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K Number
K111864
Device Name
E-CUBE 9
Manufacturer
ALPINION MEDICAL SYSTEMS CO., LTD
Date Cleared
2011-07-15

(15 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); Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate).
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
More Information

K060993

Not Found

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use.

No
The device is described as an "ultrasound imaging system for medical diagnosis" and its intended use is for "evaluation of soft tissue and blood flow." These descriptions indicate diagnostic rather than therapeutic purposes.

Yes

The "Intended Use" explicitly states "evaluation of soft tissue and blood flow," and the "Device Description" identifies it as an "ultrasound imaging system for medical diagnosis." Furthermore, its predicate device, K060993 LOGIQ P5/A5, is described as a "Diagnostic Ultrasound System." These statements clearly indicate its purpose is to aid in diagnosis.

No

The device description explicitly states it is an "ultrasound imaging system" and mentions hardware components like a "17" wide 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 describes the device as being used by a qualified physician for the evaluation of soft tissue and blood flow in various clinical applications. This involves direct imaging of the patient's body.
  • Device Description: The device is described as an "ultrasound imaging system for medical diagnosis." Ultrasound is a non-invasive imaging modality that works by sending sound waves into the body and receiving the echoes.
  • IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside of the living body (in vitro).

This device clearly operates in vivo (within the living body) to produce images for diagnosis, which is the opposite of how IVDs function.

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); Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate).

Product codes

IYN, IYO, ITX

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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)

Indicated Patient Age Range

Not Found

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 9, did not require clinical studies to support substantial equivalence.

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

Not Found

Predicate Device(s)

K060993 LOGIQ P5/A5 Diagnostic Ultrasound System

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

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

SC1-6L3-12
C1-6L3-12H
SVC1-6SP1-5
VC1-6E3-10

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 ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
FetalPPPPPPPP
AbdominalPPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ
(breast, testes, thyroid)PPPPPPP
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPPP
Trans-vaginalPPPPPP
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)PPPPPPP
Musculo-skeletal
(Superficial)PPPPPPP
Intravascular
Cardiac AdultPPPPPPP
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselPPPPPPP
Urology (including prostate)PPPPPPP
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 ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
FetalPPPPPPP
AbdominalPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPP
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)PPPPPPP

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 ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
FetalPPPPPPP
AbdominalPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPP
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)PPPPPPP

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 ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
FetalPPPPPPPP
AbdominalPPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPPP
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)PPPPPPP

= 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 ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
FetalPPPPPPPP
AbdominalPPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPPP
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)PPPPPPPP
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 ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other **
(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPP
Small Organ
(breast, testes, thyroid)PPPPPPP
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)PPPPPPP
Musculo-skeletal
(Superficial)PPPPPPP
Intravascular
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral vesselPPPPPPP
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 ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other**
(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPP
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/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 ApplicationMode of Operation
BMPWDCWDColor
DopplerPower
DopplerTissue
Harmonic
ImagingCombined*
(Specify)Other **
(Specify)
Ophthalmic
Fetal
AbdominalPPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricPPPPPPP
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 AdultPPPPPPP
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 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-rectalPPPPPP
Trans-vaginalPPPPPP
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)PPPPPP

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