(30 days)
No
The document does not mention AI, ML, or related terms, nor does it describe any training or test sets typically associated with AI/ML development. The description focuses on standard ultrasound system features and safety testing.
No
The device is an ultrasound imaging system intended for medical diagnosis and evaluation, not for treating conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is for "evaluation of soft tissue and blood flow," and the "Device Description" clearly labels it as an "ultrasound imaging system for medical diagnosis." These phrases directly indicate its diagnostic purpose.
No
The device description explicitly states it is an "ultrasound imaging system" and mentions hardware components like a "flat panel display" and "control panel," indicating it is a physical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "evaluation of soft tissue and blood flow" in various anatomical sites. This describes a diagnostic imaging system used on the patient, not a device used to test samples from the patient (like blood, urine, or tissue) in a laboratory setting.
- Device Description: The description confirms it's an "ultrasound imaging system for medical diagnosis." Ultrasound is a non-invasive imaging modality applied externally or internally to the body.
- Input Imaging Modality: The input modalities are "Ultrasonic Pulsed Doppler Imaging System" and "Ultrasonic Pulsed Echo Imaging System," both of which are methods for generating images of internal body structures and blood flow.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
In summary, this device is a medical imaging system used for in-vivo diagnosis, not an in-vitro diagnostic device.
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 & pediatric); Peripheral Vascular (PV); and Urology (including prostate).
Product codes
IYN, IYO, ITX
Device Description
E-CUBE 7 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 18.5" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Trans-rectal; Trans-vaginal; Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac (adult & pediatric); Peripheral Vascular (PV); Urology (including prostate).
Indicated Patient Age Range
Adult & Pediatric (for Cardiac applications). Specific age ranges for other applications are not mentioned but implied by "Fetal" and "Pediatric" indications.
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 7, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K120060 E-CUBE 9 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) Summary
DEC 2 1 2012
In accordance with 21CFR807.92, the following summary of information is provided;
Date Nov 13ª 2012
Submitter: ALPINION MEDICAL SYSTEMS Co., Ltd. Address: 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu, Seoul, Republic of Korea 152-848
· Primary Contact Person
Donghwan Kim QARA Manager Address: 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu, Seoul, Republic of Korea 152-848 Phone: +82 70 7465 2068 Fax: +82 2 851 5590 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
E-CUBE 7 Device Trade Name:
Common/Usual Name: Ultrasonic Pulsed Doppler Imaging System
Classification Names System, Imaging, Pulsed Doppler Ultrasonic
Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550 90-Product Code: IYN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO
Diagnostic Ultrasound Transducer, 21CFR 892.1570, 90-ITX
K120060 E-CUBE 9 Diagnostic Ultrasound System Predicate Device(s)
Device Description: E-CUBE 7 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 18.5" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
Indications For Use: The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ testes. thyroid); Trans-rectal(TR); Trans-vaginal(TV); (breast, Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult & pediatric); Peripheral Vascular (PV); and Urology (including prostate).
ALPINION MEDICAL SYSTEMS Co., Ltd.
E-J
1
E-CUBE 7 employs the same fundamental scientific technology as Technology: its predicate device.
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
E-CUBE 7 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 7 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 7
- � 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 7, did not require clinical studies to support substantial equivalence.
Conclusion:
Alpinion Medical Systems Co., Ltd. considers E-CUBE 7 to be as safe, as effective. Performance, technology and software are substantially equivalent to the predicate device.
The discussion about the technological and software . differences between E-CUBE 7 and the predicate device: Some image parameters are added for operational convenience which means these parameters do not affect to the measurement accuracy. So there is no significant difference in essential performance, safety and effectiveness with the predicate device and the image parameter functions do not change the intended use.
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 quidance documents.
F-2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized eagle-like symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 21, 2012
Mr. Donghwan Kim QARA Manger Alpinion Medical Systems, Co., Ltd l, 6 and 7FL, Verti Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu Seoul, 152-848 REPUBLIC OF KOREA
Re: K123611
Trade/Device Name: E-Cube 7 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX · Dated: November 21, 1012 Received: November 21, 2012
Dear Mr. Kim:
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.
This determination of substantial equivalence applies to the E-Cube 7 and the following transducers intended for use with the E-Cube 7 Ultrasonic pulsed Doppler Imaging System, as described in your premarket notification:
| Transducer Model Number | ||
|---|---|---|
| C1-6 | E3-10 | L3-12H |
| L3-12 | VC1-6 | SP3-8 |
| SP1-5 | L3-8 | |
| EN3-10 | SC1-6 |
3
Page 2-Mr. Kim
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 aft the Art or any Federal statutes and regulations administered by other Federal agencies. Your 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements 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.
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/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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Janine M. Morris -S
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: E-CUBE 7
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&pediatric); Peripheral Vascular (PV); and Urology (including prostate).
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Janine M. Morris -S
2012.12.21 11:07:34 -05'00' (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) K123611
E-I
5
E-CUBE 7 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 | P | P | P | P | P | P | P | N | |
| Abdominal | P | P | P | P | P | P | P | N | |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | N | |
| Small Organ | |||||||||
| (breast, testes, thyroid) | P | P | P | P | P | P | P | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | N | P | ||
| Trans-vaginal | P | P | P | P | P | N | P | ||
| 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 | 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 | P | P | P | P | P | P | P | ||
| Urology (including prostate) | P | P | P | P | P | P | P | N |
N = new indication; P = previously cleared by FDA K121729; 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 Diagnostics and Radiological Health (OIR) Janine M. Morris -S
2012.12.21 11:22:39 -05'00'
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) K123611
6
Diagnostic Ultrasound Indications for Use
E-CUBE 7 with C1-6 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 | P | P | P | | P | P | P | P | | |
| 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 | | | | | | | | | | |
| 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) | P | P | P | | P | P | P | P | | |
N = new indication; P = previously cleared by FDA K121729; 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 Diagnostics and Radiological Health (OIR)
Janine M. Morris -S 2012.12.21 11:23:01 -05'00'
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) K123611
7
E-CUBE 7 with L3-12 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 | P | P | P | P | P | P | P | |||
| 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 K121729; E = added under appendix |
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; ** Other: 3D, 4D
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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Janine M. Morris -5 2012.12.21 11:23:26 -05'00'
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) K123611
E-4
8
Diagnostic Ultrasound Indications for Use
E-CUBE 7 with SP1-5 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 | 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 | |||||||||
| 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 | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) |
Combined B/Color Doppler/PWD, B/Color Doppler/PWD, "Other" 2D / 3D / 4D
- Combined: 8/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 Diagnostics and Radiological Health (OIR) Janine M. Morris -S 2012.12.21 11:23:55 -05'00'
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) K123611
9
E-CUBE 7 with EN3-10 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 | 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 | P | P | P | P | P | N | P | ||
| Trans-vaginal | P | P | P | P | P | N | 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 | |||||||||
| Urology (including prostate) | P | P | P | P | P | N | P |
- 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 Diagnostics and Radiological Health (OIR) Janine M. Morris -S 2012.12.21 11:24:17 -05'00' (Division Sign Off) Division of Radiological Health
Office of In Vitro Diagnostic and Radiological Health
510(k) K123611
E-R
10
Diagnostic Ultrasound Indications for Use
E-CUBE 7 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 | 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 | P | P | P | P | P | P | |||
| Trans-vaginal | 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 | |||||||||
| Urology (including prostate) | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA K121729; E = added under appendix * Combined: 8/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 Diagnostics and Radiological Health (OIR) Janine M. Morris -S 2012.12.21 11:25:34 -05'00'
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) K123611.
11
Diagnostic Ultrasound Indications for Use
E-CUBE 7 with VC1-6 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 | P | P | P | P | P | P | P | P | |
| 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 | |||||||||
| 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) | P | P | P | P | P | P | P | N |
- 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 Diagnostics and Radiological Health (OIR) Janine M. Morris -S
2012.12.21 11:25:57 -05.00 (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) k/23611
12
Diagnostic Ultrasound Indications for Use
E-CUBE 7 with L3-8 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 | P | P | P | P | P | N | P | ||
| Small Organ | |||||||||
| (breast, testes, thyroid) | P | P | P | P | P | N | P | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | P | P | P | P | P | N | P | ||
| Musculo-skeletal | |||||||||
| (Superficial) | P | P | P | P | P | N | P | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | P | P | P | P | P | N | P | ||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA K120060; 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 Diagnostics and Radiological Health (OIR) Janine M. Morris -S 2012.12.21 11:26:19 -05'00'
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) k/23611
E-d
13
E-CUBE 7 with SC1-6 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 | P | P | P | P | P | P | P | ||
| 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 | |||||||||
| 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) | P | P | P | P | P | P | P |
- 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 Diagnostics and Radiological Health (OIR) Janine M. Morris -S 2012.12.21 1:1:26:44-05'00' (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) k/236//
14
E-CUBE 7 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 | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | N | P | ||
| Small Organ | |||||||||
| (breast, testes, thyroid) | P | P | P | P | P | N | P | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | P | P | P | P | P | N | P | ||
| Musculo-skeletal | |||||||||
| (Superficial) | P | P | P | P | P | N | P | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | P | P | P | P | P | N | P | ||
| Urology (including prostate) | |||||||||
| N = new indication; P = previously cleared by FDA K120060; 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 Diagnostics and Radiological Health (OIR) Janine M. Morris -S 2012.12.21 11:27:10 -05'00' (Division Sign Off). Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) k/236//
15
E-CUBE 7 with SP3-8 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 | 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 | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | 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 K120060; 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 Diagnostics and Radiological Health (OIR)
Janine M. Morris -S 2012.12.21 11:27:39 -05.00. (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) K123611