Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary does not mention AI, ML, or any related terms, nor does it describe any features or performance studies indicative of AI/ML technology.

Therapeutic

No
The device is described as an "ultrasound imaging system for medical diagnosis" and is intended for "evaluation of soft tissue and blood flow," indicating diagnostic rather than therapeutic use.

Diagnostic

Yes

The device is an ultrasound imaging system specified for "medical diagnosis" and is intended for use by a "qualified physician for the evaluation of soft tissue and blood flow." These descriptions clearly indicate its purpose is to aid in diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states "E-CUBE 9 product is an ultrasound imaging system for medical diagnosis" and mentions hardware components like a "wide flat panel display, ergonomic control panel". The performance studies also detail testing related to hardware safety and performance (biocompatibility, acoustic output, thermal, electrical, electromagnetic, and mechanical safety).

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for the "evaluation of soft tissue and blood flow" in various anatomical sites using ultrasound imaging. This is a diagnostic imaging device, not a device that performs tests on samples taken from the body (like blood, urine, or tissue).
Device Description: The description confirms it's an "ultrasound imaging system for medical diagnosis."
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or performing tests on specimens outside of the body, which are hallmarks of IVD devices.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is used to visualize structures and blood flow within the body directly.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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).

Product codes

IYN, IYO, ITX

Device Description

E-CUBE 9 product is an ultrasound imaging system for medical diagnosis. This product can be used for the applications of abdominal, obstetrics, gynecology, small parts, cardiology, vascular, etc.
The system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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).

Indicated Patient Age Range

Adult & pediatric, Fetal

Intended User / Care Setting

Qualified physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Summary of Non-Clinical Tests:
E-CUBE 9 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 9 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 9:

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K060993 LOGIQ P5/A5 Diagnostic Ultrasound System

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

MAR 1 6 2012

(120060)

Page 1 at 2

510(K)-E-CUBE 9

510(k) Summary

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

Date	Jan 5 th 2012
Submitter:	ALPINION MEDICAL SYSTEMS Co., Ltd.
Address: 1,6 and 7FL, 222-22, Guro-dong, Guro-gu, Seoul, 152-848, Korea Republic
Primary Contact Person	Donghwan Kim
QARA Manager
Address: 1,6 and 7FL, 222-22, Guro-dong, Guro-gu, Seoul, 152-848, Korea Republic
Phone: +82 70 7465 2068
Fax: +82 2 851 5594
Email: donghwan.kim@alpinion.com
Secondary Contact Person	Yuchi Chu
Address: Suite 229, 10604 NE 38th Place, Kirkland, WA 98033, United States
Phone: 425 949 4907
Fax: 425 949 4908
Email: ychu@alpinionus.com
Device Trade Name:	E-CUBE 9
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-IYN
Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO
Diagnostic Ultrasound Transducer, 21CFR 892.1570, 90-ITX
Predicate Device(s)	K060993 LOGIQ P5/A5 Diagnostic Ultrasound System

ALPINION MEDICAL SYSTEMS Co., Ltd.

.

1

K120060
Page 2 of 2

E-CUBE 9 product is an ultrasound imaging system for medical Device Description: diagnosis. This product can be used for the applications of abdominal, obstetrics, gynecology, small parts, cardiology, vascular, etc.

The system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality

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).

Technology:

Determination of Substantial Equivalence:

E-CUBE 9 employs the same fundamental scientific technology as its predicate device.

Summary of Non-Clinical Tests:

E-CUBE 9 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 9 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 9:

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

Alpinion Medical Systems Co., Ltd. Considers E-CUBE 9 to be as Conclusion: safe, as effective, and performance is 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.

ALPINION MEDICAL SYSTEMS Co., Ltd.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Alpinion Medical Systems Co., Ltd. % Mr. Yuchi Chu Correspondent AUS Co., Inc. 10604 NE 38th Place, Suite 229 KIRKLAND WA 98033

Re: K120060

Trade/Device Name: E-CUBE 9 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: January 9, 2012 Received: January 9, 2012

Dear Mr. Chu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the E-CUBE 9, as described in your premarket notification:

Transducer Model Number

SC1-6	L3-12H
C1-6	SP1-5
SVC1-6	E3-10
VC1-6	L3-8
L3-12	SP3-8

MAR. 1 6 2012

3

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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); 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.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

If you have any questions regarding the content of this letter, please contact Joshua Nipper at (301) 796-6524.

Sincerely Yours,

Janine M. Morris

Acting Directd Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

4

Indications for Use

510(k) Number (if known): K111864

Device Name: E-CUBE 9

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)

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

AND/OR

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

(Division Sign-Off)
Division Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K120060

ALPINION MEDICAL SYSTEMS Co., Ltd.

5

Diagnostic Ultrasound Indications for Use Form

E-CUBE 9 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
Doppler	Power
Doppler	Tissue
Harmonic
Imaging	Combined*
(Specify)	Other**
(Specify)
Ophthalmic
Fetal	P	P	P		P	P		P	P
Abdominal	P	P	P		P	P	P	P	P
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	N	N	N		N	N	N	N	N
Small Organ
(breast, testes, thyroid)	P	P	P		P	P	N	P
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)	P	P	P		P	P	N	P
Musculo-skeletal
(Superficial)	P	P	P		P	P	N	P
Intravascular
Cardiac Adult	P	P	P	N	P	P	P	P
Cardiac Pediatric	N	N	N	N	N	N	N	N
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel	P	P	P		P	P	N	P
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, Office of In-Vitro Diagnostic Devices (OIVD)

E-2

Prescription User (Per 21 CFR 801.109)

ALPINION MEDICAL SYSTEMS Co., Ltd.

sion Sign Division of Radiologica! Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K =

6

Diagnostic Ultrasound Indications for Use Form

E-CUBE 9 with SC1-6 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 | Color
Doppler | Power
Doppler | Tissue
Harmonic
Imaging | | |
| 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 | N | N | N | | N | N | N | N | |
| Small Organ
(breast, testes, thyroid) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Trans-rectal | | | | | | | | | |
| Trans-vaginal | | | | | | | | | |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Cardiac Adult | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | | | | | |
| Peripheral vessel | | | | | | | | | |
| Urology (including prostate) | N | N | N | | N | N | N | N | |

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

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

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

Prescription User (Per 21 CFR 801.109)
ALPINION MEDICAL SYSTEMS Co., Ltd.
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K
K120060

7

Diagnostic Ultrasound Indications for Use Form

E-CUBE 9 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	Color
Doppler	Power
Doppler	Tissue
Harmonic
Imaging	Combined*
(Specify)	Other**
(Specify)
Ophthalmic
Fetal	P	P	P		P	P	P	P
Abdominal	P	P	P		P	P	P	P
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	N	N	N		N	N	N	N
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)	N	N	N		N	N	N	N

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

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

The even do not write below this line-continue on another bage in meeded) Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)
ALPINION MEDICAL SYSTEMS Co., Ltd.
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K	K120868

8

Diagnostic Ultrasound Indications for Use Form

E-CUBE 9 with SVC1-6 Transducer

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

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

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

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

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

E-2

(Prescription User (Per 21 CFR 801.109)

ALPINION MEDICAL SYSTEMS Co., Ltd.
(Division Sign-Off)
Division of Radiological Devices

ામદિક વા on and Satery

ETOK

9

Diagnostic Ultrasound Indications for Use Form

E-CUBE 9 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	Color
Doppler	Power
Doppler	Tissue
Harmonic
Imaging	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	N	N	N	.	N	N	N	N	N
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)	N	N	N		N	N	N	N

N = 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.

(Division Sign-Off)
Division of Radiological Devices
Office of Na Vitro Diagnostic Device Evaluation and Safety

510K. K120060

10

Diagnostic Ultrasound Indications for Use Form

E-CUBE 9 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	Color
Doppler	Power
Doppler	Tissue
Harmonic
Imaging	Combined*
(Specify)	Other**
(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	N	N	N	N	N	N	N
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
(Conventional)	P	P	P		P	P	N	P
Musculo-skeletal
(Superficial)	P	P	P		P	P	N	P
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel	P	P	P		P	P	N	P
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.
	(Division Sign-Off)
	Division of Radiological Devices
	Office of In Vitro Diagnostic Device Evaluation and Safety
510K

11

Diagnostic Ultrasound Indications for Use Form

E-CUBE 9 with L3-12H Transducer

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

| Clinical Application | Mode of Operation | | | | | Tissue
Harmonic
Imaging | Combined*
(Specify) | Other**
(Specify) | |
|------------------------------------------|-------------------|---|-----|-----|------------------|-------------------------------|------------------------|----------------------|------------------|
| | B | M | PWD | CWD | Color
Doppler | | | | Power
Doppler |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | N | N | N | | N | N | | N | |
| Small Organ
(breast, testes, thyroid) | 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 | |
| Musculo-skeletal
(Superficial) | 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 | |
| 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 MEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

ALPINION MEDICAL SYSTEMS Co., Ltd.
(Division Sign-OH)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

610K.

12

Diagnostic Ultrasound Indications for Use Form

E-CUBE 9 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	Color
Doppler	Power
Doppler	Tissue
Harmonic
Imaging	Combined*
(Specify)	Other**
(Specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P	P
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	N	N	N		N	N	N	N
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethrai.
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeietal
(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)

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 ANQTHER 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.

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K120068

E-d

13

Diagnostic Ultrasound Indications for Use Form

E-CUBE 9 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	Color Doppler	Power Doppler	Tissue Harmonic Imaging	Combined* (Specify)	Other** (Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
(breast, testes, thyroid)
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)	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 IE NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

ALPINION MEDICAL SYSTEMS Co., Ltd.

Division of Radiological Devices Office of In Vitro Diagnostic luation and Safety

510K Kianna66

14

Diagnostic Ultrasound Indications for Use Form

E-CUBE 9 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	Color
Doppler	Power
Doppler	Tissue
Harmonic
Imaging	Combined*
(Specify)	Other**
(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	N	N	N		N	N	N
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	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 IE NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

	ALPINION MEDICAL SYSTEMS Co., Ltd.
	(Division Sign-Off)
	Division of Radiological Devices
510K	Office of in Vitro Diagnostic Device Evaluation and Safety
	K120068

15

Diagnostic Ultrasound Indications for Use Form

E-CUBE 9 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	Color
Doppler	Power
Doppler	Tissue
Harmonic
Imaging	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.

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K120068