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K Number
K121937
Device Name
E-CUBE INNO
Manufacturer
ALPINION MEDICAL SYSTEMS CO., LTD
Date Cleared
2012-07-26

(24 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
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); Pediatric; Small Organ (breast, testes, thyroid); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate).
Device Description
E-CUBE inno product is a mobile 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 ergonomic control panel with easy user interface, optimal image quality.
More Information

K113690

K113690

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 focus is on standard ultrasound imaging capabilities and safety standards.

No
The device is an ultrasound imaging system used for diagnosis and evaluation, not for treatment.

Yes

The "Device Description" explicitly states, "E-CUBE inno product is a mobile ultrasound imaging system for medical diagnosis." Also, the "Intended Use / Indications for Use" section describes its use for "evaluation of soft tissue and blood flow" in various clinical applications.

No

The device description explicitly states it is a "mobile ultrasound imaging system" and mentions "ergonomic control panel," indicating it includes hardware components beyond just software.

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 the "evaluation of soft tissue and blood flow" in various anatomical sites. This describes a diagnostic imaging system used to visualize internal structures and processes within the body.
  • Device Description: The description confirms it's a "mobile ultrasound imaging system for medical diagnosis." Ultrasound is an imaging modality, not a method for testing samples outside the body.
  • Input Imaging Modality: The input modalities are "Ultrasonic Pulsed Doppler Imaging System" and "Ultrasonic Pulsed Echo Imaging System." These are ultrasound technologies used for imaging.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body, which are the defining characteristics of an IVD.

In summary, the device is an ultrasound imaging system used for non-invasive diagnosis by visualizing internal structures and blood flow, which falls under the category of medical imaging devices, not In Vitro Diagnostics.

N/A

Intended Use / Indications for Use

The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate).

Product codes

IYN, IYO, ITX

Device Description

E-CUBE inno product is a mobile 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 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

Anatomical Site

Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); Urology (including prostate).

Indicated Patient Age Range

Adult, Pediatric, 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)

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

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

Not Found

Predicate Device(s)

K113690 LOGIQ i, LOGIQ e, Vivid e

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

0

JUL 26 2012

510(k) E-CUBE inno

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

Jun 29" 2012 Date

ALPINION MEDICAL SYSTEMS Co., Ltd. Submitter: 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 Email: donghwan.kim@alpinion.com

Secondary Contact Yuchi Chu

Address: Suite 229, 10604 NE 38th Place, Kirkland, WA 98033, Person United States Phone: 425 949 4907 Fax: 425 949 4908 Email: ychu@alpinionus.com

  • Device Trade Name: E-CUBE inno
    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) K113690 LOGIQ i, LOGIQ e, Vivid e

Device Description: E-CUBE inno product is a mobile 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 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); Musculo-skeletal(Conventional); Musculoskeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate).

ALPINION MEDICAL SYSTEMS Co., Ltd.

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| Feature | Proposed
E-CUBE inno
ALPINION MEDICAL SYSTEMS Co.,
Ltd. | Predicate
LOGIQ e
GE Healthcare |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | K113690 | |
| 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,
Pediatric;
Small Organ (breast, testes, thyroid);
Musculo-skeletal(Conventional);
Musculo-skeletal (Superficial);
Cardiac adult;
Peripheral Vascular (PV);
and 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:
Fatal/OB;
Abdominal(GYN & Urology);
Pediatric;
Small Organ (breast, testes, thyroid);
Musculo-skeletal Conventional and
Superficial;
Cardiac (adult and pediatric);
Peripheral Vascular (PV);
Urology (including prostate);
Intra-operative (abdominal, thoracic, PV)
Neonatal Cephalic &Adult Cephalic;
Trans-esophageal;
Trans-rectal;
Trans-vaginal (TV); and Thoracic/Pleural |
| | Discussion of differences
●
The individual functions of E-CUBE inno has essential performance and safety
effectiveness same as LOGIQ e, even though E-CUBE inno has limited scope of
the indications comparing with the predicate. | |
| Dimensions
and weight | Therefore, E-CUBE inno is substantially equivalent with predicate device.
Weight: approx. 7.2kg (excluding Option)
Height: 83.5~415 mm
Width: 410 mm
Depth: 371 mm | Weight: approx. 4.6kg(with battery)
Height: 61mm/1410 mm
Width: 340mm
Depth: 287mm/ 337mm with handle |
| Monitor | 15 inch LCD
Display size: 1024 X 768
Monitor tilt

  • More than 165 degrees | 15 inch TFT LCD
    Display size : 1024 X 768
    Monitor tilt
  • 160 degrees (maximum) |
    | Electrical
    power | Voltage:24V 6.5A
    Frequency: 50/60Hz
    Power: 120 VA MAX with Peripherals | Voltage: 20V 5A
    Frequency: 50/60Hz
    Power: Max. 130 VA with Peripherals |
    | Consol design | 1 Active Probe Port
    Integrated HDD (Capacity: 500G)
    Rear Handle
    On-board Storage for Peripherals
  • B/W Printer, Color Printer, DVD RW
    USB ports, internal ECG | 1 Active Probe Port
    Integrated HDD(Capacity: 160G)
    Rear Handle
    Lithium ion battery pack(Standard)
    On-board Storage for Peripherals
  • B/W Printer, Color Printer, DVD RW,
    USB ports, USB ECG(AHA/IEC) Support
    CWD Support |
    | | Discussion of differences | |
    | | E-CUBE inno has more storage capacity of image than Logiq e and it is not related | |
    | | with the safety and effectiveness and essential performance. | |
    | | E-CUBE inno doesn't include a Lithium ion battery pack but this is not essential | |
    | | parts. | |
    | Operating Mode | B Mode
    M Mode
    Color Flow Mode
    Power Doppler Mode
    Pulse Wave Doppler Mode
    Continuous Wave Doppler
    SRI | B Mode
    M Mode
    Anatomical M mode
    Color Flow Mode
    Power Doppler Mode
    Pulse Wave Doppler Mode
    Continuous Wave Doppler Mode
    Tissue Doppler Imaging
    SRI |
    | | Discussion of difference | |
    | | E-CUBE inno includes essential operating mode for diagnosis and is
    Substantially Equivalent | |
    | Labeling
    and/or
    promotional
    materials | Section 6 User manual
    Section 6A Catalog E-CUBE inno | Section 3B User manual GE Logiq e
    Section 3C Catalog GE Logiq e |
    | Accessories or
    kits | Color printer
    B/W printer
    DVD-RW
    Ultrasonic gel
    Cidex OPA (disinfectant agents)
    Cidex Plus (disinfectant agents)
    SC1-6 Biopsy Starter kit
    L3-12 Biopsy Starter kit
    Patient ECG cable((AHA/IEC) | Color printer
    B/W printer
    DVD-RW
    Footswitch
    Lithium ion battery pack(Standard)
    Aquasonic 100 Scan Gel
    Scan Ultrasound Gel
    Cidex OPA (disinfectant agents)
    Sterile Ultrasound Probe Sheath Set
    Sterile Ultrasound Cord Sheath Set
    Sanitary Rectal/Vaginal Probe Cover
    Sterile Combination Probe and Cord Cover Set
    Sterile Ultrasound Probe Sheath Set for Wide Aperture Sector Probes
    USB ECG(AHA/IEC) Support
    Isolation/Docking Cart |
    | | Discussion of difference | |
    | | E-CUBE inno doesn't include a lithium ion battery, Footswitch but this is not | |
    | | essential parts. | |
    | 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. Obstetric
  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 | 9. Pediatrics
  52. B-Mode
  53. M-Mode
  54. Doppler Mode |
    | Acoustic output | Track 3 | Track 3 |

E-CUBE inno employs the same fundamental scientific technology Technology: as its predicate device.

ALPINION MEDICAL SYSTEMS Co., Ltd. •

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ALPINION MEDICAL SYSTEMS Co., Ltd.

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The indications for use, material, form factor, performance, and safety characteristics between E-CUBE inno and the predicate device are the same except for Intra-operative (abdominal, thoracic, PV); Neonatal Cephalic &Adult Cephalic; Trans-esophageal; Trans-rectal; Trans-vaginal (TV); and Thoracic/Pleural. The primary difference is cosmetic structure and component used only. Therefore, we can claim the substantially equivalence of E-CUBE inno to the predicate device.

ALPINION MEDICAL SYSTEMS Co., Ltd.

F-4

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Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

E-CUBE inno 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 inno 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 inno:

  • NEMA UD2, UD3 �
  • AIUM Medical Ultrasound Safety �
  • IEC60601-1
  • IEC60601-1-2 �
  • IEC60601-2-37
  • ISO 10993-1 �

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

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

Conclusion:

ALPINION MEDICAL SYSTEMS Co., Ltd. considers E-CUBE inno 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.

ALPINION MEDICAL SYSTEMS Co., Ltd.

는-5

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Appendix B - Decision Summary for Web Posting

Decision Summary, K 121937

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

6

Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

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

JUL 2 6 2012

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

Re: K121937

Trade/Device Name: E-CUBE inno Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: June 28, 2012 Received: July 2, 2012

Dear Mr. Kim:

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 inno, as described in your premarket notification:

Transducer Model Number

| C1-6i
SP1-5i | L3-8i
L3-12i |

--------------------------------------------------------------------------------------------------------------------------------

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

7

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 Jeffrey Ballyns at (301) 796-6105.

Sincerely Yours,

hul D'O'hurn for.

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

8

Indications for Use Statement

510(k) Number (if known):

Device Name: E-CUBE inno

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); 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)

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મું દિવ

(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)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K. 5121937

ALEINION MEDICAL SYSTEMS Co., Ltd.

9

Diagnostic Ultrasound Indications for Use

E-CUBE inno Ultrasound System

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

| Clinical Application | Mode of Operation | | | | | | | Combined*
(Specify) | Other**
(Specify) |
|------------------------------------|-------------------|---|-----|-----|------------------|------------------|-------------------------------|------------------------|----------------------|
| | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Tissue
Harmonic
Imaging | | |
| Ophthalmic | | | | | | | | | |
| Fetal | 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 | N | N | N | | N | N | N | N | |
| (breast, testes, thyroid) | N | N | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Trans-rectal | | | | | | | | | |
| Trans-vaginal | | | | | | | | | |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skeletal
(Conventional) | N | N | N | | N | | N | N | |
| Musculo-skeletal
(Superficial) | N | N | N | | N | | N | N | |
| Intravascular | | | | | | | | | |
| Cardiac Adult | N | N | N | N | N | N | N | N | |
| Cardiac Pediatric | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Intra-cardiac | | | | | | | | | |
| Peripheral vessel | N | N | N | | N | N | N | N | |
| Urology (including prostate) | N | N | N | | N | N | N | N | |

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

  • Combined: B/M, B/PWD, B/CF, B/PD, B/CF/PWD, B/CF/M, Dual B; **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 Co., Ltd.

(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

RIOK

E-2 ه LF, -

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Diagnostic Ultrasound Indications for Use

E-CUBE inno with C1-6i 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
FetalNNNNNNN
AbdominalNNNNNNN
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricNNNNNNN
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/M, B/PWD, B/CF, B/PD, B/CF/PWD, B/CF/M, Dual B; **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 Co., Ltd.

E-3 · 1 --

Muhd DDA
Division Sign-Off

Gotogical Devices ce Evelusion and Se Office of in Vitro

11

Diagnostic Ultrasound Indications for Use

E-CUBE inno with SP1-5i 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
AbdominalNNNNNNNN
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricNNNNNNNN
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)

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

  • Combined: B/M, B/PWD, B/CF, B/PD, B/CF/PWD, B/CF/M, Dual B; **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 Co., Ltd.

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

K121037

510K

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12

Diagnostic Ultrasound Indications for Use

E-CUBE inno with L3-8i Transducer

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

Clinical ApplicationMode of OperationCombined* (Specify)Other** (Specify)
BMPWDCWDColor DopplerPower DopplerTissue Harmonic Imaging
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricNNNNNNN
Small Organ
(breast, testes, thyroid)NNNNNNN
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)NNNNNNN
Musculo-skeletal (Superficial)NNNNNNN
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselNNNNNNN
Urology (including prostate)

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

  • Combined: B/M, B/PWD, B/CF, B/PD, B/CF/PWD, B/CF/M, Dual 8; **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 Co., Ltd.

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K121937

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Diagnostic Ultrasound Indications for Use E-CUBE inno with L3-12i 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
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricNNNNNNN
Small Organ
(breast, testes, thyroid)NNNNNNN
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)NNNNNNN
Musculo-skeletal
(Superficial)NNNNNNN
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselNNNNNNN
Urology (including prostate)

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

  • Combined: B/M, B/PWD, B/CF, B/PD, B/CF/PWD, B/CF/M, Dual B; ** 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 Co., Ltd.
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510KK121937

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