(26 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the device description focuses on hardware and basic software functionalities like needle guidance based on magnetic detection.
No
The document explicitly states the intended use is for "Diagnostic ultrasound imaging or fluid flow analysis". While it mentions aiding in procedures like needle guidance, the core function is diagnostic imaging to visualize anatomy or procedures, not to deliver therapeutic treatment.
Yes
Explanation: The 'Intended Use / Indications for Use' explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". The device is described as a "sonography system" that acquires and displays "real-time ultrasound images," which are used for diagnostic purposes in various anatomical sites.
No
The device description explicitly states it is a "portable, software-controlled sonography system" with a physical casing, screen, and transducers, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes diagnostic ultrasound imaging and fluid flow analysis of various parts of the human body. This is a form of in vivo imaging, meaning it's performed on a living organism.
- Device Description: The description details a portable ultrasound system that acquires and displays real-time ultrasound images. This aligns with in vivo imaging technology.
- Lack of IVD Characteristics: There is no mention of analyzing samples taken from the human body (like blood, urine, tissue, etc.) or performing tests in vitro (in a lab setting).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device operates by sending and receiving sound waves through the body to create images, which is a different diagnostic approach.
N/A
Intended Use / Indications for Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body. The indications for use of the eZono™ 4000, as defined by FDA guidance documents, are: Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testicle), Musculo-skeletal (Conventional), Musculo-sketal (Superficial). Invasive diagnosic or therapeutic procedures, Retroperitoneum, Female reproductive system and fetus. Superficial structures & pathologies, Peripheral Vessel, Magnetic Needle guidance.
This applies to the system and the supported transducers: L3-12NGS, CL1-6, and L3-12.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The eZono 4000 system is a portable, software-controlled sonography system based on a digital architecture. It supports linear and curvi-linear transducers. The eZono 4000 system has an ergonomic design optimized for stable handling without sharp edges and is very easy to carry with its low weight of 11.5lbs (5.2kg). The robust casing provided with an anti-slip bottom side. The brilliant 12-inch screen with more than 60 million colors makes it possible to acquire and display high-resolution, real-time ultrasound images. The eZono Needle Guide System detects the position and orientation of magnetized needles in the presence of the probe and displays this information relative to the ultrasound image. This guides the operator to better visualize the needle in the ultrasound image during ultrasound guided needling procedures.
The eZono 4000™ Ultrasound System has similar construction, manufacturing materials, operating principals and specifications as the predicate device. The eZono 4000 Ultrasound System magnetic needle guidance system has similar operating principals and specifications as the predicate device.
The differences between the eZono 4000 Ultrasound System and the predicate eZono 3000 Ultrasound System include the following:
- Added the clinical application "magnetic needle guidance" to the system.
- Add supported transducer: L3-12NGS, L3-12 and CL1-6.
- Introduced the trade name of eZono 4000 and eZGuide for the ultrasound system and needle guidance system respectively.
- Add the following supported accessories:
- eZono 4000 Sterile Needle Magnetizer with trade name "eZMag"
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
- Fetal
- Abdominal
- Pediatric
- Small Organ (breast, thyroid, testicle)
- Musculo-skeletal (Conventional)
- Musculo-skeletal (Superficial)
- Retroperitoneum
- Female reproductive system & fetus
- Superficial structures & pathologies
- Peripheral Vessel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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, eZono 4000 System, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K120234, K112953, K111818, K130173
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K140254
Page 1 of
eZono AG
eZono™ 4000 Diagnostic Ultrasound System 510(k) Premarket Notification
November 22, 2013
510(k) Summary
In accordance with 21 CFR 807.92(c) the following summary of information is provided:
FEB 2 6 2014
| Date Prepared: | November 22, 2013 | |
|---|---|---|
| Submitter: | eZono AG | |
| Spitzweidenweg 30 | ||
| Jena, GERMANY D-07743 | ||
| Contact Person: | Graham Cox | |
| CEO | ||
| eZono AG | ||
| Spitzweidenweg 30 | ||
| Jena, GERMANY D-07743 | ||
| Telephone: | 425.408.0743 | |
| FR Numbers/Product Codes: | 892.1550/IYN, Ultrasonic Pulsed Doppler Imaging System | |
| 892.1560/IYO, Ultrasonic Pulsed Echo Imaging System | ||
| 892.1570/ITX, Diagnostic Ultrasound Transducer | ||
| Common Name: | Diagnostic Ultrasound System with Accessories | |
| Trade Name: | eZono™ 4000 Ultrasound System | |
| Regulatory Class: | Class II | |
| Classification Panel: | Radiology | |
| Predicate Device(s): | eZono™ 3000 Series Ultrasound System (K120234) | |
| Terason t3000 Ultrasound Systems With Updated Needle Guidance Graphics (K112953) | ||
| Ultrasonix Sonixgps Needle Sensor (K111818) | ||
| SonoSite M-Turbo (K130173) | ||
| Intended Use/ | Diagnostic ultrasound imaging or fluid flow analysis of the human body | |
| Indications For Use: | The indications for use of the eZono™ 4000, as defined by FDA guidance documents, are: | |
| Fetal | Invasive diagnostic or therapeutic | |
| Abdominal | Retroperitoneum | |
| Pediatric | Female reproductive system and | |
| Small Organ (breast, thyroid, | Superficial structures & pathologies |
Musculo-skeletal
Musculo-skeletal (Superficial)
Peripheral Vessel
Magnetic Needle guidance
1
Device Description: The eZono 4000 system is a portable, software-controlled sonography system based on a digital architecture. It supports linear and curvi-linear The eZono 4000 system has an ergonomic design transducers. optimized for stable handling without sharp edges and is very easy to carry with its low weight of 11.5lbs (5.2kg). The robust casing provided with an anti-slip bottom side. The brilliant 12-inch screen with more than 60 million colors makes it possible to acquire and display highresolution, real-time ultrasound images. The eZono Needle Guide System detects the position and orientation of magnetized needles in the presence of the probe and displays this information relative to the ultrasound image. This quides the operator to better visualize the needle in the ultrasound image during ultrasound guided needling procedures.
The eZono 4000™ Ultrasound System has similar construction, Device
Modifications :
manufacturing materials, operating principals and specifications as the predicate device. The eZono 4000 Ultrasound System magnetic needle guidance system has similar operating principals and specifications as the predicate device.
The differences between the eZono 4000 Ultrasound System and the predicate eZono 3000 Ultrasound System include the following:
-
- Added the clinical application "magnetic needle quidance" to the system.
-
- Add supported transducer: L3-12NGS, L3-12 and CL1-6.
- ని. Introduced the trade name of eZono 4000 and eZGuide for the ultrasound system and needle guidance system respectively.
-
- Add the following supported accessories:
-
- eZono 4000 Sterile Needle Magnetizer with trade name "eZMag"
510(k) Summary
2
K140254
Page 3 of 3
Determination of
Substantial
Equivalence:
Summary of Non-Clinical Tests: The eZono 4000 System has been found to conform to the system specifications, thermal, electrical, electromagnetic and mechanical safety, and to FDA consensus, medical device safety standards, and international harmonized standards. The eZono 4000 System and its applications comply with the following standards:
- AAM1 HE75:2009 Human factors engineering Design of 1. medical devices
-
- IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-
- IEC 60601-1-2 Medical Electrical Equipment, Part 1: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
-
- IEC 60601-2-37 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- ട്. IEC 62304 Medical device software - Software life cycle processes
- റ. IEC 62366 Medical devices - Application of usability engineering to medical devices
-
- ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing
-
- ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ல் ISO 10993-10 Biological evaluation of medical devices -Part 10: Tests for irritation and delayed-type hypersensitivity
-
- ISO 14971 Medical devices - application of risk management to medical devices
The following quality assurance measures were applied to the development of the system:
- Risk Analysis .
- . Requirements Reviews
- ↓ Design Reviews
- . Testing on unit level (Module verification)
- . Integration testing (System verification)
- . Final Acceptance Testing (Validation)
- Performance testing (Verification) �
- Safety testing (Verification)
Transducer materials and other patient contact materials are biocompatible.
Summary of Non-Clinical Tests:
The subject of this premarket submission, eZono 4000 System, did not require clinical studies to support substantial equivalence.
Substantial Equivalence:
The modified eZono 4000 System has similar construction, manufacturing materials, operating principals and specifications as the predicate devices. Therefore, eZono AG considers the modified eZono 4000 System substantially equivalent to the predicate devices.
510(k) Summary
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three curved lines representing its wings or feathers.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 26, 2014
eZono AG % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K140254 Trade/Device Name: eZono™ 4000 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: February 4, 2014 Received: February 5, 2014
Dear Mr. Job:
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 following transducers intended for use with the eZono 1 4000, as described in your premarket notification:
Transducer Model Number
L3-12NGS
CLI-6
L3-12
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.
4
Page 2-Mr. Job
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. 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/Medicall.bevices/Safety/ReportalProblem/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,
Smh.7)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure .
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140554
Device Name eZono™ 4000
Indications for Use (Describe)
Intended Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications For Use:
The indications for use of the eZono™ 4000. as defined by FDA guidance documents, are:
Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testicle), Musculo-skeletal (Conventional), Musculo-sketal (Superficial). Invasive diagnosic or therapeutic procedures, Retroperitoneum, Female reproductive system and fetus. Superficial structures & pathologies, Peripheral Vessel, Magnetic Needle guidance
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
Smh.7)
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."
6
- :
、・
۱۳۹۰۰ ۱۳۹۰ ۱۳۹۸-۰۹-
| System:
| eZono™ 4000 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Currently Supported1 | |||||||||
| Transducer: | |||||||||
| Intended | Diagnostic ultrasound imaging or fluid flow analysis of the human | ||||||||
| body as follows: | |||||||||
| Use: | |||||||||
| Clinical Application | Mode of Operation | ||||||||
| General | |||||||||
| (Track I | |||||||||
| only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | |||||||||
| (CD) | Combine | ||||||||
| d (B+CD) | Other* | ||||||||
| (Color | |||||||||
| Power | |||||||||
| Doppler) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | ||||
| Abdominal | P | P | P | P | P | ||||
| Intra-operative (Abdominal | |||||||||
| organs and vascular) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging | Laparoscopic | ||||||||
| & Other | Pediatric | P | P | P | P | P | |||
| Small Organ (breast, thyroid, | |||||||||
| testicles) | P | P | P | P | P | ||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | P | P | P | P | P | ||||
| Musculo-skel. (Superfic.) | P | P | P | P | P | ||||
| Intravascular | |||||||||
| Invasive diagnostic or | |||||||||
| therapeutic procedures (e.g. | |||||||||
| biopsies, punctures, free | |||||||||
| fluid detection, regional | |||||||||
| anesthesia, vascular access, | |||||||||
| magnetic needle guidance) | N | N | N | N | N | ||||
| Retroperitoneum | P | P | P | P | P | ||||
| Female reproductive system | |||||||||
| & Fetus (transcutaneous) | P | P | P | P | P | ||||
| Superficial structures & | |||||||||
| pathologies | P | P | P | P | P | ||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | |||||||||
| Intra-cardiac | |||||||||
| Other (spec.) | |||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | |||
| Vessel | Magnetic needle guidance | N | N | N | N | N |
Table 1.3- 1 Indications for Use Form - eZono 4000 System
Prescription Use (Per 21 CFR 801.109)
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
"Exemples of other modes of operation may include Dopler, 3-D Imaging, Harmanic Imaging, Tissue Motion Dopper, and
Color Velocity Imaging
- Supported transfucer models are L3-12NGS, CL1-6, and L3-12. See their corresponding IFU tables.
All items marked "P" were proviously cleared in 510(k) K120234
7
| System:
| eZono™ 4000 | ||||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | ||||||||
| L3-12NGS | ||||||||
| Intended | ||||||||
| Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human | |||||||
| body as follows: | ||||||||
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track I | ||||||||
| only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | ||||||||
| (CD) | Combined | |||||||
| (B+CD) | Other* | |||||||
| (Color | ||||||||
| Power | ||||||||
| Doppler) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Abdominal | ||||||||
| organs and vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | N | |||
| Small Organ (breast, thyroid, | ||||||||
| testicles) | N | N | N | N | N | |||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | N | |||
| Musculo-skel. (Superfic.) | N | N | N | N | N | |||
| Intravascular | ||||||||
| Invasive diagnostic or | ||||||||
| therapeutic procedures (e.g. | ||||||||
| biopsies, punctures, free | ||||||||
| fluid detection, regional | ||||||||
| anesthesia, vascular access, | ||||||||
| magnetic needle guidance) | N | N | N | N | N | |||
| Retroperitoneum | ||||||||
| Female reproductive system | ||||||||
| & Fetus | ||||||||
| Superficial structures & | ||||||||
| pathologies (Incl. lungs) | N | N | N | N | N | |||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Intra-cardiac | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | ||
| Magnetic needle guidance | N | N | N | N | N |
Table 1.3- 2 Indications for Use Form - eZono 4000, L3-12NGS Transducer
Prescription Use (Per 21 CFR 801.109)
N= new indicallon; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
"Examples of other modes of operation may include Dopter. 3-D Imaging, Harmonic Inaging, Tissue Molion Doppler, and Color Velocity Imaging
All items marked "P" were previously cleared in 510(k) K120234
8
| System:
| eZono™ 4000 | ||||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | ||||||||
| CL1-6 | ||||||||
| Intended | ||||||||
| Use: Diagnostic ultrasound imaging or fluid flow analysis of the human | ||||||||
| body as follows: | ||||||||
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track I | ||||||||
| only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | ||||||||
| (CD) | Combine | |||||||
| d (B+CD) | Other* | |||||||
| (Color | ||||||||
| Power | ||||||||
| Doppler) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | N | N | N | N | |||
| Abdominal | N | N | N | N | N | |||
| Intra-operative (Abdominal | ||||||||
| organs and vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | N | N | N | N | N | |||
| Small Organ (breast, thyroid, | ||||||||
| testicles) | ||||||||
| Neonatal Cephalic | N | N | N | N | N | |||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | N | |||
| Musculo-skel. (Superfic.) | N | N | N | N | N | |||
| Intravascular | ||||||||
| Invasive diagnostic or | ||||||||
| therapeutic procedures (e.g. | ||||||||
| biopsies, punctures, free | ||||||||
| fluid detection, regional | ||||||||
| anesthesia, vascular access) | ||||||||
| N | N | N | N | N | ||||
| Retroperitoneum | N | N | N | N | N | |||
| Female reproductive system | ||||||||
| & Fetus | N | N | N | N | N | |||
| Superficial structures & | ||||||||
| pathologies (Incl. lungs) | N | N | N | N | N | |||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Intra-cardiac | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | ||
| Vessel | Magnetic needle guidance |
Table 1.3- 3 Indications for Use Form -- eZono 4000, CL1-6 Transducer
Prescription Use (Per 21 CFR 801.109)
N= new indication: P= previously cleared by FDA: E= added under Appendix E
Additional Comments:
"Examples of other modes of operation may include. A-mode, Amplitude Doppler. 3-D Imaging. Harmonic Inasue Motion Doper, and
Color Velocity imaging
All items marked "P" were previously cleared in 510(k) K120234
9
| System: | eZono™ 4000 | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | L3-12 | |||||||
| Intended | Diagnostic ultrasound imaging or fluid flow analysis of the human | |||||||
| Use: | body as follows: | |||||||
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track I | ||||||||
| only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | ||||||||
| (CD) | Combined | |||||||
| (B+CD) | Other* | |||||||
| (Color | ||||||||
| Power | ||||||||
| Doppler) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Abdominal | ||||||||
| organs and vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | Laparoscopic | |||||||
| & Other | Pediatric | N | N | N | N | N | ||
| Small Organ (breast, thyroid, | N | |||||||
| testicles) | N | N | N | N | ||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethra! | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | N | N | N | N | N | |||
| Musculo-skel. (Superfic.) | N | N | N | N | N | |||
| Intravascular | ||||||||
| Invasive diagnostic or | ||||||||
| therapeulic procedures (e.g. | ||||||||
| biopsies, punctures, free | ||||||||
| fluid detection, regional | ||||||||
| anesthesia. vascular access) | N | N | N | N | N | |||
| Retroperitoneum | ||||||||
| Female reproductive system | ||||||||
| & Fetus | ||||||||
| Superficial structures & | N | N | N | |||||
| pathologies (Incl. lungs) | N | N | ||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Intra-cardiac | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | ||
| Vessel | Magnetic needle guidance |
Table 1.3- 4 Indications for Use Form -- eZono 4000, L3-12 Transducer
Prescription Use (Per 21 CFR 801.109)
N= new indication: P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
"Examples of other modes of operation may include Doppler, 3-0 Imaging, Harmonic Imaging, Tissue Motion Dopper, and Color Velocity Imaging
All items marked "P" were previously cleared in 510(k) K120234
Indications for Use