LogoFDA 510(k) Search
K Number
K121888
Device Name
E-CUBE 15
Manufacturer
ALPINION MEDICAL SYSTEMS CO., LTD
Date Cleared
2012-07-26

(28 days)

Product Code
IYOITXIYN
Regulation Number
892.1560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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); Small Organ (breast, testes, thyroid); Trans-rectal(TR); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate).
Device Description
E-CUBE 15 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 18.5" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
More Information

K120060

Not Found

No
The document does not mention AI, ML, or related terms, nor does it describe any training or test sets typically associated with AI/ML development. The description focuses on standard ultrasound system features and safety testing.

No
The device is described as an "ultrasound imaging system for medical diagnosis," intended for "evaluation of soft tissue and blood flow." Its purpose is diagnostic, not therapeutic.

Yes
The device is described as an "ultrasound imaging system for medical diagnosis" intended for the "evaluation of soft tissue and blood flow." This directly states its purpose in diagnosing medical conditions.

No

The device description explicitly states it is an "ultrasound imaging system" and mentions hardware components like a "flat panel display" and "ergonomic control panel," indicating it is a hardware device with integrated software, not a software-only medical device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for "evaluation of soft tissue and blood flow" in various anatomical sites. This describes a diagnostic imaging procedure performed directly on the patient, not a test performed on a sample of biological material outside the body.
  • Device Description: The description confirms it's an "ultrasound imaging system for medical diagnosis." Ultrasound is a non-invasive imaging modality.
  • Input Imaging Modality: The input modality is "Ultrasonic," which is used for imaging the body directly.
  • Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This ultrasound system does not fit that description.

N/A

Intended Use / Indications for Use

The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); 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).
E-CUBE 15 is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body for the following clinical applications: Fetal, Abdominal, Small Organ (breast, testes, thyroid), Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Peripheral Vessel, and Urology (Including prostate). Also covers specific transducer indications.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

E-CUBE 15 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 18.5° wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic Pulsed Doppler Imaging System, Ultrasonic Pulsed Echo Imaging System

Anatomical Site

Soft tissue, blood flow, Fetal, Abdominal (renal & GYN/pelvic), Small Organ (breast, testes, thyroid), Trans-rectal(TR), Trans-vaginal(TV), Musculo-skeletal(Conventional), Musculo-skeletal (Superficial), Cardiac (adult), Peripheral Vascular (PV), Urology (including prostate)

Indicated Patient Age Range

Adult, Fetal

Intended User / Care Setting

Qualified physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Summary of Non-Clinical Tests:
E-CUBE 15 has been evaluated for biocompatibility, acoustic output as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. E-CUBE 15 and its application comply with voluntary standards as detailed in this premarket submission. The following quality management system measures were applied to the development of E-CUBE 15:

  • NEMA UD2, UD3 .
  • AIUM Medical Ultrasound Safety .
  • IEC60601-1 .
  • IEC60601-1-2
  • IEC60601-2-37 (3rd Edition)
  • ISO 10993-1
    Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:
The subject of this premarket submission, E-CUBE 15, did not require clinical studies to support substantial equivalence.

Conclusion:
Alpinion Medical Systems Co., Ltd. considers E-CUBE 15 to be as safe, as effective, and performance is substantially equivalent to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K120060

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

0

JUL 26 2012

510(K) E-CUBE 15

510(k) Summary

In accordance with 21CFR807.92, the following summary of information is provided;

Date June 26" 2012 Submitter: ALPINION MEDICAL SYSTEMS Co., Ltd. Address: 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu, Seoul, Republic of Korea 152-848, Primary Contact Person Donghwan Kim QARA Manager Address: 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu, Seoul, Republic of Korea 152-848. Phone: +82 70 7465 2068 Fax: +82 2 851 5594 Emall: donghwan.kim@alpinion.com Secondary Contact Yuchi Chu Person Address: Suite 229, 10604 NE 38th Place, Kirkland, WA 98033, United States Phone: 425 949 4907 Fax: 425 949 4908 Email: ychu@alpinionus.com Device Trade Name: E-CUBE 15 Common/Usual Name: Ultrasonic Pulsed Doppler Imaging System Classification Names System, Imaging, Pulsed Doppler Ultrasonic Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550 90-Product Code: IYN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO , I Y/V Diagnostic Ultrasound Transducer, 21CFR 892.1570, 90-ITX Predicate Device(s) K120060 E-CUBE 9 Diagnostic Utrasound System

ALPINION MEDICAL SYSTEMS Co., Ltd.

F-1

ట

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510(k) E-CUBE 15

| Device Description: E-CUBE 15 product is an ultrasound imaging system for medical
diagnosis. The system platform provides optimal patient diagnosis
workflow with the 18.5° 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); Small Organ (breast, testes,
Trans-reclal(TR);
thyrold);
Musculo-
skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac
(adult); Peripheral Vascular (PV); and Urology (including prostate).
Technology: E-CUBE 15 employs the same fundamental scientific technology as
its predicate device.

| Feature | Proposed
E-CUBE 15
ALPINION MEDICAL SYSTEMS Co.,
Ltd. | Predicate
E-CUBE 9
ALPINION MEDICAL SYSTEMS Co.,
Ltd. | |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510(k)
Number | | K120060 | |
| Indications for
use | The device is intended for use by a
qualified physician for the evaluation of
soft tissue and blood flow in the clinical
applications:
Fétal:
Abdominal (renal & GYN/pelvic);
Small Organ (breast, testes, thyroid):
Trans-rectal(TR);
Trans-vaginal(TV):
Musculo-skeletal(Conventional);
Musculo-skeletal Superficial);
Cardiac (adult):
Peripheral Vascular (PV):
Urology (including prostate). | The device is intended for use by a
qualified physician for the evaluation of
soft tissue and blood flow in the clinical
applications:
Fetal:
Abdominal (renal & GYN/pelvic);
Pediatric;
Small Organ (breast, testes, thyroid);
Trans-rectal(TR);
Trans-vaginal(TV);
Musculo-skeletal(Conventional):
Musculo-skeletal (Superficial);
Cardiac (adult & pediatric);
Perpheral Vascular (PV):
Urology (including prostate). | |
| | Discussion of differences
●
The individual functions of E-CUBE 15 has essential performance and safety
effectiveness same as E-CUBE 9, even though E-CUBE 15 as limited scope of
the indications comparing with the predicate.
Therefore, E-CUBE 15 substantially equivalent with predicate device. | | |
| Dimensions
and weight | Weight: approx. 105kg
Height: 1413/1848 mm
Width: 585mm
Depth: 670mm | Weight: approx. 89.5kg
Height: 1340/1600 mm
Width: 590mm
Depth: 850mm | |
| Monitor | 18.5" Wide LCD | 17" Wide LCD | |
| | 18.5" Wide LCD | 18.5" Wide LCD | |
| | Display size: 1366 X 768 | Display size: 1366 X 768 | |
| | Recording area: 880 X 660 | Recording area: 880 X 660 | |
| | | | |
| | Adjustable Tilt/Swivel, up/down, rotate | Adjustable Tilt/Swivel, up/down, rotate | |
| | Digital Brightness/Contrast Adjustment | Digital Brightness/Contrast Adjustment | |
| | | | |
| Electrical | Voltage: 100120V, 200240V | Voltage: 100120V, 200240V | |
| power | Frequency: 50/60Hz | Frequency: 50/60Hz | |
| | Power: Max. 900 VA with Built-in and | Power: Max. 600 VA with Built-in and | |
| | On-Board Peripherals | On-Board Peripherals | |
| | | | |
| Consol design | • 3 active Probe Ports | • 3 active Probe Ports | |
| | (4 Probe Ports Option) | | |
| | • Touch panel | | |
| | • Integrated HDD (Capacity: 500G) | • Integrated HDD (Capacity: 500G) | |
| | • Integrated DVD-R/W Drive | • Integrated DVD-R/W Drive | |
| | • On-board Storage for Peripherals | • On-board Storage for Peripherals | |
| | - B/W Printer | - B/W Printer | |
| | Color Printer, | Color Printer, | |
| | DVD recorder | DVD recorder | |
| | • Control panel lift mechanism | • Control panel lift mechanism | |
| | • 5 Transducer holders, detachable for | • 5 Transducer holders, detachable for | |
| | cleaning and washing | cleaning and washing | |
| | • Integrated Gel warmer | • Integrated Gel warmer | |
| | - 3 temperature levels | - 3 temperature levels | |
| | • Front Handle | • Front Handle | |
| | • Rear Handle | • Rear Handle | |
| | • Wheel-lock Mechanism | • Wheel-lock Mechanism | |
| | - Front & Back -Wheel: Total lock | - Front & Back -Wheel: Total lock | |
| | • 8 USB ports: Touch module side (2ea) | • 5 USB ports: Front Side (1ea) Back | |
| | Back side (6ea) | side (6ea) | |
| | • Thumbnail images on-screen | • Thumbnail images on-screen | |
| | • On-line Help key | • On-line Help key | |
| | • ECG Module | • ECG Module | |
| | • Patient ECG Lead Wires | • Patient ECG Lead Wires | |
| | Discussion of differences | | |
| | E-CUBE 15 has 3 or 4 (optional) probe ports, 8 USB ports: Touch module side | | |
| | (2ea) Back side (6ea) and Touch panel. But, E-CUBE 9 has 3 probe ports and 5 | | |
| | USB ports: Front Side (1ea) Back side (6ea). It is not related with the safety, | | |
| | effectiveness and essential performance. | | |
| | | | |
| Operating | • B-Mode | • B-Mode | |
| Mode | • M-Mode | • M-Mode | |
| | • Anatomical M-mode | • Anatomical M-mode | |
| | • Pulsed Wave (PW) Doppler with High | • Pulsed Wave (PW) Doppler with High | |
| | PRF | PRF | |
| | • Continuous Wave (CW) Doppler | • Continuous Wave (CW) Doppler | |
| | • Color Flow-Mode | • Color Flow-Mode | |
| | | | |
| | Power Doppler Mode THI (PI/FTHI) Tissue Doppler Imaging Beam Steering Panoramic B/CF Spatial compounding Frequency compounding Xpeed on 2D / CF/PW Auto IMT Auto traces PW Directional Power Doppler Mode SRI Full SRI ECG | Power Doppler Mode THI (PI/FTHI) Tissue Doppler Imaging Beam Steering Panoramic B/CF Spatial compounding Frequency compounding Xpeed on 2D / CF/PW Auto IMT Auto traces PW Directional Power Doppler Mode SRI Full SRI ECG 3D/4D Volume Mode | |
| | Discussion of difference
3D/4D is an image representation of a volume or 3D object, such as the heart
or fetus. Surface rendering can be used to visualize surfaces. Another image
presentation is volume rendering, in which surfaces can be semitransparent or
2D slice planes through the object. Alternatively, there is simultaneous viewing
of different 2D-slice planes (side by side). | | |
| | E-CUBE 15 includes essential operating mode for diagnosis and is
Substantially Equivalent. | | |
| Labeling
and/or
promotional
materials | Section 6B Catalog E-CUBE 15 | Section 3C Catalog E-CUBE9 | |
| Accessories or
kits | Color printer
B/W printer
DVR
DVD-RW
Footswitch
Probe Holder
Ultrasonic gel
Cidex OPA (disinfectant agents)
Cidex Plus (disinfectant agents)
SC1-6 Biopsy guide kit
L3-12 Biopsy guide kit
E3-10 Reusable Biopsy needle guide
E3-10 Disposable Biopsy needle guide
ECG Module
Patient ECG Lead Wires | Color printer
B/W printer
DVR
DVD-RW
Footswitch
Probe Holder
Ultrasonic gel
Cidex OPA (disinfectant agents)
Cidex Plus (disinfectant agents)
SC1-6 Biopsy guide kit
L3-12 Biopsy guide kit
E3-10 Reusable Biopsy needle guide
E3-10 Disposable Biopsy needle guide
ECG Module
Patient ECG Lead Wires | |
| | | | |
| Measurement
and
Calculation
functions | 1. General

  1. B-Mode
  2. M-Mode
  3. Doppler Mode | 1. General
  4. B-Mode
  5. M-Mode
  6. Doppler Mode | |
    | | 2. Abdomen
  7. B-Mode
  8. M-Mode
  9. Doppler Mode | 2. Abdomen
  10. B-Mode
  11. M-Mode
  12. Doppler Mode. | |
    | | 3. Small Parts
  13. B-Mode
  14. M-Mode
  15. Doppler Mode | 3. Small Parts
  16. B-Mode
  17. M-Mode
  18. Doppler Mode | |
    | | 4. Obstetrics
  19. B-Mode
  20. M-Mode:
  21. Doppler Mode | 4. Obstetrics
  22. B-Mode
  23. M-Mode:
  24. Doppler Mode | |
    | | 5. Gynecology
  25. B-Mode
  26. M-Mode:
  27. Doppler Mode | 5. Gynecology
  28. B-Mode
  29. M-Mode:
  30. Doppler Mode | |
    | | 6. Cardiology
  31. B-Mode:
  32. M-Mode
  33. Doppler Mode | 6. Cardiology
  34. B-Mode:
  35. M-Mode
  36. Doppler Mode | |
    | | 7. Vascular
  37. B-Mode
  38. M-Mode
  39. Doppler Mode | 7. Vascular
  40. B-Mode
  41. M-Mode
  42. Doppler Mode | |
    | | 8. Urology
  43. B-Mode
  44. M-Mode
  45. Doppler Mode | 8. Urology
  46. B-Mode
  47. M-Mode
  48. Doppler Mode | |
    | | | 9. Pediatrics
  49. B-Mode
  50. M-Mode
  51. Doppler Mode | |
    | | Discussion of difference | | |
    | | Measurement and Calculation functions of E-CUBE 15 are not include Pediatrics. | | |
    | | It is not related with the safety, effectiveness and essential performance. | | |
    | Acoustic
    output
    | Track 3 | Track 3 | |

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ALPINION MEDICAL SYSTEMS Co., Ltd.

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510(k) E-CUBE 15 대

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ALPINION MEDICAL SYSTEMS Co., Ltd.

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510(k) E-CUBE 15

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ALPINION MEDICAL SYSTEMS Co., Ltd.

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510(k) E-CUBE 15

(pediatric). The primary difference is cosmetic structure and component used only. Therefore, we can claim the substantially equivalence of E-CUBE 15 to the predicate device.

1

ALPINION MEDICAL SYSTEMS Co., Ltd.

દ-ડ

5

Determination of Substantial Equivalenço:

Summary of Non-Clinical Tests:

E-CUBE 15 has been evaluated for biocompatibility, acoustic output as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. E-CUBE 15 and its application comply with voluntary standards as detailed in this premarket submission. The following quality management system measures were applied to the development of E-CUBE 15:

  • NEMA UD2, UD3 .
  • AIUM Medical Ultrasound Safety .
  • IEC60601-1 .
  • IEC60601-1-2
  • IEC60601-2-37 (3rd Edition)
  • ISO 10993-1

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, E-CUBE 15, did not require clinical studies to support substantial equivalence.

Conclusion:

Alpinion Medical Systems Co., Ltd. considers E-CUBE 15 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.

F-6

6

Appendix B - Decision Summary for Web Posting

Decision Summary, K 1 21 889

This 510(k) was reviewed under OIVD's Pilot Triage Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant's 510(k) summary for a summary of the information that supports this SE determination.

OIVD, 6/12/12, v1.2

7

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Mr. Donghwan Kim QARA Manager Alpinion Medical Systems Co., Ltd. 1. 6. and 7FL Verdi Tower 72. Digital-ro (St) 26-gil (Rd), Guro-gu SEOUL 152-848 REPUBLIC OF KOREA

SEP 2 5 2012

Re: K121888 Trade/Device Name: E-CUBE 15 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, and ITX Dated: June 26, 2012 Received: June 28, 2012

Dear Mr. Kim:

This letter corrects our substantially equivalent letter of July 26, 2012.

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 15, as described in your premarket notification:

Transducer Model Number
SC1-6HL8-17X
L3-12HSC1-4H
SP1-5XE3-10H

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

8

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 (OS) 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 Jeffrey Ballyns at (301) 796-6105.

Sincerely Yours,

Muhal D. O'Ke for

Janine M. Morris Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

9

Indications for Use

510(k) Number (if known):

Device Name: E-CUBE 15

Indications for Use:

The device is intended for use by a qualified physicien for the evaluation of soft lissue and blood now in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Small Organ (breast, testes, ന്നും നീ സംഭവിഠ-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (ədult); Peripheral Vascular (PV); and Urology (Including prostate).

Over-The-Counter Use AND/OR Prescription Use (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

(Division Sign-Olm
Division of Radiological Devices
Office of In Vitro Diagnostic Davice Eveluadon and Safety

Diagnostic Device Evaluation and Safety
K121888
510K

ALPINION MEDICAL SYSTEMS Co., Ltd.

10

E-CUBE 15 Ultrasound System

Intended Use: Dlagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other*
(Specify)
Ophthalmic
FetalNNNNNNN
AbdominalNNNNNNN
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
(breast, testes, thyroid)NNNNNNN
Neonatal Cephalic
Adult Cephalic
Trans-rectalNNNNNNN
Trans-vaginalNNNNNNN
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)NNNNNNN
Musculo-skeletal
(Superficial)NNNNNNN
Intravascular
Cardiac AdultNNNNNNNN
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselNNNNNNNN
Urology (Including prostate)NNNNNNN

N = new indication; P = previously cleared by FDA: E = added under expendix

· Combinsd: B/Color Doppler, B/PWD, B/Color Dappler/PWD; **Other: SD, 4D

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE JE NEEDED)

Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)

Prescription User (Par 21 CFR 801.108)

ALPINION MEDICAL SYSTEMS Co., Ltd.

(Division Sign-Off)

Division of Radiological Devices

Office of in Vitro Diagnostic Device Evaluation and Safety

K121888
510K

11

E-CUBE 15 with SC1-6H Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
BMFWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
FetalNNNNNNN
AbdominalNNNNNNN
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (Including prostate)NNNNNNN
N = new indication; P = previously cleared by FDA; E = added under appendix

· Combined: B/Calar Doppler, B/PWD, B/Color Doppler/PWD; **Oltrer: 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 (Pet 21 CFR 801.108)

ALPINION MEDICAL SYSTEMS Co., Ltd.
(Division Sign Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation

Office of In Vitro Oragnosue Device Evalual tion and Salety

510K_K121888

12

E-CUBE 15 with L3-12H Transducer

Intended Use: Dlagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
(breast, testes. thyroid)PPPPPP
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)PPPPPP
Musculo-skeletal
(Superficial)PPPPPP
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselPPPPPP
Urology (Including prostate)
N = new indication; P = previously cleared by FDA; E = added under appendix

• Combined: B/Calor Dappler, B/PWD, B/Color Doppler/PWO; **Other: 3D, 40

(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 Co., Ltd.
(Division Sign-Off)
Dryttuun of Bedical D

un of Radiciouical Devic Office of In Vitro D.

610K 512188

13

E-CUBE 15 with SP1-5X Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
Fetal
AbdominalNNNNNNN
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Cardiac AdultNNNNNNNN
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (Including prostate)

4 Combined: B/Color Dopplar, B/PWD, B/Color Doppter/PWD; **Other, SD, 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 801.108)

ALBION MEDICAL SYSTEMS Co., Ltd.

(Division Sign-Off)

Division of Racistogical Dav office of In Vitro Diagnostic De salion and Safety

610K 5121888

દ-ડ

14

E-CUBE 15 with L8-17X Transducer

Ințended Use: Dlagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
(breast, testes, thyroid)NNNNNN
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)NNNNNN
Musculo-skeletal
(Superficial)NNNNNN
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselNNNNNN
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 NEFDED)

Concurrence of CDRH, Office of In-Vitro Disgnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

ALPINION MEDICAL SYSTEMS Co., Ltd.
(Division Stamp)

LUVES of Anticlogical Dev grostic Davice Evaluation and Safaty

Kla888

15

E-CUBE 15 with SC1-4H Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of OperationDopplerTissue Harmonic ImagingCombined* (Specify)Other** (Specify)
BMPWDCWDColor DopplerPower Doppler
Ophthalmic
FetalNNNNNNN
AbdominalNNNNNNN
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (Including prostate)NNNNNNN
N = new indication; P = previously cleared by FDA; E = added under appendix

· Combined: B/Color Doppler, B/PWD, B/Color Dappler/PWD; ** Other: JD, 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 101.108)

ALPINION MEDICAL SYSTEMS Co., Ltd.

(Division Sign-Off)

Chination of Rac. Diogreal Devices wine of in Vitro Diagon as Device Evaluation and Saleg

510K

E-7

ਕਾਰੀ

16

E-CUBE 15 with E3-10H Transducer

Intended Use: Diagnostic ultrasound Imaging or fluid flow anaiysis of the human body as follows:

Clinical ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other*
(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
(breast, testes, thyroid)
Neonatal Cephalic
Adult Cephalic
Trans-rectalNNNNNNN
Trans-vaginalNNNNNNN
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vessel
Urology (Including prostate)

N = new Indication; P = previously cleared by FDA; E = added under appendix

· Cambined: 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 (Par 21 CFR 801.109)

MEDICAL SYSTEMS Co. Ltd. Short Stone

on of Redioksunal Cavices Office ut In

810K K121888

. E-8