E-CUBE i7

K153424 · Alpinion Medical Systems Co., Ltd. · IYN · Feb 26, 2016 · Radiology

Device Facts

• Record ID: K153424
• Device Name: E-CUBE i7
• Applicant: Alpinion Medical Systems Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Feb 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Adult Cephalic; Trans-rectal (TR); Trans-vaginal (TV); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Peripheral Vascular (PV); and Urology (including prostate).

Device Story

E-CUBE i7 is a portable/mobile diagnostic ultrasound system; provides soft tissue and blood flow imaging. Inputs: ultrasound signals from compatible transducers (convex, linear, endocavity, sector phased). Processing: system platform transforms signals into images using modes including B, M, Color/Power/Pulsed Wave/Continuous Wave Doppler, and Tissue Doppler Imaging. Output: real-time ultrasound images on 15.6" display. Used in clinical settings by physicians for diagnostic evaluation. Features include Xpeed, Full SRI, and Spatial Compounding. Output assists clinicians in visualizing anatomy and hemodynamics to support diagnostic decision-making; benefits patients through non-invasive diagnostic assessment.

Clinical Evidence

No clinical data required; substantial equivalence supported by bench testing, including biocompatibility, acoustic output, thermal, electrical, electromagnetic, and mechanical safety testing.

Technological Characteristics

Ultrasound imaging system; portable/mobile form factor. Transducers: C1-6T, L3-12T, EC3-10T, EV3-10T, IO8-17T, SP1-5T, SP3-8T, C5-8NT. Modes: B, M, PWD, CWD, Color/Power Doppler, TDI. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD2/UD3, AIUM safety. Biocompatible patient-contact materials.

Indications for Use

Indicated for qualified physicians to evaluate soft tissue and blood flow in fetal, abdominal, pediatric, small organ, adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, peripheral vascular, and urological clinical applications.

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

• E-CUBE inno Diagnostic Ultrasound System (K121937)
• E-CUBE 15 Diagnostic Ultrasound System (K150773)
• RS80A Diagnostic Ultrasound System (K151663)
• E-CUBE 5 Diagnostic Ultrasound System (K142733)

Submission Summary (Full Text)

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

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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

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

February 26, 2016

ALPINION MEDICAL SYSTEMS Co., Ltd. % Mr. Donghwan Kim OARA Manager 1FL and 6FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd) Guro-gu, Seoul 08393 REPUBLIC OF KOREA

Re: K153424 Trade/Device Name: E-CUBE i7 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 29, 2016 Received: February 1, 2016

Dear Mr. Kim:

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.

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

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.

Michael D. O'Hara

For

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

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K153424

Device Name E-CUBE i7

Indications for Use (Describe)

The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Adult Cephalic; Trans-rectal (TR); Trans-vaginal (TV); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Peripheral Vascular (PV); and Urology (including prostate).

| Type of Use (Select one or both, as applicable) | <span> <span style="padding-right: 20px;"> <span style="vertical-align: middle;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="vertical-align: middle;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

[[e-mail]](mailto:[e-mail])

*"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of*

"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."

Form Approved: OMB No. 0910-0120

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

# E-CUBE i7 Ultrasound 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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(Specify) |
| Ophthalmic | | | | | | | | | |
| Fetal | N | N | N | | N | N | N | N | |
| Abdominal | N | N | N | N | N | N | N | N | |
| Intra-operative (Specify) | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | N | N | N | N | N | N | N | N | |
| Small Organ | N | N | N | | N | N | N | N | |
| (breast, testes, thyroid) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | N | N | N | N | N | N | N | N | |
| Trans-rectal | N | N | N | | N | N | N | N | |
| Trans-vaginal | N | N | N | | N | N | N | N | |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skeletal | N | N | N | | N | N | N | N | |
| (Conventional) | | | | | | | | | |
| Musculo-skeletal | N | N | N | | N | N | N | N | |
| (Superficial) | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Cardiac Adult | N | N | N | N | N | N | N | N | |
| Cardiac Pediatric | N | N | N | N | N | N | N | N | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | | | | | |
| Peripheral vessel | N | N | N | | N | N | N | N | |
| Urology (including prostate) | N | N | N | | N | N | N | N | |

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

* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

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

Concurrence of CDRH

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

# E-CUBE i7 with C1-6T 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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(Specify) |
| Ophthalmic | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | P | |
| Abdominal | P | P | P | | P | P | P | P | |
| Intra-operative (Specify) | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | |
| Small Organ<br>(breast, testes, thyroid) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Trans-rectal | | | | | | | | | |
| Trans-vaginal | | | | | | | | | |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Cardiac Adult | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | | | | | |
| Peripheral vessel | | | | | | | | | |
| Urology (including prostate) | P | P | P | | P | P | P | P | |

N = new indication; P = previously cleared by FDA K 142733; E = added under appendix

* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

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

Concurrence of CDRH

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

# E-CUBE i7 with EC3-10T 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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(Specify) |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ | | | | | | | | | |
| (breast, testes, thyroid) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Trans-rectal | P | P | P | | P | P | P | P | |
| Trans-vaginal | P | P | P | | P | P | P | P | |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | |
| (Conventional) | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | |
| (Superficial) | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Cardiac Adult | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | | | | | |
| Peripheral vessel | | | | | | | | | |
| Urology (including prostate) | P | P | P | | P | P | P | P | |

N = new indication; P = previously cleared by FDA K 142733; E = added under appendix

* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

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

Concurrence of CDRH

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

# E-CUBE i7 with EV3-10T 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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(Specify) | |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| (breast, testes, thyroid) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Trans-rectal | P | P | P | | P | P | P | P | | |
| Trans-vaginal | P | P | P | | P | P | P | P | | |
| Trans-urethral | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| (Conventional) | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| (Superficial) | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Urology (including prostate) | P | P | P | | P | P | P | P | | |

N = new indication; P = previously cleared by FDA K 142733; E = added under appendix

* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

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

Concurrence of CDRH

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

# E-CUBE i7 with L3-12T 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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(Specify) |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | |
| Small Organ | P | P | P | | P | P | P | P | |
| (breast, testes, thyroid) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Trans-rectal | | | | | | | | | |
| Trans-vaginal | | | | | | | | | |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skeletal | P | P | P | | P | P | P | P | |
| (Conventional) | | | | | | | | | |
| Musculo-skeletal | P | P | P | | P | P | P | P | |
| (Superficial) | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Cardiac Adult | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | P | P | P | |
| Urology (including prostate) | P | P | P | | P | P | P | P | |

N = new indication; P = previously cleared by FDA K 142733; E = added under appendix

* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

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

Concurrence of CDRH

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

# E-CUBE i7 with C5-8NT 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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(Specify) | |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | N | N | N | | N | N | N | N | | |
| Intra-operative (Specify) | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Pediatric | N | N | N | | N | N | N | N | | |
| Small Organ | | | | | | | | | | |
| (breast, testes, thyroid) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| (Conventional) | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| (Superficial) | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | N | N | N | | N | N | N | N | | |
| Intravascular (Cardiac) | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Urology (including prostate) | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under appendix * Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

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

Concurrence of CDRH

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

# E-CUBE i7 with IO8-17T 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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(Specify) |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ<br>(breast, testes, thyroid) | N | N | N | | N | N | N | N | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Trans-rectal | | | | | | | | | |
| Trans-vaginal | | | | | | | | | |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | N | N | |
| Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | N | |
| Intravascular | | | | | | | | | |
| Cardiac Adult | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | | | | | |
| Peripheral vessel | | | | | | | | | |
| Urology (including prostate) | | | | | | | | | |

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

* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

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

Concurrence of CDRH

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

# E-CUBE i7 with SP1-5T 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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(Specify) |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | N | N | N | N | N | N | N | N | |
| Intra-operative (Specify) | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | N | N | N | N | N | N | N | N | |
| Small Organ<br>(breast, testes, thyroid) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | N | N | N | N | N | N | N | N | |
| Trans-rectal | | | | | | | | | |
| Trans-vaginal | | | | | | | | | |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Cardiac Adult | N | N | N | N | N | N | N | N | |
| Cardiac Pediatric | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | | | | | |
| Peripheral vessel | | | | | | | | | |
| Urology (including prostate) | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under appendix * Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

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

Concurrence of CDRH

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

# E-CUBE i7 with SP3-8T 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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(Specify) |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | N | N | N | N | N | N | N | N | |
| Intra-operative (Specify) | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | N | N | N | N | N | N | N | N | |
| Small Organ | | | | | | | | | |
| (breast, testes, thyroid) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | N | N | N | N | N | N | N | N | |
| Trans-rectal | | | | | | | | | |
| Trans-vaginal | | | | | | | | | |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | |
| (Conventional) | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | |
| (Superficial) | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Cardiac Adult | N | N | N | N | N | N | N | N | |
| Cardiac Pediatric | N | N | N | N | N | N | N | N | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | | | | | |
| Peripheral vessel | | | | | | | | | |
| Urology (including prostate) | | | | | | | | | |

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

* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

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

Concurrence of CDRH

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

# 510(k) Summary

In accordance with 21CFR807.92, the following summary of information is provided;

| Date | November 23rd 2015 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | ALPINION MEDICAL SYSTEMS Co., Ltd.<br>Address: 1FL and 6FL, Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu,<br>Seoul, 08393, Republic of Korea |
| Primary Contact<br>Person | Donghwan Kim<br>Quality Management Representative(QMR)<br>Address: 1FL and 6FL, Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu,<br>Seoul, 08393, Republic of Korea<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Secondary Contact<br>Person | JULIAN LEE<br>Address: 21312 30th Dr SE Ste 100 Bothell, WA 98021, United States<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Device Trade Name: | E-CUBE i7 |
| Common/Usual<br>Name: | Ultrasonic Pulsed Doppler Imaging System |
| Classification Names | System, Imaging, Pulsed Doppler Ultrasonic |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550 90-IYN<br>Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO<br>Diagnostic Ultrasound Transducer, 21CFR 892.1570, 90-ITX |
| Primary Predicate<br>Device | K121937 E-CUBE inno Diagnostic Ultrasound System |
| Predicate Device(s) | K150773 E-CUBE 15 Diagnostic Ultrasound System<br>K151663 RS80A Diagnostic Ultrasound System<br>K142733 E-CUBE 5 Diagnostic Ultrasound System |
| Device Description: | E-CUBE i7 product is an ultrasound imaging system for medical<br>diagnosis. This device is available for portable(only body) and mobile(with<br>system cart). Also, this innovative system platform provides optimal<br>patient diagnosis workflow with the 15.6" wide flat panel display,<br>ergonomic control panel with easy user interface, optimal image quality. |
| | 1. Signal Mode:<br>B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode,<br>Pulsed Wave Doppler(PWD) mode, Continuous wave Doppler (CWD)<br>mode, Tissue Doppler Imaging(TDI) mode<br>2. Combination Mode:<br>B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/CF/M |

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

Acoustic output track:

Track 3

Types of transducers compatible with the device:

| | C1-6T | L3-12T | EC3-10T | EV3-10T | | I08-17T | SP1-5T | SP3-8T | C5-8NT |
|-------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------|-------------------------------|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Applicable<br>frequency | 1~6MHz | 3~12MHz | 3~10MHz | 3~10MHz | Applicable<br>frequency | 8~17MHz | 1~5MHz | 3~8MHz | 5~8MHz |
| Intended<br>Usage | Fetal,<br>Abdominal,<br>Pediatric,Urology | Pediatric,<br>Small Organ,<br>Musculoskeletal<br>(Conventional),<br>Musculo-skeletal<br>(Superficial),<br>Peripheral<br>vessel | Trans-rectal,<br>Trans-vaginal,<br>Urology | Trans-rectal,<br>Trans-vaginal,<br>Urology | Intended<br>Usage | Small Organ,<br>Musculo-skeletal<br>(Conventional),<br>Musculo-skeletal<br>(Superficial) | Abdominal,<br>Pediatric,<br>Adult Cephalic,<br>Cardiac Adult | Abdominal,<br>Pediatric,<br>Adult Cephalic<br>Cardiac Adult,<br>Cardiac Pediatric | Abdominal,<br>Pediatric,<br>Cardiac Pediatric |
| Applicable<br>mode | B/M/PWD/<br>Color Doppler/<br>Power Doppler/<br>Tissue Harmonic<br>Imaging/<br>Combined | B/M/PWD/<br>Color Doppler/<br>Power Doppler/<br>Tissue Harmonic<br>Imaging/<br>Combined | B/M/PWD/<br>Color Doppler/<br>Power Doppler/<br>Combined | B/M/PWD/<br>Color Doppler/<br>Power Doppler/<br>Combined | Applicable<br>mode | B/M/PWD/<br>Color Doppler/<br>Power Doppler/<br>Tissue Harmonic<br>Imaging/<br>Combined | B/M/PWD/CWD<br>Color Doppler/<br>Power Doppler/<br>Tissue Harmonic<br>Imaging/<br>Combined | B/M/PWD/CWD<br>Color Doppler/<br>Power Doppler/<br>Tissue Harmonic<br>Imaging/<br>Combined | B/M/PWD/<br>Color Doppler/<br>Power Doppler/<br>Tissue Harmonic<br>Imaging/<br>Combined |
| Scanning<br>depth(mm) | 300 | 100 | 100 | 100 | Scanning<br>depth(mm) | 300 | 300 | 300 | 140 |
| FOV | 60(°) | N/A | 142(°) | 142(°) | FOV | N/A | 90(°) | 90(°) | 93.6(°) |
| Steer Angle | N/A | Max 9(°) | N/A | N/A | Steer Angle | 15(°) | 45(°) | 45(°) | N/A |
| Total<br>number of<br>element | 128 | 128 | 128 | 128 | Total<br>number of<br>element | 128 | 64 | 64 | 128 |
| Predicate | Previously<br>cleared<br>(K142733) | Previously<br>cleared<br>(K142733) | Previously<br>cleared<br>(K142733) | Previously<br>cleared<br>(K142733) | Predicate | I08-17<br>(K150772) | SP1-5i/SP1-5X<br>(K121937/K150773) | SP3-8/SP1-5X<br>(K150773/K150773) | C5-8N<br>(K150772) |

Indications For Use: The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Adult Cephalic; Trans-rectal (TR); Trans-vaginal (TV); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Peripheral Vascular (PV); and Urology (including prostate).

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

Determination of

Substantial Equivalence: Comparison with Predicate devices:
1) E-CUBE i7 and E-CUBE inno (Primary Predicate Device)

| Feature | Proposed<br>E-CUBE i7 | Predicate<br>E-CUBE inno<br>(K121937) |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for use | The device is intended for use by a<br>qualified physician for the<br>evaluation of soft tissue and blood<br>flow in the clinical applications;<br><br>Fetal;<br>Abdominal (renal & GYN/pelvic);<br>Pediatric;<br>Small Organ (breast, testes,<br>thyroid);<br>Adult Cephalic;<br>Trans-rectal(TR);<br>Trans-vaginal(TV);<br>Musculo-skeletal (Conventional);<br>Musculo-skeletal (Superficial);<br>Cardiac (Adult);<br>Cardiac (Pediatric);<br>Peripheral Vessel (PV);<br>Urology (including prostate). | The device is intended for use by a<br>qualified physician for the<br>evaluation of soft tissue and blood<br>flow in the clinical applications;<br><br>Fetal;<br>Abdominal (renal & GYN/pelvic);<br>Pediatric;<br>Small Organ (breast, testes,<br>thyroid);<br><br>Musculo-skeletal (Conventional);<br>Musculo-skeletal (Superficial);<br>Cardiac (Adult);<br><br>Peripheral Vascular (PV);<br>Urology (including prostate). |
| Electrical<br>power | Voltage: 19V, ---10.53A<br>Frequency: 50/60Hz<br>Power: 200W Max | Voltage:24V---, 6.5A<br>Frequency: 50/60Hz<br>Power: 120 VA MAX with<br>Peripherals |
| Imaging<br>modes | 2D (B) mode<br>M mode<br>Anatomical M<br>Color Flow Doppler (CF) mode<br>Power Doppler (PD) mode<br>Directional PD<br>Pulsed wave Doppler (PWD) mode<br>Continuous wave Doppler (CWD)<br>mode<br>Tissue Doppler imaging (TDI)<br>mode | 2D (B) mode<br>M mode<br>Color Flow (CF) mode<br>Power Doppler (PD) mode<br>Pulsed wave Doppler (PWD) mode<br>Continuous wave Doppler (CWD)<br>mode…