E-CUBE 9
Device Facts
| Record ID | K111864 |
|---|---|
| Device Name | E-CUBE 9 |
| Applicant | Alpinion Medical Systems Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Jul 15, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
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); Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate).
Device Story
E-CUBE 9 is an ultrasound imaging system for medical diagnosis. It processes ultrasonic signals to produce images of soft tissue and blood flow. Operated by qualified physicians in clinical settings, the system features a 17-inch display and ergonomic control panel. It supports various imaging modes including B-mode, M-mode, Pulsed Wave Doppler (PWD), Color Doppler, Power Doppler, Tissue Harmonic Imaging, and 3D/4D. The device aids clinicians in visualizing anatomy and hemodynamics to support diagnostic decision-making. Patient benefits include non-invasive diagnostic assessment across multiple clinical applications.
Clinical Evidence
Bench testing only. No clinical studies were required to support substantial equivalence.
Technological Characteristics
Ultrasound imaging system utilizing pulsed Doppler and pulsed echo imaging. Supports multiple transducer models (SC1-6, L3-12, L3-12H, SVC1-6, SP1-5, E3-10, C1-6, VC1-6). Features 17-inch wide flat panel display. Complies with medical device safety standards for biocompatibility, acoustic output, and electrical/mechanical safety.
Indications for Use
Indicated for qualified physicians to evaluate soft tissue and blood flow in fetal, abdominal, pediatric, small organ, trans-rectal, trans-vaginal, musculoskeletal, adult 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
- LOGIQ P5/A5 Diagnostic Ultrasound System (K060993)
Related Devices
- K132687 — E-CUBE 7 · Alpinion Medical Systems Co., Ltd. · Nov 27, 2013
- K123611 — E-CUBE 7 · Alpinion Medical Systems Co., Ltd. · Dec 21, 2012
- K123610 — E-CUBE 15 · Alpinion Medical Systems Co., Ltd. · Feb 1, 2013
- K120060 — E-CUBE 9 · Alpinion Medical Systems Co., Ltd. · Mar 16, 2012
- K110943 — LOGIQ E9 · GE Healthcare · Jul 22, 2011
Submission Summary (Full Text)
{0}------------------------------------------------
510(K)-E-CUBE 9
ﺎﻧﮯ :J
K111864
# 510(k) Summary
JUL 15 2011
In accordance with 21CFR807.92, the following summary of information is provided;
Feb 14" 2011 Date
ALPINION MEDICAL SYSTEMS Co., Ltd. Submitter: Address: 1 and 6FL, 222-22, Guro-dong, Guro-gu, Seoul, 152-848, Korea Republic
Primary Contact Person Donghwan Kim QARA Manager Address: 1 and 6FL, 222-22, Guro-dong, Guro-gu, Seoul, 152-848, Korea Republic Phone: +82 70 7465 2068 Fax: +82 2 851 5594 Email: donghwan.kim@alpinion.com
Secondary Contact Yuchi Chu Address: Suite 226, 10604 NE 38th Place, Kirkland, WA 98033, Person United States Phone: 425 949 4907 Fax: 425 949 4908 Email: ychu@vimedus.com
Device Trade Name: E-CUBE 9
Common/Usual Name: Ultrasonic Pulsed Doppler Imaging System
Classification Names System, Imaging, Pulsed Doppler Ultrasonic
Product Code: Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550 90-IYN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21CFR 892.1570, 90-ITX
Predicate Device(s) K060993 LOGIQ P5/A5 Diagnostic Ultrasound System
{1}------------------------------------------------
.. "
Device Description: E-CUBE 9 product is an ultrasound imaging system for medical diagnosis. This product can be used for the applications of abdominal, obstetrics, gynecology, small parts, cardiology, vascular, etc. The system platform provides optimal patient diagnosis workflow with the 17" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality 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); Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate).
- Technology: E-CUBE 9 employs the same fundamental scientific technology as its predicate device.
Determination of Summary of Non-Clinical Tests: Substantial Equivalence:
> E-CUBE 9 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 9 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 9:
- � 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 9, did not require clinical studies to support substantial equivalence.
- Conclusion: Alpinion Medical Systems Co., Ltd. Considers E-CUBE 9 to be as safe, as effective, and performance is 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.
{2}------------------------------------------------
Image /page/2/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines that suggest the wings and body of the bird.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Alpinion Medical Systems Co., Ltd % Mr. Marc M. Mouser Engineering Leader & FDA Officer Coordinator Reviewer Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607
JUL 15 2011
Re: K111864
Trade/Device Name: E-CUBE 9 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 2, 2011 Received: June 30, 2011
Dear Mr. Mouser:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the E-CUBE 9 Ultrasound System, as described in your premarket notification:
#### Transducer Model Number
| SC1-6 | L3-12 |
|--------|--------|
| C1-6 | L3-12H |
| SVC1-6 | SP1-5 |
| VC1-6 | E3-10 |
{3}------------------------------------------------
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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); 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.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
If you have any questions regarding the content of this letter, please contact Lauren Hefner at (301) 796-6881.
Sincerely Yours,
Mary S. Patil
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
510(K)-E-CUBE 9
# Indications for Use
510(k) Number (if known):
Device Name: E-CUBE 9
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); Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate).
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
Mary Pastel
(Division Sign-Off)
Nivision of Office of In Vitro
510K K111864
ALPINION MEDICAL SYSTEMS
{5}------------------------------------------------
# E-CUBE 9 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 | | | | | | | | | | |
| Small Organ<br>(breast, testes, thyroid) | P | P | P | | P | P | P | P | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Trans-rectal | P | P | P | | P | P | | P | | |
| Trans-vaginal | P | P | P | | P | P | | P | | |
| 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 | P | P | P | | P | P | P | P | | |
| Cardiac Pediatric | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | P | P | P | | |
| Urology (including prostate) | P | P | P | | P | P | P | P | | |
| N = new indication; P = previously cleared by FDA; E = added under appendix | | | | | | | | | | |
*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)
Prescription User (Per 21 CFR 801.109)
ALPINION MEDICAL SYSTEMS
Mary Slatl
(Division Sign Off)
E-2
Office of In Vitro D aluation and Safety
510K K111864
{6}------------------------------------------------
# E-CUBE 9 with SC1-6 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 | | |
| 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; E = added under appendix
* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
ALPINION MEDICAL SYSTEMS
";
Mary S. Patil
(Division Sign-Off)
Division of Radiological Devices Office of In aluation and Safety
510K K11186cl
E-3
{7}------------------------------------------------
#### E-CUBE 9 with C1-6 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 | |
| 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; E = added under appendix
* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
ALPINION MEDICAL SYSTEMS
Mary Slattl
E-4
Division of Radiologic Office of In ion and Safety
510K K111864
{8}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form
# E-CUBE 9 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 | |
= 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)
Prescription User (Per 21 CFR 801.109)
ALPINION MEDICAL SYSTEMS
Maus Pastel
(Division Sign-Off)
E-S
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K KIIIR64
{9}------------------------------------------------
# E-CUBE 9 with VC1-6 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; 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)
Office of In Vitro
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
ALPINION MEDICAL SYSTEMS
Mary S Patil
(Division Sign-Off)
sion Sign-Off)
Radiological Devices
tion and Safety
510K K111864/
E-R
{10}------------------------------------------------
### E-CUBE 9 with L3-12 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<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; E = added under appendix
* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
ALPINION MEDICAL SYSTEMS
Mary S. Postle
(Division Sign Off)
Division of Radiologi Office of In Vit aluation and Safety
510K K111864
E-7
{11}------------------------------------------------
510(K)-E-CUBE 9
#### Diagnostic Ultrasound Indications for Use Form
### E-CUBE 9 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 | P | P | P | | P | P | | P | | |
| Small Organ<br>(breast, testes, thyroid) | 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 | | |
| Musculo-skeletal<br>(Superficial) | 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 | | |
| Urology (including prostate) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under appendix
* Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
ALPINION MEDICAL SYSTEMS
Maus. Pastl
(Division Sign-Off)
E-8
Division of Radiological Devices Office of In Evaluation and Safety
510K K111864
{12}------------------------------------------------
#### E-CUBE 9 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 | | | | | | | | | |
| (breast, testes, thyroid) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Trans-rectal | | | | | | | | | |
| Trans-vaginal | | | | | | | | | |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | |
| (Conventional) | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | |
| (Superficial) | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Cardiac Adult | P | P | P | | P | P | P | P | |
| Cardiac Pediatric | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | | | | | |
| Peripheral vessel | | | | | | | | | |
| Urology (including prostate) | | | | | | | | | |
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 IE NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
ALPINION MEDICAL SYSTEMS
Mary S. Pastell
(Division Sign-Off)
E-d
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K111864
{13}------------------------------------------------
### E-CUBE 9 with E3-10 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 | |
| Trans-vaginal | 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 | |
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)
Prescription User (Per 21 CFR 801.109)
ALPINION MEDICAL SYSTEMS
Mary S/Patel
(Divison Sign Off)
E-10
Division of Radiologic Office of In ice Evaluation and Safety
510K Killsley
