(103 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML technology.
No.
The device is clearly described as an "ultrasound imaging system for medical diagnosis" and its "Intended Use" specifies "diagnostic ultrasound system," with no mention of therapeutic applications.
Yes
The "Intended Use / Indications for Use" explicitly states that "The X-CUBE 70 diagnostic ultrasound system is intended for use by... a licensed physician who is qualified for the evaluation of soft tissue and blood flow..." The "Device Description" also notes that it is "an ultrasound imaging system for medical diagnosis." Furthermore, the "Predicate Device(s)" section lists "K200450 X-CUBE 70 Diagnostic Ultrasound System." These statements all confirm its diagnostic purpose.
No
The device description explicitly states it is an "ultrasound imaging system," which is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The X-CUBE 70 is described as an "ultrasound imaging system for medical diagnosis." Ultrasound is a non-invasive imaging technique that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
- Intended Use: The intended use describes the clinical applications and anatomical sites where the ultrasound system is used for imaging and evaluation of soft tissue and blood flow. This is consistent with an imaging device, not an IVD.
Therefore, the X-CUBE 70 is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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; 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; Harnonic 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.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
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).
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission, X-CUBE 70, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K181277, K150773, K181617, K161439, K173713, K201632
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
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: K211299
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 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
- 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) K211299
Device Name X-CUBE 70
Indications for Use (Describe)
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; 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; Harnonic 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.
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 | Color | ||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | P | P | |
| Abdominal | P | P | P | P | P | P | P | P | |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | P | |
| Small Organ | |||||||||
| (breast, testes, thyroid) | P | P | P | P | P | P | P | ||
| Neonatal Cephalic | P | P | P | P | P | P | P | ||
| Adult Cephalic | P | P | P | P | P | P | P | ||
| 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) | P | P | P | P | P | P | P | ||
| Musculo-skeletal | |||||||||
| (Superficial) | P | P | P | P | P | P | P | ||
| Intravascular | |||||||||
| Cardiac Adult | P | P | P | P | P | P | P | P | |
| Cardiac Pediatric | P | P | P | P | P | P | P | P | |
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | P | P | P | P | P | P | P | P | |
| Urology (including prostate) | P | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K200450; 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:
| 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 | 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 K200450; 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 | Color | ||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | 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 K200450; 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 L3-15H 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 | N | N | N | N | N | N | N | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | N | N | N | N | N | N | N | ||
| Musculo-skeletal | 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 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 | Color | ||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | P | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | ||
| Small Organ | P | P | P | P | P | P | P | ||
| (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 | P | P | P | P | P | P | P | ||
| (Conventional) | |||||||||
| Musculo-skeletal | P | P | P | P | P | P | P | ||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | P | P | P | P | P | P | P | ||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K200450; 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 SL3-19X 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 | 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 | 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 | N | N | N | N | N | N | N | ||
| Musculo-skeletal | 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)
9
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 | Color | ||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ | |||||||||
| (breast, testes, thyroid) | P | P | P | P | P | P | 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 K200450; 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 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 | Color | ||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ | |||||||||
| (breast, testes, thyroid) | P | P | P | P | P | P | 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 | |||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K200450; 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 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 | Color | |||||
| Doppler | Power | |||||||||
| Doppler | Tissue | |||||||||
| Harmonic | ||||||||||
| Imaging | Combined* | |||||||||
| (Specify) | Other** | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | P | |||
| Intra-operative (Specify) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | P | |||
| Small Organ | ||||||||||
| (breast, testes, thyroid) | ||||||||||
| Neonatal Cephalic | 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 K200450; 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 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 | Color | ||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | P | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | ||
| Small Organ | |||||||||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K200450; 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 SC2-9H Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Tissue
Harmonic
Imaging | Combined*
(Specify) | Other**
(Specify) |
|------------------------------|---|---|-----|-----|------------------|------------------|-------------------------------|------------------------|----------------------|
| Ophthalmic | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | P | |
| Abdominal | P | P | P | | P | P | P | P | |
| Intra-operative (Specify) | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | |
| Small Organ | | | | | | | | | |
| (breast, testes, thyroid) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Trans-rectal | | | | | | | | | |
| Trans-vaginal | | | | | | | | | |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | |
| (Conventional) | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | |
| (Superficial) | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Cardiac Adult | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | | | | | |
| Peripheral vessel | | | | | | | | | |
| Urology (including prostate) | P | P | P | | P | P | P | P | |
N = new indication; P = previously cleared by FDA K200450; 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 SC2-11H 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 | Color | ||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| 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 | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| Musculo-skeletal | |||||||||
| 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 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 | Color | ||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | P | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | ||
| Small Organ | |||||||||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | 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 K200450; 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 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 | Color | ||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | P | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | ||
| Small Organ | |||||||||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | 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 K200450; 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 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 | Color | ||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | P | P | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | ||
| Small Organ | |||||||||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | 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 K200450; 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 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 | Color | ||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | P | P | |
| Abdominal | P | P | P | P | P | P | P | P | |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | P | |
| Small Organ | |||||||||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | P | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K200450; 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 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 K200450; 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 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 | 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 | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K200450; 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 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 | 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 K200450; 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 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 | Color | ||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ | |||||||||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | P | 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 K200450; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
ALPINION MEDICAL SYSTEMS Co., Ltd.
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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 | Color | ||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ | |||||||||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | P | ||
| Trans-vaginal | P | P | P | P | P | P | P | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K200450; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
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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 | Color | ||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ | |||||||||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | P | P | P |
| Trans-vaginal | P | 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 | P |
N = new indication; P = previously cleared by FDA K200450; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
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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 | 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 | 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 K200450; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
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26
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 70 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 K200450 X-CUBE 70 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 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.
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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.
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Determination of Substantial Equivalence: Comparison table with Predicate devices:
| Model | Proposed
X-CUBE 70
ALPINION Medical
Systems Co., Ltd. | Predicate
X-CUBE 70
ALPINION Medical
Systems Co., Ltd. | Reference
E-CUBE 12
ALPINION Medical
Systems Co., Ltd. | Reference
E-CUBE 15
ALPINION Medical
Systems Co., Ltd. | Reference
E-CUBE 8
ALPINION Medical
Systems Co., Ltd. | Reference
E-CUBE 11
ALPINION Medical
Systems Co., Ltd. | Reference
HS70A
Samsung
Medison co., ltd |
|--------------------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------|
| Feature | K211299 | K200450 | 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 | 90kg | 94 kg | 105 kg | 55 kg | 94 kg | 99.4 kg |
| Height | 1325/1560 mm | 1325/1560 mm | 1,420/1,520 mm | 1,413/1,848 mm | 8301,430 mm | 1,455/1,695 mm | 1,4301,710 mm |
| | | | | | | | |
| Width | 554 mm | 554 mm | 590 mm | 585 mm | 532 mm | 590 mm | 557 mm |
| Depth | 815 mm | 815 mm | 895 mm | 670 mm | 787 mm | 895 mm | 791860 mm |,
| Electrical Power | | | | | | | |
| Voltage | 100-120V
200-240V~ | 100-120V~,
200-240V~ | 100-120V~,
200-240V~ | 100-120V~,
200-240V~ | 100-120V~,
200-240V~ | 100-120V~,
200-240V~ | 100-240V~ |
| Frequency | 50-60 Hz | 50-60 Hz | 50/60 Hz | 50-60 Hz | 50-60 Hz | 50/60 Hz | 50/60Hz |
| Power | Max. 700VA | 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 PD mode | √ | √ | √ | √ | √ | √ | √ |
| - Pulsed wave Doppler
(PWD) mode | √ | √ | √ | √ | √ | √ | √ |
| - Continuous wave
Doppler (CWD) mode | √ | √ | √ | √ | √ | √ | √ |
| - High PRF Doppler
mode | √ | √ | √ | √ | √ | √ | √ |
| - Tissue Doppler
imaging (TDI) mode | √ | √ | √ | √ | √ | √ | √ |
| - 3D/4D mode | √ | √ | √ | √ | √ | √ | √ |
| Imaging Functions | | | | | | | |
| - 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 | √ | √ | √ | √ | | | |
| - Auto EF | √ | | | | | | √ |
| - Point Shear Wave
Elastography (PSWE) | √ | √ | | | | | |
| - Microvascular
Imaging (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 | √ | √ | | | | | |
| EV2-11H Reusable
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 | √ | √ | √ | √ | √ | √ | |
| S10(K) X-CUBE 70 | | | | | | | |
| - IEC 60601-1 | √ | √ | √ | √ | √ | √ | |
| - IEC 60601-1-2 | √ | √ | √ | √ | √ | √ | |
| - IEC 60601-2-37 | √ | √ | √ | √ | √ | √ | |
29
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32
510(k) X-CUBF 70
33
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
- � 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 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.
34
- 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 70 to be as safe, and effective as the predicate device