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

Device Description

E-CUBE 7 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 18.5" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the ALPINION MEDICAL SYSTEMS E-CUBE 7:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria in terms of numerical performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K120060 E-CUBE 9 Diagnostic Ultrasound System). This means the acceptance criteria are implicitly that the E-CUBE 7 perform comparably to the predicate device in aspects of safety and effectiveness for its intended uses.

The "reported device performance" is also not given in quantitative metrics. The document only asserts that "Performance, technology and software are substantially equivalent to the predicate device." and that "Some image parameters are added for operational convenience which means these parameters do not affect to the measurement accuracy."

Therefore, I cannot populate a table with numerical acceptance criteria and reported performance based on the provided text.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "The subject of this premarket submission, E-CUBE 7, did not require clinical studies to support substantial equivalence."

This indicates that there was no test set of clinical data used to evaluate the device's performance against specific metrics. The assessment relied on non-clinical tests and a comparison to the predicate device's existing clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no clinical studies were performed, there was no test set requiring expert-established ground truth.

4. Adjudication Method for the Test Set

As no clinical test set was used, there was no adjudication method employed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC study was conducted. The E-CUBE 7 is an ultrasound imaging system, not an AI-assisted diagnostic tool in the sense of providing automated interpretations to human readers. Therefore, the concept of readers improving with vs. without AI assistance is not applicable to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone algorithm performance study was performed, as the device is an ultrasound imaging system operated by a physician, not a standalone AI algorithm.

7. The Type of Ground Truth Used

Given that no clinical studies were performed, there was no specific ground truth established for the E-CUBE 7's performance in a clinical context. The basis for clearance is substantial equivalence to the predicate device, K120060, which would have established its own safety and effectiveness through prior regulatory processes.

8. The Sample Size for the Training Set

Since no clinical studies involving machine learning or AI models were conducted, there was no training set batch of data mentioned or used.

9. How the Ground Truth for the Training Set Was Established

As there was no training set, this question is not applicable.

Summary of Findings:

The 510(k) submission for the ALPINION MEDICAL SYSTEMS E-CUBE 7 (K132687) did not involve clinical studies or performance evaluations against specific acceptance criteria for a new clinical dataset. Instead, the clearance was based on:

Substantial Equivalence: The device was determined to be substantially equivalent to a legally marketed predicate device (K120060 E-CUBE 9 Diagnostic Ultrasound System).
Non-Clinical Tests: Evaluation of biocompatibility, acoustic output, and thermal, electrical, electromagnetic, and mechanical safety, confirming conformity to applicable medical device safety standards.
Quality Management System: Adherence to established quality management system measures (Risk Management, Requirements Reviews, Design Reviews, Component Verification, System Verification, Performance Testing, Safety Testing, Design Validation).

The document explicitly states that "E-CUBE 7... did not require clinical studies to support substantial equivalence." Therefore, details regarding clinical acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or types of ground truth for new clinical data are not present in this submission.

Summary

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K132687
page 1 of 2

Section F 510(k) Summary

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

Aug 26" 2013 Date

Date	Aug 26 2013
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 Person	Donghwan KimQARA ManagerAddress: 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd),Guro-gu, Seoul, Republic of Korea 152-848Phone: +82 70 7465 2068Fax: +82 2 851 5590Email: donghwan.kim@alpinion.com
Secondary ContactPerson	JULIAN LEEAddress: 21312 30th Dr SE Ste 100 Bothell, WA 98021, UnitedStatesPhone: 425 949 1059Fax: 425 949 4910Email: julian.lee@alpinionusa.com
Device Trade Name:	E-CUBE 7
Common/Usual Name:	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
Predicate Device(s)	K120060 E-CUBE 9 Diagnostic Ultrasound System
Device Description:	E-CUBE 7 product is an ultrasound imaging system for medicaldiagnosis. The system platform provides optimal patient diagnosisworkflow with the 18.5" wide flat panel display, ergonomic controlpanel with easy user interface, optimal image quality.
Indications For Use:	The device is intended for use by a qualified physician for theevaluation of soft tissue and blood flow in the clinical applications;Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Trans-rectal(TR); Trans-vaginal(TV);Musculo-skeletal(Conventional); Musculo-skeletal (Superficial);Cardiac (adult & pediatric); Peripheral Vascular (PV); and Urology(including prostate).

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

Technology: E-CUBE 7 employs the same fundamental scientific technology as its predicate device.

Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

E-CUBE 7 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 7 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 7:

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

Conclusion:

ALPINION MEDICAL SYSTEMS Co., Ltd. considers E-CUBE 7 to be as safe, as effective. Performance, technology and software are substantially equivalent to the predicate device.

The discussion about the technological and software differences between E-CUBE 7 and the predicate device: Some image parameters are added for operational convenience which means these parameters do not affect to the measurement accuracy. So there is no significant difference in essential performance, safety and effectiveness with the predicate device and the image parameter functions do not change the intended use.
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.

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Image /page/2/Picture/0 description: The image shows a circular logo. The logo features a symbol of three curved lines resembling a bird in flight. The symbol is enclosed within a circular border containing text, which appears to be the name of an organization or agency.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Conter - WO66-G609 Silver Spring, MD 20093-0002

November 27, 2013

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

Re: K132687

Trade/Device Name: E-cube 7 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: 1YN. 1YO, ITX Dated: August 26. 2013 Received: September 4, 2013

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 reclassilied 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. Iisting of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRFI 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 7. as described in your premarket notification:

	Transducer Model Number
C1-6	1.3-12	SP1-5
EN3-10	E3-10	VC1-6
1.3-8	SC1-6	1.3-12H
SP3-8	C5-8	1.3-1211WD
IO3-12	L8-17	CW 2.0
CW5.0	EV3-10	EC3-10

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Page 2—Mr. Kim

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

http://www.lda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours.

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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Section E Indications for Use Statement

510(k) Number (if known): K132687

Device Name: E-CUBE 7

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); Trans-rectal(TR); Trans-vaginal(TV); 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_ (Part 21 CFR 807 Subpart C)

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Sm.h.7)

AND/OR

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K132687 -510(k) _______________________________________________________________________________________________________________________________________________________________________

ALPINION MEDICAL SYSTEMS Co., Ltd.

E-1

K132687

Page 001 of 020

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E-CUBE 7 Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation B | M | PWD | CWD | Color Power TIssuo Combinod. Other

	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal	P	P	P		P	P	P	P	P
Abdominal	P	P	P		P	P	P	P	P
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	P	P
Small Organ(breast, testes, thyroid)	P	P	P		P	P	P	P
Neonatal Cephalic
Adult Cephalic
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	N	P	P	P	P
Cardiac Pediatric	P	P	P	N	P	P	P	P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel	P	P	P		P	P	P	P
Urology (including prostate)	P	P	P		P	P	P	P	P

N = new indication; P = previously cleared by FDA K123611; E = added under appendix · Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D

emember a cool stepper on the reverse stepper, then set it.

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ALPINION MEDICAL SYSTEMS Co., Ltd.

E-2

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E-CUBE 7 with C1-6 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

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

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E-CUBE 7 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 K121729; E = added under appendix

" Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 40

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ALPINION MEDICAL SYSTEMS Co., Ltd.

E-4

K132687

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

E-CUBE 7 with SP1-5 Transducer

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	P	P	P	N	P	P	P	P
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)

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

N = new indication; P = previously cleared by FDA K121729; E = add

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

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ALPINION MEDICAL SYSTEMS Co., Ltd.

E-S

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

E-CUBE 7 with EN3-10 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	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

Combined: B/Color Doppier, B/PWD, B/Color Doppler/PWD; **Other; 30, 4D

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

E-CUBE 7 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	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
Trans-vaginal	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

N = new indication; P = previously cleared by FDA K121729; E = added * Combined: 8/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D. 4D

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ALPINION MEDICAL SYSTEMS Co., Ltd.

-E-7

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

E-CUBE 7 with VC1-6 Transducer

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

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

Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 40

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ALPINION MEDICAL SYSTEMS Co., Ltd.

1 E-8

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

E-CUBE 7 with L3-8 Transducer

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

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

N = new indication; P = previously cleared by FDA K120060; E = added under appendix

Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 40

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

E-CUBE 7 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 K120060; E = added under appendix

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

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ALPINION MEDICAL SYSTEMS Co., Ltd.

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Diagnostic Ultrasound Indications for Use

E-CUBE 7 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 K120060; E = added under appendix

A. Combined, D/Color Doppler, D/CWD, D/Color Doppler/TWD, M/Color 3D, 4D

" 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)

ALPINION MEDICAL SYSTEMS Co., Ltd.

Page 011 of 020

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

E-CUBE 7 with SP3-8 Transducer

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

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

N = new indication; P = previously cleared by FDA K 120060; E = added under appendix

Combined: B/Color Doppler, B/PWD, B/Color Dopplar/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)

ALPINION MEDICAL SYSTEMS Co., Ltd.

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

E-CUBE 7 with C5-8 Transducer

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

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

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

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

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

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

Prescription User (Per 21 CFR 801.109)

ALPINION MEDICAL SYSTEMS Co., Ltd.

K132687

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

Diagnostic Ultrasound Indications for Use E-CUBE 7 with L3-12HWD 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	Combinod*(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
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)	N	N	N		N	N		N
Musculo-skeletal(Superficial)	N	N	N		N	N		N
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)

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

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

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

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

Prescription User (Per 21 CFR 801.109)

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

E-CUBE 7 with IO3-12 Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ(breast, testes, thyroid)	N	N	N		N	N	. N	N
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; E = added under appendix

• Combined: B/Cotor 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)

CONVENIENCE OF BOTH A SINGLE & MULTI-DOSE VIAL

Prescription User (Per 21 CFR 801.109)

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

E-CUBE 7 with L8-17 Transducer

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

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	N	N	N		N	N	N	N
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, Office of In-Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

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

E-CUBE 7 with CW 2.0 Transducer

Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color	Power	Tissue	Combined®	Other **
					Oopplar	Doppler	Harmonic	(Specify)	(Spocity)
							Imaging

Ophihalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
(breast, lestes, thyrold)
Neonata) Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral									-
Trans-esoph. (non-Card.)
Muscuto-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
intravascular
Cardiac Adult				P
Cardlac Pediatric				P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (Including prostate)

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

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVO)

Prescription User (Per 21 CFR 801.109)

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

E-CUBE 7 with CW5.0 Transducer

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)

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

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

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

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

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

Prescription User (Per 21 CFR 801.109)

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

E-CUBE 7 with EV3-10 Transducer

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

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

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

Combined: B/Color Doppler, B/PWD, B/Color Dappler/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)

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

E-CUBE 7 with EC3-10 Transducer

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

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

N « new indicalion; 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)

Prescription User (Per 21 CFR 801.109)

ALPINION MEDICAL SYSTEMS Co., Ltd.

E-20

Page 020 of 020

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.