The diagnostic ultrasound system (DUS-5000) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), transvaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.

Device Description

The DUS-5000 Diagnostic Ultrasound System, which applies advanced technologies such as Phased Inversion Harmonic Compound Imaging (eHCI), Multi-Beam-Forming (mBeam), Speckle Resistance Imaging (eSRI), and Spatial Compounding Imaging, etc. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in B-mode, M-mode, PW-mode, Color-mode, PDI/DPDI mode. This system provides a series of probes that include linear array, convex array, micro-convex array with a frequency range of approximately 2.5 MHz to11 MHz.

AI/ML Overview

The DUS-5000 Diagnostic Ultrasound System is a medical device intended for diagnostic ultrasound imaging and fluid flow analysis. The acceptance criteria and the study proving the device meets these criteria are outlined below, derived from parts {0} through {15} of the provided text.

Based on the provided information, clinical testing was not required for this device, as stated in section {2}. This implies that the device's performance was evaluated through non-clinical means and comparison to a predicate device. Therefore, details regarding test sets, ground truth establishment, expert adjudication, or MRMC studies for clinical performance are not available in this document. The "acceptance criteria" in this context refer to the successful completion of non-clinical safety and performance standards and demonstrating substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Given that clinical testing was not required, the acceptance criteria are primarily related to non-clinical safety and performance standards, and comparison to the predicate device. The performance is assessed by confirming the device meets these standards and functions identically or equivalently to the predicate.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Non-clinical Safety Standards	IEC 60601-1: Electrical Safety	Subject device has successfully completed these standards.
	IEC 60601-1-2: Electromagnetic Compatibility	Subject device has successfully completed these standards.
	Acoustic Output Testing (per FDA guidance Sep 9, 2008)	Subject device has successfully completed these standards.
	ISO 10993-1, ISO 10993-5, ISO 10993-10 (Biocompatibility)	Subject device has successfully completed these standards.
Comparison to Predicate Device (K123249)	Identical Technology Characteristics	Confirmed to be identical.
	Same Intended Use	Confirmed to be the same.
	Same Product Design	Confirmed to be the same.
	Same Materials and Manufacturing Process	Confirmed to be the same.
	Same Performance Effectiveness	Confirmed to be the same.
	Same Performance Safety	Confirmed to be the same.
	Same Needle-Guide Bracket Material, Property, Sterilization Methods	Confirmed to be the same.
Functional Equivalence	Acquire and display Ultrasound images in B-mode, M-mode, PW-mode, Color-mode, PDI/DPDI mode across various probes	Confirmed ({"Its function is to acquire and display Ultrasound images in B-mode, M-mode, PW-mode, Color-mode, PDI/DPDI mode."})
Frequency Range	Probes with frequency range of approximately 2.5 MHz to 11 MHz	Confirmed ({"This system provides a series of probes that include linear array, convex array, micro-convex array with a frequency range of approximately 2.5 MHz to11 MHz."})
Clinical Applications (General)	Abdominal, Obstetrics, Gynecology, Pediatric, Small Parts, Urology, Peripheral Vascular, Musculoskeletal, Transvaginal, Cardiac	All listed applications supported by the device (P = previously cleared) as explicitly or implicitly covered in the Indications for Use forms for the various transducers. Specifically, the DUS-5000 is "applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), transvaginal and cardiac clinical applications" (as per section {1}).

2. Sample size used for the test set and the data provenance

Since clinical testing was not required (section {2}), there is no mention of a clinical "test set" in terms of patient data or provenance. The "test set" in this context refers to the device itself undergoing non-clinical technical evaluations and comparisons to the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as clinical testing was not required (section {2)} and no expert-based ground truth establishment for clinical performance is reported. The "ground truth" for the non-clinical evaluations would be the established engineering and biocompatibility standards themselves.

4. Adjudication method for the test set

Not applicable, as clinical testing was not required (section {2)} and no clinical test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is a diagnostic ultrasound system and not explicitly stated to be an AI-assisted device. Furthermore, clinical testing was not required (section {2}), so no MRMC study or AI assistance evaluation was conducted or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as the device is a diagnostic ultrasound system, not an algorithm-only device. Additionally, clinical testing was not required (section {2)}.

7. The type of ground truth used

For non-clinical evaluation, the "ground truth" is established through adherence to national and international safety standards (e.g., IEC 60601-1, IEC 60601-1-2, Acoustic Output Guidelines, ISO 10993 series) and by demonstrating identical or equivalent performance to the legally marketed predicate device (Model U50 Diagnostic Ultrasound System, K123249).

8. The sample size for the training set

Not applicable, as clinical testing was not required (section {2}). This device is a diagnostic ultrasound system, and the submission does not mention machine learning or AI components that would typically require a training set of data.

9. How the ground truth for the training set was established

Not applicable, as clinical testing was not required (section {2}), and no training set is mentioned.

Summary

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

DUS-5000 Diagnostic Ultrasound System

page 1 of 3

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 21 CFR 807.92.

The assigned 510(k) number is:

Submitter

Advanced Instrumentations, Inc. 6800 N.W. 77th Court Miami, Fl 33166 Telephone: 305-477-6331 305-477-5351 Fax:

Registration # 1066270

Official correspondent :

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

Date Prepared:

OCT 25 2013

October 24, 2013

Device name and classification:

DUS-5000 Diagnostic Ultrasound System Device Name: .
Classification Name: 892.1550 System, Imaging, Pulsed Doppler Ultrasonic 0 Product code: IYN 892.1560 Ultrasonic, Pulsed echo, Imaging Product code: IYO 892.1570 Transducer, Ultrasonic, Diagnostic Product code: ITX

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

Regulatory Class: Class II .

Predicate Device:

Model U50 Diagnostic Ultrasound System, K123249 Manufacturer: EDAN Instruments

Device Description:

Its function is to acquire and display Ultrasound images in B-mode, M-mode, PW-mode, Color-mode, PDI/DPDI mode. This system provides a series of probes that include linear array, convex array, micro-convex array with a frequency range of approximately 2.5 MHz to11 MHz.

Intended Use:

Effectiveness and Safety Contraindications:

Clinical Test

Clinical testing is not required

Non-clinical test:

{2}------------------------------------------------

K132059
Page 3 of 3

The following safety standards are conducted on the subject device:

1. IEC 60601 -1 Electrical Safety
1. IEC 60601-1-2 Electromagnetic Compatibility
1. Acoustic output testing as per the quideline "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 identical technology characteristics, same intended use, same product design, materials and manufacturing process, as well as same performance effectiveness, performance safety and the same needle-guide bracket material, property and sterilization methods as the predicate device.

Substantially Equivalent Determination:

This premarket notification submission demonstrates that DUS-5000 Diagnostic Ultrasound System is substantially equivalent to the predicate device.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the HHS emblem, which is a stylized representation of a human figure embracing the world. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem. The emblem is black and the text is also black.

Public Health Service

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

October 25, 2013

Advanced Instrumentations, Inc. % Jorge Millan, Ph.D. Official Correspondent Hialeah Technology Center, Inc. 601 West 20 Street HIALEAH FL 33010

Re: K132059

Trade/Device Name: DUS-5000 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 8, 2013 Received: October 10, 2013

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.

This determination of substantial equivalence applies to the following transducers intended for use with the DUS-5000 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

C352UB	E612UB	C422UB
L1042UB	C612UB	L552UB
L742UB	C6152UB

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.

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

Page 2-Dr. Millan

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.lda.gov/MedicalDevices/Safets/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Imgur

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Advanced Instrumentations DUS-5000 Diagnostic Ultrasound System 510K Submission

Indications for Use

510(k) Number (if known): K132059

Device Name: DUS-5000 Diagnostic Ultrasound System

Intended Use:

The diagnostic ultrasound system (DUS-5000) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vasculoskeletal (conventional and superficial), transvaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.

Or Over the Counter Use _ Prescription Use (21 CFR Part 801 Subpart D)

(21 CFR Part 801 Subpan C)

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Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

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

ﺮ ﺩﺭ

Diagnostic Ultrasound Indications for Use Form

DUS-5000 Diagnostic Ultrasound System

Intended Use: Diagnostic ultrasound imaging or Nuid flow analysis of the human body as follows:

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined(Specify) [1]	Other(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics	P	P	P		P	P	P
	Abdominal	P	P	P		P	P	P
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Specify) *	P	P	P		P	P	P
FetalImaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	P	P	P		P	P	P
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P		P	P	P
	Musculo-skeletal (Superficial)	P	P	P		P	P	P
	Intravascular
	Other (Specify) **	P	P	P		P	P	P
	Adult Cardiac	P	P	P		P	P	P
Cardiac	Pediatric Cardiac	P	P	P		P	P	P
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular	P	P	P		P	P	P
vascular	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDV/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breas Nole

** Other use includes Urology, Kidney, Gynecology -

111:PDI: Power Doppler Imaging , DPDI; Directional Power Doppler Imaging

(2); Biopsy Gujdance

[3]; Harmonic Imaging, This feature does not use contrast agent.

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Concurrence of CDRH: Office of In Vitro Diugnostics and Radiological Health (OIR)

Prescription Use (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form

DUS-5000 with C352UB Transducer

Intended Use: Diagnostic ultrasound imaging or theid flow analysis of the human body as follows:

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined(Specify) [1]	Other(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics	P	P	P		P	P	P
	Abdominal	P	P	P		P	P	P
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
FetalImaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **	P	P	P		P	P	P
	Adult Cardiac
Cardiac	Pediatric Cardiac
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular
vascular	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M. B+PW. B+Color, B+PDI/DPDI, B+Color+PW, I}+PDI/DPDJ +PW * Small Organ includes Thyroid, Testes, Breast |Cleured applications under K123249 Note

** Qther use includes Urology, Kidney, Gynecology

[1]: PDI: Power Doppler Imaging , DPDI: Directional Power Doppler Imaging

[2]: Bionsy Guidance

[3]; Harmonic Imaging, This feature does not use contrast agent.

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Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription Use (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form

DUS-5000 with L1042UB
Transducer

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined(Specify)1	Other(Specify)23
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *	P	P	P	P	P	P	P
FetalImaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal (Conventional)	P	P	P	P	P	P	P
	Musculo-skeletal (Superficial)	P	P	P	P	P	P	P
	Intravascular
	Other (Specify) **
	Adult Cardiac
Cardiac	Pediatric Cardiac
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheralvascular	Peripheral vascular	P	P	P	P	P	P	P
vascular	Other (Specify)

N = new indication: P = previously cleared by FDA: E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, 13+PDV/DPDI, B+Color+PW, B+PDI/DPDI +PW · Small Organ includes Thyroid, Testes, Breast |Cleared applications under_ K123249___________________________________________________________________________________________ Note

· Other use includes Urology, Kidney, Gynecology

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------111: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging
121: Bionsv Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

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Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription Use (Pcr 21 CFR 801.109)

6-4

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

DUS-5000 with L742UB Transducer

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined(Specify)[1]	Other(Specify)[2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
FetalImaging& Other	Small Organ (Specify) *	P	P	P	P	P	P	P
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal (Conventional)	P	P	P	P	P	P	P
	Musculo-skeletal (Superficial)	P	P	P	P	P	P	P
	Intravascular
	Other (Specify) **
	Adult Cardiac
	Pediatric Cardiac
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheralvascular	Peripheral vascular	P	P	P	P	P	P	P
	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW · Small Organ includes Thyroid, Testes, Breast (Cleared applications under K123249_ Nore

** Other use includes Urology, Kidney, Gynecology

111: PD1: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging 12): Biopsy Guidance

131: Harmonic Imaging, This feature does not use contrast agent

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Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription Use (Pcr 21 CFR 801,109)

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DUS-5000 with E612UB Transducer

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined (Specify) [1]	Other (Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
Fetal	Neonatal Cephalic
Imaging	Adult Cephalic
& Other	Trans-rectal
	Trans-vaginal	P	P	P		P	P	P
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **
	Adult Cardiac
	Pediatric Cardiac
Cardiac	Intravascular(Cardiac)
	Trans-csoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular
vascular	Other (Specify)

N = new indication: P = previously cleared by FDA: E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M. B+PW. B+Color, B+P()//DPD). B+Color+PW. B+PD)//DPDI +PW * Small Organ includes Thyroid, Testes, Breast |Cleared applications under_K123249_ Nolc

** Other use includes Urology, Kidney, Gynecology

ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ [ I ]: PDI: Power Doppler Imaging , DPD]; Directional Power Doppler Imaging

[2]: Biopsy Guidance

[3]: Harmonic Jmaging, This feature does not use contrast agent.

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Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription Use (Per 21 CFR 801.109)

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Diagnostic Ultrasound Indications for Use Form

DUS-5000 with C612UB Transducer

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined(Specify) 111	Other(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	l.aparoscopic
	Pediatric	P	P	P	P	P	P	P
	Small Organ (Specify) *
FetalImaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **
	Adult Cardiac
	Pediatric Cardiac	P	P	P	P	P	P	P
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheralvascular	Peripheral vascular
	Other (Specify)

N = new indication; P = previously cicared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M. B+PW. B+Color, B+PDI/DPDI. B+Color+PW. B+PDJ/DPDI +PW * Small Organ includes Thyroid, Testes, Breast (Cleared applications under K123249____________________________________________________________________________________________ Nole

** Other use includes Unplogy, Kidney, Gynecology

11): PDI: Power Doppler Imaging ,DPI)); Directional Power Doppler Imaging , commen

121: Biopsy Guidance

[3]; Harmonic Imaging, This feature does not use contrast agent.

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Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription Use (Per 21 CFR 801.109) -

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DUS-5000 with C6152UB Transducer

	Clinical Application	Mode of Operation
General	Specific	િ	M	PW	C.W	Color	Combined(Specify)	Other(Specify) ואנג
Ophthalmic	Ophthalmic
	Fetal / Obsteiries
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Specify) *
Fetal	Neonatal Cephalic
Imaging	Adult Cephalic
& Other	Trans-rectal
	Trans-vaginal
	Trans-urcthral
	Musculo-skeletal(Conventional)
	Musculo-skelctal (Superficial)
	Intravascular
	Other (Specify) **
	Adult Cardiac
	Pediatric Cardiac	P	P	ાંગ		P	p	P
Cardiac	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular
vascular	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Dopply: Imaging Additional comments: Combined mode: B+M. B+PW, B+Color, B+PDI/DPDI、B+Color+PW. B+PDI/DPDI +PW · Small Organ includes Thyroid, Testes, Breast |Cleared applications under K123248___ Note

** Other use includes Urology, Kidney, Gynccology

[1]: PDI: Power Doppler Imaging, DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance

131: Harmonic Imaging, This feature does not use contrast agent.

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Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription Use (Per 21 CFR 801.109)

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Diagnostic Ultrasound Indications for Use Form

DUS-5000 with C422UB Transducer

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined(Specify) [1]	Other(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal	P	P	P	P	P	P	P
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
FetalImaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **
	Adult Cardiac	P	P	P	P	P	P	P
	Pediatric Cardiac
Cardiac	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra- cardiac
Peripheralvascular	Peripheral vascular
	Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M. B+PW, B+Color, B+PDI/DPDI. B+Color+PW. B+PDI/DPDI +PW * Small Organ includes Thyroid. Testes, Breast ICleared applications under_K123249_ Note -

** Other use includes Urology, Kidney, Gynecology,

[]]: PDI: Power Doppler Imaging .DPDI: Directional Power Doppler Imaging

[2]; Bjopsy Guidance _________________________________________________________________________________________________________________________________________________________ -

[3]: Harmonic Imaging, This feature does not use contrast agent,

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (O!R)

Prescription Use (Per 21 CFR 801.109)

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

DUS-5000 with L552UB Transducer

	Clinical Application	Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined(Specify) [1]	Other(Specify) [2][1][3]
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric	P	P	P		P	P	P
	Small Organ (Specify) *		P	P	P		P	P
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal (Conventional)	P	P	P		P	P	P
	Musculo-skeletal (Superficial)	P	P	P		P	P	P
	Intravascular
	Other (Specify) **
Cardiac	Adult Cardiac
	Pediatric Cardiac
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular	P	P	P		P	P	P
vascular	Other (Specify)

N = new indication; P = previously cleared by FDA: E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M. B+PW. B+Color, B+PDI/DPDI. B+Color+PW. B+PDJ/DPD) +PW · Small Organ includes Thyroid, Testes, Breast |Cleared applications under K123249 Note

** Other use includes Urology, Kidney, Gynecology

・ 111: PD1: Power Doppler Imaging JDPDI: Directional Power Doppler Imaging

12): Biopsy Guidance

[3]: Harmonic Imaging, This feature does not use contrast agent.

(PLEASE DO NOT WRITE BELOW THIS LINE: - CONTINUI: ON ANOTHIER PAGE IF NEEDED)

Concurrence of CDRH; Office of in Vitro Diagnostics and Radiological Health (OIR)

Prescription Use (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form

DUS-5000 with LS52UB Transducer

Clinical Application		Mode of Operation
		B	M	PW	CW	Color	Combined(Specify)1	Other(Specify)2,3
General	Specific
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P
	Small Organ (Specify) *	P	P	P	P	P	P	P
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	P	P	P	P	P	P	P
	Musculo-skeletal (Superficial)	P	P	P	P	P	P	P
	Intravascular
	Other (Specify) **
Cardiac	Adult Cardiac
	Pediatric Cardiac
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra- cardiac
Peripheralvascular	Peripheral vascular	P	P	P	P	P	P	P
	Other (Specify)

** Other use includes Urology, Kidney, Gynecology.

11): PDI: Power Doppler Imaging JDPDI: Directional Power Doppler Imaging

[2] Biopsy Guidance

131: Harmonic Imaging, This feature does not use contrast agent.

(PLEASE DO NOT WRITE BIELOW THIS LINE: - CONTINUI: ON ANDTHIER PAGIE IF NI!!!!)]!!))

Concurrence of CDRH: Office of In Vitro Diagnostics and Radiological Health (OIR)

Prescription Use (Per 21 CFR 801.109)

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.