E-CUBE 11
Device Facts
| Record ID | K161439 |
|---|---|
| Device Name | E-CUBE 11 |
| Applicant | Alpinion Medical Systems Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Sep 21, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Adult Cephalic; Trans-rectal (TR); Trans-vaginal (TV); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Peripheral Vascular (PV); and Urology (including prostate).
Device Story
E-CUBE 11 is an ultrasound imaging system for medical diagnosis. It processes acoustic signals from various transducers (convex, linear, phased array, volume, pencil) to generate diagnostic images and flow analysis. The system features a wide flat panel display and an ergonomic control panel. It supports multiple imaging modes: 2D(B), M-mode, Color M, Anatomical M, Color Flow Doppler, Power Doppler, Directional PD, PWD, CWD, High PRF, Tissue Doppler, and 3D/4D. Used in clinical settings by physicians, the system aids in visualizing soft tissue and blood flow. Output is displayed on the system monitor for real-time clinical assessment, supporting diagnostic decision-making across various anatomical regions. The device incorporates proprietary imaging functions like Xpeed, Full SRI, and Spatial Compounding to optimize image quality.
Clinical Evidence
No clinical studies were required to support substantial equivalence. Evidence is based on bench testing, including biocompatibility, acoustic output measurements, and thermal, electrical, electromagnetic, and mechanical safety testing in accordance with recognized standards.
Technological Characteristics
Ultrasound imaging system using piezoelectric transducers (convex, linear, phased, volume, pencil). Frequencies range from 1-12 MHz. Connectivity includes standard ultrasound interfaces. Safety compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD2, NEMA UD3. Biocompatible patient-contact materials per ISO 10993-1.
Indications for Use
Indicated for use by a qualified physician for the evaluation of soft tissue and blood flow in fetal, abdominal, pediatric, small organ, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal, cardiac, peripheral vascular, and urological clinical 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 15 (K150773)
- E-CUBE i7 (K153424)
- E-CUBE 7 (K132687)
Related Devices
- K181617 — E-CUBE 8 · Alpinion Medical Systems Co., Ltd. · Oct 11, 2018
- K172732 — E-CUBE 8 · Alpinion Medical Systems Co., Ltd. · Dec 14, 2017
- K181277 — E-CUBE 12 · Alpinion Medical Systems Co., Ltd. · Sep 28, 2018
- K142884 — E-CUBE 12 · Alpinion Medical Systems Co., Ltd. · Oct 28, 2014
- K123610 — E-CUBE 15 · Alpinion Medical Systems Co., Ltd. · Feb 1, 2013
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ALPINION MEDICAL SYSTEMS Co., Ltd. % Mr. Donghwan Kim Quality Management Representative (QMR) 1FL and 6FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu Seoul 08393 REPUBLIC OF KOREA
September 22, 2016
Re: K161439 Trade/Device Name: E-CUBE 11 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: August 19, 2016 Received: August 22, 2016
Dear Mr. Kim:
This letter corrects our substantially equivalent letter of September 21, 2016.
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
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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.
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
Jeff Bollyer
for Robert Ochs, Ph.D. 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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K161439
Device Name E-CUBE 11
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 (TR); Trans-vaginal (TV); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Peripheral Vascular (PV); and Urology (including prostate).
| Type of Use (Select one or both, as applicable) | <span> <span style="text-decoration: underline;">Prescription Use</span> (Part 21 CFR 801 Subpart D) </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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:
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*"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."*
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### E-CUBE 11 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 | 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<br>(breast, testes, thyroid) | N | N | N | | N | N | N | N | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | N | N | N | | N | N | N | N | |
| 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<br>(Conventional) | N | N | N | | N | N | N | N | |
| Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | N | |
| Intravascular | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| Cardiac Adult | N | N | N | N | N | N | N | N | |
| Cardiac Pediatric | N | N | N | N | N | N | N | N | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| Peripheral vessel | N | N | N | | N | N | N | N | |
| 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, Office of In-Vitro Diagnostic Devices (OIVD)
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### E-CUBE 11 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 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<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 | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Urology (including prostate) | P | P | P | P | P | P | P | P | | | |
N = new indication; P = previously cleared by FDA K150773; E = added under appendix
* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
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### E-CUBE 11 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) | N | N | N | | N | N | N | N | | |
| Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | N | | |
| Intravascular | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Urology (including prostate) | P | P | P | | P | P | P | P | | |
N = new indication; P = previously cleared by FDA K150773; E = added under appendix
* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
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### E-CUBE 11 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 | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Urology (including prostate) | P | P | P | | P | P | P | P | P | |
N = new indication; P = previously cleared by FDA K150773; E = added under appendix
* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
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# E-CUBE 11 L3-12H™ with 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 | N | P | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Trans-rectal | | | | | | | | | |
| Trans-vaginal | | | | | | | | | |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | P | P | P | | P | P | N | P | |
| Musculo-skeletal<br>(Superficial) | P | P | P | | P | P | N | P | |
| Intravascular | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| Cardiac Adult | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| Peripheral vessel | N | N | N | | N | N | N | N | |
| 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, Office of In-Vitro Diagnostic Devices (OIVD)
{8}------------------------------------------------
# E-CUBE 11 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<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) | 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 | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| Cardiac Adult | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | P | P | P | |
| Urology (including prostate) | | | | | | | | | |
N = new indication; P = previously cleared by FDA K150773; E = added under appendix
* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
{9}------------------------------------------------
### E-CUBE 11 with SP1-5 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 | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | P | P | P | |
| Cardiac Pediatric | N | N | N | N | N | N | N | N | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| 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, Office of In-Vitro Diagnostic Devices (OIVD)
{10}------------------------------------------------
### E-CUBE 11 with MP3-8 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 | N | N | N | | N | N | N | N | |
| Intra-operative (Specify) | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | N | N | N | | N | N | N | N | |
| 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>( <i>Conventional</i> ) | | | | | | | | | |
| Musculo-skeletal<br>( <i>Superficial</i> ) | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| Cardiac Adult | N | N | N | N | N | N | N | N | |
| Cardiac Pediatric | N | N | N | N | N | N | N | N | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| Peripheral vessel | | | | | | | | | |
| Urology (including prostate) | | | | | | | | | |
| 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 | P |
| Abdominal | P | P | P | P | P | P | P | P | P |
| Intra-operative (Specify) | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | P | 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 | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| Cardiac Adult | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| Peripheral vessel | | | | | | | | | |
| Urology (including prostate) | P | P | P | P | P | P | P | P | N |
N = new indication; P = previously cleared by FDA; E = added under appendix
* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
{11}------------------------------------------------
### E-CUBE 11 with SVC1-6H Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA K150773; E = added under appendix
* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
{12}------------------------------------------------
#### E-CUBE 11 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 | Power | Tissue | Combined* | Other** | | | |
| | | | | | Doppler | Doppler | Harmonic | (Specify) | (Specify) | | | |
| | | | | | | | Imaging | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | N | N | N | N | N | N | N | N | | | | |
| 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 | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Urology (including prostate) | P | P | P | P | P | P | P | P | | | | |
N = new indication; P = previously cleared by FDA K150773; E = added under appendix
* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
{13}------------------------------------------------
#### E-CUBE 11 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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(Specify) |
| Ophthalmic | | | | | | | | | |
| Fetal | N | N | N | | N | N | N | N | |
| 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 | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| Cardiac Adult | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| Peripheral vessel | | | | | | | | | |
| Urology (including prostate) | P | P | P | P | P | P | P | P | |
N = new indication; P = previously cleared by FDA K150773; E = added under appendix
* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
{14}------------------------------------------------
#### E-CUBE 11 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<br>Doppler | Power<br>Doppler | Tissue<br>Harmonic<br>Imaging | Combined*<br>(Specify) | Other**<br>(Specify) |
| Ophthalmic | | | | | | | | | |
| Fetal | N | N | N | | N | N | N | N | N |
| 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 | P |
| Trans-vaginal | P | P | P | P | P | P | P | P | P |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skeletal<br>( <i>Conventional</i> ) | | | | | | | | | |
| Musculo-skeletal<br>( <i>Superficial</i> ) | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| Cardiac Adult | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| Peripheral vessel | | | | | | | | | |
| Urology (including prostate) | P | P | P | | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K150773; E = added under appendix
* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other:…
