Who is the manufacturer of E-CUBE 8?

Alpinion Medical Systems Co., Ltd. filed the 510(k) submission for E-CUBE 8 (K172732).

What is the FDA product code for E-CUBE 8?

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 8?

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

What are the predicate devices for E-CUBE 8?

E-CUBE 11 (K161439); E-CUBE i7 (K153424); E-CUBE 7 (K132687); HS70A (K163691); EPIQ 5 / EPIQ 7 (K163120).

Who can help prepare an FDA 510(k) submission like E-CUBE 8?

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 8

K172732 · Alpinion Medical Systems Co., Ltd. · IYN · Dec 14, 2017 · Radiology

Device Facts

Record ID	K172732
Device Name	E-CUBE 8
Applicant	Alpinion Medical Systems Co., Ltd.
Product Code	IYN · Radiology
Decision Date	Dec 14, 2017
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); Neonatal Cephalic, Adult Cephalic; Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vascular (PV); and Urology (including prostate).

Device Story

E-CUBE 8 is an ultrasound imaging system for medical diagnosis; utilizes various transducers (convex, phased, linear, endocavity, pencil) to acquire acoustic signals; transforms signals into B-mode, M-mode, Doppler (Color, Power, PWD, CWD), and harmonic images; features include Xpeed, Full SRI, spatial/frequency compounding, panoramic imaging, stress echo, Cube Strain, Live HQ, and needle visualization; operated by physicians in clinical settings; provides real-time visualization and measurements on a wide flat panel display; output supports clinical decision-making for soft tissue and blood flow evaluation; benefits include optimized diagnostic workflow and image quality.

Clinical Evidence

No clinical data was required to support substantial equivalence. The device was evaluated through bench testing, including biocompatibility, acoustic output, thermal, electrical, electromagnetic, and mechanical safety testing, confirming conformance to applicable standards.

Technological Characteristics

Ultrasound imaging system with multiple transducer types (convex, linear, phased, endocavity, pencil). Supports B, M, PWD, CWD, Color/Power Doppler, and Tissue Harmonic Imaging. Connectivity via standard ultrasound interfaces. Biocompatible patient-contact materials. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD-2, and NEMA UD-3.

Indications for Use

Indicated for qualified physicians to evaluate soft tissue and blood flow in fetal, abdominal, pediatric, small organ, neonatal/adult cephalic, trans-rectal/vaginal, musculoskeletal, cardiac, peripheral vascular, and urological applications.

Regulatory Classification

Identification

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

Predicate Devices

E-CUBE 11 (K161439)
E-CUBE i7 (K153424)
E-CUBE 7 (K132687)
HS70A (K163691)
EPIQ 5 / EPIQ 7 (K163120)

Related Devices

K181617 — E-CUBE 8 · Alpinion Medical Systems Co., Ltd. · Oct 11, 2018
K161439 — E-CUBE 11 · Alpinion Medical Systems Co., Ltd. · Sep 21, 2016
K123611 — E-CUBE 7 · Alpinion Medical Systems Co., Ltd. · Dec 21, 2012
K132687 — E-CUBE 7 · Alpinion Medical Systems Co., Ltd. · Nov 27, 2013
K213523 — X-CUBE i8, X-CUBE i9 · Alpinion Medical Systems Co., Ltd. · Jan 28, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ December 14, 2017 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. ALPINION MEDICAL SYSTEMS Co., Ltd. % Boyeon CHO Quality Management Representative (QMR) 1FL and 6FL, Verdi Tower, 72, Digital-ro 26-gil, Guro-gu Seoul. 08393 REPULIC OF KOREA Re: K172732 Trade/Device Name: E-CUBE 8 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 27, 2017 Received: November 29, 2017 Dear Boyeon CHO: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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. {1}------------------------------------------------ Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. #### 510(k) Number (if known) #### K172732 Device Name E-CUBE 8 #### Indications for Use (Describe) 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); Neonatal Cephalic, Adult Cephalic; Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vascular (PV); and Urology (including prostate). Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # E-CUBE 8 Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | | |------------------------------------------|-------------------|---|-----|-----|------------------|------------------|-------------------------------|------------------------|----------------------| | | B | M | PWD | CWD | Color Doppler | Power Doppler | Tissue Harmonic Imaging | Combined* (Specify) | Other** (Specify) | | Ophthalmic | | | | | | | | | | | Fetal | N | N | N | N | N | N | N | N | N | | Abdominal | N | N | N | N | N | N | N | N | N | | Intra-operative (Specify) | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | Laparoscopic | | | | | | | | | | | Pediatric | N | N | N | N | N | N | N | N | N | | Small Organ (breast, testes, thyroid) | N | N | N | N | N | N | N | N | N | | Neonatal Cephalic | N | N | N | N | N | N | N | N | N | | Adult Cephalic | N | N | N | N | N | N | N | N | N | | Trans-rectal | N | N | N | N | N | N | N | N | N | | Trans-vaginal | N | N | N | N | N | N | N | N | N | | Trans-urethral | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | Musculo-skeletal (Conventional) | N | N | N | N | N | N | N | N | N | | Musculo-skeletal (Superficial) | N | N | N | N | N | N | N | N | N | | Intravascular | | | | | | | | | | | Cardiac Adult | N | N | N | N | N | N | N | N | N | | Cardiac Pediatric | N | N | N | N | N | N | N | N | N | | Intravascular (Cardiac) | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | Peripheral vessel | N | N | N | N | N | N | N | N | N | | Urology (including prostate) | N | N | N | N | N | N | N | N | N | 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) {4}------------------------------------------------ ## E-CUBE 8 with C1-6CT 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) | 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 | N | N | | N | N | N | N | | N = new indication; P = previously cleared; 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) {5}------------------------------------------------ ### E-CUBE 8 with C5-8NT Transducer Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | | Other** (Specify) | |------------------------------------------|-------------------|---|-----|-----|------------------|------------------|-------------------------------|------------------------|--|----------------------| | | B | M | PWD | CWD | Color Doppler | Power Doppler | Tissue Harmonic Imaging | Combined* (Specify) | | | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | P | P | P | | P | P | P | P | | | | Intra-operative (Specify) | | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Pediatric | P | P | P | | P | P | P | P | | | | Small Organ (breast, testes, thyroid) | | | | | | | | | | | | Neonatal Cephalic | N | N | N | | N | N | N | N | | | | Adult Cephalic | | | | | | | | | | | | Trans-rectal | | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | | Trans-urethral | | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Cardiac Adult | P | P | P | | P | P | P | P | | | | Cardiac Pediatric | N | N | N | | N | N | N | N | | | | 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 K153424; E = added under appendix * Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {6}------------------------------------------------ ### E-CUBE 8 L3-12T with 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 | | | Intra-operative (Specify) | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | Laparoscopic | | | | | | | | | | | Pediatric | P | P | P | | P | P | P | P | | | Small Organ (breast, testes, thyroid) | P | P | P | | P | P | P | P | | | Neonatal Cephalic | N | N | N | | N | N | N | N | | | Adult Cephalic | | | | | | | | | | | Trans-rectal | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | Trans-urethral | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | Musculo-skeletal (Conventional) | P | P | P | | P | P | P | P | | | Musculo-skeletal (Superficial) | P | P | P | | P | P | P | P | | | Intravascular | | | | | | | | | | | Cardiac Adult | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | Peripheral vessel | P | P | P | | P | P | P | P | | | Urology (including prostate) | | | | | | | | | | N = new indication; P = previously cleared by FDA K153424; 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) {7}------------------------------------------------ ## E-CUBE 8 with L3-12H Transducer Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | | | |------------------------------------------|-------------------|---|-----|-----|------------------|------------------|-------------------------------|------------------------|----------------------|--| | | B | M | PWD | CWD | Color Doppler | Power Doppler | Tissue Harmonic Imaging | Combined* (Specify) | Other** (Specify) | | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | 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) | P | P | P | | P | P | P | P | | | | Neonatal Cephalic | N | N | N | | N | N | N | N | | | | Adult Cephalic | | | | | | | | | | | | Trans-rectal | | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | | Trans-urethral | | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | | Musculo-skeletal (Conventional) | P | P | P | | P | P | P | P | | | | Musculo-skeletal (Superficial) | P | P | P | | P | P | P | P | | | | Intravascular | | | | | | | | | | | | Cardiac Adult | | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | | Peripheral vessel | P | P | P | | P | P | P | P | | | | Urology (including prostate) | | | | | | | | | | | N = new indication; P = previously cleared by FDA K161439; E = added under appendix * Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD) Prescription User (Per 21 CFR 801.109) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {8}------------------------------------------------ # E-CUBE 8 L3-12H™P with 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) | P | P | P | | P | P | P | P | | | Neonatal Cephalic | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | Trans-rectal | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | Trans-urethral | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | Musculo-skeletal (Conventional) | P | P | P | | P | P | P | P | | | Musculo-skeletal (Superficial) | P | P | P | | P | P | P | P | | | Intravascular | | | | | | | | | | | Cardiac Adult | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | Peripheral vessel | P | P | P | | P | P | P | P | | | Urology (including prostate) | | | | | | | | | | N = new indication; P = previously cleared by FDA K161439; 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) {9}------------------------------------------------ ## E-CUBE 8 with SP3-8T 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 | N | | | Abdominal | P | P | P | P | P | P | P | P | | | Intra-operative (Specify) | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | Laparoscopic | | | | | | | | | | | Pediatric | P | P | P | P | P | P | P | P | | | Small Organ (breast, testes, thyroid) | | | | | | | | | | | Neonatal Cephalic | N | N | N | N | N | N | N | N | | | Adult Cephalic | P | P | P | P | P | P | P | P | | | Trans-rectal | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | Trans-urethral | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | Intravascular | | | | | | | | | | | Cardiac Adult | P | P | P | P | P | P | P | P | | | Cardiac Pediatric | P | P | P | P | P | P | P | P | | | Intravascular (Cardiac) | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | Peripheral vessel | | | | | | | | | | | Urology (including prostate) | | | | | | | | | | N = new indication; P = previously cleared by FDA K153424; 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) {10}------------------------------------------------ ## E-CUBE 8 with P1-5CT 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 | N | N | N | | N | N | N | N | | | 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 | N | N | N | N | N | N | N | N | | | 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/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {11}------------------------------------------------ ## E-CUBE 8 with VC1-6T 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 | 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 (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 | N = new indication; P = previously cleared; 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) {12}------------------------------------------------ ### E-CUBE 8 with EV3-10T 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 | Power | Tissue | Combined* | Other** | | | | | | | Doppler | Doppler | Harmonic Imaging | (Specify) | (Specify) | | Ophthalmic | | | | | | | | | | | Fetal | N | N | N | | N | N | N | N | | | Abdominal | | | | | | | | | | | Intra-operative (Specify) | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | Laparoscopic | | | | | | | | | | | Pediatric | | | | | | | | | | | Small Organ (breast, testes, thyroid) | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | Trans-rectal | P | P | P | | P | P | P | P | | | Trans-vaginal | P | P | P | | P | P | P | P | | | 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 | N | N | N | | N | N | N | N | | | Urology (including prostate) | P | P | P | | P | P | P | P | | N = new indication; P = previously cleared by FDA K153424; 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) {13}------------------------------------------------ ### E-CUBE 8 with EC3-10T 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 | N | | | Abdominal | | | | | | | | | | | Intra-operative (Specify) | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | Laparoscopic | | | | | | | | | | | Pediatric | | | | | | | | | | | Small Organ (breast, testes, thyroid) | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | Trans-rectal | P | P | P | P | P | P | P | P | | | Trans-vaginal | P | P | P | P | P | P | P | P | | | 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 | N | N | N | N | N | N | N | N | | | Urology (including prostate) | P | P | P | P | P | P | P | P | | N = new indication; P = previously cleared by FDA K153424; 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) {14}------------------------------------------------ ### E-CUBE 8 with E3-10 Transducer Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | | |------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|-------------------------------|------------------------|----------------------| | | B | M | PWD | CWD | Color Doppler | Power Doppler r | Tissue Harmonic Imaging | Combined* (Specify) | Other** (Specify) | | Ophthalmic | | | | | | | | | | | Fetal | P | P | P | | P | P | P | P | | | Abdominal | | | | | | | | | | | Intra-operative (Specify) | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | Laparoscopic | | | | | | | | | | | Pediatric | | | | | | | | | | | Small Organ (breast, testes, thyroid) | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | Trans-rectal | P | P | P | | P | P | P | P | | | Trans-vaginal | P | P | P | | P | P | P | P | | | 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 | N | N | N | N | N | N | N | N | | | Urology (including prostate) | P | P | P | | P | P | P | P | | N = new indication; P = previously cleared by FDA K132687; 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) {15}------------------------------------------------ ### E-CUBE 8 with CW2.0 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 | | | | | | | | | | | Small Organ (breast, testes, thyroid) | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | Trans-rectal | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | Trans-urethral | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | Intravascular | | | | | | | | | | | Cardiac Adult | | | | P | | | | | | | Cardiac Pediatric | | | | P | | | | | | | Intravascular (Cardiac) | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | Peripheral vessel | | | | | | | | | | | Urology (including prostate) | | | | | | | | | | N = new indication; P = previously cleared by FDA K161439; 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) {16}--------------…