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, thyroid), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardia (adult& pediatric), Peripheral Vascular (PV), and Urology (including prostate).

Device Description

E-CUBE 8 product is an ultrasound imaging system for medical diagnosis. This innovative system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.

AI/ML Overview

The provided document is a 510(k) summary for the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE 8 ultrasound system. This type of submission to the FDA focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information provided primarily addresses equivalence and adherence to standards for safety and performance, rather than specific acceptance criteria and study designs typically found for novel devices or AI/ML-driven diagnostics.

Based on the document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria (e.g., specific accuracy, sensitivity, or specificity thresholds) or independent reported device performance metrics in the way one would for an AI/ML diagnostic or a more novel technology. Instead, it demonstrates performance by:

Claiming Substantial Equivalence: The primary "performance" metric is that the E-CUBE 8 is "as safe, as effective" and its "Performance, technology and software are substantially equivalent" to several predicate ultrasound devices (e.g., K172732, K161439, K153424, K132687, K163691, K163120).
Listing Supported Indications and Imaging Modes: The device supports a wide range of clinical applications (Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculoskeletal (Conventional & Superficial), Cardiac (Adult & Pediatric), Peripheral Vascular, Urology) and various imaging modes (2D(B), Harmonic, M, Color M, Anatomical M, Color Flow Doppler (CF), Power Doppler (PD), Directional PD, Pulsed Wave Doppler (PWD), Continuous Wave Doppler (CWD), High PRF Doppler, Tissue Doppler Imaging (TDI), 3D/4D). The presence of these modes and applications, matching those of predicate devices, implicitly serves as a performance metric of functional equivalence.
Compliance with Voluntary Standards: Adherence to standards like IEC60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, ISO14971, AIUM Medical Ultrasound Safety, NEMA UD 2, and NEMA UD 3 indicates that the device meets established safety and basic performance criteria common to ultrasound systems.

Acceptance Criteria (Implicitly based on predicate device equivalence and standards compliance):

Acceptance Criteria Category	Reported Device Performance (E-CUBE 8)
Functional Equivalence	The E-CUBE 8 supports the same extensive range of clinical applications and imaging modes (2D(B), Harmonic, M, Color M, Anatomical M, Color Flow Doppler, Power Doppler, Directional PD, Pulsed Wave Doppler, Continuous Wave Doppler, High PRF Doppler, Tissue Doppler Imaging, 3D/4D) as its predicate devices (K172732, K161439, K153424, K132687, K163691, K163120). Differences (e.g., monitor option, transducers) do not affect safety or effectiveness. The new L8-17H transducer and new indications for VC1-6T and VE3-10H also achieve equivalence.
Safety Compliance	Conforms to IEC60601-1 (General Safety), IEC60601-1-2 (EMC), IEC60601-2-37 (Ultrasound Safety), ISO10993-1 (Biocompatibility), ISO14971 (Risk Management), AIUM Medical Ultrasound Safety, NEMA UD 2 (Acoustic Output Measurement), NEMA UD 3 (Acoustic Output Display). Transducer materials are biocompatible.
Software Development	Followed quality management system measures: Requirements Reviews, Design Reviews, Component Verification, Integration Review (System Verification), Performance Testing (System Verification), Safety Testing (Compliance Test), Design Validation.
Acoustic Output	Acoustic output tracked to Track 3. Specific scanning depths and element counts are provided for various transducers, indicating characterized performance within established safety limits for ultrasound devices.

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

The document states: "The subject of this premarket submission, E-CUBE 8, did not require clinical studies to support substantial equivalence." This means there was no specific test set of patient data used in a clinical study to evaluate the device against acceptance criteria in the typical sense for a new diagnostic claim. Instead, the evaluation was primarily based on engineering tests, compliance with standards, and comparison of technical specifications to predicate devices. Therefore, details regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set are not applicable here.

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

As no clinical studies were required, there was no "test set" in the context of diagnostic performance involving ground truth established by experts.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an ultrasound system, not an AI-driven image analysis tool intended to assist human readers for diagnostic interpretation in the manner described. The document does not mention any AI components in K181617.

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

Not applicable. The E-CUBE 8 is an ultrasound imaging system, an equipment device, not a standalone AI algorithm. The document makes no mention of AI/ML functionality.

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

Not applicable, as no clinical studies with "ground truth" for diagnostic performance were conducted. The "ground truth" in this context refers to the established safety and performance characteristics of legally marketed predicate ultrasound devices and the voluntary standards for ultrasound equipment.

8. The sample size for the training set

Not applicable. This device is an ultrasound system hardware/software combination, not an AI/ML product developed with a training dataset.

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

Not applicable, as no AI/ML training set was involved.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 11, 2018

Alpinion Medical Systems Co., Ltd. Boyeon CHO QARA Manager 1FL and 6FL, Verdi Tower, 72, Digital-ro 26-gil, Guro-gu SEOUL 08393 REPUBLIC OF KOREA

Re: K181617

Trade/Device Name: E-CUBE 8 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: July 10, 2018 Received: July 12, 2018

Dear Boyeon CHO:

We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Hsl 2. Nils

for Robert A. Ochs. Ph.D. 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K181617

Device Name E-CUBE 8

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 instruction of infinition for 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 FDA 3881 (7/17)

PSC Publishing Services (301) 443-6740 EF

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E-CUBE 8 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	P	P	P		P	P	P	P
Adult Cephalic	P	P	P		P	P	P	P
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	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	P	N
Urology (including prostate)	P	P	P		P	P	P	P	P

N = new indication; P = previously cleared by FDA K172732 ; 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, Office of In-Vitro Diagnostic Devices (OIVD)

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E-CUBE 8 with C1-6CT 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)	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)	P	P	P		P	P	P	P

N = new indication; P = previously cleared by FDA K172732; 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, Office of In-Vitro Diagnostic Devices (OIVD)

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E-CUBE 8 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 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	P	P	P		P	P	P	P
Adult Cephalic
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
Cardiac Pediatric	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)

N = new indication; P = previously cleared by FDA K172732; E = added under appendix

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

Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

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

E-CUBE 8 L3-12T with 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)	P	P	P		P	P	P	P
Neonatal Cephalic	P	P	P		P	P	P	P
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 K172732; 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, Office of In-Vitro Diagnostic Devices (OIVD)

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

E-CUBE 8 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	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)	P	P	P		P	P	P	P
Neonatal Cephalic	P	P	P		P	P	P	P
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 K172732; 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, Office of In-Vitro Diagnostic Devices (OIVD) Prescription User (Per 21 CFR 801.109)

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E-CUBE 8 L3-12H™ with 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	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)	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 K172732; 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, Office of In-Vitro Diagnostic Devices (OIVD)

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E-CUBE 8 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 Doppler	Power Doppler	Tissue Harmonic Imaging	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	P	P	P		P	P	P	P
Adult Cephalic	P	P	P		P	P	P	P
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
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 K172732; 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, Office of In-Vitro Diagnostic Devices (OIVD)

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

E-CUBE 8 with P1-5CT 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	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	P	P	P		P	P	P	P
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
Cardiac Pediatric	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)

N = new indication; P = previously cleared by FDA K172732; 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, Office of In-Vitro Diagnostic Devices (OIVD)

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

E-CUBE 8 with VC1-6T 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	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	P

N = new indication; P = previously cleared FDA K172732; 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, Office of In-Vitro Diagnostic Devices (OIVD)

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

E-CUBE 8 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	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal	P	P	P		P	P	P	P
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	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 K172732; 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, Office of In-Vitro Diagnostic Devices (OIVD)

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

E-CUBE 8 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 Doppler	Power Doppler	Tissue Harmonic Imaging	Combined* (Specify)	Other** (Specify)
Ophthalmic
Fetal	P	P	P		P	P	P	P
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	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 K172732; 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, Office of In-Vitro Diagnostic Devices (OIVD)

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

E-CUBE 8 with E3-10 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	PowerDopplerr	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal	P	P	P		P	P	P	P
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	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 K172732; 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, Office of In-Vitro Diagnostic Devices (OIVD)

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

E-CUBE 8 with CW2.0 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 K172732; 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, Office of In-Vitro Diagnostic Devices (OIVD)

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

E-CUBE 8 with CW5.0 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			P
Urology (including prostate)

N = new indication; P = previously cleared by FDA K172732; 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, Office of In-Vitro Diagnostic Devices (OIVD)

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

E-CUBE 8 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	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal	P	P	P		P	P	P	P	P
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	N	N	N		N	N	N	N	N
Urology (including prostate)	P	P	P		P	P	P	P	P

N = new indication; P = previously cleared by FDA K161439; 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, Office of In-Vitro Diagnostic Devices (OIVD)

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

E-CUBE 8 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)	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	N	N	N		N	N	N	N
Urology (including prostate)	P	P	P		P	P	P	P

N = new indication; P = previously cleared by FDA K161439; 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, Office of In-Vitro Diagnostic Devices (OIVD)

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

E-CUBE 8 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)	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	N	N	N		N	N	N	N
Urology (including prostate)	P	P	P		P	P	P	P

N = new indication; P = previously cleared by FDA K161439; 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, Office of In-Vitro Diagnostic Devices (OIVD)

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

E-CUBE 8 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	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)	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	N	N	N		N	N	N	N
Urology (including prostate)	P	P	P		P	P	P	P

N = new indication; P = previously cleared by FDA K161439; 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, Office of In-Vitro Diagnostic Devices (OIVD)

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

E-CUBE 8 with L8-17H 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
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	N	N	N		N	N	N	N
(breast, testes, thyroid)
Neonatal Cephalic	N	N	N		N	N	N	N
Adult Cephalic
Trans-rectal
Trans-vaginal
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
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel	N	N	N		N	N	N	N
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, Office of In-Vitro Diagnostic Devices (OIVD)

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

E-CUBE 8 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	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)	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 K153424; 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, Office of In-Vitro Diagnostic Devices (OIVD)

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

510(k) Summary

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

July 18th, 2018 Date
Submitter: ALPINION MEDICAL SYSTEMS Co., Ltd. Address: 1FL and 6FL, Verdi Tower, 72, Digital-ro 26-gil, Guro-gu, Seoul, Republic of Korea
Primary Contact Boyeon CHO Person Quality Management Representative(QMR) Address: 1FL and 6FL, Verdi Tower, 72, Digital-ro 26-gil, Guro-qu, Seoul, Republic of Korea Phone: +82 70 7465 2104 Fax: +82 2 851 5595 Email: qa ra@alpinion.com
Secondary JULIAN LEE Contact Person Address: 21312 30th Dr SE Ste 100 Bothell, WA 98021, United States Phone: 425 949 1059 Fax: 425 949 4910 Email: julian.lee@alpinionusa.com
- Device Trade E-CUBE 8 Name:
- Common/ Ultrasonic Pulsed Doppler Imaging System

Usual Name:

Classification System, Imaging, Pulsed Doppler Ultrasonic Names
Product Code: Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550 90-IYN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21CFR 892.1570, 90-ITX
- Primary K172732 E-CUBE 8 Diagnostic Ultrasound System Predicate Device
- Predicate K161439 E-CUBE 11 Diagnostic Ultrasound System Devices K153424 E-CUBE i7 Diagnostic Ultrasound System K132687 E-CUBE 7 Diagnostic Ultrasound System K163691 HS70A Diagnostic Ultrasound System K163120 EPIQ 5 / EPIQ 7 Diagnostic Ultrasound System
- E-CUBE 8 product is an ultrasound imaging system for medical diagnosis. Device Description: This innovative system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.

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

1. Signal Mode:

2D(B) mode, Harmonic mode (HAR), M mode, Color M mode, Anatomical M mode, Color Flow Doppler(CF) Mode, Power Doppler(PD) Mode, Directional PD mode, Pulsed Wave Doppler(PWD) Mode, Continuous Wave Doppler(CWD) Mode, High PRF Doppler mode, Tissue Doppler Imaging(TDI) Mode, 3D/4D mode

2. Combination Mode:

B/Color Doppler, B/PWD, B/Color Doppler/PWD

Acoustic output track:

Track 3

	C1-6CT	C5-8NT	SC1-4H	SC1-4HS	SC1-6H
Transducertype	Convex	Convex	Convex	Convex	Convex
Applicablefrequency	1~6MHz	5~8MHz	1~4MHz	1~4MHz	1~6MHz
Intendedusage	Fetal,Abdominal,Pediatric,Musculo-skeletal,PeripheralvesselUrology	Abdominal,Pediatric,NeonatalCephalicCardiac Adult,CardiacPediatricPeripheralvessel	Fetal,Abdominal,Pediatric,Musculo-skeletal,PeripheralvesselUrology	Fetal,Abdominal,Pediatric,Musculo-skeletal,PeripheralvesselUrology	Fetal,Abdominal,Pediatric,Musculo-skeletal,PeripheralvesselUrology
Applicablemode	B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined	B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined	B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined	B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined	B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined
ScanningDepth (mm)	300	140	300	300	300
Total numberof element	128	128	192	166	192
Predicate	Previouslycleared(K172732)	Previouslycleared(K153424)	Previouslycleared(K161439)	Previouslycleared(K161439)	Previouslycleared(K161439)

Types of transducers compatible with the device :

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

	CW2.0	CW5.0	EV3-10T	EC3-10T	E3-10
Transducertype	PencilDoppler	PencilDoppler	Endocavity	Endocavity	Endocavity
Applicablefrequency	2.0MHz	5.0MHz	3~10MHz	3~10MHz	3~10MHz
Intendedusage	Cardiac Adult,CardiacPediatric	Cardiac Adult,CardiacPediatricPeripheralvessel	Fetal,Trans-rectal,Trans-vaginal,PeripheralvesselUrology	Fetal,Trans-rectal,Trans-vaginal,PeripheralvesselUrology	Fetal,Trans-rectal,Trans-vaginal,PeripheralvesselUrology
Applicablemode	CWD	CWD	B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined	B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined	B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined
ScanningDepth (mm)	N/A	N/A	100	100	140
Total numberof element	2(TX1, RX1)	2(TX1, RX1)	128	128	128
Predicate	Previouslycleared(K161439)	Previouslycleared(K161439)	Previouslycleared(K153424)	Previouslycleared(K153424)	Previouslycleared(K132687)

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

	L3-12H	L3-12T	L3-12HWD	L8-17H	IO8-17T
Transducertype	Linear	Linear	Linear	Linear	Linear
Applicablefrequency	3~12MHz	3~12MHz	3~12MHz	8~17MHz	8~17MHz
Intendedusage	AbdominalPediatric,Small Organ(breast,testes,thyroid),NeonatalCephalicMusculo-skeletal,Peripheralvessel	AbdominalPediatric,Small Organ(breast,testes,thyroid),NeonatalCephalicMusculo-skeletal,Peripheralvessel	FetalAbdominalPediatric,Small Organ(breast,testes,thyroid),NeonatalMusculo-skeletal,Peripheralvessel	Fetal,Abdominal,Pediatric,Small Organ(breast,testes,thyroid),NeonatalCephalic,Musculo-skeletal,Peripheralvessel	Small Organ(breast,testes,thyroid),Musculo-Skeletal,Peripheralvessel
Applicablemode	B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined	B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined	B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined	B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined	B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined
ScanningDepth (mm)	100	100	100	100	100
Total numberof element	192	128	192	192	128
Predicate	Previouslycleared(K161439)	Previouslycleared(K153424)	Previouslycleared(K161439)	NEW	Previouslycleared(K153424)

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

	SP3-8T	P1-5CT	VE3-10H	VC1-6T	-	-
Transducertype	SectorPhased	SectorPhased	VolumeEndocavity	VolumeConvex
Applicablefrequency	3~8MHz	1~5MHz	3~10MHz	1~6MHz
Intendedusage	FetalAbdominal,Pediatric,NeonatalCephalicAdultCephalic,Cardiac Adult,CardiacPediatric	FetalAbdominal,Pediatric,AdultCephalic,Cardiac Adult,CardiacPediatricPeripheralvessel	Fetal,Trans-rectal,Trans-vaginal,Peripheralvessel,Urology	Fetal,Abdominal,Pediatric,Urology
Applicablemode	B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined	B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined	B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined/Others	B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging/Combined/Others
ScanningDepth (mm)	300	300	140	300	-	-
Total numberof element	64	64	192	128	-	-
Predicate	Previouslycleared(K1534324)	Previouslycleared(K172732)	Previouslycleared(K161439)	Previouslycleared(K172732)	-	-

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), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculoskeletal (Conventional); Musculo-skeletal (Superficial), Cardiac (Adult& Pediatric), Peripheral Vascular(PV) and Urology (including prostate).

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

Determination of

Substantial Equivalence: Comparison table with Predicate devices:

Model	ProposedE-CUBE 8ALPINION MedicalSystems Co., Ltd.	PredicateE-CUBE 8ALPINION MedicalSystems Co., Ltd.K172732	PredicateE-CUBE 11ALPINION MedicalSystems Co., Ltd.K161439	PredicateE-CUBE i7ALPINION MedicalSystems Co., Ltd.K153424	PredicateE-CUBE 7ALPINION MedicalSystems Co., Ltd.K132687	PredicateHS70ASamsungMedison co., ltdK163691	PredicateEPIQ 5 and EPIQ 7Philips UltrasoundInc.K163120
Feature	-
Indications for Use
- Fetal	√	√	√	√	√	√	√
- Abdominal(Renal&GYN/Pelvic)	√	√	√	√	√	√	√
- Pediatric	√	√	√	√	√	√	√
- Small Organ(breast, testes, thyroid)	√	√	√	√	√	√	√
- Neonatal Cephalic	√	√	√	√	√	√	√
- Adult Cephalic	√	√	√	√	√	√	√
- Trans-rectal	√	√	√	√	√	√	√
- Trans-vaginal	√	√	√	√	√	√	√
- Musculo-skeletal(Conventional)	√	√	√	√	√	√	√
- Musculto skeletal(Superficial)	√	√	√	√	√	√	√
- Cardiac (Adult)	√	√	√	√	√	√	√
- Cardiac (Pediatric)	√	√	√	√	√	√	√
- Peripheral Vessel	√	√	√	√	√	√	√
- Urology(including prostate)	√	√	√	√	√	√	√
Imaging modes
- 2D(B) mode	√	√	√	√	√	√	√
- Harmonic mode	√	√	√	√	√	√	√
- M mode	√	√	√	√	√	√	√
- Color M mode	√	√	√	√	√	√	√
- Anatomical M mode	√	√	√	√	√	√	√
- Color Flow Doppler (CF) mode	√	√	√	√	√	√	√
- Power Doppler (PD) mode	√	√	√	√	√	√	√
- Directional PD mode	√	√	√	√	√	√	√
- Pulsed wave Doppler(PWD) mode	√	√	√	√	√	√	√
- Continuous waveDoppler (CWD) mode	√	√	√	√	√	√	√
- High PRF Doppler mode	√	√	√	√	√	√	√
- Tissue Dopplerimaging (TDI) mode	√	√	√	√	√	√	√
- 3D/4D mode	√	√	√	√	√	√	√
Imaging modes
- 2D(B) mode	√	√	√	√	√	√	√
- Harmonic mode	√	√	√	√	√	√	√
- M mode	√	√	√	√	√	√	√
- Color M mode	√	√	√	√	√	√	√
- Anatomical M mode	√	√	√	√	√	√	√
- Color Flow Doppler (CF)mode	√	√	√	√	√	√	√
- Power Doppler (PD)mode	√	√	√	√	√	√	√
- Directional PD mode	√	√	√	√	√	√	√
- Pulsed wave Doppler(PWD) mode	√	√	√	√	√	√	√
- Continuous waveDoppler (CWD) mode	√	√	√	√	√	√	√
- High PRF Doppler mode	√	√	√	√	√	√	√
- Tissue Dopplerimaging (TDI) mode	√	√	√	√	√	√	√
- 3D/4D mode	√	√	√	√	√	√	√
Imaging Functions
- Xpeed™	√	√	√	√	√	√	√
- Full SRI™	√	√	√	√	√	√	√
-Spatial CompoundingImage (SCI)	√	√	√	√	√	√	√
- Frequency Compoundingimage (FCI)	√	√	√	√	√	√	√
- Panoramic	√	√	√	√	√	√	√
- Stress Echo	√	√	√	√	√	√	√
- Cube Strain™	√	√	√	√	√	√	√
- Live HQ ™	√	√	√	√	√	√	√
- Needle Vision™/Needle Vision™ Plus	√	√	√	√	√	√	√
- Elastography	√	√	√	√	√	√	√
- Cube viewTM	√	√	√	√	√	√
- Volume AdvanceTM
• Free Angle MSV	√					√
• AnySliceTM	√	√				√
• Volume Analysis	√	√				√
Thermal, Mechanical and Electrical safety
NEMA UD2, UD3	√	√	√	√	√	√	√
AIUM Medical Ultrasound Safety	√	√	√	√	√	√	√
IEC 60601-1	√	√	√	√	√	√	√
IEC 60601-1-2	√	√	√	√	√	√	√
IEC 60601-2-37	√	√	√	√	√	√	√

ALPINION MEDICAL SYSTEMS Co., Ltd.

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Summary of Non-Clinical Tests:

E-CUBE 8 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 8 and its application comply with voluntary standards as detailed in this premarket submission.

� IEC60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety
� IEC60601-1-2. Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
� IEC60601-2-37, Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
� ISO10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
� ISO14971, Application of risk management to medical devices
� AIUM Medical Ultrasound Safety
� NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
� NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic ultrasound Equipment

The following quality management system measures were applied to the development of E-CUBE 8:

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 8, did not require clinical studies to support substantial equivalence.

Discussion:

E-CUBE 8 was compared with the predicate devices. The subject device is in conformance with applicable safety standards.

Additionally, the differences between E-CUBE 8 (Subjective) and E-CUBE 8 (Predicate) are monitor's option (with/without touchscreen) and applications of transducer.

Therefore, the differences between E-CUBE 8 and the predicate devices would not affect the safety, effectiveness and essential performance.

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ALPINION MEDICAL SYSTEMS Co., Ltd. considers E-CUBE 8 to be as safe, Conclusion: as effective. Performance, technology and software are substantially equivalent to the predicate devices.

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.