U50 Diagnostic Ultrasound System

K142511 · Edan Instruments, Inc. · IYN · Feb 20, 2015 · Radiology

Device Facts

• Record ID: K142511
• Device Name: U50 Diagnostic Ultrasound System
• Applicant: Edan Instruments, Inc.
• Product Code: IYN · Radiology
• Decision Date: Feb 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

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 Story

Portable diagnostic ultrasound system; acquires/displays ultrasound images for clinical evaluation. Inputs: ultrasound signals via various transducers (linear, convex, micro-convex, phased array). Processing: multi-beam-forming, phased inversion harmonic compound imaging (eHCI), spatial compounding, speckle resistance imaging (eSRI). Outputs: B-mode, M-mode, PW-mode, CW-mode, Color-mode, PDI/DPDI images. Used in hospitals/clinics by physicians or qualified professionals. Output viewed on integrated display; assists in diagnostic imaging and fluid flow analysis. Benefits: provides non-invasive diagnostic visualization of internal structures and blood flow.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), acoustic output (FDA guidance), and biocompatibility (ISO 10993).

Technological Characteristics

Portable ultrasound system; 330mm x 320mm x 220mm; 7.8kg. Transducers: linear, convex, micro-convex, phased array (2.0-15 MHz). Imaging modes: B, M, PW, CW, Color, PDI/DPDI. Features: eHCI, spatial compounding, multi-beam-forming, eSRI. Biocompatibility per ISO 10993. Electrical safety per IEC 60601-1.

Indications for Use

Indicated for ultrasound evaluation of adults, pregnant women, and pediatric patients in hospitals and clinics. Applications include abdominal, obstetrics, gynecology, pediatric, small parts (thyroid, testes, breast), urology, peripheral vascular, musculoskeletal (conventional and superficial), endovaginal, and cardiac.

Regulatory Classification

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.

Predicate Devices

• U50 Diagnostic ultrasound system (K123249)
• DC-6 Diagnostic Ultrasound System (K072164)
• GE LOGIQ E9 Diagnostic Ultrasound System (K082185)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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<br>(Specify) [1] | Other<br>(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 |
| Fetal<br>Imaging<br>& 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.

(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 C352UB Transducer

|--|

| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(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) * | | | | | | | |
| Fetal<br>Imaging<br>& 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 | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |

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

(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 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<br>(Specify) [1] | Other<br>(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 |
| Fetal<br>Imaging<br>& 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.

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

Concurrence of Center for Devices and Radiological Health (CDRH)

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

### 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<br>(Specify) [1] | Other<br>(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 |
| Fetal<br>Imaging<br>& 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 * 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.

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

Concurrence of Center for Devices and Radiological Health (CDRH)

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

### U50 with E612UB Transducer

| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& 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 | | | | | | | |
| | | | | | | | | |
| Peripheral<br>vascular | 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)

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

### 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<br>(Specify) [1] | Other<br>(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) * | | | | | | | |
| Fetal<br>Imaging<br>& 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) | | | | | | | |

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.

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

Concurrence of Center for Devices and Radiological Health (CDRH)

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

### 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<br>(Specify) [1] | Other<br>(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) * | | | | | | | |
| Fetal<br>Imaging<br>& 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) | | | | | | | |

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.

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

Concurrence of Center for Devices and Radiological Health (CDRH)

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

### 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) * | | | | | | | |
| Fetal<br>Imaging<br>& 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 | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |

N = new indication: P = previously cleared by FDA: E = added under this appendix PDI= Power Doppler Imaging Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast 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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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<br>(Specify) [1] | Other<br>(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 |
| Fetal<br>Imaging<br>& 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 | | | | | | | |
| Peripheral<br>vascular | 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<br>(Specify) [1] | Other<br>(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<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& 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 | | | | | | | |
| Peripheral<br>vascular | 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.

(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 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<br>(Specify) [1] | Other<br>(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 |
| Fetal<br>Imaging<br>& 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 | | | | | | | |
| Peripheral<br>vascular | 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)

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

# 510(k) Summary

### Prepared in accordance with the requirements of 21 CFR Part 807.92

| 1. Submitter: | Edan Instruments, Inc.<br>3/F-B, Nanshan Medical Equipments Park, Nanhai Rd 1019#,<br>Shekou, Nanshan Shenzhen, 518067 P.R. China<br>Tel.: [phone]<br>Fax: [phone] |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Cherry Sun |
| Date prepared: | August 18, 2014 |
| 2. Device name<br>and classification: | Device Name: Diagnostic Ultrasound System<br>Model: U50<br>Classification Name:<br>892.1550 System, Imaging, Pulsed Doppler, Ultrasonic<br>Product code: IYN<br>892.1560 Ultrasonic, Pulsed echo, Imaging<br>Product code: IYO<br>892.1570 Transducer, Ultrasonic, Diagnostic<br>Product code: ITX<br>Regulatory Class: Class II |
| 3. Predicate<br>Device(s): | U50 Diagnostic ultrasound system/ K123249/ Shenzhen EDAN Instruments CO., Ltd<br>DC-6 Diagnostic Ultrasound System/ K072164/ Shenzhen Mindray Bio-medical Electronics Co., Ltd.<br>GE LOGIQ E9 Diagnostic Ultrasound System/K082185/General Electric Co., Ltd. |
| 4. Device<br>Description: | The modifications are listed as below:<br>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 | Compariso<br>n U50 2.0<br>with 1.0<br>and DC-6 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/<br>K# | Mindray<br>Instruments | EDAN Instruments | EDAN Instruments | |
| Indication for<br>Use | DC-6 Diagnostic<br>Ultrasound System<br>is a general<br>purpose, mobile,<br>software<br>controlled,<br>Ultrasound<br>diagnostic system.<br>Its function is to<br>acquire and display<br>ultrasound images<br>in<br>B-Mode, M-Mode,<br>PW-Mode, CW<br>mode,<br>Color-Mode, Color<br>M-Mode,<br>Power/Dirpower<br>Mode or the<br>combined mode<br>(i.e.<br>B/M-Mode). This<br>system is a Track 3<br>device that<br>employs an array<br>of probes that<br>include linear<br>array, convex array<br>and phased array<br>with a frequency<br>range of<br>approximately<br>2.5MHz to | The U50 is a portable<br>Diagnostic<br>Ultrasound System,<br>which applies<br>advanced<br>technologies such as<br>Phased Inversion<br>Harmonic Compound<br>Imaging (eHCI),<br>Spatial Compounding<br>Imaging,<br>Multi-Beam-Forming…