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, Trans-vaginal, Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vascular (PV): and Urology (including prostate).

Device Description

E-CUBE 15 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 18.5" (or 19.5") wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
Modes of operation:

Signal Mode:
B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode, Pulsed Wave Doppler(PWD) mode, Tissue Harmonic Imaging (THI)
Combination Mode:
B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/PD/PWD, B/CF/M
Acoustic output track: Track 3

AI/ML Overview

The provided text describes the "E-CUBE 15 Diagnostic Ultrasound System" and its various transducers but does not contain information about specific acceptance criteria, studies proving performance, sample sizes, data provenance, expert ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies related to any AI components. The document is a 510(k) premarket notification to the FDA, focusing on establishing substantial equivalence to previously cleared predicate devices for various clinical applications and operating modes.

The document lists the intended uses and technical specifications of the E-CUBE 15 system and its transducers, comparing it to predicate devices (E-CUBE 9 and iU22). The "Summary of Non-Clinical Tests" mentions evaluation for biocompatibility, acoustic output, and thermal, electrical, electromagnetic, and mechanical safety, conforming to applicable medical device safety standards. It also lists quality management system measures applied during development.

Crucially, the "Summary of Clinical Tests" section explicitly states:
"The subject of this premarket submission, E-CUBE 15, did not require clinical studies to support substantial equivalence."

This means that for the purposes of this 510(k) submission, the device's substantial equivalence was established through non-clinical testing and comparison to predicate devices, rather than through clinical trials with defined acceptance criteria for AI performance, independent test sets, expert ground truth, or MRMC studies.

Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes, data provenance, expert adjudication, MRMC studies, or standalone algorithm performance for AI components cannot be extracted from this document, as it appears the submission did not rely on such data for device clearance. The document focuses on hardware aspects and basic functional modes, not advanced AI features requiring such rigorous evaluation.

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 features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and recognizable, representing the department's role in promoting health and well-being.

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

July 23, 2015

ALPINION MEDICAL SYSTEMS Co., Ltd. % Mr. Donghwan Kim Quality Management Representative (QMR) 1, 6 and 7FL Verdi Tower 72, Digital-ro(St) 26-gil(Rd) Guro-gu Seoul 152-848 REPUBLIC OF KOREA

Re: K150773

Trade/Device Name: E-CUBE 15 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed Doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: June 19, 2015 Received: June 22, 2015

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 (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.

Michael O'Hara For

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)

K150773

Device Name

E-CUBE 15 Diagnostic Ultrasound System

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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 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."

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

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

E-CUBE 15 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	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal	P	P	P		P	P	P	P	P
Abdominal	P	P	P		P	P	P	P	P
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	P	P
Small Organ(breast, testes, thyroid)	P	P	P		P	P	P	P
Neonatal Cephalic
Adult Cephalic	N	N	N	N	N	N	N	N
Trans-rectal	P	P	P		P	P	P	P	N
Trans-vaginal	P	P	P		P	P	P	P	N
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)	P	P	P		P	P		P
Musculo-skeletal(Superficial)	P	P	P		P	P	P	P
Intravascular
Cardiac Adult	P	P	P	P	P	P	P	P
Cardiac Pediatric	P	P	P	P	P	P	P	P
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

N = new indication; P = previously cleared by FDA K123610; 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 15 with SC1-6H Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(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(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
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 K123610; 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 15 with L3-12H Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color Doppler	Power Doppler	Tissue Harmonic Imaging	Combined* (Specify)	Other** (Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ(breast, testes, thyroid)	P	P	P		P	P	P	P
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)	P	P	P		P	P	P	P
Musculo-skeletal(Superficial)	P	P	P		P	P	P	P
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel	P	P	P		P	P	P	P
Urology (including prostate)

N = new indication; P = previously cleared by FDA K123610; 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 15 with SP1-5X Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal
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(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic	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	P	P	P	P	P	P	P	P
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)

N = new indication; P = previously cleared by FDA K123610; 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 15 with L8-17X Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ(breast, testes, thyroid)	P	P	P		P	P	P	P
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)	P	P	P		P	P	P	P
Musculo-skeletal(Superficial)	P	P	P		P	P	P	P
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel	P	P	P		P	P	P	P
Urology (including prostate)

N = new indication; P = previously cleared by FDA K123610; 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 15 with SC1-4H Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(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(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
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 K123610; 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 15 with E3-10H Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(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	P
Trans-vaginal	P	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	P

N = new indication; P = previously cleared by FDA K123610; 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 15 with SVC1-6 Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal	P	P	P		P	P	P	P	P
Abdominal	P	P	P		P	P	P	P	P
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	P	P
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
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)	P	P	P		P	P	P	P	P

N = new indication; P = previously cleared by FDA K123610; 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 15 with L3-12X Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	P
Small Organ(breast, testes, thyroid)	P	P	P		P	P	P	P
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)	P	P	P		P	P	P	P
Musculo-skeletal(Superficial)	P	P	P		P	P	P	P
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel	P	P	P		P	P	P	P
Urology (including prostate)

N = new indication; P = previously cleared by FDA K123610; 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}------------------------------------------------

E-CUBE 15 with L3-8 Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	P
Small Organ(breast, testes, thyroid)	P	P	P		P	P	P	P
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)	P	P	P		P	P	P	P
Musculo-skeletal(Superficial)	P	P	P		P	P	P	P
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel	P	P	P		P	P	P	P
Urology (including prostate)

N = new indication; P = previously cleared by FDA K123610; E = added under appendix

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

Concurrence of CDRH

Prescription User (Per 21 CFR 801.109)

ALPINION MEDICAL SYSTEMS Co., Ltd.

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

E-CUBE 15 with SP3-8 Transducer

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

Clinical Application	B	M	PWD	CWD	Color Doppler	Power Doppler	Tissue Harmonic Imaging	Combined* (Specify)
Ophthalmic
Fetal
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(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	P	P	P	P	P	P	P	P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)

N = new indication; P = previously cleared by FDA K123610; 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

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

E-CUBE 15 with CW 2.0 Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
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				P
Cardiac Pediatric				P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)

N = new indication; P = previously cleared by FDA K123610; 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

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

E-CUBE 15 with CW 5.0 Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
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			P
Cardiac Pediatric			P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)

N = new indication; P = previously cleared by FDA K123610; 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

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

E-CUBE 15 with C5-8 Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color Doppler	Power Doppler	Tissue Harmonic Imaging	Combined* (Specify)	Other** (Specify)
Ophthalmic
Fetal
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(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	P	P	P		P	P	P	P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)

N = new indication; P = previously cleared by FDA K132687; 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

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

E-CUBE 15 with TEE3-7 Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
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	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

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

E-CUBE 15 with SVC1-6H Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal	N	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(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
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)	N	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

{19}------------------------------------------------

E-CUBE 15 with SPN1-5X Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(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	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
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

{20}------------------------------------------------

E-CUBE 15 with SC1-4HS 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	Power	Tissue	Combined*	Other**
					Doppler	Doppler	Harmonic	(Specify)	(Specify)
							Imaging
Ophthalmic
Fetal	N	N	N		N	N	N	N
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
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
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

{21}------------------------------------------------

E-CUBE 15 with IO3-12 Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ(breast, testes, thyroid)	P	P	P		P	P	P	P
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
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)

N = new indication; P = previously cleared by FDA K132687; 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

{22}------------------------------------------------

E-CUBE 15 with IO8-17 Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color Doppler	Power Doppler	Tissue Harmonic Imaging	Combined* (Specify)	Other** (Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ(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(Conventional)	N	N	N		N	N	N	N
Musculo-skeletal(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

{23}------------------------------------------------

E-CUBE 15 with EV3-10H Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	N	N	N	N	N	N	N	N
Trans-vaginal	N	N	N	N	N	N	N	N
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)	N	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

{24}------------------------------------------------

E-CUBE 15 with EC3-10H Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	N	N	N	N	N	N	N	N
Trans-vaginal	N	N	N	N	N	N	N	N
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)	N	N	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

{25}------------------------------------------------

E-CUBE 15 with EV3-10X Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	N	N	N	N	N	N	N	N
Trans-vaginal	N	N	N	N	N	N	N	N
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)	N	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

{26}------------------------------------------------

E-CUBE 15 with EC3-10X Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	N	N	N	N	N	N	N	N	N
Trans-vaginal	N	N	N	N	N	N	N	N	N
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)	N	N	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

{27}------------------------------------------------

E-CUBE 15 with MP1-5X Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(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	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
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

{28}------------------------------------------------

E-CUBE 15 with VE3-10H Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmoniclmaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	N	N	N		N	N	N	N	N
Trans-vaginal	N	N	N		N	N	N	N	N
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)	N	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

{29}------------------------------------------------

E-CUBE 15 with C5-8N Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(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

{30}------------------------------------------------

Section F 510(k) Summary

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

Date	March 20th 2015							SC1-4H	E3-10H	SVC1-6	L3-12X
Submitter:	ALPINION MEDICAL SYSTEMS Co., Ltd.Address: 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu,Seoul, Republic of Korea 152-848		L3-12H	SC1-6H	L8-17X	SP1-5X	Applicablefrequency	1~4MHz	3~10 MHz	1~6 MHz	3~12 MHz
Primary ContactPerson	Donghwan KimQuality Management Representative(QMR)Address: 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu,Seoul, Republic of Korea 152-848Phone: +82 70 7465 2068Fax: +82 2 6220 2162Email: donghwan.kim@alpinion.com	Applicablefrequency	3~12MHz	1~6MHz	8~17MHz	1~5MHz	IntendedUsage	Fetal,Abdominal,Pediatric,Urology	Trans-rectal,Trans-vaginal	Fetal,Abdominal,Pediatric,Urology	Pediatric,Musculo-skeletal(conventional,superficial),Peripheralvessel
Secondary ContactPerson	JULIAN LEEAddress: 21312 30th Dr SE Ste 100 Bothell, WA 98021, United StatesPhone: 425 949 1059Fax: 425 949 4910Email: julian.lee@alpinionusa.com	IntendedUsage	Small Organ,Musculo-skeletal(conventional, superficial),Peripheralvessel	Fetal.Abdominal,Pediatric,Urology	Small Organ,Musculo-skeletal(conventional,superficial),Peripheralvessel	Abdominal,Pediatric.Cardiac Adult	Foot printsize (mm)	72.4 x 16.8	21.5 x 18.2	59.2 x 45.2	58.2 X 10.4
Device Trade Name:	E-CUBE 15	Foot printsize (mm)	44.8 x 7.8	72.4 x 16.8	58.2 x 10.4	24.8 x 17.6	Applicablemode	B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging	B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging	B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging	B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging
Common/UsualName:	Ultrasonic Pulsed Doppler Imaging System	Applicablemode	B/M/PWD/Color Doppler/Power Doppler	B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaqinq	B/M/PWD/Color Doppler/Power doppler	B/M/PWD/CWD/Color Doppler/Power Doppler/Tissue HarmonicImaging	Scanningdepth(mm)	300	140	300	100
Classification Names	System, Imaging, Pulsed Doppler Ultrasonic	Scanningdepth(mm)	100	300	100	300	FOV	60(°)	145(°)	79(°)	N/A
Product Code:	Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550 90-IYNUltrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer, 21CFR 892.1570, 90-ITX	FOV	N/A	60(°)	N/A	90(°)	Steer Angle	N/A	N/A	N/A	15(°)
Predicate Device(s)	K120060 E-CUBE 9 Diagnostic Ultrasound System	Steer Angle	15(%)	N/A	15(%)	45(°)	Totalnumber ofelement	192	192	128	256
Device Description:	E-CUBE 15 product is an ultrasound imaging system for medicaldiagnosis. The system platform provides optimal patient diagnosisworkflow with the 18.5" (or 19.5") wide flat panel display, ergonomiccontrol panel with easy user interface, optimal image quality.	Totalnumber ofelement	192	192	256	વેદ	Elementspacing	0.342mm	0.135mm	0.414mm	0.2mm
	Modes of operation:1. Signal Mode:B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode,Pulsed Wave Doppler(PWD) mode, Tissue Harmonic Imaging(THI)2. Combination Mode:B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/PD/PWD, B/CF/MAcoustic output track:	Elementspacing	0.2mm	0.342mm	0.150mm	0.2mm	elevatinglength	13.5mm	6mm	13mm	4.5mm
	Track 3	elevatinglength	4.5mm	13.5mm	4mm	13.5mm

ALPINION MEDICAL SYSTEMS Co., Ltd.

{31}------------------------------------------------

Types of transducers compatible with the device:

{32}------------------------------------------------

510(k) E-CUBE 15

	L3-8	SP3-8	CW2.0	CW5.0
Applicablefrequency	3~8 MHz	3~8 MHz	2.0 MHz	5.0 MHz
IntendedUsage	Pediatric,Musculo-skeletal(conventional,superficial),Peripheralvessel	Abdominal,Pediatric,CardiacPediatric,	Cardiac(Adult&Pediatric)	Cardiac(Adult&Pediatric)
Foot printsize (mm)	44.8 x 7.8	16 x 12.8	17.2 x 17.2	11.3 x 11.3
Applicablemode	B/M/PWD/Color Doppler/Power Doppler	B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging	CWD	CWD
Scanningdepth(mm)	100	300	N/A	N/A
FOV	N/A	90(°)	N/A	N/A
Steer Angle	15(°)	45(°)	N/A	N/A
Totalnumber ofelement	128	64	2(TX1, RX1)	2(TX1, RX1)
Elementspacing	0.3mm	0.15mm	N/A	N/A
elevatingdepth	7.0mm	13.5mm	N/A	N/A

	SVC1-6H	SC1-4HS	C5-8	SPN1-5X
Applicablefrequency	1~6 MHz	1~4 MHz	5~8 MHz	1~5MHz
IntendedUsage	Fetal,Abdominal,Pediatric,Urology	Fetal,Abdominal,PediatricUrology	Abdominal,Pediatric,Cardiac Pediatric	Abdominal,Pediatric,Adult CephalicCardiac Adult
Foot printsize (mm)	59.2*45.2	68 x 15.9 mm	35 x 6.2 mm	24.8 x 17.6
Applicablemode	B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging	B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging	B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging	B/M/PWD/CWD/Color Doppler/Power Doppler/Tissue HarmonicImaging
Scanningdepth(mm)	300	300	140	300
FOV	1.4mm(@65mm)0.8mm(@105mm)	2.0mm(@65mm)1.4mm(@105mm)	0.8mm(@65mm)0.8mm(@105mm)	2.0mm(@65mm)1.4mm(@105mm)
Steer Angle	3.7mm(@65mm)4.5mm(@105mm)	2.8mm(@65mm)3.9mm(@105mm)	3.9mm(@65mm)7.0mm(@105mm)	2.68mm(@65mm)3.9mm(@105mm)
Totalnumber ofelement	79(°)	73(°)	92(°)	90(°)
Elementspacing	N/A	NA	NA	45(°)
elevatinglength	Curved lineararray40mm Radius ofcurvature	Curved lineararray46mm Radius ofcurvature	Curved lineararray14mm Radius ofcurvature	Linear phasedarray

{33}------------------------------------------------

	TEE3-7	IO3-12	108-17	SC1-4M		EV3-10H	EC3-10H	EV3-10X	EC3-10X
Applicablefrequency	3~7MHz	3~12MHz	8~17MHz	1~4MHz	Applicablefrequency	3-10 MHz	3-10 MHz	3-10 MHz	3-10 MHz
IntendedUsage	Cardiac(Adult)	Small Organ	Pediatric, SmallOrgan, Musculo-skeletal(Conventional),Musculo-skeletal(Superficial),Peripheralvessel	Fetal,Abdominal,Urology	IntendedUsage	Trans-rectal,Trans-vaginal,Urology	Trans-rectal,Trans-vaginal,Urology	Trans-rectal,Trans-vaginal,Urology	Trans-rectal,Trans-vaginal,Urology
Foot printsize (mm)	Ø 14	22.8 x 6.4 mm	36.7 x 4.2	72.4 x 16.8	Foot printsize (mm)	21.5 x 18.6	21.5 x 18.6	21.5 x 18.6	21.5 x 18.6
Applicablemode	B/M/PWD/CWD/Color Doppler/Power Doppler/Tissue HarmonicImaging	B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging	B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging	B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging	Applicablemode	B/M/PWD/Color Doppler/Power Doppler	B/M/PWD/Color Doppler/Power Doppler	B/M/PWD/Color Doppler/Power Doppler	B/M/PWD/Color Doppler/Power Doppler
Scanningdepth(mm)	140	100	100	300	Scanningdepth(mm)	140	140	140	140
FOV	2.0mm(@65mm)1.4mm(@105mm)	0.3mm(@25mm)0.5 (@45mm)	N/A	60(°)	FOV	152(°)	152(°)	202(°)	202(°)
Steer Angle	2.68mm(@65mm)3.9mm(@105mm)	1.1mm(@25mm)1.3mm(@45mm)	15(°)	N/A	Steer Angle	N/A	N/A	N/A	N/A
Totalnumber ofelement	90(°)	NA	128	192 X 2	Totalnumber ofelement	192	192	256	256
Elementspacing	45(°)	15(°)	0.200mm	0.342mm	Elementspacing	0.14mm	0.14mm	0.14mm	0.14mm
elevatinglength	Linear phasedarray	Linear array16mm aperture	3.5mm	13.5mm	elevatinglength	6mm	6mm	6mm	6mm

{34}------------------------------------------------

	MP1-5X	VE3-10H	C5-8N
Applicablefrequency	1~5MHz	3-10 MHz	5~8 MHz
IntendedUsage	Fetal,Abdominal,Pediatric, AdultCephalic,Cardiac Adult	Trans-rectal,Trans-vaginal,Urology	Abdominal,Pediatric,Cardiac Pediatric
Foot printsize (mm)	24.8 x 17.6	24.4 x 24.4	25.5 x 9
Applicablemode	B/M/PWD/CWDColor Doppler/Power Doppler/Tissue HarmonicImaging	B/M/PWD/Color Doppler/Power Doppler	B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging/Combined
Scanningdepth(mm)	300	140	140
FOV	90(°)	152(°)	93.6(°)
Steer Angle	45(°)	N/A	N/A
Totalnumber ofelement	96	192	128
Elementspacing	0.2mm	0.14mm	0.195mm
elevatinglength	13.5mm	6mm	6mm

The device is intended for use by a qualified physician for the evaluation Indications For Use: 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, Trans-vaginal, Musculoskeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vascular (PV); and Urology (including prostate).

Determination of Substantial

Equivalence:

Comparison with Predicate device:

1) E-CUBE 15 and E-CUBE 9
Feature	ProposedE-CUBE 15	PredicateE-CUBE 9(K120060)
Indicationsfor 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& pediatric);Peripheral Vascular (PV);Urology (including prostate).	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);Trans-rectal(TR);Trans-vaginal(TV);Musculo-skeletal(Conventional);Musculo-skeletal (Superficial);Cardiac (adult & pediatric);Peripheral Vascular (PV);Urology (including prostate).
Electricalpower	Voltage: 100~~120V, 200~~240VFrequency: 50/60HzPower: Max. 900 VA with Built-in and On-Board Peripherals	Voltage: 100~~120V, 200~~240VFrequency: 50/60HzPower: Max. 600 VA with Built-in and On-Board Peripherals

ALPINION MEDICAL SYSTEMS Co., Ltd.

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510(k) E-CUBE 15

OperatingMode	B ModeM ModeColor Flow ModePW Doppler ModePower Doppler ModeContinuous wave Doppler modeTissue Harmonic Imaging Mode3D/4D ModeXpeed™FullSRI™Spatial CompoundingFrequency CompoundingPanoramicStress EchoCube Strain™Live HQ™Needle Vision™/Needle Vision™PlusElastography	B ModeM ModeColor Flow ModePW Doppler ModePower Doppler ModeContinuous wave Doppler modeTissue Harmonic Imaging Mode3D/4D ModeXpeed™FullSRI™Spatial CompoundingFrequency CompoundingPanoramicStress EchoCube Strain™Live HQ™Needle Vision™/Needle Vision™Plus
Thermal,mechanicalandelectricalsafety	The E-CUBE 15 has beendesigned to conform to thefollowing standards:- NEMA UD2, UD3- AIUM Medical Ultrasound Safety- IEC60601-1- IEC60601-1-2- IEC60601-2-37	The E-CUBE 9 has been designedto conform to the followingstandards:- NEMA UD2, UD3- AIUM Medical Ultrasound Safety- IEC60601-1- IEC60601-1-2- IEC60601-2-37

2) E-CUBE 15 and iU22

Feature	ProposedE-CUBE 15	PredicateiU 22(K132304)
Manufacturer	Alpinion Medical System	Philips
Indicationsfor use	The device is intended for use by aqualified physician for theevaluation of soft tissue and bloodflow 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& pediatric);Peripheral Vascular (PV);Urology (including prostate).	The clinical environments wherethe EPIQ Diagnostic UltrasoundSystem can be used includeClinics, Hospitals, and clinicalpoint-of-care for diagnosis ofpatients;Fetal;AbdominalPediatric;Small Organ (breast, thyroid,testicle);Cephalic(Adult, neonatal)Trans-rectal(TR);Trans-vaginal(TV);Musculo-skeletal(Conventional);Musculo-skeletal (Superficial);Cardiac (adult, pediatric, fetal,trans-esophageal);Peripheral VascularUrologyGynecologicalIntra-operative(vascular, cardic)Fetal EchoVascular (cerebral)
Electricalpower	Voltage: 100~~120V, 200~~240VFrequency: 50/60HzPower: Max. 900 VA with Built-inand On-Board Peripherals	Voltage: 100~~127V, 220~~240VFrequency: 50/60HzPower: 750VA~900VA

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OperatingMode	B ModeM ModeColor Flow ModePW Doppler ModePower Doppler ModeContinuous wave Doppler modeTissue Harmonic Imaging Mode3D/4D ModeXpeed™FullSRITMSpatial CompoundingFrequency CompoundingPanoramicStress EchoCube Strain™Live HQ™Needle Vision™/Needle Vision™PlusElastography	M-modeSpectral DopplerPulsed wave (PW) DopplerAuto DopplerSteerable continuous wave (CW) DopplerTissue Doppler Imaging (TDI)Live xPlane imagingLive volume imaging/Live 3D Echo3D/4D and MPR imagingAdaptive broadband flow imagingContrast imagingInterventional imagingTissue Harmonic Imaging (THI)Color Power Angio imaging (CPA)Freehand 3D volume and MPRimagingSpatio-Temporal Image Correlation(STIC) imagingPanoramic SonoCT imagingStrain based elastographyShear wave elastography
Thermal,mechanicalandelectricalsafety	The E-CUBE 15 has beendesigned to conform to thefollowing standards:- NEMA UD2, UD3- AIUM Medical Ultrasound Safety- IEC60601-1- IEC60601-1-2- IEC60601-2-37	Philips Ultrasound performed thefollowing testing to ensure thesafety and effectiveness of theEPIQ device:- IEC60601-1- IEC60601-1-2- IEC60601-1-6- IEC60601-2-37- ISO 10993

Summary of Non-Clinical Tests:

E-CUBE 15 has been evaluated for biocompatibility, acoustic output as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. E-CUBE 15 and its application comply with voluntary standards as detailed in this premarket submission. The following quality management system measures were applied to the development of E-CUBE 15:

Medical Device Risk Management �
� Requirements Reviews
� Design Reviews
� Component Verification
� Integration Review (System Verification)
� Performance Testing (System Verification)
� Safety Testing (Compliance Test)
� Design Validation

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, E-CUBE 15, did not require clinical studies to support substantial equivalence.

Discussion:

E-CUBE 15 and the predicate device have differences in clinical applications and operating modes. Several transducers are changed for these purposes. These design changes have been verified via non-clinical

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testing. The subject device is in conformance with applicable safety standards. Therefore, the differences between E-CUBE 15 and the predicate would not affect the safety, effectiveness and essential performance of E-CUBE 15.

Conclusion: ALPINION MEDICAL SYSTEMS Co., Ltd. considers E-CUBE 15 to be as safe, as effective. Performance, technology and software are substantially equivalent to the predicate device.
ALPINION MEDICAL SYSTEMS Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA or the requirements will be published in guidance documents.

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.