Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML technology.

Therapeutic

No
The device is described as an "ultrasound imaging system for medical diagnosis" and its intended use is for "evaluation of soft tissue and blood flow." These descriptions indicate that the device is used for diagnostic purposes, not for treatment.

Diagnostic

Yes
The "Device Description" explicitly states that "E-CUBE 15 product is an ultrasound imaging system for medical diagnosis."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "ultrasound imaging system" with a "system platform" including a "flat panel display" and "control panel," indicating it is a hardware device that performs imaging.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description and Intended Use: The description clearly states that the E-CUBE 15 is an ultrasound imaging system used for medical diagnosis by a qualified physician. It uses ultrasonic waves to visualize soft tissue and blood flow within the body.
Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. It directly interacts with the body to generate images.

Therefore, the E-CUBE 15 is a medical imaging device, not an in vitro diagnostic device.

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 (comma separated list FDA assigned to the subject device)

90-IYN, 90-IYO, 90-ITX

Device Description

E-CUBE 15 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic Pulsed Doppler Imaging System, Ultrasonic Pulsed Echo Imaging System

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); and Urology (including prostate).

Indicated Patient Age Range

Not Found

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)

E-CUBE 15 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 15 and its application comply with voluntary standards as detailed in this premarket submission. The subject of this premarket submission, E-CUBE 15, did not require clinical studies to support substantial equivalence.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K120060

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

K123610

510(k) E-CUBE 15

FEB 0 1 2013

F-1

510(k) Summary

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

Nov 16" 2012 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 Person

Donghwan Kim' 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 5590 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 15

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

K120060 E-CUBE 9 Diagnostic Ultrasound System Predicate Device(s)

1

Device Description:

E-CUBE 15 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.

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: E-CUBE 15 employs the same fundamental scientific technology as its predicate device. :.

Summary of Non-Clinical Tests:

Determination of Substantial Equivalence:

E-CUBE 15 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 15 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 15:

◆ NEMA UD2, UD3
AIUM Medical Ultrasound Safety
IEC60601-1
IEC60601-1-1
IEC60601-1-2
IEC60601-2-37
ISO 10993-1

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, E-CUBE 15, did not require clinical studies to support substantial equivalence.

Conclusion:

Alpinion Medical Systems Co., Ltd. considers E-CUBE 15 to be as safe, as effective, and performance is substantially equivalent to the predicate device.

F-2

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.

2

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

February 1, 2013

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

Re: K123610

Trade/Device Name: E-CUBE 15 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: November 21, 2012 Received: November 21, 2012

Dear Mr. Kim

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 15, as described in your premarket notification:

Transducer Model Number

SC1-6H	SVC1-6
L3-12H	L3-12X
SP1-5X	L3-8
L8-17X	SP3-8
SC1-4H	CW 2.0
E3-10H	CW 5.0

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,

Sean M. Boyd - S
for

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

Enclosure(s)

4

Indications for Use

510(k) Number (if known):

Device Name: E-CUBE 15

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

Prescription Use_ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR

(Part 21 CFR 807 Subpart C)

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

(Division Sign C

vision Sign On

Olvision of Radiologic

Office of in Vitro Ulagnostics a

510(k) K123610

5

Diagnostic Ultrasound Indications for Use

E-CUBE 15 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	N
Abdominal	P	P	P		P	P	P	P	N
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	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	P	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	P	P
Urology (including prostate)	P	P	P		P	P	P	P

N = new indication; P = previously cleared by FDA K121888; E = added under appendix

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

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Concurrence of CDRH, Office of In-VitrPMagn89f18 Bevices (OIVD)

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

Prescription User (Per 21 CFR 801.109)

51000 K123610

6

Diagnostic Ultrasound Indications for Use

E-CUBE 15 with SC1-6H Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	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)	P	P	P	P	P	P	P	P	P

N = new indication; P = previously cleared by FDAK121888; 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 (OIVP)

(Division Sign Off)

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health Prescription User (Per 21 CFR 801.109)

7

Diagnostic Ultrasound Indications for Use

E-CUBE 15 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	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)	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 K120060; 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)

/

(Division Sign Off)

Division of Radiological Health

Prescription User (Per 21 CFR 801.109)

Office of In Vitro Diagnostics and Radiological Health

TO Diagnosed and Treatment Program, Patient

E-4

8

Diagnostic Ultrasound Indications for Use

E-CUBE 15 with SP1-5X 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-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Cardiac Adult	P	P	P	P	P	P	P	P
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)

N = new indication; P = previously cleared by FDA K121888; E = added under appendix

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

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

(Division Sign Off)

Division of Radiological Health

Prescription User (Per 21 CFR 801.109)

Office of In Vitro Diagnostics and Radiological Hosetth

ALPINION MEDICAL SYSTEMS Co., LEGORI

9

Diagnostic Ultrasound Indications for Use

E-CUBE 15 with L8-17X 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	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	P
Musculo-skeletal						P	P
(Superficial)	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 K121888; E = added under appendix

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

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

Prescription User (Per 21 CFR 801.109)
----------------------------------------	--

(Division Sign Off)

Division of Radiological Health

Office of State Procurement

ALPINION MEDICAL SYSTEMS Co., Ltd.
510(k)

E-6

10

Diagnostic Ultrasound Indications for Use

E-CUBE 15 with SC1-4H 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) | P | P | P | | P | P | P | P | |

N = new indication; P = previously cleared by FDA K121888; E = added under appendix

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

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

Prescription User (Per 21 CFR 801.109)

Thision Sign C

(Division Sign Off)

Division of Radiological Health

ALPINION MEDICAL SYSTEMS Co., Ltd. Million of In Vitto Dlagnostics and Radiological Health

点11

11

Diagnostic Uitrasound Indications for Use

E-CUBE 15 with E3-10H Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	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	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

N = new indication; P = previously cleared by FDA K121888; 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)

(Division Sign Off)

Division of Radiological Health

ALPINION MEDICAL SYSTEMS Co., Ltd.

510(k) K123610

. E-8

12

Diagnostic Ultrasound Indications for Use

E-CUBE 15 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	P	P	P		P	P	P	P	P
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)	P	P	P		P	P	P	P	P

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

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

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

Prescription User (Per 21 CFR 801.109)

(Division Sign Off) .

Division of Radiological Heatth

Diagnostics and Radiological Health ALPINION MEDICAL SYSTEMS Co., Ltd. 510k

E-d

13

Diagnostic Ultrasound Indications for Use

E-CUBE 15 L3-12X with Transducer

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

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

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Prescription User (Per 21 CFR 801.109)

Division of Radiological Health Office of In Vitro Disanostics and Radiological Health

E-10

14

Diagnostic Ultrasound Indications for Use

E-CUBE 15 L3-8 with Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Tissue
Harmonic
Imaging	Combined*
(Specify)	Other**
(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P
Small Organ	P	P	P		P	P	P
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal	P	P	P		P	P	P
(Conventional)
Musculo-skeletal	P	P	P		P	P	P
(Superficial)
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 K120060; 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)

(Division's Sign Off)

Division of Radiological Health

ALPINION MEDICAL SYSTEMS Co., Ltd.Office of In Vitro Diagnostics and Radiological Health

15

Diagnostic Ultrasound Indications for Use

E-CUBE 15 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	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 K120060; E = added under appendix

510(k)

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-Vitto Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Division Sign Off Division of Radiological Health

Lack of clear vision and/or poorly defined product backlog.

16

Diagnostic Ultrasound Indications for Use

E-CUBE 15 with CW 2.0 Transducer

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

Clinical Application	Mode of Operation
B	M	PWD	CWD	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
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Cardiac Adult				N
Cardiac Pediatric				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-Vityo Diagnostic Devices (OIVD)

ಕೆಗಾಗಿ

Prescription User (Per 21 CFR 801.109)
----------------------------------------

(Division Sign Off) Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health ALPINION MEDICAL SYSTEMS Co., Ltd

E-13

17

Diagnostic Ultrasound Indications for Use

E-CUBE 15 with CW 5.0 Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	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
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Cardiac Adult				N
Cardiac Pediatric				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 Diagnøstic Devices (OIVD)

51000

(Division Sign On)

Prescription User (Per 21 CFR 801 109)

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health
Ltd.