Who is the manufacturer of E-CUBE INNO?

Alpinion Medical Systems Co., Ltd. filed the 510(k) submission for E-CUBE INNO (K121937).

What is the FDA product code for E-CUBE INNO?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for E-CUBE INNO?

510(k) clearance (submission type: Traditional).

What are the predicate devices for E-CUBE INNO?

LOGIQ i, LOGIQ e, Vivid e (K113690).

Who can help prepare an FDA 510(k) submission like E-CUBE INNO?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

E-CUBE INNO

K121937 · Alpinion Medical Systems Co., Ltd. · IYN · Jul 26, 2012 · Radiology

Device Facts

Record ID	K121937
Device Name	E-CUBE INNO
Applicant	Alpinion Medical Systems Co., Ltd.
Product Code	IYN · Radiology
Decision Date	Jul 26, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric

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); Musculoskeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate).

Device Story

Mobile ultrasound imaging system; performs diagnostic ultrasound imaging and fluid flow analysis. Inputs: ultrasonic signals via transducers (C1-6i, SP1-5i, L3-8i, L3-12i). Processing: B-mode, M-mode, Color Flow, Power Doppler, Pulse Wave Doppler, Continuous Wave Doppler, and Speckle Reduction Imaging (SRI). Outputs: real-time ultrasound images/data on 15-inch LCD monitor. Used in clinical settings by physicians. Healthcare providers use visual output for soft tissue and blood flow evaluation to support clinical diagnosis. Benefits: non-invasive diagnostic imaging for various anatomical regions.

Clinical Evidence

Bench testing only. No clinical studies were required to support substantial equivalence. Device evaluated for biocompatibility (ISO 10993-1), acoustic output (NEMA UD2, UD3), and thermal/electrical/electromagnetic safety (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37).

Technological Characteristics

Mobile ultrasound system; 15-inch LCD (1024x768); 1 active probe port; 500GB HDD. Modes: B, M, Color Flow, Power Doppler, PWD, CWD, SRI. Power: 24V 6.5A. Biocompatible patient-contact materials. Standards: NEMA UD2/UD3, AIUM safety, IEC 60601 series, ISO 10993-1.

Indications for Use

Indicated for qualified physicians evaluating soft tissue and blood flow in fetal, abdominal (renal/GYN/pelvic), pediatric, small organ (breast/testes/thyroid), musculoskeletal (conventional/superficial), adult cardiac, peripheral vascular, and urological (including prostate) 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 i, LOGIQ e, Vivid e (K113690)

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Submission Summary (Full Text)

{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. E-J {1}------------------------------------------------ | 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 1) B-mode 2) M-Mode: 3) Doppler Mode | | | 2. Abdomen 1) B-Mode 2) M-Mode 3) Doppler Mode | 2. Abdomen 1) B-Mode 2) M-Mode 3) Doppler Mode | | | 3. Small Parts 1) B-Mode 2) M-Mode 3) Doppler Mode | 3. Small Parts 1) B-Mode 2) M-Mode 3) Doppler Mode | | | 4. Obstetrics 1) B-Mode 2) M-Mode: 3) Doppler Mode | 4. Obstetric 1) B-Mode: 2) M-Mode: 3) Doppler Mode | | | 5. Gynecology 1) B-Mode 2) M-Mode: 3) Doppler Mode | 5. Gynecology 1) B-Mode 2) M-Mode 3) Doppler Mode | | | 6. Cardiology 1) B-Mode 2) M-Mode 3) Doppler Mode | 6. Cardiology 1) B-Mode 2) M-Mode 3) Doppler Mode: | | | 7. Vascular 1) B-Mode 2) M-Mode 3) Doppler Mode | 7. Vascular 1) B-Mode 2) M-Mode 3) Doppler Mode | | | 8. Urology 1) B-Mode 2) M-Mode 3) Doppler Mode | 8. Urology 1) B-Mode 2) M-Mode 3) Doppler Mode | | | 9. Pediatrics 1) B-Mode 2) M-Mode 3) Doppler Mode | 9. Pediatrics 1) B-Mode 2) M-Mode 3) 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. • . F-2 . + {2}------------------------------------------------ 플러블로 ALPINION MEDICAL SYSTEMS Co., Ltd. . · · ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------F-3 {3}------------------------------------------------ <Conclusion> 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 {4}------------------------------------------------ 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 {5}------------------------------------------------ #### 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) E-1 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, - {10}------------------------------------------------ ### 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 Application | Mode of Operation | | | | | | | | | |------------------------------|-------------------|---|-----|-----|------------------|------------------|-------------------------------|------------------------|----------------------| | | B | M | PWD | CWD | Color Doppler | Power Doppler | Tissue Harmonic Imaging | Combined* (Specify) | Other** (Specify) | | Ophthalmic | | | | | | | | | | | Fetal | N | N | N | | N | N | N | N | | | Abdominal | N | N | N | | N | N | N | N | | | Intra-operative (Specify) | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | Laparoscopic | | | | | | | | | | | Pediatric | N | N | N | | N | N | N | N | | | Small Organ | | | | | | | | | | | (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) | 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. 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 Application | Mode of Operation | | | | | | | | | | |------------------------------------------|-------------------|---|-----|-----|------------------|------------------|-------------------------------|------------------------|----------------------|--| | | B | M | PWD | CWD | Color Doppler | Power Doppler | Tissue Harmonic Imaging | Combined* (Specify) | Other** (Specify) | | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | 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 (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 | N | N | N | N | N | N | N | N | | | | 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 E-4 {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 Application | Mode of Operation | | | | | | | | Combined* (Specify) | Other** (Specify) | |------------------------------------------|-------------------|---|-----|-----|---------------|---------------|-------------------------|---|---------------------|-------------------| | | B | M | PWD | CWD | Color Doppler | Power Doppler | Tissue Harmonic Imaging | | | | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intra-operative (Specify) | | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Pediatric | N | N | N | | N | N | N | N | | | | Small Organ (breast, testes, thyroid) | N | N | N | | N | N | 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 | N | | | | Musculo-skeletal (Superficial) | N | N | N | | N | N | N | N | | | | Intravascular | | | | | | | | | | | | Cardiac Adult | | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | | Peripheral vessel | N | N | N | | N | N | N | N | | | | 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 E-5 · {13}------------------------------------------------ # 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 Application | Mode of Operation | | | | | | | | | |------------------------------------------|-------------------|---|-----|-----|------------------|------------------|-------------------------------|------------------------|----------------------| | | B | M | PWD | CWD | Color Doppler | Power Doppler | Tissue Harmonic Imaging | Combined* (Specify) | Other** (Specify) | | Ophthalmic | | | | | | | | | | | Fetal | | | | | | | | | | | Abdominal | | | | | | | | | | | Intra-operative (Specify) | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | Laparoscopic | | | | | | | | | | | Pediatric | N | N | N | | N | N | N | N | | | Small Organ (breast, testes, thyroid) | N | N | N | | N | N | 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 | N | | | Musculo-skeletal (Superficial) | N | N | N | | N | N | N | N | | | Intravascular | | | | | | | | | | | Cardiac Adult | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | Peripheral vessel | N | N | N | | N | N | N | N | | | 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 | | | 510K | K121937 | E-6