(126 days)
Not Found
No
The document describes standard ultrasound imaging modes and image processing techniques, but there is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/test sets for algorithms.
No
The device is described as an "ultrasound imaging system for medical diagnosis" intended for "evaluation of soft tissue and blood flow." Its listed functions are for imaging and diagnosis, not for treating conditions.
Yes
This device is explicitly described as an "ultrasound imaging system for medical diagnosis" in the "Device Description" section. Additionally, all listed predicate devices include "Diagnostic Ultrasound System" in their names.
No
The device description explicitly states it is an "ultrasound imaging system" and is available in "portable(only body) and mobile(with system cart)" configurations, indicating it includes hardware components beyond just software.
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 Function: The description clearly states that this device is an ultrasound imaging system used for medical diagnosis by evaluating soft tissue and blood flow within the body. It uses ultrasonic waves to create images.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the patient. Its function is based on non-invasive imaging.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric, Small Organ (breast, testes, thyroid); Adult Cephalic; Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vascular (PV); and Urology (including prostate).
Product codes
IYN, IYO, ITX
Device Description
E-CUBE i7 product is an ultrasound imaging system for medical diagnosis. This device is available for portable (only body) and mobile (with system cart). Also, this innovative system platform provides optimal patient diagnosis workflow with the 15.6" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
Signal Mode: B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode, Pulsed Wave Doppler(PWD) mode, Continuous wave Doppler (CWD) mode, Tissue Doppler Imaging(TDI) mode, 3D, 4D
B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/CF/M
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic Pulsed Doppler Imaging
Anatomical Site
Soft tissue, Fetal, Abdominal (renal & GYN/pelvic), Pediatric, Small Organ (breast, testes, thyroid), Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac (adult & pediatric), Peripheral Vascular (PV), Urology (including prostate).
Indicated Patient Age Range
Adult, Pediatric, Fetal, Neonatal Cephalic
Intended User / Care Setting
Qualified physician
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, E-CUBE i7, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K153424, K150773, K172732, K132687
Reference Device(s)
Not Found
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
January 24, 2019
Image /page/0/Picture/1 description: The image contains 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. Below the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Alpinion Medical Systems Co., Ltd. Boyeon Cho OA/RA Manager 5fl, i dong, 77, heungan-daero 81 beon-gil dongan-gu ANYANG-SI, GYEONGGI-DO 14117 REPUBLIC OF KOREA
Re: K182594
Trade/Device Name: E-CUBE i7 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: December 28, 2018 Received: December 31, 2018
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K182594
Device Name E-CUBE i7
Indications for Use (Describe)
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric, Small Organ (breast, testes, thyroid); Adult Cephalic; Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vascular (PV); and Urology (including prostate).
| 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."
Type of Use (Select one or both, as applicable)
3
E-CUBE i7 Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | P | N | |
| Abdominal | P | P | P | P | P | P | P | P | N |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | P | N |
| Small Organ | |||||||||
| (breast, testes, thyroid) | P | P | P | P | P | P | P | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | P | P | P | P | P | P | P | P | |
| 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) | 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 | N | |
| Urology (including prostate) | P | P | P | P | P | P | P | N |
N = new indication; P = previously cleared by FDA; E = added under appendix * Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
4
E-CUBE i7 with C1-6T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | 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 K153424; 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
5
E-CUBE i7 with EC3-10T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | 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 K153424; 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
6
E-CUBE i7 with EV3-10T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | 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 K153424; 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
7
E-CUBE i7 with L3-12T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | 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 K153424; 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
8
E-CUBE i7 with C5-8NT Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | 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 | |||||||||
| 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 K153424; 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
9
E-CUBE i7 with IO8-17T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ | P | P | P | P | P | P | P | ||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| 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 | |||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K153424; 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
10
E-CUBE i7 with SP1-5T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| 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 | P | 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 K153424; 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
11
E-CUBE i7 with SP3-8T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||
| Doppler | Power | ||||||||
| Doppler | Tissue | ||||||||
| Harmonic | |||||||||
| Imaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| 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 | P | 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 | 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 K153424; 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
12
E-CUBE i7 with L3-12HW0 Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | 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 K172732; 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
13
E-CUBE i7 with L8-17H Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | 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) | N | N | N | N | N | N | N | N | |
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | N | N | N | N | N | N | N | N | |
| Musculo-skeletal | |||||||||
| (Superficial) | N | 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 | 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
14
E-CUBE i7 with L3-8H Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | 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) | N | N | N | N | N | N | N | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | N | N | N | N | N | N | N | ||
| Musculo-skeletal | |||||||||
| (Superficial) | N | N | N | N | N | N | N | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | N | N | N | N | N | N | N | ||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
15
E-CUBE i7 with VC1-6T Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | 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 K172732; 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
16
E-CUBE i7 with IO3-12 Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | Combined*
(Specify) | Other**
(Specify) |
|------------------------------|-------------------|---|-----|-----|------------------|------------------|-------------------------------|------------------------|----------------------|
| | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Tissue
Harmonic
Imaging | | |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ | P | P | P | P | P | P | P | P | |
| (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 K132687; 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
17
E-CUBE i7 with CW2.0 Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | 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 K172732; 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
18
E-CUBE i7 with CW5.0 Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | Combined*
(Specify) | Other**
(Specify) |
|------------------------------|-------------------|---|-----|-----|------------------|------------------|-------------------------------|------------------------|----------------------|
| | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Tissue
Harmonic
Imaging | | |
| 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 K172732; 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
19
510(k) Summary
In accordance with 21CFR807.92, the following summary of information is provided;
| Date | Jan. 04, 2019 |
|---|---|
| Submitter: | ALPINION MEDICAL SYSTEMS Co., Ltd. |
| Address: 5fl, i dong ,77, heungan-daero 81beon-gil, dongan-gu, anyang- | |
| si, gyeonggi-do , REPUBLIC OF KOREA, 14117 | |
| Primary Contact | |
| Person | Boyeon CHO |
| Quality Management Representative(QMR) | |
| Address: 5fl, i dong ,77, heungan-daero 81beon-gil, dongan-gu, anyang- | |
| si, gyeonggi-do , REPUBLIC OF KOREA, 14117 | |
| Phone: +82 70 7465 2104 | |
| Fax: +82 2 851 5593 | |
| Email: qa_ra@alpinion.com | |
| Secondary Contact | |
| Person | JULIAN LEE |
| Address: 21312 30th Dr SE Ste 100 Bothell, WA 98021, United States | |
| Phone: 425 949 1059 | |
| Fax: 425 949 4910 | |
| Email: julian.lee@alpinionusa.com | |
| Device Trade Name: | E-CUBE i7 |
| Common/Usual | |
| Name: | Ultrasonic Pulsed Doppler Imaging System |
| Classification Names | System, Imaging, Pulsed Doppler Ultrasonic |
| 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 | |
| Primary Predicate | |
| Device | K153424 E-CUBE i7 Diagnostic Ultrasound System |
| K150773 E-CUBE 15 Diagnostic Ultrasound System | |
| K172732 E-CUBE 8 Diagnostic Ultrasound System | |
| K132687 E-CUBE 7 Diagnostic Ultrasound System | |
| Device Description: | E-CUBE i7 product is an ultrasound imaging system for medical |
| diagnosis. This device is available for portable(only body) and mobile(with | |
| system cart). Also, this innovative system platform provides optimal | |
| patient diagnosis workflow with the 15.6" wide flat panel display, | |
| ergonomic control panel with easy user interface, optimal image quality. | |
| 1. Signal Mode: | |
| B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode, | |
| Pulsed Wave Doppler(PWD) mode, Continuous wave Doppler (CWD) | |
| mode, Tissue Doppler Imaging(TDI) mode, 3D, 4D |
B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/CF/M
20
Acoustic output track:_
Track 3
Track 3
| Types of transducers compatible with the device: | ||||
|---|---|---|---|---|
| C1-6T | L3-12T | EC3-10T | EV3-10T | IO8-17T | SP1-5T | SP3-8T | C5-8NT | ||
|---|---|---|---|---|---|---|---|---|---|
| Previously | |||||||||
| cleared | K153424 | K153424 | K153424 | K153424 | Previously | ||||
| cleared | K153424 | K153424 | K153424 | K153424 | |||||
| Applicable | |||||||||
| frequency | 1~6MHz | 3~12MHz | 3~10MHz | 3~10MHz | Applicable | ||||
| frequency | 8~17MHz | 1~5MHz | 3~8MHz | 5~8MHz | |||||
| Intended | |||||||||
| Usage | Fetal. | ||||||||
| Abdominal, | |||||||||
| Pediatric, | |||||||||
| Urology | Pediatric, | ||||||||
| Small Organ, | |||||||||
| Musculoskeletal | |||||||||
| (Conventional), | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial), | |||||||||
| Peripheral | |||||||||
| vessel | Trans-rectal, | ||||||||
| Trans-vaginal, | |||||||||
| Urology | Trans-rectal, | ||||||||
| Trans-vaginal, | |||||||||
| Urology | Intended | ||||||||
| Usage | Small Organ, | ||||||||
| Musculo-skeletal | |||||||||
| (Conventional), | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | Abdominal, | ||||||||
| Pediatric, | |||||||||
| Adult Cephalic, | |||||||||
| Cardiac Adult | Abdominal, | ||||||||
| Pediatric, | |||||||||
| Adult Cephalic | |||||||||
| Cardiac Adult, | |||||||||
| Cardiac Pediatric | Abdominal, | ||||||||
| Pediatric, | |||||||||
| Cardiac Pediatric | |||||||||
| Applicable | |||||||||
| mode | B/M/PWD/ | ||||||||
| Color Doppler/ | |||||||||
| Power Doppler/ | |||||||||
| Tissue Harmonic | |||||||||
| Imaging/ | |||||||||
| Combined | B/M/PWD/ | ||||||||
| Color Doppler/ | |||||||||
| Power Doppler/ | |||||||||
| Tissue Harmonic | |||||||||
| Imaging/ | |||||||||
| Combined | B/M/PWD/ | ||||||||
| Color Doppler/ | |||||||||
| Power Doppler/ | |||||||||
| Combined | B/M/PWD/ | ||||||||
| Color Doppler/ | |||||||||
| Power Doppler/ | |||||||||
| Combined | Applicable | ||||||||
| mode | B/M/PWD/ | ||||||||
| Color Doppler/ | |||||||||
| Power Doppler/ | |||||||||
| Tissue Harmonic | |||||||||
| Imaging/ | |||||||||
| Combined | B/M/PWD/CWD | ||||||||
| Color Doppler/ | |||||||||
| Power Doppler/ | |||||||||
| Tissue Harmonic | |||||||||
| Imaging/ | |||||||||
| Combined | B/M/PWD/CWD | ||||||||
| Color Doppler/ | |||||||||
| Power Doppler/ | |||||||||
| Tissue Harmonic | |||||||||
| Imaging/ | |||||||||
| Combined | B/M/PWD/ | ||||||||
| Color Doppler/ | |||||||||
| Power Doppler/ | |||||||||
| Tissue Harmonic | |||||||||
| Imaging/ | |||||||||
| Combined | |||||||||
| Scanning | |||||||||
| depth(mm) | 300 | 100 | 100 | 100 | Scanning | ||||
| depth(mm) | 300 | 300 | 300 | 140 | |||||
| FOV | 60(°) | N/A | 142(°) | 142(°) | FOV | N/A | 90(°) | 90(°) | 93.6(°) |
| Steer Angle | N/A | Max 9(°) | N/A | N/A | Steer Angle | 15(°) | 45(°) | 45(°) | N/A |
| Total | |||||||||
| number of | |||||||||
| element | 128 | 128 | 128 | 128 | Total | ||||
| number of | |||||||||
| element | 128 | 64 | 64 | 128 |
| L3-12HWD | L3-8H | L8-17H | IO3-12 | |
|---|---|---|---|---|
| Previously | ||||
| cleared | K172732 | New | New | K132687 |
| Applicable | ||||
| frequency | 3~12MHz | 3~8MHz | 8~17MHz | 3~12MHz |
| Intended | ||||
| Usage | Small Organ, | |||
| Musculo-skeletal | ||||
| (Conventional), | ||||
| Musculo-skeletal | ||||
| (Superficial), | ||||
| Peripheral | Small Organ, | |||
| Musculo-skeletal | ||||
| (Conventional), | ||||
| Musculo-skeletal | ||||
| (Superficial), | ||||
| Peripheral | Small Organ, | |||
| Musculo-skeletal | ||||
| (Conventional), | ||||
| Musculo-skeletal | ||||
| (Superficial), | ||||
| Peripheral | Small Organ |
21
| vessel | vessel | vessel | ||
|---|---|---|---|---|
| Applicable | ||||
| mode | B/M/PWD/ | |||
| Color Doppler/ | ||||
| Power Doppler/ | ||||
| Tissue Harmonic | ||||
| Imaging/ | ||||
| Combined | B/M/PWD/ | |||
| Color Doppler/ | ||||
| Power Doppler/ | ||||
| Tissue Harmonic | ||||
| Imaging/ | ||||
| Combined | B/M/PWD/ | |||
| Color Doppler/ | ||||
| Power Doppler/ | ||||
| Tissue Harmonic | ||||
| Imaging/ | ||||
| Combined | B/M/PWD/ | |||
| Color Doppler/ | ||||
| Power Doppler/ | ||||
| Tissue Harmonic | ||||
| Imaging/ | ||||
| Combined | ||||
| Scanning | ||||
| depth(mm) | 100 | 100 | 100 | 100 |
| FOV | N/A | N/A | NA | NA |
| Steer Angle | Max 9(°) | 15(°) | 15(°) | 15(°) |
| Total | ||||
| number of | ||||
| element | 192 | 166 | 192 | 80 |
| VC1-6T | CW2.0 | CW5.0 | |
|---|---|---|---|
| Previously | |||
| cleared | K172732 | K172732 | K172732 |
| Applicable | |||
| frequency | 1~6MHz | 2MHz | 5MHz |
| Intended | |||
| Usage | Fetal, | ||
| Abdominal, | |||
| Pediatric, | |||
| Urology | Cardiac Adult, | ||
| Cardiac | |||
| Pediatric | Cardiac Adult, | ||
| Cardiac | |||
| Pediatric | |||
| Applicable | |||
| mode | B/M/PWD/ | ||
| Color Doppler/ | |||
| Power Doppler/ | |||
| Tissue Harmonic | |||
| Imaging/ | |||
| Combined/ | |||
| 3D/4D | CWD | CWD | |
| Scanning | |||
| depth(mm) | 300 | N/A | N/A |
| FOV | 79(°) | N/A | N/A |
| Steer Angle | N/A | N/A | N/A |
| Total | |||
| number of | |||
| element | 128 | 2(TX1, RX1) | 2(TX1, RX1) |
Indications For Use: The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric, Small Organ (breast, testes, thyroid); Adult Cephalic; Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vascular (PV); and Urology (including prostate).
22
Comparison with Predicate devices: Determination of Substantial
Equivalence: 1) E-CUBE i7 and E-CUBE i7 (Primary Predicate Device)
Substrate
Equivalence
| Feature | Proposed
E-CUBE i7 | Predicate
E-CUBE i7
(K153424) |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for use | The device is intended for use by a
qualified physician for the
evaluation of soft tissue and blood
flow in the clinical applications;
Fetal;
Abdominal (renal & GYN/pelvic);
Pediatric;
Small Organ (breast, testes,
thyroid);
Adult Cephalic;
Trans-rectal(TR);
Trans-vaginal(TV);
Musculo-skeletal(Conventional);
Musculo-skeletal (Superficial);
Cardiac (Adult);
Cardiac (Pediatric);
Peripheral Vessel (PV);
Urology (including prostate). | The device is intended for use by a
qualified physician for the
evaluation of soft tissue and blood
flow in the clinical applications;
Fetal;
Abdominal (renal & GYN/pelvic);
Pediatric;
Small Organ (breast, testes,
thyroid);
Adult Cephalic;
Trans-rectal(TR);
Trans-vaginal(TV);
Musculo-skeletal(Conventional);
Musculo-skeletal (Superficial);
Cardiac (Adult);
Cardiac (Pediatric);
Peripheral Vessel (PV);
Urology (including prostate). |
| Electrical
power | Voltage: 19V, 10.5A
Frequency: 50/60Hz
Power: 200W Max | Voltage: 19V, 10.53A
Frequency: 50/60Hz
Power: 200W Max |
| Imaging
modes | 2D (B) mode
M mode
Anatomical M
Color Flow Doppler (CF) mode
Power Doppler (PD) mode
Directional PD
Pulsed wave Doppler (PWD) mode
Continuous wave Doppler (CWD)
mode
Tissue Doppler imaging (TDI)
mode
3D/4D mode | 2D (B) mode
M mode
Anatomical M
Color Flow Doppler (CF) mode
Power Doppler (PD) mode
Directional PD
Pulsed wave Doppler (PWD) mode
Continuous wave Doppler (CWD)
mode
Tissue Doppler imaging (TDI)
mode |
| Image
processing
technology | Xpeed™
Full SRI™
Spatial Compounding Image (SCI)
ECG mode | Xpeed™
Full SRI™
Spatial Compounding Image (SCI) |
| Software
feature | Panoramic
Needle Vision™
/Needle Vision™ Plus
Cube View™
Cube Strain™
Stress Echo | Panoramic
Needle Vision™
/Needle Vision™ Plus
Cube View™ |
| Thermal,
mechanical
and
electrical
safety | The E-CUBE i7 has been designed
to conform to the following
standards:
NEMA UD2
AIUM Medical Ultrasound Safety
IEC60601-1
IEC 60601-1-2:2007
IEC 60601-2-37:2007+AMD1:2015
IEC61000-3-2:2014
IEC 61000-3-3:2013
IEC 61000-4-2:2008
IEC 61000-4-
3:2006+A1:2007+A2:2010
IEC61000-4-4:2012 | The E-CUBE i7 has been designed
to conform to the following
standards:
NEMA UD2
AIUM Medical Ultrasound Safety
IEC60601-1
IEC 60601-1-2:2007
IEC 60601-2-37:2007+AMD1:2015
IEC61000-3-2:2014
IEC 61000-3-3:2013
IEC 61000-4-2:2008
IEC 61000-4-
3:2006+A1:2007+A2:2010
IEC61000-4-4:2012 |
ALPINION MEDICAL SYSTEMS Co., Ltd.
23
| | IEC61000-4-5:2014
IEC61000-4-6:2013
IEC61000-4-11:2004
IEC61000-4-8:2009 | IEC61000-4-5:2014
IEC61000-4-6:2013
IEC61000-4-11:2004
IEC61000-4-8:2009 |
|--------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| option | Wireless LAN | - |
2) E-CUBE i7 and E-CUBE 15
| Feature | Proposed
E-CUBE i7 | Predicate
E-CUBE 15
(K150773) |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for use | The device is intended for use by a
qualified physician for the
evaluation of soft tissue and blood
flow in the clinical applications;
Fetal;
Abdominal (renal & GYN/pelvic);
Pediatric;
Small Organ (breast, testes,
thyroid);
Adult Cephalic;
Trans-rectal(TR);
Trans-vaginal(TV);
Musculo-skeletal(Conventional);
Musculo-skeletal (Superficial);
Cardiac (Adult);
Cardiac (Pediatric);
Peripheral Vessel (PV);
Urology (including prostate). | The device is intended for use by a
qualified physician for the
evaluation of soft tissue and blood
flow in the clinical applications;
Fetal:
Abdominal (renal & GYN/pelvic);
Pediatric,
Small Organ (breast,
testes,thyroid);
Adult Cephalic;
Trans-rectal(TR);
Trans-vaginal(TV);
Musculo-skeletal(Conventional);
Musculo-skeletal (Superficial);
Cardiac (Adult);
Cardiac (Pediatric);
Peripheral Vascular (PV);
Urology (including prostate). |
| Electrical
power | Voltage: 19V, --- 10.5A
Frequency: 50/60Hz
Power: 200W Max | Voltage: 100120V, 200240V
Frequency: 50/60Hz
Power: Max. 900 VA with Built-in
and On-Board Peripherals |
| Imaging
modes | 2D (B) mode
M mode
Anatomical M
Color Flow Doppler (CF) mode
Power Doppler (PD) mode
Directional PD
Pulsed wave Doppler (PWD) mode
Continuous wave Doppler (CWD)
mode
Tissue Doppler imaging (TDI)
mode
3D/4D mode | 2D(B) Mode
M Mode
Color Flow Doppler (CF) Mode
Power Doppler (PD) Mode
Pulsed wave Doppler (PWD) Mode
Continuous wave Doppler (CWD)
Mode
Tissue Doppler imaging (TDI)
Mode
3D/4D Mode
Elastography |
| Image
processing
technology | Xpeed™
Full SRI™
Spatial Compounding Image (SCI)
ECG mode | Xpeed™
FullSRI™
Spatial Compounding Image (SCI)
ECG Mode
Frequency
Compounding
Image
(FCI) |
| Software
feature | Panoramic
Needle Vision™ | Panoramic
Needle Vision™ |
24
| /Needle Vision™ Plus | /Needle Vision™ Plus | |
|---|---|---|
| Cube View™ | Cube View™ | |
| Cube Strain™ | Cube Strain™ | |
| Stress Echo | Stress Echo | |
| Live HQ™ | ||
| Thermal, | ||
| mechanical | ||
| and | ||
| electrical | ||
| safety | The E-CUBE i7 has been designed | |
| to conform to the following | ||
| standards: | ||
| NEMA UD2 | ||
| AIUM Medical Ultrasound Safety | ||
| IEC60601-1 | ||
| IEC 60601-1-2 | ||
| IEC 60601-2-37 | ||
| IEC61000-3-2 | ||
| IEC 61000-3-3 | ||
| IEC 61000-4-2 | ||
| IEC 61000-4-3 | ||
| IEC61000-4-4 | ||
| IEC61000-4-5 | ||
| IEC61000-4-6 | The E-CUBE i7 has been designed | |
| to conform to the following | ||
| standards: | ||
| NEMA UD2 | ||
| AIUM Medical Ultrasound Safety | ||
| IEC60601-1 | ||
| IEC 60601-1-2 | ||
| IEC 60601-2-37 | ||
| IEC61000-3-2 | ||
| IEC 61000-3-3 | ||
| IEC 61000-4-2 | ||
| IEC 61000-4-3 | ||
| IEC61000-4-4 | ||
| IEC61000-4-5 | ||
| IEC61000-4-6 | ||
| IEC61000-4-8 | ||
| IEC61000-4-11 | IEC61000-4-8 | |
| IEC61000-4-11 | ||
| option | Wireless LAN | - |
3 E-CUBE i7 and E-CUBE 8
| Feature | Proposed
E-CUBE i7 | Predicate
E-CUBE 8
(K172732) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for use | The device is intended for use by a
qualified physician for the
evaluation of soft tissue and blood
flow in the clinical applications;
Fetal;
Abdominal (renal & GYN/pelvic);
Pediatric;
Small Organ (breast, testes,
thyroid);
Adult Cephalic;
Trans-rectal(TR);
Trans-vaginal(TV);
Musculo-skeletal(Conventional);
Musculo-skeletal (Superficial);
Cardiac (Adult);
Cardiac (Pediatric);
Peripheral Vessel (PV);
Urology (including prostate). | The device is intended for use by a
qualified physician for the
evaluation of soft tissue and blood
flow in the clinical applications;
Fetal;
Abdominal (renal & GYN/pelvic);
Pediatric,
Small Organ (breast,
testes,thyroid);
Adult Cephalic;
Trans-rectal(TR);
Trans-vaginal(TV);
Musculo-skeletal(Conventional);
Musculo-skeletal (Superficial);
Cardiac (Adult);
Cardiac (Pediatric);
Peripheral Vascular (PV);
Urology (including prostate).
Neonatal Cephalic |
| Electrical
power | Voltage: 19V, 10.5A
Frequency: 50/60Hz
Power: 200W Max | Voltage: 100120V, 200240V
Frequency: 50/60Hz
Power: 450 VA |
| Imaging
modes | 2D (B) mode
M mode
Anatomical M
Color Flow Doppler (CF) mode
Power Doppler (PD) mode
Directional PD
Pulsed wave Doppler (PWD) mode
Continuous wave Doppler (CWD)
mode
Tissue Doppler imaging (TDI)
mode | 2D(B) Mode
M Mode
Color Flow Doppler (CF) Mode
Power Doppler (PD) Mode
Pulsed wave Doppler (PWD) Mode
Continuous wave Doppler (CWD)
Mode
Tissue Doppler imaging (TDI)
Mode |
25
| 3D/4D mode | 3D/4D Mode | |
|---|---|---|
| Elastography | ||
| Image | ||
| processing | ||
| technology | XpeedTM | XpeedTM |
| Full SRITM | FullSRITM | |
| Spatial Compounding Image (SCI) | Spatial Compounding Image (SCI) | |
| ECG mode | Frequency Compounding Image | |
| (FCI) | ||
| Software | ||
| feature | Panoramic | Panoramic |
| Needle VisionTM | Needle VisionTM | |
| /Needle VisionTM Plus | /Needle VisionTM Plus | |
| Cube ViewTM | Cube ViewTM | |
| Cube StrainTM | Cube StrainTM | |
| Stress Echo | Stress Echo | |
| Volume AdvanceTM | ||
| Thermal, | ||
| mechanical | ||
| and | ||
| electrical | ||
| safety | The E-CUBE i7 has been designed | |
| to conform to the following | ||
| standards: | ||
| NEMA UD2 | ||
| AIUM Medical Ultrasound Safety | ||
| IEC60601-1 | ||
| IEC 60601-1-2 | ||
| IEC 60601-2-37 | ||
| IEC61000-3-2 | ||
| IEC 61000-3-3 | ||
| IEC 61000-4-2 | ||
| IEC 61000-4-3 | ||
| IEC61000-4-4 | ||
| IEC61000-4-5 | ||
| IEC61000-4-6 | ||
| IEC61000-4-8 | ||
| IEC61000-4-11 | The E-CUBE 8 has been designed | |
| to conform to the following | ||
| standards: | ||
| NEMA UD2 | ||
| AIUM Medical Ultrasound Safety | ||
| IEC60601-1 | ||
| IEC 60601-1-2 | ||
| IEC 60601-2-37 | ||
| IEC61000-3-2 | ||
| IEC 61000-3-3 | ||
| IEC 61000-4-2 | ||
| IEC 61000-4-3 | ||
| IEC61000-4-4 | ||
| IEC61000-4-5 | ||
| IEC61000-4-6 | ||
| IEC61000-4-8 | ||
| IEC61000-4-11 | ||
| option | Wireless LAN | Wireless LAN |
4 E-CUBE i7 and E-CUBE 7
| Feature | Proposed
E-CUBE i7 | Predicate
E-CUBE 7
(K132687) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for use | The device is intended for use by a
qualified physician for the
evaluation of soft tissue and blood
flow in the clinical applications;
Fetal;
Abdominal (renal & GYN/pelvic);
Pediatric;
Small Organ (breast, testes,
thyroid);
Adult Cephalic;
Trans-rectal(TR);
Trans-vaginal(TV);
Musculo-skeletal(Conventional);
Musculo-skeletal (Superficial);
Cardiac (Adult);
Cardiac (Pediatric);
Peripheral Vessel (PV);
Urology (including prostate). | The device is intended for use by a
qualified physician for the
evaluation of soft tissue and blood
flow in the clinical applications;
Fetal;
Abdominal (renal & GYN/pelvic);
Pediatric,
Small Organ (breast,
testes,thyroid);
Trans-rectal(TR);
Trans-vaginal(TV);
Musculo-skeletal(Conventional);
Musculo-skeletal (Superficial);
Cardiac (Adult);
Cardiac (Pediatric);
Peripheral Vascular (PV);
Urology (including prostate). |
| Electrical
power | Voltage: 19V, ---10.5A
Frequency: 50/60Hz
Power: 200W Max | Voltage: 100120V, 200240V
Frequency: 50/60Hz
Power: 600 VA |
| Imaging
modes | 2D (B) mode
M mode | 2D(B) Mode
M Mode |
26
| | Anatomical M
Color Flow Doppler (CF) mode
Power Doppler (PD) mode
Directional PD | Color Flow Doppler (CF) Mode
Power Doppler (PD) Mode |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Pulsed wave Doppler (PWD) mode
Continuous wave Doppler (CWD)
mode
Tissue Doppler imaging (TDI)
mode | Pulsed wave Doppler (PWD) Mode
Continuous wave Doppler (CWD)
Mode |
| | 3D/4D mode | 3D/4D Mode |
| Image
processing
technology | Xpeed™
Full SRI™
Spatial Compounding Image (SCI)
ECG mode | Xpeed™
FullSRI™
Spatial Compounding Image (SCI)
ECG Mode
Frequency Compounding Image
(FCI) |
| Software
feature | Panoramic
Needle Vision™
/Needle Vision™ Plus
Cube View™
Cube Strain™
Stress Echo | Panoramic |
| Thermal,
mechanical
and
electrical
safety | The E-CUBE i7 has been designed
to conform to the following
standards:
NEMA UD2
AIUM Medical Ultrasound Safety
IEC60601-1
IEC 60601-1-2
IEC 60601-2-37
IEC61000-3-2
IEC 61000-3-3
IEC 61000-4-2
IEC 61000-4-3
IEC61000-4-4
IEC61000-4-5
IEC61000-4-6
IEC61000-4-8
IEC61000-4-11 | The E-CUBE 7has been designed
to conform to the following
standards:
NEMA UD2
AIUM Medical Ultrasound Safety
IEC60601-1
IEC 60601-1-2
IEC 60601-2-37
IEC61000-3-2
IEC 61000-3-3
IEC 61000-4-2
IEC 61000-4-3
IEC61000-4-4
IEC61000-4-5
IEC61000-4-6
IEC61000-4-8
IEC61000-4-11 |
| option | Wireless LAN | - |
Summary of Non-Clinical Tests:
E-CUBE i7 has been evaluated for biocompatibility, acoustic output as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. E-CUBE i7 and its application comply with voluntary standards as detailed in this premarket submission.
- IEC60601-1, Medical electrical equipment Part 1: General � requirements for basic safety and essential performance
- � IEC60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
- � IEC60601-2-37, Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical
27
Diagnostic and Monitoring Equipment
- � ISO10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
- � ISO14971, Application of risk management to medical devices
- � AIUM Medical Ultrasound Safety
The following quality management system measures were applied to the development of E-CUBE i7:
- � 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, E-CUBE i7, did not require clinical studies to support substantial equivalence.
Discussion:
E-CUBE i7 was compared with the predicate devices (K153424, K150773). E-CUBE i7 and predicate model K153424 is difference between the ECG, 3D/4D function, several image functions. The subject device is in conformance with applicable safety standards.
Therefore, the differences between E-CUBE i7 and the predicate devices would not affect the safety, effectiveness and essential performance.
- ALPINION MEDICAL SYSTEMS Co., Ltd. considers E-CUBE i7 to be as Conclusion: safe, as effective. Performance, technology and software are substantially equivalent to the predicate devices.
ALPINION MEDICAL SYSTEMS Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA or the requirements will be published in quidance documents.