The diagnostic ultrasound system (DUS 60) 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 clinical applications, by or on the order of a physician or similarly qualified health care professional.

Device Description

The DUS 60 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, etc. 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 present the returned echo information on the monitor; which can be displayed in the following modes: B/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.

AI/ML Overview

The provided 510(k) summary does not contain information about a study with acceptance criteria and device performance metrics in the way typically associated with AI/ML-driven device evaluations (e.g., sensitivity, specificity, accuracy).

Instead, this submission for the Edan Instruments DUS 60 Digital Ultrasonic Diagnostic Imaging System focuses on Substantial Equivalence to legally marketed predicate devices. The "effectiveness and safety considerations" are primarily based on non-clinical tests and a comparison to predicate devices, asserting that its design and performance are similar.

Therefore, the sections of your request related to acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this specific 510(k) submission.

Here's a breakdown of the information that is available in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance
Electrical Safety	Compliance with IEC 60601-1	Device is conducted on IEC 60601-1 (implying compliance, though specific results are not provided).
Electromagnetic Compatibility	Compliance with IEC 60601-1-2	Device is conducted on IEC 60601-1-2 (implying compliance).
Ultrasonic Safety & Essential Performance	Compliance with IEC 60601-2-37	Device is conducted on IEC 60601-2-37 (implying compliance).
Acoustic Output	Compliance with FDA guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (Sept 9, 2008)	Acoustic output testing as per the guideline (implying compliance). Specific output levels are not provided.
Biocompatibility	Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10	Device is conducted on ISO 10993-1, ISO 10993-5, and ISO 10993-10 (implying compliance), particularly for needle-guide bracket material.
Intended Use & Design	Same intended use and similar product design as predicate devices.	The subject device has "same intended use, similar product design" as predicate devices.
Performance Effectiveness & Safety	Same performance effectiveness and safety as predicate devices. Differences do not affect basic design principles, usage, effectiveness, or safety.	The subject device has "same performance effectiveness, performance safety as the predicate devices." Differences "do not affect" these.

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

Not applicable. The submission states: "Clinical test: Clinical testing is not required." The evaluation is based on non-clinical testing and comparison to predicate devices, not on a clinical test set with patient data for performance evaluation.

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

Not applicable. No clinical test set or ground truth established by experts is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set or adjudication process is mentioned.

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:

No. This device is a diagnostic ultrasound imaging system, not an AI-assisted diagnostic tool described in the typical sense of a MRMC study for AI. The submission does not mention any AI component or human-in-the-loop performance improvement study.

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

No. This is a hardware device (ultrasound system), not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. No clinical ground truth is mentioned. The ground for "equivalence" is based on adherence to safety and performance standards, and comparison of technical specifications and intended use with predicate devices.

8. The sample size for the training set:

Not applicable. This submission does not describe an AI/ML device requiring a training set.

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

Not applicable. This submission does not describe an AI/ML device requiring a training set or ground truth establishment.

In summary: This 510(k) submission for the DUS 60 Digital Ultrasonic Diagnostic Imaging System demonstrates substantial equivalence through adherence to recognized electrical, safety, acoustic, and biocompatibility standards, and by affirming that its intended use and general design principles are the same as previously cleared predicate devices. It does not involve or require clinical performance studies, AI/ML components, or associated analyses like those requested in your prompt.

Summary

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K13/1830
page 1 of 3

510(k) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Edan Instruments. Inc. 1. Submitter:
3/F-B. Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou, Nanshan Shenzhen, 518067 P.R. China

EP 1 7 2013

Tel .: +86 75526856469 Fax: +86 75526882223

Contact Person: Cherry Sun

June 13th, 2013

Device Name:

Device name and classification:

Prepare date:

Digital Ultrasonic Diagnostic Imaging System, Model DUS 60

Classification Name:

System, Imaging, Pulsed echo, Ultrasonic 892.1560

Product code: IYO

Transducer, Ultrasonic. Diagnostic 892.1570

Product code: ITX

Regulatory Class: Class Il

Predicate Device:

M5 Diagnostic Ultrasound System K 102991 Manufacturer: Shenzhen Mindrav Bio-Medical Electronics Co., Ltd. DC-6 Diagnostic Ultrasound System K072164 Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. U50 Diagnostic Ultrasound System. K123249 Manufacturer: SHENZHEN EDAN INSTRUMENTS CO., LTD

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K131830
Page 2 of 3

4. DeviceDescription:	The DUS 60 is a portable Diagnostic Ultrasound System, which appliesadvanced technologies such as Phased Inversion Harmonic CompoundImaging (eHCI), Double-Beam-Forming (D Beam), Speckle ResistanceImaging(eSRI), scan receiving aperture(SRA) and SpatialCompounding Imaging, etc. Various image parameter adjustments, 12.1inch LCD and diverse probes are configured to provide clear and stableimages. It is intended for diagnostic ultrasound imaging analysis inhospitals and clinics.
	It is designed to produce ultrasound waves into body tissue and presentthe returned echo information on the monitor; which can be displayed inthe following modes: B/2B/4B-Mode, M-Mode, B+M Mode or PWMode. Supported probe types include convex, linear, micro-convex,endocavity (transvaginal, endorectal) probes. The device can detect theprobe automatically.
	The system consists of 7 major functional blocks, including a main unit,a display subsystem, a transducer and transceiver subsystem, digitalbeamformer, keyboard and power subsystem.
5. Intended Use:	The diagnostic ultrasound system (DUS 60) 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 clinical applications, by or on the order of a physician or similarly qualified health care professional.

6. 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.

(5) ISO 10993-1, ISO 10993-5 and ISO 10993-10 Biological evaluation of medical devices

7.Comparison to the predicate device

The subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate devices. The differences between the subject

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

K131830
Page 3 of 3

device and predicate devices do not affect the basic design principle, usage, effectiveness and safety of the subject device. And they don't affect the former's effectiveness and safety.

The subject device has the same needle-guide bracket material, property, and sterilization methods as those of the predicate device U50, therefore, the needle-guide bracket will not cause any safety and effectiveness issues.

8. Substantially Equivalent Determination

Verification and validation testing was conducted on the DUS 60 Digital Ultrasonic Diagnostic Imaging System. This premarket notification submission demonstrates that DUS 60 Digital Ultrasonic Diagnostic Imaging System is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three angled shapes that resemble a person with outstretched arms, representing health and well-being.

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

September 17, 2013

Edan Instruments, Inc. % Ms. Cherry Sun Certification Engineer 3/F - B, Nanshan Medical Equipments Park Nanhai Road 1019#, Shekou, Nanshan Shenzhen, 518067 CHINA

Re: K131830

Trade/Device Name: Digital Ultrasonic Diagnostic Imaging System, Model DUS 60 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: June 7, 2013 Received: June 20, 2013

Dear Ms. Sun:

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 60 Digital Ultrasonic Diagnostic Imaging System, as described in your premarket notification:

Transducer Model Number

C361-2	C363-2	C341-2
L741-2	L743-2	L761-2
C611-2	E741-2	E611-2

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

hup://www.fda.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.fda.gov/MedicalDevices/Safety/ReportaProblem/dcfault.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/Resourcesfor You/Industrv/default.htm.

Sincerely yours,

Sm.h.7)

for

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

Enclosure

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Indications for Use Statement

510(k) Number K131830

Device Name: Digital Ultrasonic Diagnostic Imaging System, Model DUS 60

Intended Use:

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Smh. 7)

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

510(k) Number K131830

Page 1 of

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Diagnostic Ultrasound Indications for Use Form

DUS 60 Digital Ultrasonic Diagnostic Imaging System |

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

Clinical Application		Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined (Specify)	Other (Specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal / Obstetrics	N	N	N			N	Note 1,2
	Abdominal	N	N	N			N	Note 1.2
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric	N	N	N			N	Note 1.2
	Small Organ (Specify) *	N	N	N			N	Note 1.2
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N			N	Note 1,2
	Trans-vaginal	N	N	N			N	Note 1,2
	Trans-urethral
	Musculo-skeletal (Conventional)	N	N	N			N	Note 1.2
	Musculo-skeletal (Superficial)	N	N	N			N	Note 1.2
	Intravascular
	Other (Specify) **	N	N	N			N	Note 1.2
Cardiac	Cardiac	N	N	N			N	Note 1,2
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra- cardiac
Peripheralvascular	Peripheral vascular	N	N	N			N	Note 1,2
	Other (Specify)

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 agent. ..........................................................................................................

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Prescription Use (Per 21 CFR 801.109)

the submit and the submit of the subject of the subject of

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

Diagnostic Ultrasound Indications for Use Form

DUS 60 with C361-2 Transducer

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

	Clinical Application		Mode of Operation
	General	Specific	B	M	PW	CW	Color	Combined (Specify)	Other (Specify)
Ophthalmic		Ophthalmic
FetalImaging& Other		Fetal / Obstetrics	N	N	N			N	Note 1,2
		Abdominal	N	N	N			N	Note 1.2
		Intra-operative (Specify)
		Intra-operative (Neuro logical)
		Laparoscopic
		Pediatric
		Small Organ (Specify) *
		Neonatal Cephalic
		Adult Cephalic
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Musculo-skeletal (Conventional)
		Musculo-skeletal (Superficial)
		Intravascular
		Other (Specify) **	N	N	N			N	Note 1,2
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

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

Small Organ includes thyroid

** Other use includes Urology ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Note 1: Biopsy Guidance ្រី នាន មួយច្រើន ស្រុក ស្រុក ក្រោយ ស្រុក ក្រោយ ស្រុក ក្រោយ និង ប្រយោជន៍ និង ប្រ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Note 2: 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 Diagnostic Device Evaluation and Safety (OIVD) Prescription Use (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form

DUS 60 with C363-2 Transducer

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

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

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 agent - - - t man

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

Concurrence of CDRH. Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Prescription Use (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form

DUS 60 with C341-2 Transducer

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

Clinical Application		Mode of Operation
General	Specific	િ	M	PW	CW	Color	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal / Obstetrics	N	N	N			N	Note 1,2
	Abdominal	N	N	N			N	Note 1.2
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
Fetal	Neonatal Cephalic
Imaging& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **	N	N	N			N	Note 1.2
	Cardiac
	Intravascular(Cardiac)
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

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

Small Organ includes thyroid ______________________________________________________________________________________________________________________________________________________________________________

** Other use includes Urology ------------------------------------------------------------------------------------------------------------------------------------------------

Note 2: 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 Diagnostic Device Evaluation and Safety (OIVD)

Prescription Use (Per 21 CFR 801.109)

{10}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

DUS 60 with L741-2 Transducer

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

Clinical Application		Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
FetalImaging& Other	Small Organ (Specify) *	N	N	N			N	Note 1.2
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	N	N	N			N	Note 1.2
	Musculo-skeletal (Superficial)	N	N	N			N	Note 1.2
	Intravascular
	Other (Specify) **
Cardiac	Cardiac
	Intravascular(Cardiac)
	Trans-esoph. (Cardiac)
	Intra- cardiac
Peripheralvascular	Peripheral vascular	N	N	N			N	Note 1.2
	Other (Specify)

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	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	and and the commend of the comments of the comments of the comments of the comments of		------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Note 1: Biopsy Guidance

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

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

Concurrence of CDRH, Office of in Vitro Diagnostic Device Evaluation and Safety (OIVD)

Prescription Use (Per 21 CFR 801.109)

and the state of the state of the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the s

and the control control control control controllers and the controlled

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

Diagnostic Ultrasound Indications for Use Form

DUS 60 with L743-2 Transducer

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

Clinical Application		Mode of Operation
General	Specific	B	M .	PW	CW	Color	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic

	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *	N	N	N			N	Note 1.2
Fetal	Neonatal Cephalic
İmaging	Adult Cephalic
& Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	N	N	N			N	Note 1.2
	Musculo-skeletal (Superficial)	N	N	N			N	Note 1.2
	Intravascular
	Other (Specify) **
	Cardiac
	Intravascular(Cardiac)
Cardiac	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular	N	N	N			N	Note 1.2
vascular	Other (Specify)

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 agent

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Prescription Use (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form

DUS 60 with L761-2 Transducer

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

Clinical Application		Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *	N	N	N			N	Note 1.2
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	N	N	N			N	Note 1,2
	Musculo-skeletal (Superficial)	N	N	N			N	Note 1.2
	Intravascular
	Other (Specify) **
Cardiac	Cardiac
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheralvascular	Peripheral vascular	N	N	N			N	Note 1,2
	Other (Specify)

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Prescription Use (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form

DUS 60 with C611-2 Transducer

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

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

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 agent

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Prescription Use (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form

DUS 60 with E741-2 Transducer

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

Clinical Application		Mode of Operation
General	Specific	B	M	PW	CW	Color	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N			N	Note 1.2
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **
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

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 agent

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Prescription Use (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form

DUS 60 with E611-2 Transducer

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

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

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 agent

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Prescription Use (Per 21 CFR 801.109)

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.