(139 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard ultrasound imaging capabilities and workflow.
No
The device is described as a "diagnostic ultrasound system" and "general purpose ultrasound imaging system for medical diagnosis assistance," specifically stating it is "used as an aid tool to diagnosis." It does not mention any therapeutic capabilities or functions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are "diagnostic ultrasound systems" and are intended for use in "clinical applications" for various anatomical sites to assist in the "evaluation of soft tissue and blood flow." The "Device Description" also refers to them as "general purpose ultrasound imaging system for medical diagnosis assistance."
No
The device description explicitly states it is a "general purpose ultrasound imaging system," which are hardware devices that generate and process ultrasound waves. The description also mentions a "wide flat panel display" and "ergonomic control panel," further indicating a hardware component.
Based on the provided information, the X-CUBE 50 and X-CUBE 60 diagnostic ultrasound systems are not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Description and Intended Use: The description clearly states that the X-CUBE 50 and X-CUBE 60 are "general purpose ultrasound imaging system for medical diagnosis assistance." Ultrasound imaging is a non-invasive technique that uses sound waves to create images of internal body structures within the body.
- Lack of Mention of Samples: The intended use and device description do not mention the analysis of any biological samples taken from the patient.
Therefore, the X-CUBE 50 and X-CUBE 60 are diagnostic imaging devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The X-CUBE 50, X-CUBE 60 diagnostic ultrasound systems are 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; 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; 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(Pulse Repetition Frequency) Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode.
The X-CUBE 50, X-CUBE 60 are intended to be used in a hospital or medical clinic.
Product codes
IYN, IYO, ITX
Device Description
The X-CUBE 50 and X-CUBE 60 products are general purpose ultrasound imaging system for medical diagnosis assistance. These products are used as an aid tool to diagnosis, such as a commonly used ultrasound diagnostic device.
Also X-CUBE 50 and X-CUBE 60 have the same operating principles, intended use, risk grade and design/manufacturing characteristics as reference/predicate devices.
This systems platform provide patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, image quality.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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(Pulse Repetition Frequency) Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode
Anatomical Site
Soft tissue, blood flow, 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; Peripheral Vessel(PV); Urology(including prostate).
Indicated Patient Age Range
Adult and Pediatric
Intended User / Care Setting
Licensed physician / hospital or medical clinic
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The subject of this premarket submission, X-CUBE 50 and X-CUBE 60, did not require clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
April 17, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a stylized image of a human figure. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION".
Alpinion Medical Systems Co., Ltd. % Boyeon CHO Quality Management Representative 4F, 15, Magokjungang 14-ro, Gangseo-gu Seoul. Seoul 07789 KOREA
Re: K223564
Trade/Device Name: X-CUBE 50, X-CUBE 60 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: March 24, 2023 Received: March 27, 2023
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.
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of 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
510(k) Number (if known) K223564
Device Name X-CUBE 50, X-CUBE 60
Indications for Use (Describe)
The X-CUBE 50, X-CUBE 60 diagnostic ultrasound systems are 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; 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; 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(Pulse Repetition Frequency) Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode.
The X-CUBE 50, X-CUBE 60 are intended to be used in a hospital or medical clinic.
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)
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FORM FDA 3881 (6/20)
Page 1 of 1
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510(k) Summary
In accordance with 21CFR807.92, the following summary of information is provided;
- Mar 24th, 2023 Date
- Submitter: ALPINION MEDICAL SYSTEMS Co., Ltd. Address: 4F, 15, Magokjungang 14-ro, Gangseo-gu, Seoul, 07789, Republic of Korea
- Primary Boyeon CHO Contact Person Quality Management Representative(QMR) Address: 4F, 15, Magokjungang 14-ro, Gangseo-qu, Seoul, 07789, Republic of Korea Phone: +82.2.3777.8600 Fax: +82.2.3777.8691 Email: ga 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 X-CUBE 50, X-CUBE 60
Trade 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
Predicate Device K220857 X-CUBE 50, X-CUBE 60 Ultrasonic Pulsed Doppler Imaging System
- Reference K221093 X-CUBE 70, X-CUBE 90 Ultrasonic Pulsed Doppler Imaging System Devices
- Proposed New The new device are as follows compared to the cleared Predicate devices. Device - X-CUBE 50 Change model name: C1-7GT → C1-6C, Add model: C1-6CT - X-CUBE 60 Add models: L10-25H. SL3-19X. C1-6CT. C1-6C - Add accessories: EC2-11H/EV2-11H Disposable Biopsy needle guide
The X-CUBE 50 and X-CUBE 60 products are general purpose ultrasound Device imaging system for medical diagnosis assistance. Description: These products are used as an aid tool to diagnosis, such as a commonly used
4
ultrasound diagnostic device.
Also X-CUBE 50 and X-CUBE 60 have the same operating principles, intended use, risk grade and design/manufacturing characteristics as reference/predicate devices.
This systems platform provide patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, image quality.
-
Patient population Adult and Pediatric
-
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(Pulse Repetition Frequency) Doppler mode, Tissue Doppler Imaging(TDI) Mode, 3D/4D mode
-
Combination Mode: B/Color Doppler, B/PWD, B/Color Doppler/PWD
-
Acoustic output track: Track 3
Indications The X-CUBE 50. X-CUBE 60 diagnostic ultrasound systems are intended for For Use: 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); 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(Pulse Repetition Frequency) Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode.
The X-CUBE 50, X-CUBE 60 are intended to be used in a hospital or medical clinic.
The difference between the X-CUBE 50 and X-CUBE 60 is the number of Differences Tx/Rx channels. X-CUBE 50 operates with 64 channels, but X-CUBE 60 between Proposed operates with 128 channels. The component constituting the Tx/Rx channel is Devices. the FE(Front End) board. Both devices are in the same except for the FE(Front End) board.
5
|--|
| Model | Proposed
X-CUBE 50,
X-CUBE 60
ALPINION Medical
Systems Co., Ltd. | Predicate
X-CUBE 50,
X-CUBE 60
ALPINION Medical
Systems Co., Ltd. | Reference
X-CUBE 70,
X-CUBE 90
ALPINION Medical
Systems Co., Ltd. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Feature | K223564 | K220857 | K221093 |
| | 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) | 70kg | 70kg | 85kg |
| Height | 1310/1670mm | 1310/1670mm | 1,440/1,605 mm |
| Width | 560mm | 560mm | 580 mm |
| Depth | 780mm | 780mm | 835 mm |
| | Electrical Power | | |
| Voltage | 100-120V~,
200-240V~ | 100-120V~,
200-240V~ | 100-120V~,
200-240V~ |
| Frequency | 50-60 Hz | 50-60 Hz | 50-60 Hz |
| Power | Max. 600VA | Max. 600VA | Max. 700VA |
| | Imaging Modes | | |
| - 2D(B) mode | √ | √ | √ |
| - Harmonic mode | √ | √ | √ |
| | | | |
| - M mode | √ | √ | √ |
| - Color M mode | √ | √ | √ |
| - Anatomical M mode | √ | √ | √ |
| - Color Flow Doppler
(CF) mode | √ | √ | √ |
| - Power Doppler (PD)
mode | √ | √ | √ |
| - Microvascular Imaging
(MVI) | √ | √ | √ |
| - Directional PD mode | √ | √ | √ |
| - Pulsed wave Doppler
(PWD) mode | √ | √ | √ |
| - Continuous wave
Doppler (CWD) mode | √ | √ | √ |
| - High PRF(Pulse
Repetition Frequency)
Doppler mode | √ | √ | √ |
| - Tissue Doppler
imaging (TDI) mode | √ | √ | √ |
| - 3D/4D mode | √ | √ | √ |
| Imaging Features | | | |
| - Xpeed™ | √ | √ | √ |
| - Full SRI™ | √ | √ | √ |
| -Spatial Compounding
Image (SCI) | √ | √ | √ |
| - Panoramic | √ | √ | √ |
| - Stress Echo | √ | √ | √ |
| - Cube Strain™ | √ | √ | √ |
| - Live HQ™ | √ | √ | √ |
| - Needle Vision™/
Needle Vision™ Plus | √ | √ | √ |
| - Elastography | √ | √ | √ |
| - Cube view™ | √ | √ | √ |
| - Contrast Enhanced
Ultrasound (CEUS) | √ | √ | √ |
| - Cube Note | √ | √ | √ |
| - B-STIC(STIC) | √ | √ | √ |
| - Auto EF | √ | √ | √ |
| - AnySlice™ | √ | √ | √ |
| - X + Compare | √ | √ | √ |
| - X + Assistant | √ | √ | √ |
| - Time Intensity Curve
(TIC) Analysis | √ | √ | √ |
| - Auto NT
Measurements | √ | √ | √ |
| - X + Auto Biometry | √ | √ | √ |
| - Auto IMT
Measurements | √ | √ | √ |
| Accessories or Kits | | | |
| Color printer | √ | √ | √ |
| B/W printer | √ | √ | √ |
| DVD-RW | √ | √ | √ |
| Foot switch | √ | √ | √ |
| Wireless LAN | √ | √ | √ |
| SC1-6 Biopsy guide kit | √ | √ | √ |
| L3-12 Biopsy guide kit | √ | √ | √ |
| L3-12X Biopsy guide kit | √ | √ | √ |
| EV2-11H Reusable
Biopsy needle guide | √ | √ | √ |
| EC2-11H/EV2-11H
Disposable Biopsy
needle guide | √ | | |
| 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
(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 Medical
Ultrasound Safety | √ | √ | √ |
| - IEC 60601-1 | √ | √ | √ |
| - IEC 60601-1-2 | √ | √ | √ |
| - IEC 60601-2-37 | √ | √ | √ |
| Transducer Comparison (related to K223564) | | | |
| C1-6C | √ | √ | √ |
| C1-6CT | √ | | |
| L10-25H | √ | | √ |
| SL3-19X | √ | | √ |
| - For C1-6C, only the model name has been changed from C1-
7GT(K220857).
- C1-6CT is the new model. However, except for the slight difference in
Applicable frequency, C1-6CT and C1-6C are the same Convex type
probe and provide the same applicable mode, indications for use, element
size, element spacing. - L10-25H and SL3-19X are the same transducers as the predicate
device(K221093). | | | |
6
510(k) X-CUBE 50 & 60
7
510(k) X-CUBE 50 & 60
8
Summary of Non-Clinical Tests:
X-CUBE 50 and X-CUBE 60 have 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 50, X-CUBE 60 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: Electromaqnetic 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 50 and X-CUBE 60:
- Medical Device Risk Management �
- � Requirements Reviews
9
- � 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 50 and X-CUBE 60, did not require clinical studies to support substantial equivalence.
Discussion:
X-CUBE 50 and X-CUBE 60 were compared with the predicate device. The subject devices are in conformance with applicable safety standards.
Therefore, the differences between X-CUBE 50 and X-CUBE 60, and the predicate device would not affect the safety, effectiveness and essential performance.
- Conclusion: The design, development and quality process of the manufacturer confirms with 21 CFR 820 and ISO 13485. The devices are designed to conform to applicable medical device safety standards and compliance. Therefore, ALPINION MEDICAL SYSTEMS Co., Ltd. considers X-CUBE 50 and X-CUBE 60 to be as safe, and effective as the predicate device.