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); Small Organ (breast, testes, thyroid); Trans-rectal(TR); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate).

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.

AI/ML Overview

The Alpinion Medical Systems E-CUBE 15 is an ultrasound imaging system that was cleared through the FDA 510(k) pathway in 2012.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the E-CUBE 15 are primarily based on demonstrating substantial equivalence to its predicate device, the E-CUBE 9 (K120060). This means the E-CUBE 15 must be as safe and effective as the predicate device for its stated indications for use.

The document highlights the following performance aspects of the E-CUBE 15, compared to the predicate E-CUBE 9:

Feature/Aspect	Predicate E-CUBE 9	Proposed E-CUBE 15	Discussion of Differences & Performance
Indications for Use	Extensive range, including Fetal, Abdominal, Pediatric, Small Organ, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional & Superficial), Cardiac (adult & pediatric), Peripheral Vascular, Urology	Fetal; Abdominal (renal & GYN/pelvic); Small Organ (breast, testes, thyroid); Trans-rectal (TR); Trans-vaginal (TV); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate).	E-CUBE 15 has a limited scope of indications compared to the predicate (e.g., no pediatric indication). However, the individual functions of E-CUBE 15 for its approved indications have "essential performance and safety effectiveness same as E-CUBE 9." This demonstrates equivalence for the specified uses.
Dimensions & Weight	Approx. 89.5kg, H: 1340/1600 mm, W: 590mm, D: 850mm	Approx. 105kg, H: 1413/1848 mm, W: 585mm, D: 670mm	Different. Not directly related to imaging performance or clinical effectiveness.
Monitor	17" Wide LCD, 1366x768 display, 880x660 recording area	18.5" Wide LCD, 1366x768 display, 880x660 recording area	Larger monitor on E-CUBE 15 (18.5" vs 17"). Display size and recording area are the same. This is considered an improvement in usability, not a difference in fundamental performance.
Electrical Power	Max. 600 VA	Max. 900 VA	Higher power for E-CUBE 15. This is likely due to the larger monitor and other potential component differences, but not explicitly linked to a change in imaging performance in the provided text.
Console Design	3 active probe ports, 5 USB ports (Front 1, Back 4), Integrated HDD (500G), DVD-R/W, On-board storage for peripherals (B/W printer, Color Printer, DVD recorder), Control panel lift, 5 Transducer holders, Integrated Gel warmer, Front/Rear Handles, Wheel-lock, Thumbnail images, On-line Help key, ECG Module	3 (4 optional) active Probe Ports, 8 USB ports (Touch module side 2, Back side 6), Touch panel, Integrated HDD (500G), DVD-R/W, On-board storage for peripherals (B/W printer, Color Printer, DVD recorder), Control panel lift, 5 Transducer holders, Integrated Gel warmer, Front/Rear Handles, Wheel-lock, Thumbnail images, On-line Help key, ECG Module	E-CUBE 15 offers more USB ports and an optional 4th probe port, plus a touch panel. These differences are stated to "not related with the safety, effectiveness and essential performance."
Operating Mode	B-Mode, M-Mode, Anatomical M-mode, PW Doppler (with High PRF), CW Doppler, Color Flow-Mode, Power Doppler Mode, THI, Tissue Doppler Imaging, Beam Steering, Panoramic B/CF, Spatial compounding, Frequency compounding, Xpeed on 2D/CF/PW, Auto IMT, Auto traces PW, Directional Power Doppler Mode, SRI, Full SRI, ECG, 3D/4D Volume Mode	B-Mode, M-Mode, Anatomical M-mode, PW Doppler (with High PRF), CW Doppler, Color Flow-Mode, Power Doppler Mode, THI, Tissue Doppler Imaging, Beam Steering, Panoramic B/CF, Spatial compounding, Frequency compounding, Xpeed on 2D/CF/PW, Auto IMT, Auto traces PW, Directional Power Doppler Mode, SRI, Full SRI, ECG	E-CUBE 15 does not include the 3D/4D Volume Mode found in the predicate. However, it is stated that "E-CUBE 15 includes essential operating mode for diagnosis and is Substantially Equivalent."
Measurement & Calculation Functions	General, Abdomen, Small Parts, Obstetrics, Gynecology, Cardiology, Vascular, Urology, Pediatrics	General, Abdomen, Small Parts, Obstetrics, Gynecology, Cardiology, Vascular, Urology	E-CUBE 15 does not include Pediatrics in its measurement and calculation functions, aligned with its reduced indications for use. This is stated to "not related with the safety, effectiveness and essential performance."
Acoustic Output	Track 3	Track 3	Match. Conforms to relevant standards.

2. Sample Size for Test Set and Data Provenance

The summary explicitly states: "The subject of this premarket submission, E-CUBE 15, did not require clinical studies to support substantial equivalence." This indicates that there was no test set of patient data used for clinical evaluation. The comparison was primarily based on technical specifications and adherence to recognized standards.

3. Number of Experts for Ground Truth and Qualifications

Since no clinical studies were performed, there were no experts establishing ground truth for a test set of patient data.

4. Adjudication Method

As no clinical studies were performed with a test set requiring interpretation, no adjudication method was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was conducted, as the device did not require clinical studies. The submission does not discuss human reader improvement with or without AI-assistance, as this is a diagnostic ultrasound system, not an AI-driven image analysis tool.

6. Standalone Performance Study

No standalone performance study of an algorithm (human-in-the-loop performance) was performed, as this is a medical imaging device and not an AI/algorithm-only device. The evaluation focused on the system as a whole and its components meeting established safety and performance standards.

7. Type of Ground Truth Used

The ground truth for demonstrating substantial equivalence was effectively the technical specifications, safety and performance characteristics of the predicate device (E-CUBE 9), and adherence to medical device safety standards. The substantial equivalence argument relies on showing that the E-CUBE 15 performs equivalently or better in essential aspects for its intended use, and any differences do not raise new questions of safety or effectiveness.

8. Sample Size for Training Set

The document does not mention any training set. As the device is a diagnostic ultrasound system and not an AI/machine learning product requiring data for model training, the concept of a training set as typically understood in AI/ML is not applicable here.

9. How Ground Truth for Training Set Was Established

Not applicable, as there was no training set.

Summary

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JUL 26 2012

510(K) E-CUBE 15

510(k) Summary

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

Date June 26" 2012 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 5594 Emall: donghwan.kim@alpinion.com Secondary Contact Yuchi Chu Person 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 Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550 90-Product Code: IYN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO , I Y/V Diagnostic Ultrasound Transducer, 21CFR 892.1570, 90-ITX Predicate Device(s) K120060 E-CUBE 9 Diagnostic Utrasound System

ALPINION MEDICAL SYSTEMS Co., Ltd.

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510(k) E-CUBE 15

Device Description: E-CUBE 15 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); Small Organ (breast, testes,Trans-reclal(TR);thyrold);Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac(adult); Peripheral Vascular (PV); and Urology (including prostate).

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

Feature	ProposedE-CUBE 15ALPINION MEDICAL SYSTEMS Co.,Ltd.	PredicateE-CUBE 9ALPINION MEDICAL SYSTEMS Co.,Ltd.
510(k)Number		K120060
Indications foruse	The device is intended for use by aqualified physician for the evaluation ofsoft tissue and blood flow in the clinicalapplications:Fétal:Abdominal (renal & GYN/pelvic);Small Organ (breast, testes, thyroid):Trans-rectal(TR);Trans-vaginal(TV):Musculo-skeletal(Conventional);Musculo-skeletal Superficial);Cardiac (adult):Peripheral Vascular (PV):Urology (including prostate).	The device is intended for use by aqualified physician for the evaluation ofsoft tissue and blood flow in the clinicalapplications: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);Perpheral Vascular (PV):Urology (including prostate).
	Discussion of differences●The individual functions of E-CUBE 15 has essential performance and safetyeffectiveness same as E-CUBE 9, even though E-CUBE 15 as limited scope ofthe indications comparing with the predicate.Therefore, E-CUBE 15 substantially equivalent with predicate device.
Dimensionsand weight	Weight: approx. 105kgHeight: 1413/1848 mmWidth: 585mmDepth: 670mm	Weight: approx. 89.5kgHeight: 1340/1600 mmWidth: 590mmDepth: 850mm
Monitor	18.5" Wide LCD	17" Wide LCD
	18.5" Wide LCD	18.5" Wide LCD
	Display size: 1366 X 768	Display size: 1366 X 768
	Recording area: 880 X 660	Recording area: 880 X 660

	Adjustable Tilt/Swivel, up/down, rotate	Adjustable Tilt/Swivel, up/down, rotate
	Digital Brightness/Contrast Adjustment	Digital Brightness/Contrast Adjustment

Electrical	Voltage: 100~~120V, 200~~240V	Voltage: 100~~120V, 200~~240V
power	Frequency: 50/60Hz	Frequency: 50/60Hz
	Power: Max. 900 VA with Built-in and	Power: Max. 600 VA with Built-in and
	On-Board Peripherals	On-Board Peripherals

Consol design	• 3 active Probe Ports	• 3 active Probe Ports
	(4 Probe Ports Option)
	• Touch panel
	• Integrated HDD (Capacity: 500G)	• Integrated HDD (Capacity: 500G)
	• Integrated DVD-R/W Drive	• Integrated DVD-R/W Drive
	• On-board Storage for Peripherals	• On-board Storage for Peripherals
	- B/W Printer	- B/W Printer
	Color Printer,	Color Printer,
	DVD recorder	DVD recorder
	• Control panel lift mechanism	• Control panel lift mechanism
	• 5 Transducer holders, detachable for	• 5 Transducer holders, detachable for
	cleaning and washing	cleaning and washing
	• Integrated Gel warmer	• Integrated Gel warmer
	- 3 temperature levels	- 3 temperature levels
	• Front Handle	• Front Handle
	• Rear Handle	• Rear Handle
	• Wheel-lock Mechanism	• Wheel-lock Mechanism
	- Front & Back -Wheel: Total lock	- Front & Back -Wheel: Total lock
	• 8 USB ports: Touch module side (2ea)	• 5 USB ports: Front Side (1ea) Back
	Back side (6ea)	side (6ea)
	• Thumbnail images on-screen	• Thumbnail images on-screen
	• On-line Help key	• On-line Help key
	• ECG Module	• ECG Module
	• Patient ECG Lead Wires	• Patient ECG Lead Wires
	Discussion of differences
	E-CUBE 15 has 3 or 4 (optional) probe ports, 8 USB ports: Touch module side
	(2ea) Back side (6ea) and Touch panel. But, E-CUBE 9 has 3 probe ports and 5
	USB ports: Front Side (1ea) Back side (6ea). It is not related with the safety,
	effectiveness and essential performance.

Operating	• B-Mode	• B-Mode
Mode	• M-Mode	• M-Mode
	• Anatomical M-mode	• Anatomical M-mode
	• Pulsed Wave (PW) Doppler with High	• Pulsed Wave (PW) Doppler with High
	PRF	PRF
	• Continuous Wave (CW) Doppler	• Continuous Wave (CW) Doppler
	• Color Flow-Mode	• Color Flow-Mode

	Power Doppler Mode THI (PI/FTHI) Tissue Doppler Imaging Beam Steering Panoramic B/CF Spatial compounding Frequency compounding Xpeed on 2D / CF/PW Auto IMT Auto traces PW Directional Power Doppler Mode SRI Full SRI ECG	Power Doppler Mode THI (PI/FTHI) Tissue Doppler Imaging Beam Steering Panoramic B/CF Spatial compounding Frequency compounding Xpeed on 2D / CF/PW Auto IMT Auto traces PW Directional Power Doppler Mode SRI Full SRI ECG 3D/4D Volume Mode
	Discussion of difference3D/4D is an image representation of a volume or 3D object, such as the heartor fetus. Surface rendering can be used to visualize surfaces. Another imagepresentation is volume rendering, in which surfaces can be semitransparent or2D slice planes through the object. Alternatively, there is simultaneous viewingof different 2D-slice planes (side by side).
	E-CUBE 15 includes essential operating mode for diagnosis and isSubstantially Equivalent.
Labelingand/orpromotionalmaterials	Section 6B Catalog E-CUBE 15	Section 3C Catalog E-CUBE9
Accessories orkits	Color printerB/W printerDVRDVD-RWFootswitchProbe HolderUltrasonic gelCidex OPA (disinfectant agents)Cidex Plus (disinfectant agents)SC1-6 Biopsy guide kitL3-12 Biopsy guide kitE3-10 Reusable Biopsy needle guideE3-10 Disposable Biopsy needle guideECG ModulePatient ECG Lead Wires	Color printerB/W printerDVRDVD-RWFootswitchProbe HolderUltrasonic gelCidex OPA (disinfectant agents)Cidex Plus (disinfectant agents)SC1-6 Biopsy guide kitL3-12 Biopsy guide kitE3-10 Reusable Biopsy needle guideE3-10 Disposable Biopsy needle guideECG ModulePatient ECG Lead Wires

MeasurementandCalculationfunctions	1. General1) B-Mode2) M-Mode3) Doppler Mode	1. General1) B-Mode2) M-Mode3) Doppler Mode
	2. Abdomen1) B-Mode2) M-Mode3) Doppler Mode	2. Abdomen1) B-Mode2) M-Mode3) Doppler Mode.
	3. Small Parts1) B-Mode2) M-Mode3) Doppler Mode	3. Small Parts1) B-Mode2) M-Mode3) Doppler Mode
	4. Obstetrics1) B-Mode2) M-Mode:3) Doppler Mode	4. Obstetrics1) B-Mode2) M-Mode:3) Doppler Mode
	5. Gynecology1) B-Mode2) M-Mode:3) Doppler Mode	5. Gynecology1) B-Mode2) M-Mode:3) Doppler Mode
	6. Cardiology1) B-Mode:2) M-Mode3) Doppler Mode	6. Cardiology1) B-Mode:2) M-Mode3) Doppler Mode
	7. Vascular1) B-Mode2) M-Mode3) Doppler Mode	7. Vascular1) B-Mode2) M-Mode3) Doppler Mode
	8. Urology1) B-Mode2) M-Mode3) Doppler Mode	8. Urology1) B-Mode2) M-Mode3) Doppler Mode
		9. Pediatrics1) B-Mode2) M-Mode3) Doppler Mode
	Discussion of difference
	Measurement and Calculation functions of E-CUBE 15 are not include Pediatrics.
	It is not related with the safety, effectiveness and essential performance.
Acousticoutput	Track 3	Track 3

ALPINION MEDICAL SYSTEMS Co., Ltd.

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510(k) E-CUBE 15 대

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ALPINION MEDICAL SYSTEMS Co., Ltd.

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510(k) E-CUBE 15

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ALPINION MEDICAL SYSTEMS Co., Ltd.

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510(k) E-CUBE 15

(pediatric). The primary difference is cosmetic structure and component used only. Therefore, we can claim the substantially equivalence of E-CUBE 15 to the predicate device.

ALPINION MEDICAL SYSTEMS Co., Ltd.

દ-ડ

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Determination of Substantial Equivalenço:

Summary of Non-Clinical Tests:

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 .
IEC60601-1-2
IEC60601-2-37 (3rd Edition)
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.

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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Appendix B - Decision Summary for Web Posting

Decision Summary, K 1 21 889

This 510(k) was reviewed under OIVD's Pilot Triage Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant's 510(k) summary for a summary of the information that supports this SE determination.

OIVD, 6/12/12, v1.2

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.

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

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

SEP 2 5 2012

Re: K121888 Trade/Device Name: E-CUBE 15 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, and ITX Dated: June 26, 2012 Received: June 28, 2012

Dear Mr. Kim:

This letter corrects our substantially equivalent letter of July 26, 2012.

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	L8-17X
L3-12H	SC1-4H
SP1-5X	E3-10H

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

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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 (OS) 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 Jeffrey Ballyns at (301) 796-6105.

Sincerely Yours,

Muhal D. O'Ke for

Janine M. Morris Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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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 physicien for the evaluation of soft lissue and blood now in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Small Organ (breast, testes, ന്നും നീ സംഭവിഠ-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (ədult); Peripheral Vascular (PV); and Urology (Including prostate).

Over-The-Counter Use AND/OR Prescription Use (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(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-Olm
Division of Radiological Devices
Office of In Vitro Diagnostic Davice Eveluadon and Safety

Diagnostic Device Evaluation and Safety
K121888
510K

ALPINION MEDICAL SYSTEMS Co., Ltd.

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E-CUBE 15 Ultrasound System

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

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

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

· Combinsd: B/Color Doppler, B/PWD, B/Color Dappler/PWD; **Other: SD, 4D

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

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

Prescription User (Par 21 CFR 801.108)

ALPINION MEDICAL SYSTEMS Co., Ltd.

(Division Sign-Off)

Division of Radiological Devices

Office of in Vitro Diagnostic Device Evaluation and Safety

K121888
510K

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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	FWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal	N	N	N		N	N	N	N
Abdominal	N	N	N		N	N	N	N
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
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/Calar Doppler, B/PWD, B/Color Doppler/PWD; **Oltrer: 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 (Pet 21 CFR 801.108)

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

Office of In Vitro Oragnosue Device Evalual tion and Salety

510K_K121888

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E-CUBE 15 with L3-12H Transducer

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

Clinical Application	Mode of Operation
	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ(breast, testes. thyroid)	P	P	P		P	P		P
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/Calor Dappler, B/PWD, B/Color Doppler/PWO; **Other: 3D, 40

(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)
Dryttuun of Bedical D

un of Radiciouical Devic Office of In Vitro D.

610K 512188

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

4 Combined: B/Color Dopplar, B/PWD, B/Color Doppter/PWD; **Other, SD, 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 801.108)

ALBION MEDICAL SYSTEMS Co., Ltd.

(Division Sign-Off)

Division of Racistogical Dav office of In Vitro Diagnostic De salion and Safety

610K 5121888

દ-ડ

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

E-CUBE 15 with L8-17X Transducer

Ințended Use: Dlagnostic 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
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 IF NEFDED)

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

Prescription User (Per 21 CFR 801.109)

ALPINION MEDICAL SYSTEMS Co., Ltd.
(Division Stamp)

LUVES of Anticlogical Dev grostic Davice Evaluation and Safaty

Kla888

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

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			Doppler		Tissue Harmonic Imaging	Combined* (Specify)
	B	M	PWD	CWD	Color Doppler	Power Doppler
Ophthalmic
Fetal	N	N	N	N	N	N	N
Abdominal	N	N	N	N	N	N	N
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
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 Dappler/PWD; ** Other: JD, 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 101.108)

ALPINION MEDICAL SYSTEMS Co., Ltd.

(Division Sign-Off)

Chination of Rac. Diogreal Devices wine of in Vitro Diagon as Device Evaluation and Saleg

510K

E-7

ਕਾਰੀ

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

E-CUBE 15 with E3-10H Transducer

Intended Use: Diagnostic ultrasound Imaging or fluid flow anaiysis 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	N
Trans-vaginal	N	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 = new Indication; P = previously cleared by FDA; E = added under appendix

· Cambined: 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 (Par 21 CFR 801.109)

MEDICAL SYSTEMS Co. Ltd. Short Stone

on of Redioksunal Cavices Office ut In

810K K121888

. E-8

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.