Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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

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 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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the eZono™ 4000 Diagnostic Ultrasound System. It is a submission for a new medical device that seeks to demonstrate substantial equivalence to previously cleared predicate devices, rather than a study proving the device meets specific acceptance criteria through a clinical trial.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or directly available in this type of regulatory submission. The submission focuses on non-clinical tests to show conformity to standards and similarities in construction, operating principles, and specifications to predicate devices.

Here's an attempt to answer the questions based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present in a 510(k) summary format:

1. A table of acceptance criteria and the reported device performance

This document does not contain a table of acceptance criteria in the sense of performance metrics typically found in a clinical study report (e.g., sensitivity, specificity, accuracy). Instead, it lists the standards to which the device conforms and the quality assurance measures applied during its development.

Acceptance Criteria (Type of Conformity/Measure)	Reported Device Performance (Nature of Conformity/Outcome)
System specifications	Conforms to system specifications
Thermal safety	Conforms to thermal safety standards
Electrical safety	Conforms to electrical safety standards
Electromagnetic safety	Conforms to electromagnetic safety standards
Mechanical safety	Conforms to mechanical safety standards
FDA consensus medical device safety standards	Conforms to FDA consensus medical device safety standards
International harmonized standards	Conforms to international harmonized standards
AAMI HE75:2009 Human factors engineering	Complies with AAMI HE75:2009
IEC 60601-1 Medical electrical equipment	Complies with IEC 60601-1
IEC 60601-1-2 EMC standard	Complies with IEC 60601-1-2
IEC 60601-2-37 Ultrasonic medical diagnostic equipment	Complies with IEC 60601-2-37
IEC 62304 Medical device software life cycle	Complies with IEC 62304
IEC 62366 Usability engineering	Complies with IEC 62366
ISO 10993-1 Biological evaluation (general)	Complies with ISO 10993-1; patient contact materials are biocompatible
ISO 10993-5 In vitro cytotoxicity	Complies with ISO 10993-5; patient contact materials are biocompatible
ISO 10993-10 Irritation & delayed-type hypersensitivity	Complies with ISO 10993-10; patient contact materials are biocompatible
ISO 14971 Risk management	Complies with ISO 14971
Risk Analysis	Applied during development
Requirements Reviews	Applied during development
Design Reviews	Applied during development
Testing on unit level (Module verification)	Applied during development
Integration testing (System verification)	Applied during development
Final Acceptance Testing (Validation)	Applied during development
Performance testing (Verification)	Applied during development
Safety testing (Verification)	Applied during development

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not Applicable. No clinical studies or test sets (in the sense of patient data for performance evaluation) are mentioned as having been required or conducted for this 510(k) submission.
Data provenance: Not Applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No test set requiring expert-established ground truth is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC study: Not Applicable. This is an ultrasound diagnostic system, and the submission is for substantial equivalence without clinical studies. It does not describe an AI component for interpretation or assistance that would necessitate an MRMC study.
Effect size: Not Applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. The device is a diagnostic ultrasound system, not a standalone AI algorithm for interpretation. Its needle guidance feature assists the human operator.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable. No clinical studies requiring ground truth were conducted or referenced in this submission for device performance. The "ground truth" for the device's claims of safety and effectiveness relies on its conformance to established standards and its substantial equivalence to predicate devices.

8. The sample size for the training set

Not Applicable. This submission describes a diagnostic ultrasound system and its software, not a machine learning model requiring a training set from patient data. The "training" for the device's development involved conformance to standards and engineering verification/validation.

9. How the ground truth for the training set was established

Not Applicable. As no training set for a machine learning model is mentioned, no ground truth establishment method for it is relevant.

Summary

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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 AGSpitzweidenweg 30Jena, GERMANY D-07743
Contact Person:	Graham CoxCEOeZono AGSpitzweidenweg 30Jena, GERMANY D-07743
Telephone:	425.408.0743
FR Numbers/Product Codes:	892.1550/IYN, Ultrasonic Pulsed Doppler Imaging System892.1560/IYO, Ultrasonic Pulsed Echo Imaging System892.1570/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:

1. Added the clinical application "magnetic needle quidance" to the system.
1. 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.
1. Add the following supported accessories:
1. eZono 4000 Sterile Needle Magnetizer with trade name "eZMag"

510(k) Summary

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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
1. IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
1. IEC 60601-1-2 Medical Electrical Equipment, Part 1: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
1. 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
1. ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing
1. 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
1. 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

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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 .

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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."

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、・

۱۳۹۰۰ ۱۳۹۰ ۱۳۹۸-۰۹-

System:eZono™ 4000
Currently Supported1Transducer:
Intended		Diagnostic ultrasound imaging or fluid flow analysis of the human

body as follows:Use:
Clinical Application						Mode of Operation
General(Track Ionly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler(CD)	Combined (B+CD)	Other*(ColorPowerDoppler)
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
IntendedUse:	Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows:
Clinical Application					Mode of Operation
General(Track Ionly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler(CD)	Combined(B+CD)	Other*(ColorPowerDoppler)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Abdominalorgans 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 ortherapeutic procedures (e.g.biopsies, punctures, freefluid detection, regionalanesthesia, 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
IntendedUse: Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows:
Clinical Application		Mode of Operation
General(Track Ionly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler(CD)	Combined (B+CD)	Other*(ColorPowerDoppler)
Ophthalmic	Ophthalmic
	Fetal	N	N			N	N	N
	Abdominal	N	N			N	N	N
	Intra-operative (Abdominalorgans 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 ortherapeutic procedures (e.g.biopsies, punctures, freefluid detection, regionalanesthesia, 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 Ionly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler(CD)	Combined(B+CD)	Other*(ColorPowerDoppler)
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 CephalicAdult 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

Regulation Number and Section

§ 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.