The diagnostic ultrasound system (U50) 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), endovaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.

Device Description

The modifications are listed as below:
Addition of CW mode – the basic system architecture previously supported CW mode.
3 new transducers C5-2b, P5-1b and L15-7b – The C5-2b and the L15-7b are new transducers. The P5-1b is the initial offering of a phased array device on this system.
Addition of HPRF to PW mode
Minor changes to the user interface

AI/ML Overview

Here's an analysis of the provided text regarding the U50 Diagnostic Ultrasound System, structured according to your requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in quantitative terms for the device's diagnostic performance (e.g., sensitivity, specificity for specific conditions). Instead, it relies on demonstrating that the device meets safety and performance standards equivalent to predicate devices. The reported device performance is that it "passed all testing" and is "substantially equivalent" to predicate devices.

The tables for each transducer (U50, C352UB, L1042UB, L742UB, E612UB, C612UB, C6152UB, C422UB, L552UB, C5-2b, P5-1b, L15-7b) outline the intended clinical applications and modes of operation supported by each transducer. These can be considered the functional performance criteria ("what it can do").

Here's an example table for the main U50 system based on the "U50 Diagnostic Ultrasound System" table in the document, as it aggregates the general capabilities:

Feature / Criterion (Implicit)	Reported Device Performance (as stated or implied)
Clinical Applications
Abdominal	P (Previously cleared by FDA)
Obstetrics	P (Previously cleared by FDA)
Gynecology	P (Previously cleared by FDA)
Pediatric	P (Previously cleared by FDA)
Small Parts (Thyroid, Testes, Breast)	P (Previously cleared by FDA)
Urology	P (Previously cleared by FDA)
Peripheral Vascular	P (Previously cleared by FDA)
Musculoskeletal (Conventional)	P (Previously cleared by FDA)
Musculoskeletal (Superficial)	P (Previously cleared by FDA)
Endovaginal	P (Previously cleared by FDA)
Cardiac (Adult & Pediatric)	P (Previously cleared by FDA)
Fetal / Obstetrics (E612UB)	N (New indication)
Abdominal (C5-2b)	N (New indication)
Other (Urology, Gynecology) (C5-2b)	N (New indication)
Adult Cardiac (P5-1b)	N (New indication)
Small Organs (L15-7b)	N (New indication)
Musculoskeletal (Conventional) (L15-7b)	N (New indication)
Musculoskeletal (Superficial) (L15-7b)	N (New indication)
Peripheral Vascular (L15-7b)	N (New indication)
Modes of Operation
B-mode	Supported (P or N for specific applications)
M-mode	Supported (P or N for specific applications)
PW-mode	Supported (P or N for specific applications); HPRF added
CW-mode	Supported (N for E612UB, C5-2b, P5-1b, L15-7b; added capability for U50 system)
Color-mode	Supported (P or N for specific applications)
PDI/DPDI (Combined mode)	Supported (Implicitly, as part of "Combined")
Biopsy Guidance	Supported (as an "Other" feature)
Harmonic Imaging	Supported (as an "Other" feature, no contrast agent)
General Performance
Displayed depth	20-320mm (Probe Dependent)
Gray Scales	256
Dynamic range	150dB
TGC	8 segments
Zoom	Up to 400%
Electrical Safety	Passed IEC 60601-1 testing
Electromagnetic Compatibility	Passed IEC 60601-1-2 testing
Acoustic Output	Passed testing as per FDA guideline
Biocompatibility	Passed ISO 10993-1, -5, -10 testing

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "Clinical testing is not required." This implies that there was no specific "test set" of patient data used for clinical validation in the traditional sense (e.g., to measure diagnostic accuracy). The evaluation was primarily based on non-clinical performance (safety, EMC, acoustic output, biocompatibility) and a comparison to predicate devices, leveraging their established clinical utility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical test set requiring ground truth established by experts was used.

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

Not applicable, as 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

Not applicable. This is a submission for a diagnostic ultrasound system (hardware and basic software functions), not an AI-powered diagnostic algorithm. No MRMC study was conducted.

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

Not applicable. This is a diagnostic ultrasound system, not an AI algorithm. Its performance is intrinsically linked to human operation.

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

Not applicable, as no clinical test set requiring ground truth was used for evaluation of the system's diagnostic accuracy. The ground truth for safety and performance (e.g., acoustic output, EMC) would be the established international and national standards and their specific test methodologies.

8. The sample size for the training set

Not applicable. This is a medical device (ultrasound system), not an AI/Machine Learning algorithm that requires a "training set" in the computational sense. The design and engineering would have been informed by general ultrasound physics, medical imaging principles, and experience with prior devices.

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

Not applicable, as no training set for an AI/ML algorithm was used.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, represented by curved lines.

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

February 20, 2015

Edan Instruments. Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K142511

Trade/Device Name: U50 Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: January 27, 2015 Received: January 30, 2015

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Robert A Ochs

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K142511

Device Name U50 Diagnostic Ultrasound System

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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008 Indication for use

Edan Instruments, Inc

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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U50 Diagnostic Ultrasound System

	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
Cardiac	Adult Cardiac	P	P	P	N	P	P	P
	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)

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

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

** Other use includes Urology, Gynecology

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

「2]: Biopsy Guidance

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

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U50 with C352UB Transducer

|--|

	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
Cardiac	Adult Cardiac
	Pediatric Cardiac
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheralvascular	Peripheral vascular
	Other (Specify)

** Other use includes Urology, Gynecology

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

「2]: Biopsy Guidance

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

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Concurrence of Center for Devices and Radiological Health (CDRH)

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U50 with L1042UB 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) [1]	Other(Specify) [2][3]
	Ophthalmic
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) **
Cardiac	Adult Cardiac
	Pediatric Cardiac
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	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, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW Note

Other Small Organ includes Thyroid, Testes, Breasts

Other materials include: Herbs, Spices

** Other use includes Urology, Gynecology

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

[2]: Biopsy Guidance

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

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Concurrence of Center for Devices and Radiological Health (CDRH)

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U50 with L742UB Transducer

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

	Clinical Application	Mode of Operation
	Specific	B	M	PW	CW	Color	Combined(Specify) [1]	Other(Specify) [2][3]
General	Specific
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) **
Cardiac	Adult Cardiac
	Pediatric Cardiac
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular	P	P	P	P	P	P	P
vascular	Other (Specify)

** Other use includes Urology, Gynecology

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

「2]: Biopsy Guidance

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

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Concurrence of Center for Devices and Radiological Health (CDRH)

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U50 with E612UB Transducer

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

Peripheralvascular	Peripheral vascular
	Other (Specify)

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

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

** Other use includes Urology, Gynecology

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

[2]: Biopsy 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 Center for Devices and Radiological Health (CDRH)

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U50 with C612UB 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) [1]	Other(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric	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
Cardiac	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheral	Peripheral vascular
vascular	Other (Specify)

** Other use includes Urology, Gynecology

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

「2]: Biopsy 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 Center for Devices and Radiological Health (CDRH)

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U50 with C6152UB 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) [1]	Other(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	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
Peripheral	Peripheral vascular
vascular	Other (Specify)

** Other use includes Urology, Gynecology

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

「2]: Biopsy 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 Center for Devices and Radiological Health (CDRH)

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U50 with C422UB 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) [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)

** Other use includes Urology, Gynecology

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

「2]: Biopsy 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 Center for Devices and Radiological Health (CDRH)

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U50 with L552UB 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) [1]	Other(Specify) [2][3]
Ophthalmic	Ophthalmic
	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
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
	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 Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

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

[2]: Biopsy 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 Center for Devices and Radiological Health (CDRH)

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U50 with C5-2b 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) [1]	Other(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics	N	N	N		N	N	N
	Abdominal	N	N	N		N	N	N
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *
Fetal	Neonatal Cephalic
Imaging	Adult Cephalic
& Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **	N	N	N		N	N	N
	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, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

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

「2]: Biopsy 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 Center for Devices and Radiological Health (CDRH)

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U50 with P5-1b 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) [1]	Other(Specify) [2][3]
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
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Other (Specify) **
Cardiac	Adult Cardiac	N	N	N	N	N	N	N
	Pediatric 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 Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

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

「2]: Biopsy Guidance

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

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Concurrence of Center for Devices and Radiological Health (CDRH)

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U50 with L15-7b 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) [1]	Other(Specify) [2][3]
Ophthalmic	Ophthalmic
	Fetal / Obstetrics
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro logical)
	Laparoscopic
	Pediatric
	Small Organ (Specify) *	N	N	N		N	N	N
FetalImaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Musculo-skeletal(Conventional)	N	N	N		N	N	N
	Musculo-skeletal (Superficial)	N	N	N		N	N	N
	Intravascular
	Other (Specify) **
Cardiac	Adult Cardiac
	Pediatric Cardiac
	Intravascular(Cardiac)
	Trans-esoph.(Cardiac)
	Intra- cardiac
Peripheralvascular	Peripheral vascular	N	N	N		N	N	N
	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 Note * Small Organ includes Thyroid, Testes, Breast

** Other use includes Urology, Gynecology

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

「2]: Biopsy Guidance

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

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Concurrence of Center for Devices and Radiological Health (CDRH)

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510(k) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

1. Submitter:	Edan Instruments, Inc.3/F-B, Nanshan Medical Equipments Park, Nanhai Rd 1019#,Shekou, Nanshan Shenzhen, 518067 P.R. ChinaTel.: (0755) 26856469Fax: +1 (408) 418-4059
Contact Person:	Cherry Sun
Date prepared:	August 18, 2014
2. Device nameand classification:	Device Name: Diagnostic Ultrasound SystemModel: U50Classification Name:892.1550 System, Imaging, Pulsed Doppler, UltrasonicProduct code: IYN892.1560 Ultrasonic, Pulsed echo, ImagingProduct code: IYO892.1570 Transducer, Ultrasonic, DiagnosticProduct code: ITXRegulatory Class: Class II
3. PredicateDevice(s):	U50 Diagnostic ultrasound system/ K123249/ Shenzhen EDAN Instruments CO., LtdDC-6 Diagnostic Ultrasound System/ K072164/ Shenzhen Mindray Bio-medical Electronics Co., Ltd.GE LOGIQ E9 Diagnostic Ultrasound System/K082185/General Electric Co., Ltd.
4. DeviceDescription:	The modifications are listed as below:Addition of CW mode – the basic system architecture previously supported CW mode.3 new transducers C5-2b, P5-1b and L15-7b – The C5-2b and the L15-7b are new transducers. The P5-1b is the initial offering of a phased array device on this system..Addition of HPRF to PW modeMinor changes to the user interface

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The diagnostic ultrasound system (U50) is applicable for adults, 5. Intended Use: 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), endovaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.

6. Predicate Device Comparison

Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table:

Item	DC-6	U50 1.0	U50 2.0	Comparison U50 2.0with 1.0and DC-6
Manufacturer/K#	MindrayInstruments	EDAN Instruments	EDAN Instruments
Indication forUse	DC-6 DiagnosticUltrasound Systemis a generalpurpose, mobile,softwarecontrolled,Ultrasounddiagnostic system.Its function is toacquire and displayultrasound imagesinB-Mode, M-Mode,PW-Mode, CWmode,Color-Mode, ColorM-Mode,Power/DirpowerMode or thecombined mode(i.e.B/M-Mode). Thissystem is a Track 3device thatemploys an arrayof probes thatinclude lineararray, convex arrayand phased arraywith a frequencyrange ofapproximately2.5MHz to	The U50 is a portableDiagnosticUltrasound System,which appliesadvancedtechnologies such asPhased InversionHarmonic CompoundImaging (eHCI),Spatial CompoundingImaging,Multi-Beam-Forming, Speckle ResistanceImaging (eSRI), etc.Its function is toacquire and displayUltrasound images inB-mode, M-mode,PW-mode,Color-mode.PDI/DPDI mode.This system providesa series of probes thatinclude linear array,convex array,micro-convex arraywith a frequencyrange ofapproximately2.5MHz to 11MHz.	The U50 is a portableDiagnosticUltrasound System,which appliesadvancedtechnologies such asPhased InversionHarmonic CompoundImaging (eHCI),Spatial CompoundingImaging,Multi-Beam-Forming, Speckle ResistanceImaging (eSRI), etc.Its function is toacquire and displayUltrasound images inB-mode, M-mode,PW-mode, CW-modeColor-mode,PDI/DPDI mode.This system providesa series of probes thatinclude linear array,convex array,micro-convex arrayand phased arraywith a frequencyrange ofapproximately2.0MHz to 15MHz.	AddCW-mode:(DC-6includesCW modeand isthereforepredicate)Add aphasedarraytransducer:Frequencyrange ischanged to2.0 MHz to15 MHz
	10.0MHz.
Intended Use	abdominal, cardiac,small parts (breast,testes, thyroid,etc.), peripheralvascular, fetal,transrectal,transvaginal,pediatric, neonatalcephalic,musculoskeletal(general andsuperficial), andintraoperative(liver, gallbladder,pancreas)exams.	Abdominal,Obstetrics, Gynecology, Pediatric, SmallParts, Urology,PeripheralVascular, Musculoskeletal (conventionalandsuperficial),Transvaginal, and Cardiacclinical applications	Abdominal,Obstetrics, Gynecology, Pediatric, SmallParts, Urology,PeripheralVascular, Musculoskeletal (conventionalandsuperficial),Transvaginal, and Cardiacclinical applications	No change
Dimensions	1390 mm (H) × 480mm (W) × 790 mm(D)	330 mm (W) × 320mm (L) × 220 mm(H)	330 mm (W) × 320mm (L) × 220 mm(H)	No change
Weight	Net weight 132 Kg	Net weight 7.8 Kg	Net weight 7.8 Kg	No change
General Imaging mode	B, M, Color,Power/DirPower,PW, CW,	B, M, Color,PDI/DPDI, PW	B, M, Color,PDI/DPDI, PW, CW	Add CWimagingmode (seeDC-6)
SpecialImagingmode	Smart 3D, iScape,Free Xros M	None	None	No change
B GeneralMeasurements	Depth, Distance,Area, Volume, TraceLength, Ratio, BHistogram , Angle,Cross Line, ParallelLine, B Profile	Distance, Area,Volume, Ratio,Histogram and Angle	Distance, Area,Volume, Ratio,Histogram and Angle	No change
M GeneralMeasurements	Distance, Time,Slope, and HeartRate	Distance, Time,Slope, and HeartRate	Distance, Time,Slope, and HeartRate	No change
D GeneralMeasurements	Time, Heart Rate,Velocity,Acceleration, RI, PIand Spectrum Trace	Time, Heart Rate,Velocity,Acceleration, RI, PIand Auto (auto trace)	Time, Heart Rate,Velocity,Acceleration, RI, PIand Auto (auto trace)	No change
Performance
Displayeddepth	26-263mm(ProbeDependent )	20-320mm( ProbeDependent )	20-320mm(ProbeDependent )	No change
Gray Scales	256	256	256	No change
Dynamicrange	192 dB	150dB	150dB	No change
TGC	8 segments	8 segments	8 segments	No change
Zoom	Up to 400%	Up to 400%	Up to 400%	No change

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The differences between the subject device and predicate devices do not affect the basic design

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principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.

7. 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) Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.

(4) ISO 10993-1, ISO 10993-5 and ISO 10993-10

The subject device passed all testing. The tests were selected to show substantial equivalence between the subject device and the predicate, and since the testing passed, substantial equivalence is shown.

8. Substantially Equivalent Determination

Verification and validation testing was conducted, and passed prespecified criteria, on the U50 Diagnostic Ultrasonic System. This premarket notification submission demonstrates that U50 Diagnostic Ultrasonic System is substantially equivalent to the predicate devices.

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.