DUS-7000 Digital Color Doppler Ultrasound System

• K Number: K172055
• Device Name: DUS-7000 Digital Color Doppler Ultrasound System
• Manufacturer: Advanced Instrumentations, Inc
• Date Cleared: 2017-08-31 ( 56 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The DUS-7000 Digital Color Doppler Ultrasound System is a general purpose ultrasonic imaging instruments intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Device Description

DUS-7000 Digital Color Doppler Ultrasound System is an integrated The preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 2.0 MHz to 15.0 MHz. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.

Predicate Devices

K142815

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging techniques and post-processing without mentioning AI or ML.

Therapeutic

No
The device is described as an "ultrasonic imaging instrument intended for use by a qualified physician for evaluation" and for "clinical diagnostic imaging applications," indicating its purpose is diagnostic imaging rather than a therapeutic intervention.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "for evaluation of Fetal, Abdominal, Pediatric, Small Organ... and Urology," which refers to diagnostic evaluation. Additionally, the "Device Description" states it is "intended for clinical diagnostic imaging applications."

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a "mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes," which are hardware components. While it is software-controlled, it is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the DUS-7000 Digital Color Doppler Ultrasound System is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• DUS-7000 Function: The DUS-7000 is an ultrasound system. It uses ultrasonic energy transmitted into the patient's body to create images of internal structures and fluid flow. This is an in vivo (within the living body) diagnostic method, not an in vitro method.
• Intended Use: The intended use clearly describes imaging various anatomical sites within the patient's body.
• Device Description: The description details the system's components and how it acquires and displays ultrasound data from within the body.

Therefore, the DUS-7000 is a diagnostic imaging device that operates in vivo, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The DUS-7000 Digital Color Doppler Ultrasound System is a general purpose ultrasonic imaging instruments intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Product codes

IYN, IYO, ITX

Device Description

DUS-7000 Digital Color Doppler Ultrasound System is an integrated The preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 2.0 MHz to 15.0 MHz. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Indicated Patient Age Range

neonatal and adult (for Cephalic and Cardiac applications)

Intended User / Care Setting

Qualified physician

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 DUS-7000 Digital Color Doppler Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output. Laboratory tests were conducted to verify that the DUS-7000 system met all design specifications and the DUS-7000 system conformed to applicable medical device standards. Phantom test was conducted to verify that the strain Elastography function was effective and Elastography performance met design specifications, including accuracy and repeatability of strain ratio measurement and etc. The DUS-7000 system has been designed and manufactured to meet the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO10993-10, UD2, and UD3.

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

Not Found

Predicate Device(s)

K142815

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 31, 2017

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

Re: K172055

Trade/Device Name: DUS-7000 Digital Color Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: June 20, 2017 Received: July 6, 2017

Dear Dr. Millan:

We have reviewed your 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 (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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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) K172055

Device Name

DUS-7000 Digital Color Doppler Ultrasound System

Indications for Use (Describe)

The DUS-7000 Digital Color Doppler Ultrasound System is a general purpose ultrasonic imaging instruments intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Type of Use (Select one or both, as applicable)

1 Prescription Use (Part 21 CFR 801 Subpart D) — Over-The-Counter Use (21 CFR 801 Subpart C)

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3

Diagnostic Ultrasound Indications for Use Form DUS-7000 Ultrasonic Diagnostic Imaging System

Clinical Application		Mode of Operation
General (Track 1 only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Power	Combined (Specify) [1]	Other (Specify) [2]
Ophthalmic	Ophthalmic
Fetal Imaging and Other	Fetal	P	P	P		P	P	Note 1	Note 2,4,5
	Abdominal	P	P	P		P	P	Note 1	Note 2,4,5
	Intra-operative (Specify)
	Intra-operative (Neurological)
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	Note 2,4
	Small Organ (Specify) *	P	P	P		P	P	Note 1	Note 2,4,6
	Neonatal Cephalic	P	P	P		P	P	Note 1	Note 2,3,4
	Adult Cephalic	P	P	P	P	P	P	Note 1	Note 2,3,4
	Trans-rectal	P	P	P		P	P	Note 1	Note 2,4
	Trans-vaginal	P	P	P		P	P	Note 1	Note 2,4
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal (Conventional)	P	P	P		P	P	Note 1	Note 2,4
	Musculo-skeletal (Superficial)	P	P	P		P	P	Note 1	Note 2,4
	Intravascular
	Other (Ob/GYN)	P	P	P		P	P	Note 1	Note 2,4,5
	Other (Urology)	P	P	P		P	P	Note 1	Notes 2, 4
Cardiac	Cardiac Adult	P	P	P	P	P	P	Note 1	Note 2,3,4
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Note 2,3.4
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)	P	P	P	P	P	P	Note 1	Note 2,3.4
	Intra-cardiac
	Other (Specify)
Peripheral Vessel	Peripheral vessel	P	P	P		P	P	Note 1	Note 2,4
	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

Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonics, The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

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

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Diagnostic Ultrasound Indications for Use Form DUS-7000 with 2P1 Phase Array Transducer

	Clinical Application								Mode of Operation
General (Track 1
only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Power	Combined
(Specify) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
Fetal Imaging
and Other	Fetal
	Abdominal	P	P	P	P	P	P	Note 1	Notes 2, 4
	Intra-operative (Specify)
	Intra-operative (Neurological)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Adult Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Ob/GYN)
	Other(Urology)
Cardiac	Cardiac Adult	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	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

Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonics, The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ breast, thyroid, testes

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

5

Diagnostic Ultrasound Indications for Use Form DUS-7000 with 5P1 Phase Array Transducer

	Clinical Application	Mode of Operation
General (Track 1
only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Power	Combined
(Specify) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
Fetal Imaging	Fetal
and Other	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neurological)
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	Notes 2,4
	Small Organ (Specify) *
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Ob/GYN)
	Other(Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	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

Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonics, The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ breast, thyroid, testes

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

6

Diagnostic Ultrasound Indications for Use Form DUS-7000 with C613 Micro-curved Array Transducer

Clinical Application		Mode of Operation
General (Track 1
only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Power	Combined
(Specify) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
Fetal Imaging
and Other	Fetal
	Abdominal	P	P	P		P	P	Note 1	Notes 2,4
	Intra-operative (Specify)
	Intra-operative (Neurological)
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	Notes 2,4
	Small Organ (Specify) *
	Neonatal Cephalic	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	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

Note 1: Other Combined includes: B/M; B/THI; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonics, The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ breast, thyroid, testes

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

7

Diagnostic Ultrasound Indications for Use Form DUS-7000 with 6V1 Micro-Curved Array Transducer

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

Clinical Application			Mode of Operation
General (Track 1
only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Power	Combined
(Specify) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
Fetal Imaging	Fetal
and Other	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neurological)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P	P	P	P	Note 1	Notes 2,4
	Trans-vaginal	P	P	P	P	P	P	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)	P	P	P	P	P	P	Note 1	Notes 2,4
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Urology)

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

Additional comments: Combined mode: B+M

Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonics, The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ breast, thyroid, testes

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

8

Diagnostic Ultrasound Indications for Use Form DUS-7000 with 6V3 Micro-Curved Array Transducer

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

Clinical Application			Mode of Operation
General (Track 1
only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Power	Combined
(Specify) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
Fetal Imaging
and Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neurological)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	P	Note 1	Notes 2,4
	Trans-rectal	P	P	P	P	P	P	Note 1	Notes 2,4
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)	P	P	P	P	P	P	Note 1	Notes 2,4
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Urology)

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

Additional comments: Combined mode: B+M

Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonics, The feature does not use contrast agents Note 3: TDI

Note 4: 3D Note 5: 4D

Note 6: Small Organ breast, thyroid, testes

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

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Diagnostic Ultrasound Indications for Use Form DUS-7000 with EC9-5 Micro-Curved Array Transducer

	Mode of Operation
General (Track 1
only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Power	Combined
(Specify) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
Fetal Imaging	Fetal
and Other	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neurological)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	Note 1	Notes 2,4
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)	P	P	P		P	P	Note 1	Notes 2,4
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	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

Note 1: Other Combined includes: B/M; B/THI; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonics, The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ breast, thyroid, testes

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

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Diagnostic Ultrasound Indications for Use Form DUS-7000 with BCC9-5 Micro-Curved Array Transducer

Clinical Application		Mode of Operation
General (Track 1
only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Power	Combined
(Specify) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
Fetal Imaging
and Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neurological)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	Note 1	Notes 2,4
	Trans-vaginal	P	P	P		P	P	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)	P	P	P		P	P	Note 1	Notes 2,4
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	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

Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonics, The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ breast, thyroid, testes

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

11

Diagnostic Ultrasound Indications for Use Form DUS-7000 with BCL10-5 Biplane (Micro-curved + Linear Array) Transducer

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

Clinical Application			Mode of Operation
General (Track 1
only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Power	Combined
(Specify) [1]	Other
(Specify) [2][
Ophthalmic	Ophthalmic
Fetal Imaging
and Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neurological)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P	P	P	P	Note 1	Notes 2,4
	Trans-vaginal	P	P	P	P	P	P	Note 1	Notes 2,4
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)	P	P	P	P	P	P	Note 1	Notes 2,4
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Urology)

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

Additional comments: Combined mode: B+M

Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonics, The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ breast, thyroid, testes

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12

Diagnostic Ultrasound Indications for Use Form DUS-7000 with C344 Curved Array Transducer

Clinical Application		Mode of Operation
General (Track 1
only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Power	Combined
(Specify) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
Fetal Imaging
and Other	Fetal	P	P	P	P	P	P	Note 1	Note 2,4
	Abdominal	P	P	P	P	P	P	Note 1	Note 2,4
	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 (Ob/GYN)	P	P	P	P	P	P	Note 1	Note 2,4
	Other (Urology)	P	P	P	P	P	P	Note 1	Note 2,4
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	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

Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonics, The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ breast, thyroid, testes

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13

Diagnostic Ultrasound Indications for Use Form DUS-7000 with C353 Curved Array Transducer

Clinical Application		Mode of Operation
General (Track 1
only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Power	Combined
(Specify) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
Fetal Imaging
and Other	Fetal	P	P	P	P	P	P	Note 1	Notes 2,4
	Abdominal	P	P	P	P	P	P	Note 1	Notes 2,4
	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 (Ob/GYN)	P	P	P	P	P	P	Note 1	Notes 2,4
	Other (Urology)	P	P	P	P	P	P	Note 1	Notes 2,4
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	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

Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonics, The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ breast, thyroid, testes

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14

Diagnostic Ultrasound Indications for Use Form DUS-7000 with C542 Curved Array Transducer

Clinical Application			Mode of Operation
General (Track 1
only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Power	Combined
(Specify) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
Fetal Imaging
and Other	Fetal
	Abdominal	P	P	P		P	P	Note 1	Notes 2,4
	Intra-operative (Specify)
	Intra-operative (Neurological)
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1	Notes 2,4
	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 (Ob/GYN)
	Other (Urology)	P	P	P		P	P	Note 1	Notes 2,4
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	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

Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonics, The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ breast, thyroid, testes

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

15

Diagnostic Ultrasound Indications for Use Form DUS-7000 with C354 Curved Array Transducer

Clinical Application			Mode of Operation
General (Track 1
only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Power	Combined
(Specify) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
Fetal Imaging
and Other	Fetal	P	P	P	P	P	P	Note 1	Note 2,4
	Abdominal	P	P	P	P	P	P	Note 1	Note 2,4
	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 (Ob/GYN)	P	P	P	P	P	P	Note 1	Note 2,4
	Other (Urology)	P	P	P	P	P	P	Note 1	Note 2,4
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	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

Note 1: Other Combined includes: B/M; B/THI; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 5: 4D

Note 2: Tissue Harmonics, The feature does not use contrast agents

Note 3: TDI Note 4: 3D

Note 6: Small Organ breast, thyroid, testes

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

16

Diagnostic Ultrasound Indications for Use Form DUS-7000 with C322 Micro-Curved Array Transducer

		Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation
General (Track 1 only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Power	Combined (Specify) [1]	Other (Specify) [2][3]
Ophthalmic	Ophthalmic
Fetal Imaging
and Other	Fetal	P	P	P		P	P	Note 1	Notes 2,4
	Abdominal	P	P	P		P	P	Note 1	Notes 2,4
	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 (Ob/GYN)	P	P	P		P	P	Note 1	Notes 2,4
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	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

Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonics, The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ breast, thyroid, testes

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

17

Diagnostic Ultrasound Indications for Use Form DUS-7000 with VC6-2 Curved Array Transducer

Clinical Application			Mode of Operation
General (Track 1
only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Power	Combined
(Specify) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
Fetal Imaging
and Other	Fetal	P	P	P	P	P	P	Note 1	Notes 2,4,5
	Abdominal	P	P	P	P	P	P	Note 1	Notes 2,4,5
	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 (Ob/GYN)	P	P	P	P	P	P	Note 1	Notes 2,4,5
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	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

Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 5: 4D

Note 2: Tissue Harmonics, The feature does not use contrast agents

Note 3: TDI Note 4: 3D

Note 6: Small Organ breast, thyroid, testes

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18

Diagnostic Ultrasound Indications for Use Form DUS-7000 with L741 Linear Array Transducer

Clinical Application		Mode of Operation
General (Track 1 only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Power	Combined (Specify) [1]	Other (Specify) [2]
Ophthalmic	Ophthalmic
Fetal Imaging and Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neurological)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *	P	P	P	P	P	P	Note 1	Notes 2,4,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card)
	Musculo-skeletal(Conventional)	P	P	P	P	P	P	Note 1	Notes 2,4
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral Vessel	Peripheral vessel	P	P	P	P	P	P	Note 1	Notes 2,4
	Other (Urology)

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

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

Additional comments: Combined mode: B+M

Note 1: Other Combined includes: B/M; B/THI; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonics, The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ breast, thyroid, testes

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19

Diagnostic Ultrasound Indications for Use Form DUS-7000 with L742 Linear Array Transducer

Clinical Application		Mode of Operation
General (Track 1
only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Power	Combined
(Specify) [1]	Other
(Specify) [2]
Ophthalmic	Ophthalmic
Fetal Imaging
and Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neurological)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *	P	P	P	P	P	P	Note 1	Notes 2,4,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal (Conventional)	P	P	P	P	P	P	Note 1	Notes 2,4
	Musculo-skeletal (Superficial)	P	P	P	P	P	P	Note 1	Notes 2,4
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P	P	P	P	P	P	Note 1	Notes 2,4
Vessel	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

Note 1: Other Combined includes: B/M; B/THI; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonics, The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ breast, thyroid, testes

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20

Diagnostic Ultrasound Indications for Use Form DUS-7000 with L752 Linear Array Transducer

	Clinical Application	Mode of Operation
General (Track 1
only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Power	Combined
(Specify) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
Fetal Imaging
and Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neurological)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *	P	P	P	P	P	P	Note 1	Notes 2,4,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal(Conventional)	P	P	P	P	P	P	Note 1	Notes 2,4
	Musculo-skeletal (Superficial)	P	P	P	P	P	P	Note 1	Notes 2,4
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P	P	P	P	P	P	Note 1	Notes 2,4
Vessel	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

Note 1: Other Combined includes: B/M; B/THI; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonics, The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ breast, thyroid, testes

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21

Diagnostic Ultrasound Indications for Use Form DUS-7000 with 10L1 Linear Array Transducer

	Clinical Application	Mode of Operation
General (Track 1
only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Power	Combined
(Specify) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
Fetal Imaging
and Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neurological)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *	P	P	P	P	P	P	Note 1	Notes 2,4,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skeletal (Conventional)	P	P	P		P	P	Note 1	Notes 2,4
	Musculo-skeletal (Superficial)	P	P	P		P	P	Note 1	Notes 2,4
	Intravascular
	Other (Ob/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	Note 1	Notes 2,4
	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

Note 1: Other Combined includes: B/M; B/THI; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonics, The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ breast, thyroid, testes

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22

Diagnostic Ultrasound Indications for Use Form DUS-7000 with MPTEE Phased Array (Multi-Plane) Transducer

Clinical Application		Mode of Operation
General (Track 1
only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Power	Combined
(Specify) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
Fetal Imaging
and Other	Fetal
	Abdominal
	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 (Ob/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)	P	P	P		P	P	Note 1	Notes 2,3,4
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	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

Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 5: 4D

Note 2: Tissue Harmonics, The feature does not use contrast agents

Note 3: TDI Note 4: 3D

Note 6: Small Organ breast, thyroid, testes

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23

Diagnostic Ultrasound Indications for Use Form DUS-7000 with MPTEE mini Phased Array (Multi-plane) Transducer

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

	Clinical Application	Mode of Operation
General (Track 1
only)	Specific (Tracks 1&3)	B	M	PW	CW	Color	Power	Combined
(Specify) [1]	Other
(Specify) [2][3]
Ophthalmic	Ophthalmic
Fetal Imaging	Fetal
and Other	Abdominal
	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 (Ob/GYN)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)	P	P	P	P	P	P	Note 1	Notes 2,3,4
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Urology)

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

Additional comments: Combined mode: B+M

Note 1: Other Combined includes: B/M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonics, The feature does not use contrast agents

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ breast, thyroid, testes

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

24

510K SUMMARY

DUS-7000 Digital Color Doppler Ultrasound System

• ADVANCED INSTRUMENTATIONS, INC SUBMITTER 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-7000 Digital Color Doppler Ultrasound System
CLASSIFICATION NAME:	892.1550
Product Code: IYN
892.1560
Product Code: IYO
892.1570
Product Code: ITX	System, Imaging, Pulsed Doppler, Ultrasonic
Ultrasonic, Pulsed Echo, Imaging
Transducer, Ultrasonic, Diagnostic
REGULATORY CLASS:	Class II
PANEL IDENTIFICATION	Radiology

DEVICE DESCRIPTION

DUS-7000 Digital Color Doppler Ultrasound System is an integrated The preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 2.0 MHz to 15.0 MHz. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.

25

Indications for Use: The DUS-7000 Digital Color Doppler Ultrasound System is a general purpose ultrasonic imaging instruments intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Predicate Devices: The proposed system is equivalent to the Sonoscape S22 ultrasound system (K142815).

Comparison with the Predicate Devices [21 CFR 807.92(a) (6)]

The DUS-7000 Digital Color Doppler Ultrasound System is comparable with and substantially equivalent to the Sonoscape S22 Digital Color Doppler Ultrasound System. Compared with the Sonoscape S22, the Subject Device DUS-7000 has the same intended uses.

Technical Characteristics Comparison:

The basic and main technical features of the subject device DUS-7000 are the same as the predicated device S22 including Design, Operation Controls, Display Modes, Measurement Items, Cine Loop and Operating and Storage Condition.

Probes Comparison:

Subject device DUS-7000 has the similar probes as the predicated device Sonoscape S22.

DUS-7000	SONOSCAPE S22	REMARK
C322 Micro-curved Array	C322 Micro-curved Array	SAME
C344 Curved Array	C344 Curved Array
C353 Curved Array	C353 Curved Array
C354 Curved Array	C354 Curved Array
C542 Curved Array	C542 Curved Array
VC6-2 Curved Array	VC6-2 Curved Array	SAME
C613 Micro-curved Array	C613 Micro-curved Array	SAME
2P1 Phased Array	2P1 Phased Array	SAME
5P1 Phased Array	5P1 Phased Array
L741 Linear Array	L741 Linear Array	SAME
L742 Linear Array	L742 Linear Array
L752 Linear Array	L752 Linear Array
10L1 Linear Array	10L1 Linear Array
6V1 Micro-curved Array	6V1 Micro-curved Array	SAME
6V3 Micro-curved Array	6V3 Micro-curved Array
EC9-5 Micro-curved Array	EC9-5 Micro-curved Array
BCC9-5 Micro-curved Array	BCC9-5 Micro-curved Array
BCL10-5 Biplane (Micro-curved	BCL10-5 Biplane (Micro-curved
+ Linear Array)	+ Linear Array)

Table 1 Probes Comparison

26

MPTEE Phased Array
(Multi-plane)
MPTEE mini Phased Array
(Multi-plane)

EFFECTIVENESS AND SAFETY CONSIDERATIONS

Clinical Test:

Clinical testing is not required.

Non-clinical Test:

The DUS-7000 Digital Color Doppler Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output. Laboratory tests were conducted to verify that the DUS-7000 system met all design specifications and the DUS-7000 system conformed to applicable medical device standards. Phantom test was conducted to verify that the strain Elastography function was effective and Elastography performance met design specifications, including accuracy and repeatability of strain ratio measurement and etc. The DUS-7000 system has been designed and manufactured to meet the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO10993-10, UD2, and UD3.

Substantially Equivalent Determination

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, thus no new question is raised regarding the safety and effectiveness. In accordance with the 21 CFR Part 807 and based on the information provided in this premarket notification, Advanced Instrumentations concludes that the DUS-7000 Digital Color Doppler Ultrasound System is substantially equivalent to the predicate devices with regards to safety and effectiveness.