The X-CUBE 70 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal: Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiatric); Peripheral Vessel(PV); and Urology(including prostate).

And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode: 3D/4D mode. The X-CUBE 70 is intended to be used in a hospital or medical clinic.

Device Description

X-CUBE 70 product is an ultrasound imaging system for medical diagnosis. This innovative system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.

AI/ML Overview

This document is an FDA 510(k) Premarket Notification stating that the Alpinion Medical Systems X-CUBE 70 ultrasound system is substantially equivalent to legally marketed predicate devices. It specifically outlines the indications for use, comparison to predicate devices, and a summary of non-clinical tests.

This document focuses on the substantial equivalence of the new device (X-CUBE 70) to existing predicate devices, primarily based on technical characteristics and compliance with safety standards, rather than proving performance against specific acceptance criteria through a clinical or algorithmic study.

Therefore, most of the requested information regarding acceptance criteria, study details, sample size, ground truth, and expert reconciliation cannot be extracted from this particular document, as it describes a regulatory submission for a medical imaging device, not a performance study of an AI/algorithm-driven device.

However, I can provide information based on what is available in the document:

Acceptance Criteria and Device Performance (Not directly addressing AI/algorithmic performance)

This section is interpreted in the context of the device's functional and safety characteristics, as the document details its equivalence to predicate ultrasound systems, not an AI component with specific performance metrics.

Acceptance Criteria Category	Reported Device Performance (Summary from doc)
Indications for Use (Clinical Applications)	The X-CUBE 70 is intended for various clinical applications including Fetal, Abdominal (renal & GYN/pelvic), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac (adult & pediatric), Peripheral Vessel, and Urology (including prostate). The tables show equivalency (mark 'N' for new or 'P' for previously cleared) to predicate devices for these applications across different transducers.
Imaging Modes	Supports 2D(B) mode, Harmonic mode (HAR), M mode, Color M mode, Anatomical M mode, Color Flow Doppler (CF) Mode, Power Doppler (PD) Mode, Directional PD mode, Pulsed Wave Doppler (PWD) Mode, Continuous Wave Doppler (CWD) Mode, High PRF Doppler mode, Tissue Doppler Imaging (TDI) Mode, and 3D/4D mode. Also supports combination modes like B/Color Doppler, B/PWD, B/Color Doppler/PWD. These modes are shown as equivalent to predicate devices.
Physical Dimensions & Weight	Weight: 90kg. Height: 1325/1560 mm. Width: 554 mm. Depth: 815 mm. (These are compared against predicate devices, generally falling within similar ranges).
Electrical Power	Voltage: 100-120V~, 200-240V~. Frequency: 50-60 Hz. Power: Max. 700VA. (These are also compared against predicate devices and found to be standard).
Imaging Functions (Advanced Features)	Includes features like Xpeed™, Full SRI™, Spatial Compounding Image (SCI), Frequency Compounding Image (FCI), Panoramic, Stress Echo, Cube Strain™, Live HQ ™, Needle Vision™ / Needle Vision™ Plus, Elastography, Cube view™, Contrast Enhanced Ultrasound (CEUS), Cube Note, B-STIC, Point Shear Wave Elastography (PSWE), Microvascular Imaging (MVI), Free Angle MSV, AnySlice™, Volume Analysis. Most are common with predicate devices.
Accessories	Compatible with various accessories like color/B/W printers, DVD-RW, foot switch, wireless LAN, various biopsy guide kits, ECG modules, ultrasound gel, and several common disinfectants.
Safety and Compliance	Evaluated for biocompatibility, acoustic output, thermal, electrical, electromagnetic, and mechanical safety. Conforms to voluntary standards including IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, AAMI/ANSI/ISO 10993-1, AAMI/ANSI/ISO 14971, AIUM MUS, NEMA UD 2-2004(R2009), NEMA UD 3-2004(R2009). Also complies with 21 CFR 820 and ISO 13485 (Quality Management System measures).

Since this document is a 510(k) submission for an ultrasound system, not an AI or algorithm-driven device that requires clinical performance studies to demonstrate accuracy in a diagnostic task, the following points are generally not applicable or stated as not required by the document:

Sample size used for the test set and the data provenance: Not mentioned as no specific performance test set (in the context of AI/algorithm accuracy) was required. The substantial equivalence relies on technical specifications and safety profile similarity to existing devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy (e.g., presence/absence of disease based on expert consensus) is not part of this type of submission for an ultrasound machine.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is an ultrasound imaging system, not an AI-assisted diagnostic tool being evaluated for reader improvement.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (ultrasound system), not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here is the adherence to safety standards and performance characteristics comparable to predicate devices.
The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set for a diagnostic algorithm.
How the ground truth for the training set was established: Not applicable.

Summary of Non-Clinical Tests (from document):
The device underwent non-clinical tests to assess biocompatibility, acoustic output, thermal, electrical, electromagnetic, and mechanical safety. It was found to conform to applicable medical device safety standards and voluntary standards (listed in the table above).

Summary of Clinical Tests (from document):
The document explicitly states: "The subject of this premarket submission, X-CUBE 70, did not require clinical studies to support substantial equivalence." This reinforces that the focus of this 510(k) submission is on technical and safety equivalence to predicate devices, not on a new clinical claim or an AI/algorithmic performance claim.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Alpinion Medical Systems Co., Ltd. % Boyeon Cho Quality Management Representative 5FL, I dong, 77, heungan-daero 81 beon-gil dongan-gu Anyang-si. Gyeonggi-do 14117 REPUBLIC OF KOREA

July 10, 2020

Re: K200450

Trade/Device Name: X-CUBE 70 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: June 12, 2020 Received: June 17, 2020

Dear Boyeon Cho:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K200450

Device Name X-CUBE 70

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

X-CUBE 70 Ultrasound System

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

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal	N	N	N		N	N	N	N	N
Abdominal	N	N	N		N	N	N	N	N
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	N	N	N		N	N	N	N	N
Small Organ(breast, testes, thyroid)	N	N	N		N	N	N	N
Neonatal Cephalic	N	N	N		N	N	N	N
Adult Cephalic	N	N	N		N	N	N	N
Trans-rectal	N	N	N		N	N	N	N	N
Trans-vaginal	N	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	N	N	N	N	N	N	N	N
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

N = new indication; P = previously cleared by FDA K181277; 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)

{4}------------------------------------------------

X-CUBE 70 with L3-8H Transducer

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

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

N = new indication; P = previously cleared by FDA K181277; 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)

{5}------------------------------------------------

X-CUBE 70 with L3-12X Transducer

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

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

N = new indication; P = previously cleared by FDA K181277; 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)

{6}------------------------------------------------

X-CUBE 70 with SL3-19H Transducer

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

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

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

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

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

{7}------------------------------------------------

X-CUBE 70 with L10-25H Transducer

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

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

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

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

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

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

X-CUBE 70 with IO7-18 Transducer

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

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

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

X-CUBE 70 with C5-8NT Transducer

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

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

N = new indication; P = previously cleared by FDA K181277; 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)

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

X-CUBE 70 with SC1-7H Transducer

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

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

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

X-CUBE 70 with SC2-9H Transducer

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

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

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

X-CUBE 70 with MP1-5X Transducer

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

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P	P
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	P
Small Organ(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic	P	P	P		P	P	P	P
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 K150773; 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)

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

X-CUBE 70 with SP3-8T Transducer

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

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P	P
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P		P	P	P	P
Small Organ(breast, testes, thyroid)
Neonatal Cephalic	P	P	P		P	P	P	P
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 K181277; 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)

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

X-CUBE 70 with SP4-12 Transducer

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

	Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal
Abdominal	N	N	N		N	N	N	N
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	N	N	N		N	N	N	N
Small Organ(breast, testes, thyroid)
Neonatal Cephalic	N	N	N		N	N	N	N
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	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)

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

X-CUBE 70 with SVC1-8H Transducer

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

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

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)

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

X-CUBE 70 with CW2.0 Transducer

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

	Mode of Operation
Clinical Application	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				P
Cardiac Pediatric				P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)

N = new indication; P = previously cleared by FDA K181277; 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)

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

X-CUBE 70 with CW5.0 Transducer

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

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

N = new indication; P = previously cleared by FDA K181277; 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)

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

X-CUBE 70 with CW8.0 Transducer

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

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

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

X-CUBE 70 with EV2-11H Transducer

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

	Mode of Operation
Clinical Application	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	N
Trans-vaginal	N	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	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)

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

X-CUBE 70 with EC2-11H Transducer

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

	Mode of Operation
Clinical Application	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	N
Trans-vaginal	N	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	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)

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

X-CUBE 70 with VE3-10H Transducer

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

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

N = new indication; P = previously cleared by FDA K181277; 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)

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

X-CUBE 70 with TEE3-7 Transducer

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

		Mode of Operation
Clinical Application	B	M	PWD	CWD	ColorDoppler	PowerDoppler	TissueHarmonicImaging	Combined*(Specify)	Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal(Superficial)
Intravascular
Cardiac Adult	P	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 K150773; 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)

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

510(k) Summary K200450

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

June 12th, 2020 Date
Submitter: ALPINION MEDICAL SYSTEMS Co., Ltd. Address: 5FL, I dong, 77, heungan-daero 81 beon-gil dongan-gu Anyang-si, Gyeonggi-do, 14117, REPUBLIC OF KOREA
Primary Contact Boyeon CHO Person Quality Management Representative(QMR) Address: 5FL, I donq, 77, heungan-daero 81 beon-qil dongan-qu Anyang-si, Gyeonggi-do, 14117, REPUBLIC OF KOREA Phone: +82 70 7465 2104 Fax: +82 2 851 5595 Email: qa ra@alpinion.com
Secondary Kevin CHUN Contact Person Address: 21222 30th Dr SE Ste C-122, Bothell, WA 98021, United States Phone: 425 949 1059 Fax: 425 949 4910 Email: kevin.chun@alpinionusa.com
- Device Trade X-CUBE 70 Name:
- Common/ Ultrasonic Pulsed Doppler Imaging System Usual Name:
- Classification System, Imaging, Pulsed Doppler Ultrasonic Names
Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550 90-IYN Product Code: Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21CFR 892.1570, 90-ITX
- Primarv K181277 E-CUBE 12 Diagnostic Ultrasound System Predicate Device
- Reference K150773 E-CUBE 15 Diagnostic Ultrasound System Devices K181617 E-CUBE 8 Diagnostic Ultrasound System K161439 E-CUBE 11 Diagnostic Ultrasound System K173713 HS70A Diagnostic Ultrasound System
- X-CUBE 70 product is an ultrasound imaging system for medical diagnosis. This Device Description: innovative system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.

{24}------------------------------------------------

1. Signal Mode:

2D(B) mode, Harmonic mode (HAR), M mode, Color M mode, Anatomical M mode, Color Flow Doppler(CF) Mode, Power Doppler(PD) Mode, Directional PD mode, Pulsed Wave Doppler(PWD) Mode, Continuous Wave Doppler(CWD) Mode, High PRF Doppler mode, Tissue Doppler Imaging(TDI) Mode, 3D/4D mode

2. Combination Mode:

B/Color Doppler, B/PWD, B/Color Doppler/PWD

Acoustic output track: Track 3

Indications The X-CUBE 70 diagnostic ultrasound system is intended for use by, or by the For Use: order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Peripheral Vessel(PV); and Urology(including prostate). And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Color M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode. The X-CUBE 70 is intended to be used in a hospital or medical clinic.

{25}------------------------------------------------

Determination of Substantial Equivalence: Comparison table with Predicate devices:

Model	ProposedX-CUBE 70ALPINION Medical SystemsCo., Ltd.	PredicateE-CUBE 12ALPINION Medical SystemsCo., Ltd.	ReferenceE-CUBE 15ALPINION Medical SystemsCo., Ltd.	ReferenceE-CUBE 8ALPINION Medical SystemsCo., Ltd.	ReferenceE-CUBE 11ALPINION Medical SystemsCo., Ltd.	ReferenceHS70ASamsungMedison co., ltd
Feature	-	K181277	K150773	K181617	K161439	K173713
	Indications for Use
- Fetal	√	√	√	√	√	√
- Abdominal(Renal&GYN/Pelvic)	√	√	√	√	√	√
- Intra-operative(Specify, Neuro)						√
- Pediatric	√	√	√	√	√	√
- Small Organ(breast, testes,thyroid)	√	√	√	√	√	√
- Neonatal Cephalic	√	√		√		√
- Adult Cephalic	√	√	√	√	√	√
- Trans-rectal	√	√	√	√	√	√
- Trans-vaginal	√	√	√	√	√	√
- Musculo-skeletal(Conventional)	√	√	√	√	√	√
- Musculto skeletal(Superficial)	√	√	√	√	√	√
- Cardiac (Adult)	√	√	√	√	√	√
- Cardiac (Pediatric)	√	√	√	√	√	√
- Peripheral Vessel	√	√	√	√	√	√
- Urology(including prostate)	√	√	√	√	√	√
	Dimensions and weight
Weight(Excluding options)	90kg	94 kg	105 kg	55 kg	94 kg	99.4 kg
Height	1325/1560 mm	1,420/1,520 mm	1,413/1,848 mm	830~1,430 mm	1,455/1,695 mm	1,430~1,710 mm
Width	554 mm	590 mm	585 mm	532 mm	590 mm	557 mm
Depth	815 mm	895 mm	670 mm	787 mm	895 mm	791~860 mm
Electrical Power
Voltage	100-120V~,200-240V~	100-120V~,200-240V~	100-120V~,200-240V~	100-120V~,200-240V~	100-120V~,200-240V~	100-240V~
Frequency	50-60 Hz	50/60 Hz	50-60 Hz	50-60 Hz	50/60 Hz	50/60Hz
Power	Max. 700VA	Max. 600VA	Max. 900VA	Max. 450VA	Max. 600VA	1,100VA
Imaging modes
- 2D(B) mode	√	√	√	√	√	√
- Harmonic mode	√	√	√	√	√	√
- M mode	√	√	√	√	√	√
- Color M mode	√	√	√	√	√	√
- Anatomical M mode	√	√	√	√	√	√
- Color Flow Doppler(CF) mode	√	√	√	√	√	√
- Power Doppler(PD) mode	√	√	√	√	√	√
- Directional PDmode	√	√	√	√	√	√
- Pulsed waveDoppler (PWD)mode	√	√	√	√	√	√
- Continuous waveDoppler (CWD)mode	√	√	√	√	√	√
- High PRF Dopplermode	√	√	√	√	√	√
- Tissue Dopplerimaging (TDI) mode	√	√	√	√	√	√

{26}------------------------------------------------

{27}------------------------------------------------

- 3D/4D mode	√	√	√	√	√
Imaging Functions
- Xpeed™	√	√	√	√	√
- Full SRI™	√	√	√	√	√
-SpatialCompounding Image(SCI)	√	√	√	√	√
- FrequencyCompoundingimage(FCI)	√	√	√	√	√
- Panoramic	√	√	√	√	√
- Stress Echo	√	√	√	√	√
- Cube Strain™	√	√	√	√	√
- Live HQ ™	√	√	√	√	√
- Needle Vision™ /Needle Vision™Plus	√	√	√	√	√
- Elastography	√	√	√	√	√
- Cube view™	√	√	√	√	√
- Contrast EnhancedUltrasound (CEUS)	√	√	√	√
- Cube Note	√	√	√
- B-STIC	√	√	√
- Point Shear WaveElastography(PSWE)	√
- MicrovascularImaging (MVI)	√
	- Volume Advance™
• Free Angle MSV	√	√		√	√
• AnySlice™	√	√		√	√
• Volume Analysis		√		√		√
	Accessories or kits
Color printer	√		√		√
B/W printer	√	√	√	√	√	√
DVD-RW	√	√	√	√	√	√
Foot switch	√	√	√	√	√	√
Wireless LAN	√		√		√	√
SC1-6 Biopsy guide kit	√	√	√	√	√
L3-12 Biopsy guide kit	√	√	√	√	√
SC1-4HS Biopsy guide kit		√
L3-12X Biopsy guide kit	√	√
EN3-10 Reusable Biopsy needle guide		√	√	√	√
EN3-10 Disposable Biopsy needle guide		√		√	√
VE3-10H Reusable Biopsy needle guide	√	√
VE3-10H Disposable Biopsy needle guide	√	√
ECG module / cable	√	√	√	√	√	√
	Disinfectant & Ultrasound Gel
Ultrasonic gel	√	√	√	√	√	√
Cidex OPA (Disinfectant agaents)	√	√	√	√	√	√
Cidex Plus (Disinfectant agaents)	√	√	√	√	√	√
Gigasept FF	√	√	√	√	√	√
(Disinfectantagaents)
Virkon(Disinfectantagaents)	√		√	√	√	√
Wavicide-01(Disinfectantagaents)	√		√	√	√
AIDAL PLUS(Disinfectantagaents)	√		√	√	√
Cetylcide-G(Disinfectantagaents)	√		√	√	√
Sporicidin(Disinfectantagaents)	√		√	√	√
Thermal, mechanical and electrical safety
- NEMA UD2, UD3	√		√	√	√	√
- AIUM MedicalUltrasound Safety	√		√	√	√	√
- IEC 60601-1	√		√	√	√	√
- IEC 60601-1-2	√		√	√	√	√
- IEC 60601-2-37	√		√	√	√	√

{28}------------------------------------------------

{29}------------------------------------------------

{30}------------------------------------------------

Summary of Non-Clinical Tests:

X-CUBE 70 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. X-CUBE 70 and its application comply with voluntary standards as detailed in this premarket submission.

� IEC60601-1:2005(Third Edition)+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment - Part 1: General Requirements for Safety
� IEC60601-1-2:2014. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC60601-2-37:2007/AMD1:2015, Medical Electrical Equipment Part 2-� 37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
� AAMI/ANSI/ISO10993-1:2009(R)2013, Biological Evaluation of Medical Devices - Part 1:Evaluation and Testing within a risk management process
� AAMI/ANSI/ISO14971:2007/(R)2010, Medical devices-Application of risk management to medical devices
� AIUM MUS, Third edition, Medical Ultrasound Safety
� NEMA UD 2-2004(R2009), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
◆ NEMA UD 3-2004(R2009), Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic ultrasound Equipment

The following quality management system measures were applied to the development of X-CUBE 70:

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, X-CUBE 70, did not require clinical studies to support substantial equivalence.

Discussion:

X-CUBE 70 was compared with the predicate device. The subject device is in conformance with applicable safety standards.

Therefore, the differences between X-CUBE 70 and the predicate device would not affect the safety, effectiveness and essential performance.

{31}------------------------------------------------

The design, development and quality process of the manufacturer confirms Conclusion: with 21 CFR 820 and ISO 13485. The device is designed to conform to applicable medical device safety standards and compliance. Therefore, ALPINION MEDICAL SYSTEMS Co., Ltd. considers X-CUBE 70 to be as safe, and effective.

ALPINION MEDICAL SYSTEMS Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA or the requirements will be published in guidance documents.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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