The D3 and D6 Digital Ultrasonic Diagnostic Imaging System are applicable for adult or children ultrasound evaluation in hospitals, clinics, gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms The D3 and D6 are intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus; Abdomen; Pediatrics; Small Organ; Neonatal head; Cardiology; Peripheral Vessel; Musculo-skeleton (both Conventional and Superficial); Urology (including prostate); Transrecta and Transvagina.

Device Description

D3 and D6 Digital Ultrasound Diagnostic Imaging System is a portable digital ultrasonic diagnostic system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications.

It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor, the resulting information is displayed in five display modes: B-Mode, 2B-Mode, 4B-Mode, M-Mode, B+M Mode. This system controlled by software is a Track 1 device that employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.0MHz-10.0MHz.

The system consists of a main unit, transducers and other accessories.

AI/ML Overview

The provided 510(k) submission for the "Digital Ultrasonic Diagnostic Imaging System, Models D3 and D6" does not contain acceptance criteria or a study proving the device meets specific performance criteria in terms of diagnostic accuracy or effectiveness.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Digital Ultrasonic Diagnostic Imaging System, K091680 from Edan Instruments, Inc.) based on:

Similar technology characteristics: The current device has similar design principles and electrical classification.
Same intended use: The indications for use are the same as the predicate device.
Non-clinical testing: This primarily involves compliance with various safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 10993-5, ISO 10993-10) and acoustic output testing.

The document explicitly states: "Clinical test: Clinical testing is not required." This means there was no study performed to establish diagnostic performance metrics (like sensitivity, specificity, accuracy) against a ground truth for the purpose of this 510(k) submission.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be provided from this document.

Here's what can be extracted based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Similar technology characteristics to predicate device (K091680)	Similar design principle, electrical classification, and accuracy as the predicate device (K091680). Differences (physical specifications, display type/mode) do not affect usage, safety, or effectiveness.
Same intended use as predicate device (K091680)	Intended for ultrasound evaluation of Fetus, Abdomen, Pediatrics, Small Organ, Neonatal head, Cardiology, Peripheral Vessel, Musculo-skeleton (Conventional and Superficial), Urology (including prostate), Transrectal, and Transvaginal, identical to the predicate.
Compliance with Electrical Safety Standard	Compliant with IEC 60601-1.
Compliance with Electromagnetic Compatibility Standard	Compliant with IEC 60601-1-2.
Acoustic Output Testing	Compliant with the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008. Also compliant with UD-2, IEC 60601-2-37.
Biocompatibility Testing	Compliant with ISO 10993-1, ISO 10993-5, and ISO 10993-10.

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

Not applicable / Not provided. The submission explicitly states "Clinical test: Clinical testing is not required." for this submission. The evaluation was based on non-clinical engineering tests and comparison to a predicate device.

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

Not applicable / Not provided. No clinical test set or ground truth was established for this 510(k) submission.

4. Adjudication method for the test set:

Not applicable / Not provided. No clinical test set requiring adjudication was used.

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 is a submission for a general diagnostic ultrasound system, not an AI-powered diagnostic tool. Clinical testing was also explicitly stated as "not required."

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

No. This device is a digital ultrasound imaging system, not a standalone algorithm.

7. The type of ground truth used:

Not applicable / Not provided. For this 510(k) submission, the "ground truth" was the performance and safety established for the predicate device, against which the new device was deemed substantially equivalent through engineering and non-clinical testing.

8. The sample size for the training set:

Not applicable / Not provided. This is an ultrasound imaging system, not an AI/Machine Learning device that utilizes a training set for model development in the context of diagnostic accuracy.

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

Not applicable / Not provided. See explanation for #8.

Summary

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Digital Ultrasonic Diagnostic Imaging System
510K Submission

OCT 12 2012

Section 5- 510(k) Summary of Safety and Effectiveness

Prepared in accordance with the requirements of 21 CFR Part 807.92

Submitter:

Edan Instruments, Inc.

3/F-B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou, Nanshan Shenzhen, 518067 P.R. China

Telephone: 0086-755-6856469

Fax: 0086-755-26882223

Contact Person: Randy Jiang Prepare date: Feb 21, 2012

Device name and Device name: Digital Ultrasonic Diagnostic Imaging System classification:

Models D3 and D6

Classification: 892.1560 System, Imaging, Pulsed echo, Ultrasonic

Product code: IYO

892.1570 Transducer, Ultrasonic, Diagnostic

Product code: ITX

Regulatory Class: Class II

Predicate Device:

Digital Ultrasonic Diagnostic Imaging System. K091680 Manufacturer: Edan Instruments, Inc.

Device Description: D3 and D6 Digital Ultrasound Diagnostic Imaging System is a portable digital ultrasonic diagnostic system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications.

The system consists of a main unit, transducers and other accessories.

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

5. Intended Use:

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
1. IEC 60601-1-2 Electromagnetic Compatibility
1. Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.
1. UD-2, IEC 60601-2-37
1. ISO 10993-1, ISO 10993-5 and ISO 10993-10

7.Comparison to the predicate device

Comparison to the predicate device, the subject device has the similar technology characteristics and has the same intended use, same design principle, same electrical classification and same accuracy. The different between the subject device and predicate device primarily includes physical specifications, display type and display mode, all the above differences do not affect the usage, safety and effectiveness, and no new question is raised regarding the safety and effectiveness.

8. Substantially Equivalent Determination

Verification and validation testing was conducted on the subject device. This premarket notification submission demonstrates that D3 and D6 Digital Ultrasonic Diagnostic Imaging System is substantially equivalent to the predicate device.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is surrounded by a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

OCT 12 2012

Edan Instruments, Inc. % Mr. Ned Devine Senior Staff Engineer/FDA Office Coordinator Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062

. Re: K122574

Trade/Device Name: Digital Ultrasonic Diagnostic Imaging System, Models D3 and D6 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: September 21, 2012 Received: September 26, 2012

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Digital Ultrasonic Diagnostic Imaging System, Models D3 and D6, as described in your premarket notification:

Transducer Model Number

D3	D6
C361-1/C341	C363-1
C321-1	C362
L741	C343-1
E741	C321
E611-1	L743
	E743
	E613

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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.

Sincerely Yours,

Zumhof D O'Hern Lier

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

Enclosure(s)

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Section 6- Indications for Use

510(k) Number (if known):

Device Name: Digital Ultrasonic Diagnostic Imaging System Models D3 and D6

Prescription Use (21 CFR Part 801 Subpart D)

Or Over the Counter Use

(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)

(Division Sign-Off)

Division of Radiotogical Devices Office of In Vitro Diagnostic Device Evaluation and Safety

Ki22574
510K.

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Diagnostic Ultrasound Indications for Use Form

D3 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
	B	M	PWD	CWD	Color Doppler	Combined (Specify)	Other* (Specify)
Ophthalmic
Fetal / Obstetrics	N	N				N	Note 1,Noter2
Abdominal	N	N				N	Note 1,Noter2
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
Pediatric	N	N				N	Note 1,Noter2
Small Organ (Specify)	N	N				N	Note 1,Noter2
Neonatal Cephalic	N	N				N	Note 1,Noter2
Adult Cephalic
Transrectal	N	N				N	Note 1,Noter2
Transvaginal	N	N				N	Note 1,Noter2
Transurethral
Musculo-skeletal (Conventional)	N	N				N	Note 1,Noter2
Musculo-skeletal (Superficial)	N	N				N	Note 1,Noter2
Intravascular
Other (Gynecology)	N	N				N
Cardiac	N	N				N	Note 1,Noter2
Intravascular
Peripheral vascular	N	N				N	Note 1,Noter2
Other (Urology)	N	N				N	Note 1,Noter2

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

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mull D'the
(Division Sign-Off)

Division of Radiological Devices
Office In Vitro Diagnostic Device Evaluation and Safety

510K K122574/

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

Diagnostic Ultrasound Indications for Use Form

D3 with C361-1 / C341 Transducer

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

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color Doppler	Combined (Specify)	Other*(Specify)
Ophthalmic
Fetal / Obstetrics	P	P				P	Note 1,Noter2
Abdominal	P	P				P	Note 1,Noter2
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
Pediatric	P	P				P
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Transrectal
Transvaginal
Transurethral
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Gynecology)	P	P				P	Note 1,Noter2
Cardiac
Intravascular
Peripheral vascular
Other (Urology)	P	P				P	Note 1,Noter2

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

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K122574

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

Diagnostic Ultrasound Indications for Use Form

D3 with C321-1 Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic
Fetal / Obstetrics	P	P				P	Note 1,Noter2
Abdominal	P	P				P	Note 1,Noter2
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
Pediatric	P	P				P	Note 1,Noter2
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Transrectal
Transvaginal
Transurethral
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Gynecology)	P	P				P	Note 1,Noter2
Cardiac	P	P				P	Note 1,Noter2
Intravascular
Peripheral vascular
Other (Urology)	P	P				P	Note 1,Noter2

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

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

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

510K -

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

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

6-4

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

Diagnostic Ultrasound Indications for Use Form

D3 with L741 Transducer

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

Clinical Application	Mode of Operation						Other*(Specify)
	B	M	PWD	CWD	ColorDoppler	Combined(Specify)
Ophthalmic
Fetal / Obstetrics
Abdominal
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
Pediatric
Small Organ (Specify)	P	P				P	Note 1,Noter2
Neonatal Cephalic	P	P				P	Note 1,Noter2
Adult Cephalic
Transrectal
Transvaginal
Transurethral
Musculo-skeletal (Conventional)	P	P				P	Note 1,Noter2
Musculo-skeletal (Superficial)	P	P				P	Note 1,Noter2
Intravascular
Other (Gynecology)
Cardiac
Intravascular
Peripheral vascular	P	P				P	Note 1,Noter2
Other (Urology)	P	P				P	Note 1,Noter2

N = new indication; P = previously cleared by FDA; E = added under this appendix Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

Small organ includes galactophore, thyroid gland, prostate

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices

510k K122574

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

Diagnostic Ultrasound Indications for Use Form

D3 with E741 Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic
Fetal / Obstetrics
Abdominal
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Transrectal	P	P				P	Note 1,Noter2
Transvaginal
Transurethral
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Gynecology)
Cardiac
Intravascular
Peripheral vascular
Other (Urology)	P	P				P	Note 1,Noter2

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

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K12257X/

ર-ઉ

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

Diagnostic Ultrasound Indications for Use Form

D3 with E611-1 Transducer

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

Clinical Application	B	M	Combined (Specify)	Other* (Specify)
Ophthalmic
Fetal / Obstetrics	P	P	P	Note 1,Noter2
Abdominal
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Transrectal
Transvaginal	P	P	P	Note 1,Noter2
Transurethral
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Gynecology)	P	P	P	Note 1,Noter2
Cardiac
Intravascular
Peripheral vascular
Other (Urology)	P	P	P	Note 1,Noter2

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

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign Off)

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

510K K122574/

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

Diagnostic Ultrasound Indications for Use Form

D6 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
	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic
Fetal / Obstetrics	N	N				N	Note 1,Note2
Abdominal	N	N				N	Note 1,Note2
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
Pediatric	N	N				N	Note 1,Note2
Small Organ (Specify)	N	N				N	Note 1,Note2
Neonatal Cephalic	N	N				N	Note 1,Note2
Adult Cephalic
Transrectal	N	N				N	Note 1,Note2
Transvaginal	N	N				N	Note 1,Note2
Transurethral
Musculo-skeletal(Conventional)	N	N				N	Note 1,Note2
Musculo-skeletal (Superficial)	N	N				N	Note 1,Note2
Intravascular
Other (Gynecology)
Cardiac	N	N				N	Note 1,Note2
Intravascular
Peripheral vascular	N	N				N	Note 1,Note2
Other (Urology)	N	N				N	Note 1,Note2

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

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K122574/

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

Diagnostic Ultrasound Indications for Use Form

D6 with C363-1 Transducer

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

Clinical Application	Mode of Operation						Other* (Specify)
	B	M	PWD	CWD	Color Doppler	Combined (Specify).
Ophthalmic
Fetal / Obstetrics	P	P				P	Note 1,Noter2
Abdominal	P	P				P	Note 1,Noter2
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
Pediatric	P	P				P	Note 1,Noter2
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Transrectal
Transvaginal
Transurethral
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Gynecology)	P	P				P	Note 1,Noter2
Cardiac
Intravascular
Peripheral vascular
Other (Urology)	P	P				P	Note 1,Noter2

N = new indication; P = previously cleared by FDA; E = added under this appendix Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

510K.

Prescription Use (Per 21 CFR 801.109)

Mmhnd DK
(Division Sign-Off)

Division of Radiological Devices
Vitro Diagnostic Devices Devices
Vitro Diagnostic Devices Custom Custom Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices
Constitution Diagnostic Devices Evelulation and Safety
Constitution of One Commend Safety

6-9

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

Diagnostic Ultrasound Indications for Use Form

D6 with C362 Transducer

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

Clinical Application	Mode of Operation						Other*(Specify)
	B	M	PWD	CWD	Color Doppler	Combined(Specify)
Ophthalmic
Fetal / Obstetrics	P	P				P	Note 1,Note2
Abdominal	P	P				P	Note 1,Note2
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
Pediatric	P	P				P	Note 1,Note2
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Transrectal
Transvaginal
Transurethral
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Gynecology)	P	P				P	Note 1,Note2
Cardiac
Intravascular
Peripheral vascular
Other (Urology)	P	P				P	Note 1,Note2

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

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K122574

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

Diagnostic Ultrasound Indications for Use Form

D6 withC343-1 Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic
Fetal / Obstetrics	P	P				P	Note 1,Noter2
Abdominal	P	P				P	Note 1,Noter2
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
Pediatric	P	P				P	Note 1,Noter2
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Transrectal
Transvaginal
Transurethral
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Gynecology)	P	P				P	Note 1,Noter2
Cardiac
Intravascular
Peripheral vascular
Other (Urology)	P	P				P	Note 1,Noter2

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

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K.122574/

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

Diagnostic Ultrasound Indications for Use Form

D6 with C321 Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color Doppler	Combined (Specify)	Other* (Specify)
Ophthalmic
Fetal / Obstetrics	P	P				P	Note 1,Noter2
Abdominal	P	P				P	Note 1,Noter2
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
Pediatric	P	P				P	Note 1,Noter2
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Transrectal
Transvaginal
Transurethral
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Gynecology)	P	P				P	Note 1,Noter2
Cardiac	P	P				P	Note 1,Noter2
Intravascular
Peripheral vascular
Other (Urology)	P	P				P	Note 1,Noter2

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

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

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

510K

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

{16}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

D6 with L743 Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic
Fetal / Obstetrics
Abdominal
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
Pediatric
Small Organ (Specify)	P	P				P	Note 1,Noter2
Neonatal Cephalic	P	P				P	Note 1,Noter2
Adult Cephalic
Transrectal
Transvaginal
Transurethral
Musculo-skeletal (Conventional)	P	P				P	Note 1,Noter2
Musculo-skeletal (Superficial)	P	P				P	Note 1,Noter2
Intravascular
Other (Gynecology)
Cardiac
Intravascular
Peripheral vascular	P	P				P	Note 1,Noter2
Other (Urology)	P	P				P	Note 1,Noter2

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

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

Small Organ includes galactophore, thyroid gland, prostate

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

510K.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

MundlADR
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

K122574

{17}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

D6 with E743 Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic
Fetal / Obstetrics
Abdominal
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Transrectal	P	P				P	Note 1,Noter2
Transvaginal
Transurethral
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Gynecology)
Cardiac
Intravascular
Peripheral vascular
Other (Urology)	P	P				P	Note 1,Noter2

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

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent.

Note 2: Needle guide bracket kit

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K12252/

{18}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

D6 with E613 Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color Doppler	Combined (Specify)	Other* (Specify)
Ophthalmic
Fetal / Obstetrics	P	P				P	Note 1,Noter2
Abdominal
Intra-operative (Specify)
Intra-operative (Neurological)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Transrectal
Transvaginal	P	P				P	Note 1,Noter2
Transurethral
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Gynecology)	P	P				P	Note 1,Noter2
Cardiac
Intravascular
Peripheral vascular
Other (Urology)	P	P				P	Note 1,Noter2

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

Additional comments: Combined mode: B+M

Note 1: This feature does not use contrast agent ..

Note 2: Needle guide bracket kit.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Michael D. O'Brien
(Division Sign-Off)

Division of Radiological Devices Office of In Vitre Diagnostic Devices
Office of In Vitce Diagnostic Device Evaluation and Safety

510K K122574

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.