gynecology, pediatrics, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial) and cardiac applications by or on the order of a physician or similarly qualified health care professional.

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Combined mode: B+M, B+PW

*Small Organ includes thyroid

**Other use includes Urology

Note 1: Biopsy guidance

Note 2: Harmonic Imaging, This feature does not use contrast agents

Product codes (comma separated list FDA assigned to the subject device)

IYO, ITX

Device Description

The DUS-6000 Digital Ultrasonic Diagnostic Imaging System is a portable diagnostic ultrasound system, which applies advanced technologies such as Phased Inversion Harmonic Compound Imaging (eHCI), Double-Beam-Forming (D Beam), Speckle Resistance Imaging (eSRI), scan receiving aperture (SRA) and Spatial Compounding Imaging. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. It is intended for diagnostic ultrasound imaging analysis in hospitals and clinics.

It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor; the resulting information is displayed in the following display modes: BB/2B/4B-Mode, M-Mode, B+M Mode or PW Mode. Supported probe types include convex, linear, micro-convex, endocavity (transvaginal, endorectal) probes. The device can detect the probe automatically.

The system consists of 7 major functional blocks, including a main unit, a display subsystem, a transducer and transceiver subsystem, digital beamformer, keyboard and power subsystem.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdominal, obstetric, gynecology, pediatrics, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial) and cardiac applications. Specific applications mentioned for various transducers include: Ophthalmic, Fetal/Obstetrics, Intra-operative (Specify), Intra-operative (Neurological), Laparoscopic, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card), Intravascular, Cardiac, Intravascular (Cardiac), Trans-esoph. (Cardiac), Intra-cardiac, Peripheral vascular.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

By or on the order of a physician or similarly qualified health care professional. Applicable for ultrasound evaluation in hospitals and clinics.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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
(3) IEC 60601-2-37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
(4) 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 Biological Evaluation of medical devices

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K131830

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

December 1, 2017

Advanced Instrumentations, Inc. % Jorge Millan, Ph.D. Regulatory Affairs Manager 6800 NW 77th Ct. MIAMI FL 33166

Re: K172931

Trade/Device Name: DUS-6000 Digital Ultrasonic Diagnostic Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: October 3, 2017 Received: October 6, 2017

Dear Dr. Millan:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

1

(1-800-638-2041 or 301-796-7100).

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K172931

Device Name

DUS-6000 Digital Ultrasonic Diaqnostic Imaqing System

Indications for Use (Describe)

The DUS-6000 Digital Ultrasonic Diagnostic Imaging System is applicable for ultrasound evaluation in hospitals and clinics. It is intended for use in Abdominal, obstetric, gynecology, pediatrics, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial) and cardiac applications by or on the order of a physician or similarly qualified health care professional.

Type of Use (Select one or both, as applicable)
ಸ
Prescription Use (Part 21 CFR 801 Subpart D)

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

PSC Publishing Services (301) 443-674

FORM FDA 3881 (8/14)

3

Diagnostic Ultrasound Indications for Use Form DUS-6000 Digital Ultrasonic Diagnostic Imaging System

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Clinical Application
General (Track 1
only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
and Other	Fetal/Obstetrics	P	P	P			P	Note 1,2
	Abdominal	P	P	P			P	Note 1,2
	Intra-operative (Specify)
	Intra-operative (Neurological)
	Laparoscopic
	Pediatric	P	P	P			P	Note 1,2
	Small Organ (Specify) *	P	P	P			P	Note 1,2
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P			P	Note 1,2
	Trans-vaginal	P	P	P			P	Note 1,2
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)	P	P	P			P	Note 1,2
	Musculo-skeletal (Superficial)	P	P	P			P	Note 1,2
	Intravascular
	Other (Specify)**	P	P	P			P	Note 1,2
Cardiac	Cardiac	P	P	P			P	Note 1,2
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
vascular	Peripheral vascular	P	P	P			P	Note 1,2
vascular	Other (Urology)

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

Additional comments: Combined mode: B+M, B+PW

*Small Organ includes thyroid

**Other use includes Urology

Note 1: Biopsy guidance

Note 2: Harmonic Imaging, This feature does not use contrast agents

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

4

Diagnostic Ultrasound Indications for Use Form DUS-6000 with C361-2 Transducer

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | B | M | PW | CW | Color | Combined
(Specify) | Other
(Specify) |
|----------------------------|---------------------------------|---|---|----|----|-------|-----------------------|--------------------|
| General (Track 1
only) | Specific (Tracks 1&3) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging
and Other | Fetal/Obstetrics | P | P | P | | | P | Note 1,2 |
| | Abdominal | P | P | P | | | P | Note 1,2 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify)** | P | P | P | | | P | Note 1,2 |
| Cardiac | Cardiac | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
vascular | Peripheral vascular | | | | | | | |
| | Other (Urology) | | | | | | | |

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

Additional comments: Combined mode: B+M, B+PW

*Small Organ includes thyroid

**Other use includes Urology

Note 1: Biopsy guidance

Note 2: Harmonic Imaging, This feature does not use contrast agents

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

5

Diagnostic Ultrasound Indications for Use Form DUS-6000 with C363-2 Transducer

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| General (Track 1
only) | Specific (Tracks 1&3) | B | M | PW | CW | Color | Combined
(Specify) | Other
(Specify) |
|----------------------------|---------------------------------|---|---|----|----|-------|-----------------------|--------------------|
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging
and Other | Fetal/Obstetrics | P | P | P | | | P | Note 1,2 |
| | Abdominal | P | P | P | | | P | Note 1,2 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify)** | P | P | P | | | P | Note 1,2 |
| Cardiac | Cardiac | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
vascular | Peripheral vascular | | | | | | | |
| | Other (Urology) | | | | | | | |

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

Additional comments: Combined mode: B+M, B+PW

*Small Organ includes thyroid

**Other use includes Urology

Note 1: Biopsy guidance

Note 2: Harmonic Imaging, This feature does not use contrast agents

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

6

Diagnostic Ultrasound Indications for Use Form DUS-6000 with C341-2 Transducer

	Clinical Application
General (Track 1
only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
and Other	Fetal/Obstetrics	P	P	P			P	Note 1,2
	Abdominal	P	P	P			P	Note 1,2
	Intra-operative (Specify)
	Intra-operative (Neurological)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify)**	P	P	P			P	Note 1,2
Cardiac	Cardiac
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
vascular	Peripheral vascular
	Other (Urology)

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

Additional comments: Combined mode: B+M, B+PW

*Small Organ includes thyroid

**Other use includes Urology

Note 1: Biopsy guidance

Note 2: Harmonic Imaging, This feature does not use contrast agents

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

7

Diagnostic Ultrasound Indications for Use Form DUS-6000 with L741-2 Transducer

| Clinical Application | | B | M | PW | CW | Color | Combined
(Specify) | Other
(Specify) |
|----------------------------|--------------------------------|---|---|----|----|-------|-----------------------|--------------------|
| General (Track 1
only) | Specific (Tracks 1&3) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging
and Other | Fetal/Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | P | P | P | | | P | Note 1,2 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | | | P | Note 1,2 |
| | Musculo-skeletal (Superficial) | P | P | P | | | P | Note 1,2 |
| | Intravascular | | | | | | | |
| | Other (Specify)** | | | | | | | |
| Cardiac | Cardiac | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
vascular | Peripheral vascular | P | P | P | | | P | Note 1,2 |
| | Other (Urology) | | | | | | | |

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

Additional comments: Combined mode: B+M, B+PW

*Small Organ includes thyroid

**Other use includes Urology

Note 1: Biopsy guidance

Note 2: Harmonic Imaging, This feature does not use contrast agents

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

8

Diagnostic Ultrasound Indications for Use Form DUS-6000 with L743-2 Transducer

	Clinical Application
General (Track 1
only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging	Fetal/Obstetrics
and Other	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neurological)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *	P	P	P			P	Note 1,2
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)	P	P	P			P	Note 1,2
	Musculo-skeletal (Superficial)	P	P	P			P	Note 1,2
	Intravascular
	Other (Specify)**
Cardiac	Cardiac Adult
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vascular	P	P	P			P	Note 1,2
Vascular	Other (Urology)

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

Additional comments: Combined mode: B+M, B+PW

*Small Organ includes thyroid

**Other use includes Urology

Note 1: Biopsy guidance

Note 2: Harmonic Imaging, This feature does not use contrast agents

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

9

Diagnostic Ultrasound Indications for Use Form DUS-6000 with L761-2 Transducer

| | Clinical Application | | B | M | PW | CW | Color | Combined
(Specify) | Other
(Specify) |
|----------------------------|--------------------------------|--|---|---|----|----|-------|-----------------------|--------------------|
| General (Track 1
only) | Specific (Tracks 1&3) | | B | M | PW | CW | Color | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging
and Other | Fetal/Obstetrics | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) * | | P | P | P | | | P | Note 1,2 |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal(Conventional) | | P | P | P | | | P | Note 1,2 |
| | Musculo-skeletal (Superficial) | | P | P | P | | | P | Note 1,2 |
| | Intravascular | | | | | | | | |
| | Other (Specify)** | | | | | | | | |
| Cardiac | Cardiac | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral
vascular | Peripheral vascular | | P | P | P | | | P | Note 1,2 |
| | Other (Urology) | | | | | | | | |

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

Additional comments: Combined mode: B+M, B+PW

*Small Organ includes thyroid

**Other use includes Urology

Note 1: Biopsy guidance

Note 2: Harmonic Imaging, This feature does not use contrast agents

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

10

Diagnostic Ultrasound Indications for Use Form DUS-6000 with C611-2 Transducer

| Clinical Application | | B | M | PW | CW | Color | Combined
(Specify) | Other
(Specify) |
|----------------------------|---------------------------------|---|---|----|----|-------|-----------------------|--------------------|
| General (Track 1
only) | Specific (Tracks 1&3) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging
and Other | Fetal/Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neurological) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | | P | Note 1,2 |
| | Small Organ (Specify) * | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify)** | | | | | | | |
| Cardiac | Cardiac | P | P | P | | | P | Note 1,2 |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
vascular | Peripheral vascular | | | | | | | |
| | Other (Urology) | | | | | | | |

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

Additional comments: Combined mode: B+M, B+PW

*Small Organ includes thyroid

**Other use includes Urology

Note 1: Biopsy guidance

Note 2: Harmonic Imaging, This feature does not use contrast agents

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

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Diagnostic Ultrasound Indications for Use Form DUS-6000 with E741-2 Transducer

	Clinical Application
General (Track 1
only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Combined
(Specify)	Other
(Specify)
	Ophthalmic
Fetal Imaging	Fetal/Obstetrics
and Other	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neurological)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P			P	Note 1,2
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify)**
Cardiac	Cardiac
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vascular
vascular	Other (Urology)

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

Additional comments: Combined mode: B+M, B+PW

*Small Organ includes thyroid

**Other use includes Urology

Note 1: Biopsy guidance

Note 2: Harmonic Imaging, This feature does not use contrast agents

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

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Diagnostic Ultrasound Indications for Use Form DUS-6000 with E611-2 Transducer

	Clinical Application
General (Track 1
only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
and Other	Fetal/Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neurological)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P			P	Note 1,2
	Trans-vaginal	P	P	P			P	Note 1,2
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify)**
Cardiac	Cardiac Adult
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
vascular	Peripheral vascular
	Other (Urology)

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

Additional comments: Combined mode: B+M, B+PW

*Small Organ includes thyroid

**Other use includes Urology

Note 1: Biopsy guidance

Note 2: Harmonic Imaging, This feature does not use contrast agents

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

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510K SUMMARY

DUS-6000 Digital Ultrasonic Diagnostic Imaging System

• SUBMITTER ADVANCED INSTRUMENTATIONS, INC 6800 NW 77th Ct, Miami, FL 33166 Phone: [phone]
• US AGENT JORGE MILLAN, PHD REGULATORY AFFAIRS MANAGER Email: [e-mail] Web: https://www.sigmabiomedical.com

DEVICE NAME AND CLASSIFICATION

TRADE NAME:	DUS-6000 Digital Ultrasonic Diagnostic Imaging System
CLASSIFICATION NAME:	892.1560
Product Code: IYO
892.1570
Product Code: ITX	System, Imaging, Pulsed echo, Ultrasonic
Transducer, Ultrasonic, Diagnostic
REGULATORY CLASS:	Class II
PANEL IDENTIFICATION	Radiology

DEVICE DESCRIPTION

The DUS-6000 Digital Ultrasonic Diagnostic Imaging System is a portable diagnostic ultrasound system, which applies advanced technologies such as Phased Inversion Harmonic Compound Imaging (eHCI), Double-Beam-Forming (D Beam), Speckle Resistance Imaging (eSRI), scan receiving aperture (SRA) and Spatial Compounding Imaging. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. It is intended for diagnostic ultrasound imaging analysis in hospitals and clinics.

It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor; the resulting information is displayed in the following display modes: BB/2B/4B-Mode, M-Mode, B+M Mode or PW Mode. Supported probe types include convex, linear, micro-convex, endocavity (transvaginal, endorectal) probes. The device can detect the probe automatically.

The system consists of 7 major functional blocks, including a main unit, a display subsystem, a transducer and transceiver subsystem, digital beamformer, keyboard and power subsystem.

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Predicate Devices: The proposed system model is substantially equivalent to diagnostic ultrasound systems cleared for marketing in the US. The DUS-6000 Ultrasound system is equivalent to the DUS 60 ultrasound system (K131830), manufactured by EDAN Instruments Inc.

Indications for Use: The DUS-6000 Digital Ultrasonic Diagnostic Imaging System is applicable for ultrasound evaluation in hospitals and clinics. It is intended for use in Abdominal, obstetric, gynecology, pediatrics, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial) and cardiac applications by or on the order of a physician or similarly qualified health care professional.

EFFECTIVENESS AND SAFETY CONSIDERATIONS

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

(3) IEC 60601-2-37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

(4) 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 Biological Evaluation of medical devices

Comparison to the predicate device

The subject device has similar technology characteristics and has the same intended use, same design principle, same electrical classification and same accuracy. There are no differences between the devices that affect the usage, safety and effectiveness. The subject device has the same needle-guide bracket material, property, and sterilization methods as those of the predicate device DUS 60, therefore, the needle-guide bracket will not cause any safety and effectiveness issues.

Substantially Equivalent Determination

This premarket notification submission demonstrates that the DUS-6000 Digital Ultrasonic Diagnostic Imaging System is substantially equivalent to the predicate devices.