E-CUBE i7

• K Number: K182594
• Device Name: E-CUBE i7
• Manufacturer: Alpinion Medical Systems Co., Ltd.
• Date Cleared: 2019-01-24 ( 126 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K153424 , K150773 , K172732 , K132687
• Predicate For: K213523

Intended Use

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

Device Description

E-CUBE i7 product is an ultrasound imaging system for medical diagnosis. This device is available for portable(only body) and mobile(with system cart). Also, this innovative system platform provides optimal patient diagnosis workflow with the 15.6" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.

1. Signal Mode:
   B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode, Pulsed Wave Doppler (PWD) mode, Continuous wave Doppler (CWD) mode, Tissue Doppler Imaging(TDI) mode, 3D, 4D

B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/CF/M

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE i7 ultrasound system. This submission primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than presenting a novel device with specific acceptance criteria that require proof through a new study.

Therefore, there is no specific study mentioned in this document that proves the device meets particular acceptance criteria in the format requested. The document asserts substantial equivalence based on comparisons to predicate devices and adherence to established safety and performance standards.

Here's an attempt to structure the information based on your request, highlighting what is (and isn't) present in the provided text:

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

Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are implicitly defined by the safety and performance characteristics of the predicate devices and relevant industry standards. The "reported device performance" is essentially the statement that the E-CUBE i7 is equivalent in performance to these predicates.

Acceptance Criteria (Implied by Predicate Equivalence & Standards)	Reported Device Performance (E-CUBE i7)
Indications for Use:	Identical to primary predicate (K153424)
Fetal, Abdominal, Pediatric, Small Organ, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional & Superficial), Cardiac (Adult & Pediatric), Peripheral Vessel, Urology (including prostate)	Same
Electrical Power:	Voltage: 19V, 10.5A; Frequency: 50/60Hz; Power: 200W Max
Imaging Modes:	2D (B) mode, M mode, Anatomical M, Color Flow Doppler (CF) mode, Power Doppler (PD) mode, Directional PD, Pulsed wave Doppler (PWD) mode, Continuous wave Doppler (CWD) mode, Tissue Doppler imaging (TDI) mode, 3D/4D mode
Image Processing Technology:	Xpeed™, Full SRI™, Spatial Compounding Image (SCI), ECG mode
Software Features:	Panoramic, Needle Vision™/Needle Vision™ Plus, Cube View™, Cube Strain™, Stress Echo
Thermal, Mechanical, Electrical Safety:	Conforms to NEMA UD2, AIUM Medical Ultrasound Safety, IEC60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC61000-3-2, IEC 61000-3-3, IEC 61000-4-2, IEC 61000-4-3, IEC61000-4-4, IEC61000-4-5, IEC61000-4-6, IEC61000-4-8, IEC61000-4-11 (identical to primary predicate)
Biocompatibility:	Transducer materials and other patient contact materials are biocompatible. (Statement from document)

The document states, "Therefore, the differences between E-CUBE i7 and the predicate devices would not affect the safety, effectiveness and essential performance." This is the core "proof" in a 510(k) context.

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

The document explicitly states: "The subject of this premarket submission, E-CUBE i7, did not require clinical studies to support substantial equivalence."
Therefore, there is no test set, sample size, or data provenance information of this nature provided.

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

Not applicable, as no clinical studies with test sets were conducted.

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

Not applicable, as no clinical studies with test sets were conducted.

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. The E-CUBE i7 is an ultrasound imaging system, and the submission does not mention any AI assistance features or MRMC studies.

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

Not applicable, as the device is a diagnostic ultrasound system and not an algorithm-only device. Performance assessment is based on demonstrating equivalence to predicate ultrasound systems through engineering and performance testing against standards, not through standalone algorithm performance studies.

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

Given that no clinical studies were performed, there's no clinical "ground truth" established in this submission. The "ground truth" for demonstrating substantial equivalence relies on:

• Engineering principles and design specifications.
• Performance testing against recognized standards (e.g., NEMA UD2, AIUM Medical Ultrasound Safety, IEC 60601 series).
• Comparison of features and specifications to legally marketed predicate devices.

8. The sample size for the training set

Not applicable, as no machine learning/AI models are discussed that would require a training set in the context of this submission. The device is an ultrasound imaging system.

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

Not applicable.

Summary

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January 24, 2019

Image /page/0/Picture/1 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, which is a blue square with the letters "FDA" in white. Below the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Alpinion Medical Systems Co., Ltd. Boyeon Cho OA/RA Manager 5fl, i dong, 77, heungan-daero 81 beon-gil dongan-gu ANYANG-SI, GYEONGGI-DO 14117 REPUBLIC OF KOREA

Re: K182594

Trade/Device Name: E-CUBE i7 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: December 28, 2018 Received: December 31, 2018

Dear Boyeon Cho:

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. 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 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.htm); good

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara

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)

K182594

Device Name E-CUBE i7

Indications for Use (Describe)

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

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

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

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E-CUBE i7 Ultrasound System

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

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

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E-CUBE i7 with C1-6T Transducer

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

Clinical Application		Mode of Operation
	B	M	PWD	CWD	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 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

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E-CUBE i7 with EC3-10T Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	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
Trans-vaginal	P	P	P		P	P	P	P
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal(Superficial)
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)	P	P	P		P	P	P	P

N = new indication; P = previously cleared by FDA 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

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E-CUBE i7 with EV3-10T Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	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 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

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E-CUBE i7 with L3-12T Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	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 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

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E-CUBE i7 with C5-8NT Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	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
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 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

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E-CUBE i7 with IO8-17T Transducer

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

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

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E-CUBE i7 with SP1-5T Transducer

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

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

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E-CUBE i7 with SP3-8T Transducer

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

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

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E-CUBE i7 with L3-12HW0 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 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

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E-CUBE i7 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
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ(breast, testes, thyroid)	N	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	N
Musculo-skeletal(Superficial)	N	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	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

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

E-CUBE i7 with L3-8H 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)	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	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

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

E-CUBE i7 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

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

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

E-CUBE i7 with IO3-12 Transducer

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

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

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

E-CUBE i7 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

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

E-CUBE i7 with CW5.0 Transducer

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

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

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

510(k) Summary

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

Date	Jan. 04, 2019
Submitter:	ALPINION MEDICAL SYSTEMS Co., Ltd.Address: 5fl, i dong ,77, heungan-daero 81beon-gil, dongan-gu, anyang-si, gyeonggi-do , REPUBLIC OF KOREA, 14117
Primary ContactPerson	Boyeon CHOQuality Management Representative(QMR)Address: 5fl, i dong ,77, heungan-daero 81beon-gil, dongan-gu, anyang-si, gyeonggi-do , REPUBLIC OF KOREA, 14117Phone: [phone]Fax: [phone]Email: [e-mail]
Secondary ContactPerson	JULIAN LEEAddress: 21312 30th Dr SE Ste 100 Bothell, WA 98021, United StatesPhone: 425 949 1059Fax: [phone]Email: [e-mail]
Device Trade Name:	E-CUBE i7
Common/UsualName:	Ultrasonic Pulsed Doppler Imaging System
Classification Names	System, Imaging, Pulsed Doppler Ultrasonic
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
Primary PredicateDevice	K153424 E-CUBE i7 Diagnostic Ultrasound SystemK150773 E-CUBE 15 Diagnostic Ultrasound SystemK172732 E-CUBE 8 Diagnostic Ultrasound SystemK132687 E-CUBE 7 Diagnostic Ultrasound System
Device Description:	E-CUBE i7 product is an ultrasound imaging system for medicaldiagnosis. This device is available for portable(only body) and mobile(withsystem cart). Also, this innovative system platform provides optimalpatient diagnosis workflow with the 15.6" wide flat panel display,ergonomic control panel with easy user interface, optimal image quality.
	1. Signal Mode:B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode,Pulsed Wave Doppler(PWD) mode, Continuous wave Doppler (CWD)mode, Tissue Doppler Imaging(TDI) mode, 3D, 4D

B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/CF/M

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

Acoustic output track:_

Track 3

Track 3

Types of transducers compatible with the device:

	C1-6T	L3-12T	EC3-10T	EV3-10T		IO8-17T	SP1-5T	SP3-8T	C5-8NT
Previouslycleared	K153424	K153424	K153424	K153424	Previouslycleared	K153424	K153424	K153424	K153424
Applicablefrequency	1~6MHz	3~12MHz	3~10MHz	3~10MHz	Applicablefrequency	8~17MHz	1~5MHz	3~8MHz	5~8MHz
IntendedUsage	Fetal.Abdominal,Pediatric,Urology	Pediatric,Small Organ,Musculoskeletal(Conventional),Musculo-skeletal(Superficial),Peripheralvessel	Trans-rectal,Trans-vaginal,Urology	Trans-rectal,Trans-vaginal,Urology	IntendedUsage	Small Organ,Musculo-skeletal(Conventional),Musculo-skeletal(Superficial)	Abdominal,Pediatric,Adult Cephalic,Cardiac Adult	Abdominal,Pediatric,Adult CephalicCardiac Adult,Cardiac Pediatric	Abdominal,Pediatric,Cardiac Pediatric
Applicablemode	B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging/Combined	B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging/Combined	B/M/PWD/Color Doppler/Power Doppler/Combined	B/M/PWD/Color Doppler/Power Doppler/Combined	Applicablemode	B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging/Combined	B/M/PWD/CWDColor Doppler/Power Doppler/Tissue HarmonicImaging/Combined	B/M/PWD/CWDColor Doppler/Power Doppler/Tissue HarmonicImaging/Combined	B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging/Combined
Scanningdepth(mm)	300	100	100	100	Scanningdepth(mm)	300	300	300	140
FOV	60(°)	N/A	142(°)	142(°)	FOV	N/A	90(°)	90(°)	93.6(°)
Steer Angle	N/A	Max 9(°)	N/A	N/A	Steer Angle	15(°)	45(°)	45(°)	N/A
Totalnumber ofelement	128	128	128	128	Totalnumber ofelement	128	64	64	128

	L3-12HWD	L3-8H	L8-17H	IO3-12
Previouslycleared	K172732	New	New	K132687
Applicablefrequency	3~12MHz	3~8MHz	8~17MHz	3~12MHz
IntendedUsage	Small Organ,Musculo-skeletal(Conventional),Musculo-skeletal(Superficial),Peripheral	Small Organ,Musculo-skeletal(Conventional),Musculo-skeletal(Superficial),Peripheral	Small Organ,Musculo-skeletal(Conventional),Musculo-skeletal(Superficial),Peripheral	Small Organ

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

	vessel	vessel	vessel
Applicablemode	B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging/Combined	B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging/Combined	B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging/Combined	B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging/Combined
Scanningdepth(mm)	100	100	100	100
FOV	N/A	N/A	NA	NA
Steer Angle	Max 9(°)	15(°)	15(°)	15(°)
Totalnumber ofelement	192	166	192	80

	VC1-6T	CW2.0	CW5.0
Previouslycleared	K172732	K172732	K172732
Applicablefrequency	1~6MHz	2MHz	5MHz
IntendedUsage	Fetal,Abdominal,Pediatric,Urology	Cardiac Adult,CardiacPediatric	Cardiac Adult,CardiacPediatric
Applicablemode	B/M/PWD/Color Doppler/Power Doppler/Tissue HarmonicImaging/Combined/3D/4D	CWD	CWD
Scanningdepth(mm)	300	N/A	N/A
FOV	79(°)	N/A	N/A
Steer Angle	N/A	N/A	N/A
Totalnumber ofelement	128	2(TX1, RX1)	2(TX1, RX1)

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

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

Comparison with Predicate devices: Determination of Substantial

Equivalence: 1) E-CUBE i7 and E-CUBE i7 (Primary Predicate Device)

Substrate
Equivalence

Feature	ProposedE-CUBE i7	PredicateE-CUBE i7(K153424)
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);Cardiac (Pediatric);Peripheral Vessel (PV);Urology (including prostate).	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);Cardiac (Pediatric);Peripheral Vessel (PV);Urology (including prostate).
Electricalpower	Voltage: 19V, 10.5AFrequency: 50/60HzPower: 200W Max	Voltage: 19V, 10.53AFrequency: 50/60HzPower: 200W Max
Imagingmodes	2D (B) modeM modeAnatomical MColor Flow Doppler (CF) modePower Doppler (PD) modeDirectional PDPulsed wave Doppler (PWD) modeContinuous wave Doppler (CWD)modeTissue Doppler imaging (TDI)mode3D/4D mode	2D (B) modeM modeAnatomical MColor Flow Doppler (CF) modePower Doppler (PD) modeDirectional PDPulsed wave Doppler (PWD) modeContinuous wave Doppler (CWD)modeTissue Doppler imaging (TDI)mode
Imageprocessingtechnology	Xpeed™Full SRI™Spatial Compounding Image (SCI)ECG mode	Xpeed™Full SRI™Spatial Compounding Image (SCI)
Softwarefeature	PanoramicNeedle Vision™/Needle Vision™ PlusCube View™Cube Strain™Stress Echo	PanoramicNeedle Vision™/Needle Vision™ PlusCube View™
Thermal,mechanicalandelectricalsafety	The E-CUBE i7 has been designedto conform to the followingstandards:NEMA UD2AIUM Medical Ultrasound SafetyIEC60601-1IEC 60601-1-2:2007IEC 60601-2-37:2007+AMD1:2015IEC61000-3-2:2014IEC 61000-3-3:2013IEC 61000-4-2:2008IEC 61000-4-3:2006+A1:2007+A2:2010IEC61000-4-4:2012	The E-CUBE i7 has been designedto conform to the followingstandards:NEMA UD2AIUM Medical Ultrasound SafetyIEC60601-1IEC 60601-1-2:2007IEC 60601-2-37:2007+AMD1:2015IEC61000-3-2:2014IEC 61000-3-3:2013IEC 61000-4-2:2008IEC 61000-4-3:2006+A1:2007+A2:2010IEC61000-4-4:2012

ALPINION MEDICAL SYSTEMS Co., Ltd.

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

	IEC61000-4-5:2014IEC61000-4-6:2013IEC61000-4-11:2004IEC61000-4-8:2009	IEC61000-4-5:2014IEC61000-4-6:2013IEC61000-4-11:2004IEC61000-4-8:2009
option	Wireless LAN	-

2) E-CUBE i7 and E-CUBE 15

Feature	ProposedE-CUBE i7	PredicateE-CUBE 15(K150773)
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);Cardiac (Pediatric);Peripheral Vessel (PV);Urology (including prostate).	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);Cardiac (Pediatric);Peripheral Vascular (PV);Urology (including prostate).
Electricalpower	Voltage: 19V, --- 10.5AFrequency: 50/60HzPower: 200W Max	Voltage: 100120V, 200240VFrequency: 50/60HzPower: Max. 900 VA with Built-inand On-Board Peripherals
Imagingmodes	2D (B) modeM modeAnatomical MColor Flow Doppler (CF) modePower Doppler (PD) modeDirectional PDPulsed wave Doppler (PWD) modeContinuous wave Doppler (CWD)modeTissue Doppler imaging (TDI)mode3D/4D mode	2D(B) ModeM ModeColor Flow Doppler (CF) ModePower Doppler (PD) ModePulsed wave Doppler (PWD) ModeContinuous wave Doppler (CWD)ModeTissue Doppler imaging (TDI)Mode3D/4D ModeElastography
Imageprocessingtechnology	Xpeed™Full SRI™Spatial Compounding Image (SCI)ECG mode	Xpeed™FullSRI™Spatial Compounding Image (SCI)ECG ModeFrequencyCompoundingImage(FCI)
Softwarefeature	PanoramicNeedle Vision™	PanoramicNeedle Vision™

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

	/Needle Vision™ Plus	/Needle Vision™ Plus
	Cube View™	Cube View™
	Cube Strain™	Cube Strain™
	Stress Echo	Stress Echo
		Live HQ™
Thermal,mechanicalandelectricalsafety	The E-CUBE i7 has been designedto conform to the followingstandards:NEMA UD2AIUM Medical Ultrasound SafetyIEC60601-1IEC 60601-1-2IEC 60601-2-37IEC61000-3-2IEC 61000-3-3IEC 61000-4-2IEC 61000-4-3IEC61000-4-4IEC61000-4-5IEC61000-4-6	The E-CUBE i7 has been designedto conform to the followingstandards:NEMA UD2AIUM Medical Ultrasound SafetyIEC60601-1IEC 60601-1-2IEC 60601-2-37IEC61000-3-2IEC 61000-3-3IEC 61000-4-2IEC 61000-4-3IEC61000-4-4IEC61000-4-5IEC61000-4-6
	IEC61000-4-8IEC61000-4-11	IEC61000-4-8IEC61000-4-11
option	Wireless LAN	-

3 E-CUBE i7 and E-CUBE 8

Feature	ProposedE-CUBE i7	PredicateE-CUBE 8(K172732)
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);Cardiac (Pediatric);Peripheral Vessel (PV);Urology (including prostate).	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);Cardiac (Pediatric);Peripheral Vascular (PV);Urology (including prostate).Neonatal Cephalic
Electricalpower	Voltage: 19V, 10.5AFrequency: 50/60HzPower: 200W Max	Voltage: 100120V, 200240VFrequency: 50/60HzPower: 450 VA
Imagingmodes	2D (B) modeM modeAnatomical MColor Flow Doppler (CF) modePower Doppler (PD) modeDirectional PDPulsed wave Doppler (PWD) modeContinuous wave Doppler (CWD)modeTissue Doppler imaging (TDI)mode	2D(B) ModeM ModeColor Flow Doppler (CF) ModePower Doppler (PD) ModePulsed wave Doppler (PWD) ModeContinuous wave Doppler (CWD)ModeTissue Doppler imaging (TDI)Mode

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

	3D/4D mode	3D/4D Mode
		Elastography
Imageprocessingtechnology	XpeedTM	XpeedTM
	Full SRITM	FullSRITM
	Spatial Compounding Image (SCI)	Spatial Compounding Image (SCI)
	ECG mode	Frequency Compounding Image(FCI)
Softwarefeature	Panoramic	Panoramic
	Needle VisionTM	Needle VisionTM
	/Needle VisionTM Plus	/Needle VisionTM Plus
	Cube ViewTM	Cube ViewTM
	Cube StrainTM	Cube StrainTM
	Stress Echo	Stress Echo
		Volume AdvanceTM
Thermal,mechanicalandelectricalsafety	The E-CUBE i7 has been designedto conform to the followingstandards:NEMA UD2AIUM Medical Ultrasound SafetyIEC60601-1IEC 60601-1-2IEC 60601-2-37IEC61000-3-2IEC 61000-3-3IEC 61000-4-2IEC 61000-4-3IEC61000-4-4IEC61000-4-5IEC61000-4-6IEC61000-4-8IEC61000-4-11	The E-CUBE 8 has been designedto conform to the followingstandards:NEMA UD2AIUM Medical Ultrasound SafetyIEC60601-1IEC 60601-1-2IEC 60601-2-37IEC61000-3-2IEC 61000-3-3IEC 61000-4-2IEC 61000-4-3IEC61000-4-4IEC61000-4-5IEC61000-4-6IEC61000-4-8IEC61000-4-11
option	Wireless LAN	Wireless LAN

4 E-CUBE i7 and E-CUBE 7

Feature	ProposedE-CUBE i7	PredicateE-CUBE 7(K132687)
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);Cardiac (Pediatric);Peripheral Vessel (PV);Urology (including prostate).	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);Trans-rectal(TR);Trans-vaginal(TV);Musculo-skeletal(Conventional);Musculo-skeletal (Superficial);Cardiac (Adult);Cardiac (Pediatric);Peripheral Vascular (PV);Urology (including prostate).
Electricalpower	Voltage: 19V, ---10.5AFrequency: 50/60HzPower: 200W Max	Voltage: 100120V, 200240VFrequency: 50/60HzPower: 600 VA
Imagingmodes	2D (B) modeM mode	2D(B) ModeM Mode

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

	Anatomical MColor Flow Doppler (CF) modePower Doppler (PD) modeDirectional PD	Color Flow Doppler (CF) ModePower Doppler (PD) Mode
	Pulsed wave Doppler (PWD) modeContinuous wave Doppler (CWD)modeTissue Doppler imaging (TDI)mode	Pulsed wave Doppler (PWD) ModeContinuous wave Doppler (CWD)Mode
	3D/4D mode	3D/4D Mode
Imageprocessingtechnology	Xpeed™Full SRI™Spatial Compounding Image (SCI)ECG mode	Xpeed™FullSRI™Spatial Compounding Image (SCI)ECG ModeFrequency Compounding Image(FCI)
Softwarefeature	PanoramicNeedle Vision™/Needle Vision™ PlusCube View™Cube Strain™Stress Echo	Panoramic
Thermal,mechanicalandelectricalsafety	The E-CUBE i7 has been designedto conform to the followingstandards:NEMA UD2AIUM Medical Ultrasound SafetyIEC60601-1IEC 60601-1-2IEC 60601-2-37IEC61000-3-2IEC 61000-3-3IEC 61000-4-2IEC 61000-4-3IEC61000-4-4IEC61000-4-5IEC61000-4-6IEC61000-4-8IEC61000-4-11	The E-CUBE 7has been designedto conform to the followingstandards:NEMA UD2AIUM Medical Ultrasound SafetyIEC60601-1IEC 60601-1-2IEC 60601-2-37IEC61000-3-2IEC 61000-3-3IEC 61000-4-2IEC 61000-4-3IEC61000-4-4IEC61000-4-5IEC61000-4-6IEC61000-4-8IEC61000-4-11
option	Wireless LAN	-

Summary of Non-Clinical Tests:

E-CUBE i7 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 i7 and its application comply with voluntary standards as detailed in this premarket submission.

• IEC60601-1, Medical electrical equipment Part 1: General � requirements for basic safety and essential performance
• � 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

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

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

The following quality management system measures were applied to the development of E-CUBE i7:

• � Medical Device Risk Management
• � Requirements Reviews
• Desian 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 i7, did not require clinical studies to support substantial equivalence.

Discussion:

E-CUBE i7 was compared with the predicate devices (K153424, K150773). E-CUBE i7 and predicate model K153424 is difference between the ECG, 3D/4D function, several image functions. The subject device is in conformance with applicable safety standards.

Therefore, the differences between E-CUBE i7 and the predicate devices would not affect the safety, effectiveness and essential performance.

• ALPINION MEDICAL SYSTEMS Co., Ltd. considers E-CUBE i7 to be as Conclusion: safe, 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 quidance 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.