LogoFDA 510(k) Search
K Number
K211300
Device Name
X-CUBE 90
Manufacturer
Alpinion Medical Systems Co., Ltd.
Date Cleared
2021-08-09

(103 days)

Product Code
IYN,ITX,IYO
Regulation Number
892.1550
Type
Traditional
Panel
Radiology
Reference & Predicate Devices
K181277,K150773,K181617,K161439,K173713,K201632,K200449
Predicate For
K220857,K221093
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The X-CUBE 90 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; Adult 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 90 is intended to be used in a hospital or medical clinic.

Device Description

X-CUBE 90 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

The provided text describes the Alpinion Medical Systems Co., Ltd. X-CUBE 90 ultrasound system and its equivalence to predicate devices, but it does not include information about acceptance criteria or a study proving device performance in the context of AI/ML.

The document is a 510(k) summary for a traditional medical device (ultrasound system), not an AI/ML-powered device. Therefore, it focuses on demonstrating substantial equivalence to previously cleared ultrasound systems based on technical characteristics, indications for use, and compliance with general medical device safety standards.

Here's what can be extracted from the document, with the understanding that the request for AI/ML-specific details cannot be fully met from the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative clinical performance acceptance criteria or report device performance in terms of metrics like sensitivity, specificity, or AUC, which are common for AI/ML devices. Instead, it demonstrates performance by comparing its features and characteristics to legally marketed predicate devices, asserting that it is as safe and effective.

The acceptance criteria are implicitly based on compliance with recognized medical device standards and having equivalent specifications and functionalities to the predicate devices.

Acceptance Criterion (Implicit)Reported Device Performance (Implicit)
Compliance with IEC 60601-1 (General Safety)X-CUBE 90 conforms to IEC60601-1:2005(Third Edition)+CORR.1:2006+CORR.2:2007+A1:2012
Compliance with IEC 60601-1-2 (EMC)X-CUBE 90 conforms to IEC60601-1-2:2014
Compliance with IEC 60601-2-37 (Ultrasonic Specific Safety)X-CUBE 90 conforms to IEC60601-2-37:2007/AMD1:2015
Biocompatibility of patient contact materialsTransducer materials and other patient contact materials are biocompatible (conforming to AAMI/ANSI/ISO10993-1:2009(R)2013)
Compliance with risk management standardsConforms to AAMI/ANSI/ISO14971:2007/(R)2010
Compliance with Acoustic Output Measurement StandardConforms to NEMA UD 2-2004(R2009)
Compliance with Real Time Display of Thermal and Mechanical AIConforms to NEMA UD 3-2004(R2009)
Indications for Use (equivalent to predicate)The X-CUBE 90 has the same clinical applications and imaging modes as its primary predicate (K200449 X-CUBE 90).
Technical Specifications (dimensions, electrical power, etc.)Specifications are comparable or slightly improved to predicate devices, not affecting safety or effectiveness.

Regarding the sections specific to AI/ML devices (points 2-9 in your request), the provided text does not contain this information as it describes a conventional ultrasound system, not an AI/ML powered one.

Therefore, the following cannot be answered from the provided document:

  • 2. Sample size used for the test set and the data provenance: Not applicable, as no AI/ML test set is mentioned.
  • 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  • 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
  • 5. 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.
  • 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
  • 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
  • 8. The sample size for the training set: Not applicable, as no AI/ML training set is mentioned.
  • 9. How the ground truth for the training set was established: Not applicable.

Summary of Non-Clinical and Clinical Tests (from the document):

  • Summary of Non-Clinical Tests: The X-CUBE 90 was evaluated for biocompatibility, acoustic output, and thermal, electrical, electromagnetic, and mechanical safety. It was found to conform to various medical device safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, AAMI/ANSI/ISO10993-1, AAMI/ANSI/ISO14971, AIUM MUS, NEMA UD 2, NEMA UD 3). Quality management system measures were also applied, including risk management, requirements reviews, design reviews, component verification, integration review, performance testing, safety testing, and design validation.
  • Summary of Clinical Tests: The submission explicitly states: "The subject of this premarket submission, X-CUBE 90, did not require clinical studies to support substantial equivalence." This is typical for 510(k) submissions of conventional devices demonstrating equivalence to existing ones.

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

August 9, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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

Re: K211300

Trade/Device Name: X-CUBE 90 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: June 10, 2021 Received: June 11, 2021

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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

  1. for 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: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K211300

Device Name X-CUBE 90

Indications for Use (Describe)

The X-CUBE 90 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; Adult 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 90 is intended to be used in a hospital or medical clinic.

Court of the collection of the United States of Manager
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 90 Ultrasound System

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

Mode of Operation
Clinical ApplicationBMPWDCWDColorDopplerPowerDopplerTissueHarmonicImagingCombined*(Specify)Other**(Specify)
Ophthalmic
FetalPPPPPPPP
AbdominalPPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPPP
Small OrganPPPPPPP
Neonatal CephalicPPPPPPP
Adult CephalicPPPPPPP
Trans-rectalPPPPPPPP
Trans-vaginalPPPPPPPP
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletalPPPPPPP
Musculo-skeletalPPPPPPP
Intravascular
Cardiac AdultPPPPPPPP
Cardiac PediatricPPPPPPPP
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselPPPPPPPP
Urology (including prostate)PPPPPPPP

N = new indication; P = previously cleared by FDA K200449; 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 90 with L3-8H Transducer

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

Mode of Operation
Clinical ApplicationBMPWDCWDColorDopplerPowerDopplerTissueHarmonicImagingCombined*(Specify)Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPPP
Small OrganPPPPPPPP
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletalPPPPPPPP
Musculo-skeletalPPPPPPPP
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselPPPPPPPP
Urology (including prostate)

N = new indication; P = previously cleared by FDA K200449; 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 90 with L3-12X Transducer

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

Mode of Operation
Clinical ApplicationBMPWDCWDColorDopplerPowerDopplerTissueHarmonicImagingCombined*(Specify)Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPP
Small OrganPPPPPPP
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletalPPPPPPP
Musculo-skeletalPPPPPPP
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselPPPPPPP
Urology (including prostate)

N = new indication; P = previously cleared by FDA K200449; 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 90 with SL3-19H Transducer

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

Mode of Operation
Clinical ApplicationBMPWDCWDColorDopplerPowerDopplerTissueHarmonicImagingCombined*(Specify)Other**(Specify)
Ophthalmic
FetalPPPPPPP
AbdominalPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPP
Small OrganPPPPPPP
Neonatal CephalicPPPPPPP
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletalPPPPPPP
Musculo-skeletalPPPPPPP
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselPPPPPPP
Urology (including prostate)

N = new indication; P = previously cleared by FDA K200449; 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 90 with SL3-19X Transducer

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

Mode of Operation
Clinical ApplicationBMPWDCWDColorDopplerPowerDopplerTissueHarmonicImagingCombined*(Specify)Other**(Specify)
Ophthalmic
FetalNNNNNNNN
AbdominalNNNNNNNN
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricNNNNNNNN
Small OrganNNNNNNNN
Neonatal CephalicNNNNNNNN
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletalNNNNNNNN
Musculo-skeletalNNNNNNNN
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselNNNNNNNN
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 90 with L10-25H Transducer

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

Mode of Operation
Clinical ApplicationBMPWDCWDColorDopplerPowerDopplerTissueHarmonicImagingCombined*(Specify)Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small OrganPPPPPPPP
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletalPPPPPPPP
Musculo-skeletalPPPPPPPP
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselPPPPPPPP
Urology (including prostate)

N = new indication; P = previously cleared by FDA K200449; 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 90 with IO7-18 Transducer

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

Mode of Operation
Clinical ApplicationBMPWDCWDColorDopplerPowerDopplerTissueHarmonicImagingCombined*(Specify)Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small OrganPPPPPPPP
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletalPPPPPPPP
Musculo-skeletalPPPPPPPP
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 K200449; 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 90 with C5-8NT Transducer

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

Mode of Operation
Clinical ApplicationBMPWDCWDColorDopplerPowerDopplerTissueHarmonicImagingCombined*(Specify)Other**(Specify)
Ophthalmic
Fetal
AbdominalPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPP
Small Organ
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
Musculo-skeletal
Intravascular
Cardiac Adult
Cardiac PediatricPPPPPPP
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)

N = new indication; P = previously cleared by FDA K200449; 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 90 with SC1-7H Transducer

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

Mode of Operation
Clinical ApplicationBMPWDCWDColorDopplerPowerDopplerTissueHarmonicImagingCombined*(Specify)Other**(Specify
Ophthalmic
FetalPPPPPPPP
AbdominalPPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPPP
Small Organ
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
Musculo-skeletal
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)PPPPPPPP

N = new indication; P = previously cleared by FDA K200449; 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 90 with SC2-9H Transducer

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

Clinical ApplicationBMPWDCWDColorDopplerPowerDopplerTissueHarmonicImagingCombined*(Specify)Other**(Specify)
Ophthalmic
FetalPPPPPPP
AbdominalPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPP
Small Organ
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
Musculo-skeletal
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)PPPPPPP

N = new indication; P = previously cleared by FDA K200449; 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 90 with SC2-11H Transducer

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

Mode of
Clinical ApplicationBMPWDCWDColorDopplerPowerDopplerTissueHarmonicCombined*(SpecifyOther**(Specifv)
Ophthalmic
Fetal
AbdominalNNNNNNNN
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricNNNNNNNN
Small Organ
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
Musculo-skeletal
Intravascular
Cardiac Adult
Cardiac PediatricNNNNNNNN
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)

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

X-CUBE 90 with MP1-5X Transducer

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

Clinical ApplicationMode of Operation
BMPWDCWDColorDopplerPowerDopplerTissueHarmonicImagingCombined*(Specify)Other**(Specify)
Ophthalmic
Fetal
AbdominalPPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPPP
Small Organ
Neonatal Cephalic
Adult CephalicPPPPPPPP
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
Musculo-skeletal
Intravascular
Cardiac AdultPPPPPPPP
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)

N = new indication; P = previously cleared by FDA K200449; 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 90 with SP3-8T Transducer

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

Mode of Operation
Clinical ApplicationBMPWDCWDColor DopplerPower DopplerTissue Harmonic ImagingCombined* (Specify)Other** (Specify)
Ophthalmic
Fetal
AbdominalPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPP
Small Organ
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
Musculo-skeletal
Intravascular
Cardiac Adult
Cardiac PediatricPPPPPPPP
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)

N = new indication; P = previously cleared by FDA K200449; 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)

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

X-CUBE 90 with SP4-12 Transducer

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

Mode of Operation
Clinical ApplicationBMPWDCWDColorDopplerPowerDopplerTissueHarmonicImagingCombined*(Specify)Other**(Specify)
Ophthalmic
Fetal
AbdominalPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPP
Small Organ
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
Musculo-skeletal
Intravascular
Cardiac Adult
Cardiac PediatricPPPPPPPP
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)

N = new indication; P = previously cleared by FDA K200449; 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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X-CUBE 90 with SVC1-8H Transducer

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

Mode of Operation
Clinical ApplicationBMPWDCWDColorDopplerPowerDopplerTissueHarmonicImagingCombined*(Specify)Other**(Specify)
Ophthalmic
FetalPPPCWDPPPPP
AbdominalPPPCWDPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPCWDPPPPP
Small Organ
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
Musculo-skeletal
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)PPPCWDPPPPP

N = new indication; P = previously cleared by FDA K200449; 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 90 with CW2.0 Transducer

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

Mode of Operation
Clinical ApplicationBMPWDCWDColorDopplerPowerDopplerTissueHarmonicImagingCombined*(Specify)Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
Musculo-skeletal
Intravascular
Cardiac AdultP
Cardiac PediatricP
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)

N = new indication; P = previously cleared by FDA K200449; 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 90 with CW5.0 Transducer

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

Mode of Operation
Clinical ApplicationBMPWDCWDColorDopplerPowerDopplerTissueHarmonicImagingCombined*(Specify)Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
Musculo-skeletal
Intravascular
Cardiac AdultP
Cardiac PediatricP
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)

N = new indication; P = previously cleared by FDA K200449; 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 90 with CW8.0 Transducer

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

Mode of Operation
Clinical ApplicationBMPWDCWDColorDopplerPowerDopplerTissueHarmonicImagingCombined*(Specify)Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
Musculo-skeletal
Intravascular
Cardiac AdultP
Cardiac PediatricP
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)

N = new indication; P = previously cleared by FDA K200449; 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 90 with EV2-11H Transducer

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

Mode of Operation
Clinical ApplicationBMPWDCWDColorDopplerPowerDopplerTissueHarmonicImagingCombined*(Specify)Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPPPP
Trans-vaginalPPPPPPP
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
Musculo-skeletal
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)PPPPPPP

N = new indication; P = previously cleared by FDA K200449; 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 90 with EC2-11H Transducer

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

Mode of Operation
Clinical ApplicationBMPWDCWDColorDopplerPowerDopplerTissueHarmonicImagingCombined*(Specify)Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPPPP
Trans-vaginalPPPPPPP
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
Musculo-skeletal
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)PPPPPPP

N = new indication; P = previously cleared by FDA K200449; 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}------------------------------------------------

X-CUBE 90 with VE3-10H Transducer

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

Mode of Operation
Clinical ApplicationBMPWDCWDColorDopplerPowerDopplerTissueHarmonicImagingCombined*(Specify)Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPPPPP
Trans-vaginalPPPPPPPP
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
Musculo-skeletal
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)PPPPPPPP

N = new indication; P = previously cleared by FDA K200449; 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)

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

X-CUBE 90 with TEE3-7 Transducer

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

Mode of Operation
Clinical ApplicationBMPWDCWDColorDopplerPowerDopplerTissueHarmonicImagingCombined*(Specify)Other**(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
Musculo-skeletal
Intravascular
Cardiac AdultPPPPPPPP
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (including prostate)

N = new indication; P = previously cleared by FDA K200449; 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)

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

510(k) Summarv

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

  • June 10th, 2021 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 dong, 77, heungan-daero 81 beon-gil 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 90 Name:
    • Common/ Ultrasonic Pulsed Doppler Imaging System Usual Name:
    • Classification System, Imaging, Pulsed Doppler Ultrasonic Names
  • 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
    • Primarv K200449 X-CUBE 90 Diagnostic Ultrasound System Predicate Device
    • Reference K181277 E-CUBE 12 Diagnostic Ultrasound System Devices K150773 E-CUBE 15 Diagnostic Ultrasound System K181617 E-CUBE 8 Diagnostic Ultrasound System K161439 E-CUBE 11 Diagnostic Ultrasound System K173713 HS70A Diagnostic Ultrasound System K201632 TOMTEC-ARENA Picture archiving and communications system
    • X-CUBE 90 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.

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

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 90 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 90 is intended to be used in a hospital or medical clinic.

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

Determination of Substantial Equivalence: Comparison table with Predicate devices:

ModelProposedX-CUBE 90ALPINION MedicalSystems Co., Ltd.PredicateX-CUBE 90ALPINION MedicalSystems Co., Ltd.ReferenceE-CUBE 12ALPINION MedicalSystems Co., Ltd.ReferenceE-CUBE 15ALPINION MedicalSystems Co., Ltd.ReferenceE-CUBE 8ALPINION MedicalSystems Co., Ltd.ReferenceE-CUBE 11ALPINION MedicalSystems Co., Ltd.ReferenceHS70ASamsungMedison co., ltd
FeatureK211300K200449K181277K150773K181617K161439K173713
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)85kg90kg94 kg105 kg55 kg94 kg99.4 kg
Height1325/1560 mm1325/1560 mm1,420/1,520 mm1,413/1,848 mm830~1,430 mm1,455/1,695 mm1,430~1,710 mm
Width554 mm554 mm590 mm585 mm532 mm590 mm557 mm
Depth815 mm815 mm895 mm670 mm787 mm895 mm791~860 mm
Electrical Power
Voltage100-120V~,200-240V~100-120V~,200-240V~100-120V~,200-240V~100-120V~,200-240V~100-120V~,200-240V~100-120V~,200-240V~100-240V~
Frequency50-60 Hz50-60 Hz50/60 Hz50-60 Hz50-60 Hz50/60 Hz50/60Hz
PowerMax. 700VAMax. 700VAMax. 600VAMax. 900VAMax. 450VAMax. 600VA1,100VA
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 PD mode√√√√√√√
- Pulsed wave Doppler(PWD) mode√√√√√√√
- Continuous waveDoppler (CWD) mode√√√√√√√
- High PRF Dopplermode√√√√√√√
- Tissue Dopplerimaging (TDI) mode√√√√√√√
- 3D/4D mode√√√√√√√
Imaging Functions
- Xpeed™√√√√√√√
- Full SRI™√√√√√√√
-Spatial CompoundingImage (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√√√√
- Auto EF√√
- 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 guidekit√
L3-12X Biopsy guidekit√√√
EV2-11H ReusableBiopsy needle guide√
EN3-10 ReusableBiopsy needle guide√√√√
EN3-10 DisposableBiopsy needle guide√√√√
VE3-10H ReusableBiopsy needle guide√√√
VE3-10H DisposableBiopsy needle guide√√√
ECG module / cable√√√√√√√
Disinfectant & Ultrasound Gel
Ultrasonic gel√√√√√√√
Cidex OPA(Disinfectant agaents)√√√√√√√
Cidex Plus(Disinfectant agaents)√√√√√√√
Gigasept FF(Disinfectant agaents)√√√√√√√
Virkon(Disinfectant agaents)√√√√√√√
Wavicide-01(Disinfectant agaents)√√√√√√
AIDAL PLUS(Disinfectant agaents)√√√√√√
Cetylcide-G(Disinfectant agaents)√√√√√√
Sporicidin(Disinfectant agaents)√√√√√√
Thermal, mechanical and electrical safety
- NEMA UD2, UD3√√√√√√√
- AIUM MedicalUltrasound Safety√√√√√√√
STO(K) X-CUBE 90
- IEC 60601-1√√√√√√√
- IEC 60601-1-2√√√√√√√
- IEC 60601-2-37√√√√√√√

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

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

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

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

510(k) X-CUBF 90

{32}------------------------------------------------

Summary of Non-Clinical Tests:

X-CUBE 90 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 90 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 90:

  • Medical Device Risk Management �
  • � Requirements Reviews
  • � Desian 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 90, did not require clinical studies to support substantial equivalence.

Discussion:

X-CUBE 90 was compared with the predicate device. The subject device is in conformance with applicable safety standards.

Therefore, the differences between X-CUBE 90 and the predicate device would not affect the safety, effectiveness and essential performance.

{33}------------------------------------------------

  • 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 SYSTEM Co., Ltd. considers X-CUBE 90 to be as safe, and effective as the predicate device

§ 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.