(121 days)
No
The document describes a standard ultrasound imaging system with various operational modes and safety testing, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device is described as an "ultrasound imaging system for medical diagnosis" and its intended use is for "evaluation of soft tissue and blood flow." It is used for diagnostic purposes, not for treating any conditions.
Yes
The "Device Description" explicitly states, "E-CUBE 15 product is an ultrasound imaging system for medical diagnosis." Also, the "Intended Use / Indications for Use" section outlines its application for "evaluation of soft tissue and blood flow," which is a diagnostic purpose.
No
The device description explicitly states it is an "ultrasound imaging system" and mentions hardware components like a "flat panel display" and "ergonomic control panel." The performance studies also detail testing for thermal, electrical, electromagnetic, and mechanical safety, which are associated with hardware.
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 the E-CUBE 15 is an ultrasound imaging system for medical diagnosis. It uses ultrasound waves to create images of internal structures and blood flow.
- Intended Use: The intended use describes the clinical applications where the ultrasound system is used to visualize and evaluate soft tissue and blood flow within the body.
- No mention of samples: There is no mention of the device analyzing samples taken from the body.
Therefore, the E-CUBE 15 is a medical imaging device, not an in vitro diagnostic device.
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 15 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 18.5" (or 19.5") wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
Modes of operation:
- Signal Mode:
B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode, Pulsed Wave Doppler(PWD) mode, Tissue Harmonic Imaging(THI) - Combination Mode:
B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/PD/PWD, B/CF/M
Acoustic output track: Track 3
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
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
Intended User / Care Setting
Qualified physician; Clinics, Hospitals, and clinical point-of-care
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)
Non-Clinical Tests:
E-CUBE 15 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 15 and its application comply with voluntary standards as detailed in this premarket submission. The following quality management system measures were applied to the development of E-CUBE 15:
- Medical Device Risk Management
- Requirements Reviews
- Design Reviews
- Component Verification
- Integration Review (System Verification)
- Performance Testing (System Verification)
- Safety Testing (Compliance Test)
- Design Validation
Transducer materials and other patient contact materials are biocompatible.
Clinical Tests:
The subject of this premarket submission, E-CUBE 15, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and recognizable, representing the department's role in promoting health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 23, 2015
ALPINION MEDICAL SYSTEMS Co., Ltd. % Mr. Donghwan Kim Quality Management Representative (QMR) 1, 6 and 7FL Verdi Tower 72, Digital-ro(St) 26-gil(Rd) Guro-gu Seoul 152-848 REPUBLIC OF KOREA
Re: K150773
Trade/Device Name: E-CUBE 15 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed Doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: June 19, 2015 Received: June 22, 2015
Dear Mr. Kim:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael O'Hara For
Robert Ochs, Ph.D. Acting 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
510(k) Number (if known)
Device Name
E-CUBE 15 Diagnostic Ultrasound System
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).
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."
Form Approved: @MB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
E-CUBE 15 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 | 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 | |||||||||
| Adult Cephalic | N | N | N | N | N | N | N | N | |
| Trans-rectal | P | P | P | P | P | P | P | N | |
| Trans-vaginal | P | P | P | P | P | P | P | N | |
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | 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 | ||
| Urology (including prostate) | P | P | P | P | P | P | P | N |
N = new indication; P = previously cleared by FDA K123610; 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 15 with SC1-6H 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 K123610; 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 15 with L3-12H 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 K123610; 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 15 with SP1-5X 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 | N | N | N | N | N | N | N | ||
| 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 K123610; 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 15 with L8-17X 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) | 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 K123610; 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 15 with SC1-4H 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 K123610; 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 15 with E3-10H 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 K123610; 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 15 with SVC1-6 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 K123610; 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 15 with L3-12X 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 K123610; 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 15 with L3-8 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 K123610; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
Concurrence of CDRH
Prescription User (Per 21 CFR 801.109)
ALPINION MEDICAL SYSTEMS Co., Ltd.
13
E-CUBE 15 with SP3-8 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 | 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 | P | |
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K123610; 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 15 with CW 2.0 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 K123610; 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 15 with CW 5.0 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 K123610; 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 15 with C5-8 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 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 15 with TEE3-7 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 | N | N | N | N | N | N | N | N | |
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
18
E-CUBE 15 with SVC1-6H 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 | N | N | N | N | N | N | N | N | |
| Abdominal | N | N | N | N | N | N | N | N | |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | N | |
| Small Organ | |||||||||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | N | N | N | N | N | N | N | N |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH
19
E-CUBE 15 with SPN1-5X 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 | N | N | N | N | N | N | N | |||
| Intra-operative (Specify) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | N | N | |||
| Small Organ | ||||||||||
| (breast, testes, thyroid) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | N | N | N | N | N | N | N | |||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | N | N | N | N | N | N | N | N | ||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral vessel | ||||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
20
E-CUBE 15 with SC1-4HS 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 | Power | Tissue | Combined* | Other** | |||
| Doppler | Doppler | Harmonic | (Specify) | (Specify) | |||||||
| Imaging | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | N | N | N | N | N | N | N | ||||
| Abdominal | N | N | N | N | N | N | N | ||||
| Intra-operative (Specify) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | N | N | N | N | N | N | N | ||||
| Small Organ | |||||||||||
| (breast, testes, thyroid) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Trans-rectal | |||||||||||
| Trans-vaginal | |||||||||||
| Trans-urethral | |||||||||||
| Trans-esoph. (non-Card.) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Superficial) | |||||||||||
| Intravascular | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Intravascular (Cardiac) | |||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Peripheral vessel | |||||||||||
| Urology (including prostate) | N | N | N | N | N | N | N |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
21
E-CUBE 15 with IO3-12 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) | |||||||||
| 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
22
E-CUBE 15 with IO8-17 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 | |||||||||
| 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
23
E-CUBE 15 with EV3-10H 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 | N | N | N | N | N | N | N | N | |
| Trans-vaginal | N | N | N | N | N | N | N | N | |
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | N | N | N | N | N | N | N | N |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
24
E-CUBE 15 with EC3-10H 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 | N | N | N | N | N | N | N | N | |
| Trans-vaginal | N | N | N | N | N | N | N | N | |
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | N | N | N | N | N | N | N | N | N |
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
25
E-CUBE 15 with EV3-10X 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 | N | N | N | N | N | N | N | N | |
| Trans-vaginal | N | N | N | N | N | N | N | N | |
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | N | N | N | N | N | N | N | N |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
26
E-CUBE 15 with EC3-10X 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 | N | N | N | N | N | N | N | N | N | |
| Trans-vaginal | N | N | N | N | N | N | N | N | N | |
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral vessel | ||||||||||
| Urology (including prostate) | N | N | N | N | N | N | N | N | N |
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
27
E-CUBE 15 with MP1-5X 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 | N | N | N | N | N | N | N | |||
| Intra-operative (Specify) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | N | N | |||
| Small Organ | ||||||||||
| (breast, testes, thyroid) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | N | N | N | N | N | N | N | |||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | N | N | N | N | N | N | N | N | ||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral vessel | ||||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
28
E-CUBE 15 with VE3-10H 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 | |||||||||
| lmaging | Combined* | ||||||||
| (Specify) | Other** | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ | |||||||||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | N | N | N | N | N | N | N | N | |
| Trans-vaginal | N | N | N | N | N | N | N | N | |
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | N | N | N | N | N | N | N | N |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
29
E-CUBE 15 with C5-8N 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 | ||||||||||
| N | N | N | N | N | N | N | ||||
| Intra-operative (Specify) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | N | N | |||
| Small Organ | ||||||||||
| (breast, testes, thyroid) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | 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
30
Section F 510(k) Summary
In accordance with 21CFR807.92, the following summary of information is provided;
| Date | March 20th 2015 | SC1-4H | E3-10H | SVC1-6 | L3-12X | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Submitter: | ALPINION MEDICAL SYSTEMS Co., Ltd. | ||||||||||
| Address: 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu, | |||||||||||
| Seoul, Republic of Korea 152-848 | L3-12H | SC1-6H | L8-17X | SP1-5X | Applicable | ||||||
| frequency | 1~4MHz | 3~10 MHz | 1~6 MHz | 3~12 MHz | |||||||
| Primary Contact | |||||||||||
| Person | Donghwan Kim | ||||||||||
| Quality Management Representative(QMR) | |||||||||||
| Address: 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu, | |||||||||||
| Seoul, Republic of Korea 152-848 | |||||||||||
| Phone: +82 70 7465 2068 | |||||||||||
| Fax: +82 2 6220 2162 | |||||||||||
| Email: donghwan.kim@alpinion.com | Applicable | ||||||||||
| frequency | 3~12MHz | 1~6MHz | 8~17MHz | 1~5MHz | Intended | ||||||
| Usage | Fetal, | ||||||||||
| Abdominal, | |||||||||||
| Pediatric, | |||||||||||
| Urology | Trans-rectal, | ||||||||||
| Trans-vaginal | Fetal, | ||||||||||
| Abdominal, | |||||||||||
| Pediatric, | |||||||||||
| Urology | Pediatric, | ||||||||||
| Musculo-skeletal | |||||||||||
| (conventional, | |||||||||||
| superficial), | |||||||||||
| Peripheral | |||||||||||
| vessel | |||||||||||
| 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 | Intended | ||||||||||
| Usage | Small Organ, | ||||||||||
| Musculo- | |||||||||||
| skeletal(conventi | |||||||||||
| onal, superficial), | |||||||||||
| Peripheral | |||||||||||
| vessel | Fetal. | ||||||||||
| Abdominal, | |||||||||||
| Pediatric, | |||||||||||
| Urology | Small Organ, | ||||||||||
| Musculo-skeletal | |||||||||||
| (conventional, | |||||||||||
| superficial), | |||||||||||
| Peripheral | |||||||||||
| vessel | Abdominal, | ||||||||||
| Pediatric. | |||||||||||
| Cardiac Adult | Foot print | ||||||||||
| size (mm) | 72.4 x 16.8 | 21.5 x 18.2 | 59.2 x 45.2 | 58.2 X 10.4 | |||||||
| Device Trade Name: | E-CUBE 15 | Foot print | |||||||||
| size (mm) | 44.8 x 7.8 | 72.4 x 16.8 | 58.2 x 10.4 | 24.8 x 17.6 | Applicable | ||||||
| mode | B/M/PWD/ | ||||||||||
| Color Doppler/ | |||||||||||
| Power Doppler/ | |||||||||||
| Tissue Harmonic | |||||||||||
| Imaging | B/M/PWD/ | ||||||||||
| Color Doppler/ | |||||||||||
| Power Doppler/ | |||||||||||
| Tissue Harmonic | |||||||||||
| Imaging | B/M/PWD/ | ||||||||||
| Color Doppler/ | |||||||||||
| Power Doppler/ | |||||||||||
| Tissue Harmonic | |||||||||||
| Imaging | B/M/PWD/ | ||||||||||
| Color Doppler/ | |||||||||||
| Power Doppler/ | |||||||||||
| Tissue Harmonic | |||||||||||
| Imaging | |||||||||||
| Common/Usual | |||||||||||
| Name: | Ultrasonic Pulsed Doppler Imaging System | Applicable | |||||||||
| mode | B/M/PWD/ | ||||||||||
| Color Doppler/ | |||||||||||
| Power Doppler | B/M/PWD/ | ||||||||||
| Color Doppler/ | |||||||||||
| Power Doppler/ | |||||||||||
| Tissue Harmonic | |||||||||||
| Imaqinq | B/M/PWD/ | ||||||||||
| Color Doppler/ | |||||||||||
| Power doppler | B/M/PWD/ | ||||||||||
| CWD/ | |||||||||||
| Color Doppler/ | |||||||||||
| Power Doppler/ | |||||||||||
| Tissue Harmonic | |||||||||||
| Imaging | Scanning | ||||||||||
| depth(mm) | 300 | 140 | 300 | 100 | |||||||
| Classification Names | System, Imaging, Pulsed Doppler Ultrasonic | Scanning | |||||||||
| depth(mm) | 100 | 300 | 100 | 300 | FOV | 60(°) | 145(°) | 79(°) | N/A | ||
| 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 | FOV | N/A | 60(°) | N/A | 90(°) | Steer Angle | N/A | N/A | N/A | 15(°) | |
| Predicate Device(s) | K120060 E-CUBE 9 Diagnostic Ultrasound System | Steer Angle | 15(%) | N/A | 15(%) | 45(°) | Total | ||||
| number of | |||||||||||
| element | 192 | 192 | 128 | 256 | |||||||
| Device Description: | E-CUBE 15 product is an ultrasound imaging system for medical | ||||||||||
| diagnosis. The system platform provides optimal patient diagnosis | |||||||||||
| workflow with the 18.5" (or 19.5") wide flat panel display, ergonomic | |||||||||||
| control panel with easy user interface, optimal image quality. | Total | ||||||||||
| number of | |||||||||||
| element | 192 | 192 | 256 | વેદ | Element | ||||||
| spacing | 0.342mm | 0.135mm | 0.414mm | 0.2mm | |||||||
| Modes of operation: |
- Signal Mode:
B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode,
Pulsed Wave Doppler(PWD) mode, Tissue Harmonic Imaging(THI) - Combination Mode:
B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/PD/PWD, B/CF/M
Acoustic output track: | Element
spacing | 0.2mm | 0.342mm | 0.150mm | 0.2mm | elevating
length | 13.5mm | 6mm | 13mm | 4.5mm |
| | Track 3 | elevating
length | 4.5mm | 13.5mm | 4mm | 13.5mm | | | | | |
ALPINION MEDICAL SYSTEMS Co., Ltd.
31
Types of transducers compatible with the device:
32
510(k) E-CUBE 15
| L3-8 | SP3-8 | CW2.0 | CW5.0 | |
|---|---|---|---|---|
| Applicable | ||||
| frequency | 3~8 MHz | 3~8 MHz | 2.0 MHz | 5.0 MHz |
| Intended | ||||
| Usage | Pediatric, | |||
| Musculo-skeletal | ||||
| (conventional, | ||||
| superficial), | ||||
| Peripheral | ||||
| vessel | Abdominal, | |||
| Pediatric, | ||||
| Cardiac | ||||
| Pediatric, | Cardiac | |||
| (Adult | ||||
| &Pediatric) | Cardiac | |||
| (Adult | ||||
| &Pediatric) | ||||
| Foot print | ||||
| size (mm) | 44.8 x 7.8 | 16 x 12.8 | 17.2 x 17.2 | 11.3 x 11.3 |
| Applicable | ||||
| mode | B/M/PWD/ | |||
| Color Doppler/ | ||||
| Power Doppler | B/M/PWD/ | |||
| Color Doppler/ | ||||
| Power Doppler/ | ||||
| Tissue Harmonic | ||||
| Imaging | CWD | CWD | ||
| Scanning | ||||
| depth(mm) | 100 | 300 | N/A | N/A |
| FOV | N/A | 90(°) | N/A | N/A |
| Steer Angle | 15(°) | 45(°) | N/A | N/A |
| Total | ||||
| number of | ||||
| element | 128 | 64 | 2(TX1, RX1) | 2(TX1, RX1) |
| Element | ||||
| spacing | 0.3mm | 0.15mm | N/A | N/A |
| elevating | ||||
| depth | 7.0mm | 13.5mm | N/A | N/A |
| SVC1-6H | SC1-4HS | C5-8 | SPN1-5X | |
|---|---|---|---|---|
| Applicable | ||||
| frequency | 1~6 MHz | 1~4 MHz | 5~8 MHz | 1~5MHz |
| Intended | ||||
| Usage | Fetal, | |||
| Abdominal, | ||||
| Pediatric, | ||||
| Urology | Fetal, | |||
| Abdominal, | ||||
| Pediatric | ||||
| Urology | Abdominal, | |||
| Pediatric, | ||||
| Cardiac Pediatric | Abdominal, | |||
| Pediatric, | ||||
| Adult Cephalic | ||||
| Cardiac Adult | ||||
| Foot print | ||||
| size (mm) | 59.2*45.2 | 68 x 15.9 mm | 35 x 6.2 mm | 24.8 x 17.6 |
| Applicable | ||||
| mode | B/M/PWD/ | |||
| Color Doppler/ | ||||
| Power Doppler/ | ||||
| Tissue Harmonic | ||||
| Imaging | B/M/PWD/ | |||
| Color Doppler/ | ||||
| Power Doppler/ | ||||
| Tissue Harmonic | ||||
| Imaging | B/M/PWD/ | |||
| Color Doppler/ | ||||
| Power Doppler/ | ||||
| Tissue Harmonic | ||||
| Imaging | B/M/PWD/ | |||
| CWD/ | ||||
| Color Doppler/ | ||||
| Power Doppler/ | ||||
| Tissue Harmonic | ||||
| Imaging | ||||
| Scanning | ||||
| depth(mm) | 300 | 300 | 140 | 300 |
| FOV | 1.4mm | |||
| (@65mm) | ||||
| 0.8mm | ||||
| (@105mm) | 2.0mm | |||
| (@65mm) | ||||
| 1.4mm | ||||
| (@105mm) | 0.8mm | |||
| (@65mm) | ||||
| 0.8mm | ||||
| (@105mm) | 2.0mm | |||
| (@65mm) | ||||
| 1.4mm | ||||
| (@105mm) | ||||
| Steer Angle | 3.7mm | |||
| (@65mm) | ||||
| 4.5mm | ||||
| (@105mm) | 2.8mm | |||
| (@65mm) | ||||
| 3.9mm | ||||
| (@105mm) | 3.9mm | |||
| (@65mm) | ||||
| 7.0mm | ||||
| (@105mm) | 2.68mm | |||
| (@65mm) | ||||
| 3.9mm | ||||
| (@105mm) | ||||
| Total | ||||
| number of | ||||
| element | 79(°) | 73(°) | 92(°) | 90(°) |
| Element | ||||
| spacing | N/A | NA | NA | 45(°) |
| elevating | ||||
| length | Curved linear | |||
| array | ||||
| 40mm Radius of | ||||
| curvature | Curved linear | |||
| array | ||||
| 46mm Radius of | ||||
| curvature | Curved linear | |||
| array | ||||
| 14mm Radius of | ||||
| curvature | Linear phased | |||
| array |
33
| TEE3-7 | IO3-12 | 108-17 | SC1-4M | EV3-10H | EC3-10H | EV3-10X | EC3-10X | ||
|---|---|---|---|---|---|---|---|---|---|
| Applicable | |||||||||
| frequency | 3~7MHz | 3~12MHz | 8~17MHz | 1~4MHz | Applicable | ||||
| frequency | 3-10 MHz | 3-10 MHz | 3-10 MHz | 3-10 MHz | |||||
| Intended | |||||||||
| Usage | Cardiac | ||||||||
| (Adult) | Small Organ | Pediatric, Small | |||||||
| Organ, Musculo- | |||||||||
| skeletal | |||||||||
| (Conventional), | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial), | |||||||||
| Peripheral | |||||||||
| vessel | Fetal, | ||||||||
| Abdominal, | |||||||||
| Urology | Intended | ||||||||
| Usage | Trans-rectal, | ||||||||
| Trans-vaginal, | |||||||||
| Urology | Trans-rectal, | ||||||||
| Trans-vaginal, | |||||||||
| Urology | Trans-rectal, | ||||||||
| Trans-vaginal, | |||||||||
| Urology | Trans-rectal, | ||||||||
| Trans-vaginal, | |||||||||
| Urology | |||||||||
| Foot print | |||||||||
| size (mm) | Ø 14 | 22.8 x 6.4 mm | 36.7 x 4.2 | 72.4 x 16.8 | Foot print | ||||
| size (mm) | 21.5 x 18.6 | 21.5 x 18.6 | 21.5 x 18.6 | 21.5 x 18.6 | |||||
| Applicable | |||||||||
| mode | B/M/PWD/ | ||||||||
| CWD/ | |||||||||
| Color Doppler/ | |||||||||
| Power Doppler/ | |||||||||
| Tissue Harmonic | |||||||||
| Imaging | B/M/PWD/ | ||||||||
| Color Doppler/ | |||||||||
| Power Doppler/ | |||||||||
| Tissue Harmonic | |||||||||
| Imaging | B/M/PWD/ | ||||||||
| Color Doppler/ | |||||||||
| Power Doppler/ | |||||||||
| Tissue Harmonic | |||||||||
| Imaging | B/M/PWD/ | ||||||||
| Color Doppler/ | |||||||||
| Power Doppler/ | |||||||||
| Tissue Harmonic | |||||||||
| Imaging | Applicable | ||||||||
| mode | B/M/PWD/ | ||||||||
| Color Doppler/ | |||||||||
| Power Doppler | B/M/PWD/ | ||||||||
| Color Doppler/ | |||||||||
| Power Doppler | B/M/PWD/ | ||||||||
| Color Doppler/ | |||||||||
| Power Doppler | B/M/PWD/ | ||||||||
| Color Doppler/ | |||||||||
| Power Doppler | |||||||||
| Scanning | |||||||||
| depth(mm) | 140 | 100 | 100 | 300 | Scanning | ||||
| depth(mm) | 140 | 140 | 140 | 140 | |||||
| FOV | 2.0mm | ||||||||
| (@65mm) | |||||||||
| 1.4mm | |||||||||
| (@105mm) | 0.3mm | ||||||||
| (@25mm) | |||||||||
| 0.5 (@45mm) | N/A | 60(°) | FOV | 152(°) | 152(°) | 202(°) | 202(°) | ||
| Steer Angle | 2.68mm | ||||||||
| (@65mm) | |||||||||
| 3.9mm | |||||||||
| (@105mm) | 1.1mm | ||||||||
| (@25mm) | |||||||||
| 1.3mm | |||||||||
| (@45mm) | 15(°) | N/A | Steer Angle | N/A | N/A | N/A | N/A | ||
| Total | |||||||||
| number of | |||||||||
| element | 90(°) | NA | 128 | 192 X 2 | Total | ||||
| number of | |||||||||
| element | 192 | 192 | 256 | 256 | |||||
| Element | |||||||||
| spacing | 45(°) | 15(°) | 0.200mm | 0.342mm | Element | ||||
| spacing | 0.14mm | 0.14mm | 0.14mm | 0.14mm | |||||
| elevating | |||||||||
| length | Linear phased | ||||||||
| array | Linear array | ||||||||
| 16mm aperture | 3.5mm | 13.5mm | elevating | ||||||
| length | 6mm | 6mm | 6mm | 6mm |
34
| MP1-5X | VE3-10H | C5-8N | |
|---|---|---|---|
| Applicable | |||
| frequency | 1~5MHz | 3-10 MHz | 5~8 MHz |
| Intended | |||
| Usage | Fetal, | ||
| Abdominal, | |||
| Pediatric, Adult | |||
| Cephalic, | |||
| Cardiac Adult | Trans-rectal, | ||
| Trans-vaginal, | |||
| Urology | Abdominal, | ||
| Pediatric, | |||
| Cardiac Pediatric | |||
| Foot print | |||
| size (mm) | 24.8 x 17.6 | 24.4 x 24.4 | 25.5 x 9 |
| Applicable | |||
| mode | B/M/PWD/CWD | ||
| Color Doppler/ | |||
| Power Doppler/ | |||
| Tissue Harmonic | |||
| Imaging | B/M/PWD/ | ||
| Color Doppler/ | |||
| Power Doppler | B/M/PWD/ | ||
| Color Doppler/ | |||
| Power Doppler/ | |||
| Tissue Harmonic | |||
| Imaging/ | |||
| Combined | |||
| Scanning | |||
| depth(mm) | 300 | 140 | 140 |
| FOV | 90(°) | 152(°) | 93.6(°) |
| Steer Angle | 45(°) | N/A | N/A |
| Total | |||
| number of | |||
| element | 96 | 192 | 128 |
| Element | |||
| spacing | 0.2mm | 0.14mm | 0.195mm |
| elevating | |||
| length | 13.5mm | 6mm | 6mm |
The device is intended for use by a qualified physician for the evaluation Indications For Use: 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, Musculoskeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vascular (PV); and Urology (including prostate).
Determination of Substantial
Equivalence:
Comparison with Predicate device:
| 1) E-CUBE 15 and E-CUBE 9 | ||
|---|---|---|
| Feature | Proposed | |
| E-CUBE 15 | Predicate | |
| E-CUBE 9 | ||
| (K120060) | ||
| 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& pediatric);
Peripheral Vascular (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 & pediatric);
Peripheral Vascular (PV);
Urology (including prostate). |
| Electrical
power | Voltage: 100120V, 200240V
Frequency: 50/60Hz
Power: Max. 900 VA with Built-in and On-Board Peripherals | Voltage: 100120V, 200240V
Frequency: 50/60Hz
Power: Max. 600 VA with Built-in and On-Board Peripherals |
ALPINION MEDICAL SYSTEMS Co., Ltd.
35
510(k) E-CUBE 15
| Operating
Mode | B Mode
M Mode
Color Flow Mode
PW Doppler Mode
Power Doppler Mode
Continuous wave Doppler mode
Tissue Harmonic Imaging Mode
3D/4D Mode
Xpeed™
FullSRI™
Spatial Compounding
Frequency Compounding
Panoramic
Stress Echo
Cube Strain™
Live HQ™
Needle Vision™/Needle Vision™
Plus
Elastography | B Mode
M Mode
Color Flow Mode
PW Doppler Mode
Power Doppler Mode
Continuous wave Doppler mode
Tissue Harmonic Imaging Mode
3D/4D Mode
Xpeed™
FullSRI™
Spatial Compounding
Frequency Compounding
Panoramic
Stress Echo
Cube Strain™
Live HQ™
Needle Vision™/Needle Vision™
Plus |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Thermal,
mechanical
and
electrical
safety | The E-CUBE 15 has been
designed to conform to the
following standards:
- NEMA UD2, UD3
- AIUM Medical Ultrasound Safety
- IEC60601-1
- IEC60601-1-2
- IEC60601-2-37 | The E-CUBE 9 has been designed
to conform to the following
standards: - NEMA UD2, UD3
- AIUM Medical Ultrasound Safety
- IEC60601-1
- IEC60601-1-2
- IEC60601-2-37 |
2) E-CUBE 15 and iU22
| Feature | Proposed
E-CUBE 15 | Predicate
iU 22
(K132304) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufactur
er | Alpinion Medical System | Philips |
| 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& pediatric);
Peripheral Vascular (PV);
Urology (including prostate). | The clinical environments where
the EPIQ Diagnostic Ultrasound
System can be used include
Clinics, Hospitals, and clinical
point-of-care for diagnosis of
patients;
Fetal;
Abdominal
Pediatric;
Small Organ (breast, thyroid,
testicle);
Cephalic(Adult, neonatal)
Trans-rectal(TR);
Trans-vaginal(TV);
Musculo-skeletal(Conventional);
Musculo-skeletal (Superficial);
Cardiac (adult, pediatric, fetal,
trans-esophageal);
Peripheral Vascular
Urology
Gynecological
Intra-operative(vascular, cardic)
Fetal Echo
Vascular (cerebral) |
| Electrical
power | Voltage: 100120V, 200240V
Frequency: 50/60Hz
Power: Max. 900 VA with Built-in
and On-Board Peripherals | Voltage: 100127V, 220240V
Frequency: 50/60Hz
Power: 750VA~900VA |
36
| Operating
Mode | B Mode
M Mode
Color Flow Mode
PW Doppler Mode
Power Doppler Mode
Continuous wave Doppler mode
Tissue Harmonic Imaging Mode
3D/4D Mode
Xpeed™
FullSRITM
Spatial Compounding
Frequency Compounding
Panoramic
Stress Echo
Cube Strain™
Live HQ™
Needle Vision™/Needle Vision™
Plus
Elastography | M-mode
Spectral Doppler
Pulsed wave (PW) Doppler
Auto Doppler
Steerable continuous wave (CW) Doppler
Tissue Doppler Imaging (TDI)
Live xPlane imaging
Live volume imaging/Live 3D Echo
3D/4D and MPR imaging
Adaptive broadband flow imaging
Contrast imaging
Interventional imaging
Tissue Harmonic Imaging (THI)
Color Power Angio imaging (CPA)
Freehand 3D volume and MPR
imaging
Spatio-Temporal Image Correlation
(STIC) imaging
Panoramic SonoCT imaging
Strain based elastography
Shear wave elastography |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Thermal,
mechanical
and
electrical
safety | The E-CUBE 15 has been
designed to conform to the
following standards:
- NEMA UD2, UD3
- AIUM Medical Ultrasound Safety
- IEC60601-1
- IEC60601-1-2
- IEC60601-2-37 | Philips Ultrasound performed the
following testing to ensure the
safety and effectiveness of the
EPIQ device: - IEC60601-1
- IEC60601-1-2
- IEC60601-1-6
- IEC60601-2-37
- ISO 10993 |
Summary of Non-Clinical Tests:
E-CUBE 15 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 15 and its application comply with voluntary standards as detailed in this premarket submission. The following quality management system measures were applied to the development of E-CUBE 15:
- Medical Device Risk Management �
- � Requirements Reviews
- � Design Reviews
- � Component Verification
- � Integration Review (System Verification)
- � Performance Testing (System Verification)
- � Safety Testing (Compliance Test)
- � Design Validation
Transducer materials and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, E-CUBE 15, did not require clinical studies to support substantial equivalence.
Discussion:
E-CUBE 15 and the predicate device have differences in clinical applications and operating modes. Several transducers are changed for these purposes. These design changes have been verified via non-clinical
37
testing. The subject device is in conformance with applicable safety standards. Therefore, the differences between E-CUBE 15 and the predicate would not affect the safety, effectiveness and essential performance of E-CUBE 15.
- Conclusion: ALPINION MEDICAL SYSTEMS Co., Ltd. considers E-CUBE 15 to be as safe, as effective. Performance, technology and software are substantially equivalent to the predicate device.
ALPINION MEDICAL SYSTEMS Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA or the requirements will be published in guidance documents.