E-CUBE 15 Diagnostic Ultrasound System
Device Facts
| Record ID | K150773 |
|---|---|
| Device Name | E-CUBE 15 Diagnostic Ultrasound System |
| Applicant | Alpinion Medical Systems Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Jul 23, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended 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).
Device Story
E-CUBE 15 is a diagnostic ultrasound system for medical imaging and fluid flow analysis. It utilizes various transducers to acquire ultrasound signals from the human body. The system processes these signals to generate B-mode, M-mode, Color Doppler, Power Doppler, Pulsed Wave Doppler (PWD), Continuous Wave Doppler (CWD), and Tissue Harmonic Imaging (THI) outputs. It features an 18.5" or 19.5" wide flat panel display and an ergonomic control panel for clinician operation in clinical settings. The system includes advanced imaging features like Xpeed, FullSRI, spatial/frequency compounding, panoramic imaging, stress echo, Cube Strain, Live HQ, Needle Vision, and elastography. These outputs assist physicians in clinical decision-making by providing diagnostic visualization of anatomy and hemodynamics, potentially improving patient assessment and diagnostic accuracy.
Clinical Evidence
No clinical studies were required to support substantial equivalence. Evidence is based on non-clinical bench testing, including biocompatibility, acoustic output, thermal, electrical, electromagnetic, and mechanical safety testing, as well as design verification and validation.
Technological Characteristics
Diagnostic ultrasound system with 18.5"/19.5" flat panel display. Supports B, M, PWD, CWD, Color/Power Doppler, and THI modes. Transducers are biocompatible. Conforms to NEMA UD2, UD3, AIUM safety standards, and IEC 60601-1, 60601-1-2, 60601-2-37. Connectivity includes built-in and on-board peripherals.
Indications for Use
Indicated for qualified physicians to evaluate soft tissue and blood flow in fetal, abdominal, pediatric, small organ, adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, peripheral vascular, and urological applications.
Regulatory Classification
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.
Predicate Devices
- E-CUBE 9 Diagnostic Ultrasound System (K120060)
- iU22 (K132304)
Reference Devices
- E-CUBE 9 (K123610)
- C5-8 (K132687)
Related Devices
- K123610 — E-CUBE 15 · Alpinion Medical Systems Co., Ltd. · Feb 1, 2013
- K121888 — E-CUBE 15 · Alpinion Medical Systems Co., Ltd. · Jul 26, 2012
- K123611 — E-CUBE 7 · Alpinion Medical Systems Co., Ltd. · Dec 21, 2012
- K132687 — E-CUBE 7 · Alpinion Medical Systems Co., Ltd. · Nov 27, 2013
- K172732 — E-CUBE 8 · Alpinion Medical Systems Co., Ltd. · Dec 14, 2017
Submission Summary (Full Text)
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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.
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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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
#### Indications for Use
510(k) Number (if known)
K150773
#### 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.
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#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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Form Approved: @MB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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# 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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(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<br>(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<br>(Conventional) | P | P | P | | P | P | | P | |
| Musculo-skeletal<br>(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
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### 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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(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<br>(breast, testes, thyroid) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Trans-rectal | | | | | | | | | |
| Trans-vaginal | | | | | | | | | |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| Musculo-skeletal<br>(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
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## 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<br>(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<br>(Conventional) | P | P | P | | P | P | P | P | |
| Musculo-skeletal<br>(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
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### 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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(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<br>(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<br>(Conventional) | | | | | | | | | |
| Musculo-skeletal<br>(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
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## 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*<br>(Specify) | Other**<br>(Specify) |
|------------------------------------------|-------------------|---|-----|-----|------------------|------------------|-------------------------------|---|------------------------|----------------------|
| | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | | | |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(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<br>(Conventional) | P | P | P | | P | P | P | P | | |
| Musculo-skeletal<br>(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
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### 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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(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<br>(breast, testes, thyroid) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Trans-rectal | | | | | | | | | |
| Trans-vaginal | | | | | | | | | |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| Musculo-skeletal<br>(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
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### 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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(Specify) | |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(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<br>(Conventional) | | | | | | | | | | |
| Musculo-skeletal<br>(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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(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<br>(breast, testes, thyroid) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Trans-rectal | | | | | | | | | |
| Trans-vaginal | | | | | | | | | |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| Musculo-skeletal<br>(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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(Specify) | |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | | |
| Small Organ<br>(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<br>(Conventional) | P | P | P | | P | P | P | P | | |
| Musculo-skeletal<br>(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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(Specify) |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | |
| Small Organ<br>(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<br>(Conventional) | P | P | P | | P | P | P | P | |
| Musculo-skeletal<br>(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<br>(breast, testes, thyroid) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Trans-rectal | | | | | | | | | |
| Trans-vaginal | | | | | | | | | |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| Musculo-skeletal<br>(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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(Specify) |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ<br>(breast, testes, thyroid) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Trans-rectal | | | | | | | | | |
| Trans-vaginal | | | | | | | | | |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| Musculo-skeletal<br>(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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(Specify) |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ<br>(breast, testes, thyroid) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Trans-rectal | | | | | | | | | |
| Trans-vaginal | | | | | | | | | |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Cardiac Adult | | | P | | | | | | |
| Cardiac Pediatric | | | P | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | |…
