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

Device Description

E-CUBE 12 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 21.5" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.

AI/ML Overview

This document is a 510(k) Premarket Notification for the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE 12 Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to a predicate device, the E-CUBE 15 Diagnostic Ultrasound System (K123610), rather than outlining specific acceptance criteria and detailed study results for a new device's performance.

Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, and the type of ground truth used as part of a comparative effectiveness study or standalone performance evaluation is not explicitly provided in the given text.

The document states: "The subject of this premarket submission, E-CUBE 12, did not require clinical studies to support substantial equivalence." This means that rigorous clinical performance studies with acceptance criteria and detailed statistical analysis, as typically expected for proving device performance, were not conducted or submitted for this specific 510(k) approval. Instead, the approval is based on comparing the new device to a legally marketed predicate.

However, I can extract and infer some information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Substantial Equivalence): The E-CUBE 12 must perform as safely and effectively as the predicate device (E-CUBE 15 K123610) for its intended uses. This is primarily demonstrated by showing conformity to applicable safety standards and similar technological characteristics.

Feature	Acceptance Criteria (Implied from Predicate Equivalence)	Reported Device Performance (E-CUBE 12)
Clinical Applications	Must be intended for similar evaluations of soft tissue and blood flow in specified clinical applications. Deviations are acceptable if safety and effectiveness are maintained via non-clinical testing.	Fetal; Abdominal (renal & GYN/pelvic); Pediatric, Small Organ (breast, testes, thyroid); Adult Cephalic; Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (adult & pediatric); Peripheral Vascular (PV); and Urology (including prostate). (Some differences exist, e.g., removal of Trans-rectal/vaginal from E-CUBE 15's indications, addition of Adult Cephalic). These differences are justified by non-clinical testing.
Modes of Operation	Must utilize comparable modes of operation, or demonstrate that new/changed modes do not negatively impact safety and effectiveness.	Signal Mode: B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode, Pulsed Wave Doppler(PWD) mode, Tissue Harmonic Imaging(THI). Combination Mode: B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/PD/PWD, B/CF/M. (Predicate also had Continuous Wave (CW) Doppler and 3D/4D Volume Mode, which are not listed for E-CUBE 12. E-CUBE 12 adds "Beam Steering", "Spatial Compounding", "Frequency Compounding", "Xpeed™", "Auto traces PW", "Directional Power Doppler Mode", "SRI", "Full SRI™".)
Safety Standards	Conformity to relevant medical device safety standards for thermal, mechanical, and electrical safety, and acoustic output.	Conforms to: NEMA UD2, UD3; AIUM Medical Ultrasound Safety; IEC60601-1; IEC60601-1-2; IEC60601-2-37. (Same as predicate E-CUBE 15). Transducer materials and other patient contact materials are biocompatible.
Technological Basis	Must employ the same fundamental scientific technology as the predicate device.	Employs the same fundamental scientific technology as the predicate device.

Missing Information Details:

Sample sizes used for the test set and the data provenance: Not provided. The submission states no clinical studies were required for substantial equivalence, implying no dedicated "test set" in the context of clinical performance evaluation studies was used. The focus was on non-clinical testing to verify design changes.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical studies with expert ground truth establishment for a test set were conducted.
Adjudication method for the test set: Not applicable, as no clinical studies with a test set requiring adjudication were conducted.
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 imaging system, not an AI-assisted diagnostic tool for interpretation, and no MRMC studies are mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical imaging device, not an algorithm being evaluated in isolation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical performance studies requiring ground truth were conducted. The "ground truth" here is conformity to safety standards and equivalence to an already approved device.
The sample size for the training set: Not applicable, as no machine learning algorithm development requiring a "training set" is described for this premarket notification.
How the ground truth for the training set was established: Not applicable for the same reason as above.

Summary of the "Study" (Non-Clinical Evaluation):

The "study" that proves the device meets the (implicit) acceptance criteria for substantial equivalence is a non-clinical evaluation rather than a traditional clinical trial.

Non-Clinical Tests: ALPINION MEDICAL SYSTEMS Co., Ltd. conducted evaluations for:
- Biocompatibility of transducer materials and patient contact materials.
- Acoustic output.
- Thermal, electrical, electromagnetic, and mechanical safety.
Standards Conformance: The device was found to conform to applicable medical device safety standards, specifically:
- NEMA UD2, UD3
- AIUM Medical Ultrasound Safety
- IEC60601-1
- IEC60601-1-2
- IEC60601-2-37
Quality Management System Measures: The development process followed these measures:
- Medical Device Risk Management
- Requirements Reviews
- Design Reviews
- Component Verification
- Integration Review (System Verification)
- Performance Testing (System Verification)
- Safety Testing (Compliance Test)
- Design Validation
Basis for Equivalence: The manufacturer concluded that the E-CUBE 12 is "as safe, as effective" as the predicate device (E-CUBE 15, K123610) because it employs the same fundamental scientific technology, and any differences in clinical applications or operating modes were verified through these non-clinical tests to not affect safety, effectiveness, and essential performance.

In essence, the "study" for this 510(k) was a comprehensive set of engineering and safety tests and a review of the design and manufacturing process, all aimed at demonstrating that the device is equivalent to a previously cleared device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or banner.

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

October 28, 2014

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

Re: K142884

Trade/Device Name: E-CUBE 12 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: September 30, 2014 Received: October 2, 2014

Dear Mr. Kim:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

This determination of substantial equivalence applies to the following transducers intended for use with the E-CUBE 12 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

SC1-4H SC1-6 L3-12 L3-12H SP1-5

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Smh.f)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142884

Device Name

E-CUBE 12 Diagnostic Ultrasound System

Indications for Use (Describe)

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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E-CUBE 12 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	N	N	N		N	N	N	N
Abdominal	N	N	N		N	N	N	N
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	N	N	N		N	N	N	N
Small Organ(breast, testes, thyroid)	N	N	N		N	N	N	N
Neonatal Cephalic
Adult Cephalic	N	N	N		N	N	N	N
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	N	N	N		N	N	N	N
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel	N	N	N		N	N	N	N
Urology (including prostate)	N	N	N		N	N	N	N

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

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

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

Concurrence of CDRH

Prescription User (Per 21 CFR 801.109)

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E-CUBE 12 with SC1-4H Transducer

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

			Mode of Operation
	в	M	PWD	CWD	Color	Power	Tissue	Combined*	Other**
					Doppler	Doppler	Harmonic	(Specify)	(Specify)
							lmaging
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)M = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =	P	P	P------------------------------------------------------------------------------------------------------------------------------------------------------------------------------		P	P	P	P

N = new indication; P = previously cleared by FDA K 121888; 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

Prescription User (Per 21 CFR 801.109)

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E-CUBE 12 with SC1-6 Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal	P	P	P		P	P	P	P
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 K111864; 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

Prescription User (Per 21 CFR 801.109)

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E-CUBE 12 with L3-12 Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	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 K111864; 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

Prescription User (Per 21 CFR 801.109)

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E-CUBE 12 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
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 K111864; 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 12 with SP1-5 Transducer

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

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

N = new indication; P = previously cleared by FDA K111864; 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

Prescription User (Per 21 CFR 801.109)

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Section F 510(k) Summary

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

Sep 19th 2014 Date Submitter: ALPINION MEDICAL SYSTEMS Co., Ltd. Address: 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu, Seoul, Republic of Korea 152-848 Primary Contact Donghwan Kim Person QARA Manager Address: 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu, Seoul, Republic of Korea 152-848 Phone: +82 70 7465 2068 Fax: +82 2 851 5594 Email: donqhwan.kim@alpinion.com Secondary Contact JULIAN LEE Address: 21312 30th Dr SE Ste 100 Bothell, WA 98021, United States Person Phone: 425 949 1059 Fax: 425 949 4910 Email: julian.lee@alpinionusa.com E-CUBE 12 Device Trade Name: Common/Usual Ultrasonic Pulsed Doppler Imaging System 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 K123610 E-CUBE 15 Diagnostic Ultrasound System Predicate Device(s) Device Description: E-CUBE 12 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 21.5" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality. Modes of operation: 1. Signal Mode: B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode, Pulsed Wave Doppler(PWD) mode, Tissue Harmonic Imaging(THI) 2. Combination Mode: B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/PD/PWD, B/CF/M Acoustic output track: Track 3

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

	SC1-4H	SC1-6	L3-12	L3-12H	SP1-5
Applicablefrequency	1~4MHz	1~6MHz	3~12MHz	3~12MHz	1~5MHz
IntendedUsage	Fetal,Abdominal,Pediatric,Urology	Fetal,Abdominal,Pediatric,Urology	Pediatric.Small Organ,Musculoskeletal(conventional& superficial),Peripheralvessel	Pediatric,Small Organ,Musculoskeletal(conventional& superficial),Peripheralvessel	Abdominal,Pediatric,Cardiac Adult
Foot printsize (mm)	72.4 x 16.8	72.4 x 16.8	44.8 x 7.8	44.8 x 7.8	24.8 x 17.6
Applicablemode	B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging	B/M/PWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging	B/M/PWD/ColorDoppler/PowerDoppler	B/M/PWD/ColorDoppler/PowerDoppler	B/M/PWD/CWD/ColorDoppler/PowerDoppler/TissueHarmonicImaging
Scanningdepth(mm)	300	300	100	100	300
FOV	60(°)	60(°)	N/A	N/A	90(°)
Steer Angle	N/A	N/A	Max 9(°)	15(°)	45(°)
Geometricalconfiguration	Curved lineararray 60mmRadius ofcurvature	Curved lineararray 60mmRadius ofcurvature	Linear array38.4mmaperture	Linear array38.4mmaperture	Linearphased array
Total numberof element	192	128	128	192	64
Elementspacing	0.342mm	0.484mm	0.3mm	0.2mm	0.3mm
elevatinglength	13.5mm	13.5mm	4.5mm	4.5mm	13.5mm

				Types of transducers compatible with the device:
--	--	--	--	--------------------------------------------------	--	--	--	--	--

Indications For

Use:

Technology:

Determination of Substantial Equivalence:

Feature	ProposedE-CUBE 12	PredicateE-CUBE 15(K123610)
---------	-----------------------	-------------------------------------

predicate device.

Comparison with Predicate device:

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

510(k) E-CUBE 12

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;Musculo-skeletal(Conventional);Musculo-skeletal Superficial);Cardiac (adult & pediatric);Peripheral Vascular (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 & pediatric);Peripheral Vascular (PV);Urology (including prostate).
Transducer	SC1-4HSC1-6L3-12L3-12H	SC1-4HSC1-6HSVC1-6L3-12HL3-12XL3-8L8-17X
	SP1-5	SP1-5XSP3-8E3-10HCW2.0CW5.0
Electricalpower	Voltage: 100~~120V, 200~~240VFrequency: 50/60HzPower: Max. 900 VA with Built-inand On-Board Peripherals	Voltage: 100~~120V, 200~~240VFrequency: 50/60HzPower: Max. 900 VA with Built-inand On-Board Peripherals
OperatingMode	B(2D) ModeM ModeColor Flow (CF) ModePower Doppler (PD) ModePulsed Wave Doppler (PWD)ModeTissue Harmonic Imaging (THI)ModeBeam SteeringSpatial CompoundingFrequency CompoundingXpeed™Auto traces PWDirectional Power Doppler ModeSRIFull SRI™	B ModeM ModeColor Flow (CF) ModePower Doppler (PD) ModePulsed Wave Doppler (PWD)ModeContinuous Wave (CW) DopplerModeTissue Harmonic Imaging (THI)Mode3D/4D Volume ModeBeam SteeringPanoramic B/CFSpatial CompoundingFrequency CompoundingXpeed on 2D / CF/PWAuto IMTAuto traces PWDirectional Power Doppler ModeSRIFull SRI

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

Thermal,mechanicalandelectricalsafety	The E-CUBE 12 has beendesigned to conform to thefollowing standards:- NEMA UD2, UD3- AIUM Medical Ultrasound Safety- IEC60601-1- IEC60601-1-2- IEC60601-2-37	The E-CUBE 15 has beendesigned to conform to thefollowing standards:- NEMA UD2, UD3- AIUM Medical Ultrasound Safety- IEC60601-1- IEC60601-1-2- IEC60601-2-37

Summary of Non-Clinical Tests:

E-CUBE 12 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 12 and its application comply with voluntary standards as detailed in this premarket submission. The following quality management system measures were applied to the development of E-CUBE 12:

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

Discussion:

E-CUBE 12 and the predicate device have differences in clinical applications and operating modes. Several transducers are changed for these purposes. These design changes have been verified via non-clinical testing. The subject device is in conformance with applicable safety standards. Therefore, the differences between E-CUBE 12 and the predicate would not affect the safety, effectiveness and essential performance of E-CUBE 12.

ALPINION MEDICAL SYSTEMS Co., Ltd. considers E-CUBE 12 to be as Conclusion: safe, as effective. Performance, technology and software are substantially equivalent to the predicate device.
ALPINION MEDICAL SYSTEMS Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA or the requirements will be published in guidance documents.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.