The device is intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal/obstetric, gynecological; Abdominal (renal, GYN/Pelvic; Intra-operative (abdominal, thoracic, and vascular). Intra-operative neurological; Pediatric; Small organ (thyroid, breast, testes, etc), Adult & Neonatal Cephalic; Trans-rectal, Trans-cranial, Trans-cranial, Trans-esophageal (non-cardiac); Musculoskeletal (conventional & superficial); 3D/4D; Cardiac - Adult/Pediatric/Fetal; Intra-Cardiac; Pelvio; Peripheral vascular; harmonic tissue and contrast imaging and Tissue elasticity.

Device Description

The z.one Ultra is a general purpose diagnostic ultrasound system which consists of a combination of portable scanner(s) less than 10 inches wide and 3 inches high, embedded in the cart, or that can be held by the user in one hand. They include buttons for controlling the system and may have a screen that display ultrasound mages and user interface or be without the screen (monitor) and user interface. The portable scanner can be held by the user in one hand accommodates a removable transducer module. Signals received from the transducer module are digitized and preprocessed. The transducer module comes into contact with the patient and both transmit and receive ultrasound energy.

The docking station (aka carts) provides holders for the portable scanner, and transducer modules, as well as battery chargers and other accessories. The modification for this submission includes new indication for use and off the shelf transducers.

AI/ML Overview

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary and associated forms do not detail specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or quantitative performance metrics for the ZONARE z.one Ultra Ultrasound System.

Instead, the submission primarily focuses on functional equivalence and compliance with recognized standards for safety and effectiveness. The "acceptance criteria" for this type of submission are implicitly tied to demonstrating that the device is "substantially equivalent" to predicate devices and adheres to relevant safety and performance standards.

The "reported device performance" is essentially that the device (including its transducers and new indications for use) performs comparably to the predicate devices and meets established safety benchmarks.

Here's how we can represent the "acceptance criteria" and "reported device performance" based on the document:

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Devices (K022858, K082326, K031066, K073709, K062247, K053069) in terms of:	"With respect to features and applications, the ZONARE z.one Ultra with the new ophthalmic indication for use and the off the shelf intra-cardiac echo catheter (View-Flex) is comparable and substantially equivalent to the currently marketed ZONARE z.one and the predicate devices listed in predicate devices section in terms of portability, features and functionality, they have the same important safety and effectiveness features, as well as design, materials, and construction."
- Portability	Comparable
- Features	Comparable
- Functionality	Comparable
- Safety and Effectiveness Features (Acoustic Output, Biocompatibility, Electrical/Mechanical Safety, etc.)	"The device has been evaluated according to the applicable medical device quality systems, safety standards for acoustic output, biocompatibility, verification, cleaning, and disinfection effectiveness as well as for thermal, electrical, and mechanical safety, those applicable to ZONARE's ultrasound product are: ISO 14971, IEC/UL 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37, IEC 62304, ISO 10993, AIUM Medical Ultrasound Safety (2002)." "The device conforms to applicable medical device safety standards and compliance for safety and effectiveness is verified through defined evaluation and market surveillance."
- Design, Materials, and Construction	Comparable
Compliance with Applicable Medical Device Safety Standards	"The device conforms to applicable medical device safety standards..." (See list of ISO/IEC standards above)

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "Clinical Tests: Not Required."

This indicates that no dedicated clinical test set (i.e., a set of patient data specifically collected for performance evaluation against a ground truth) was used in this 510(k) submission. The basis for safety and effectiveness is the substantial equivalence to previously cleared devices and compliance with non-clinical standards.

Therefore, information regarding data provenance (country of origin, retrospective/prospective) and sample size for a test set is not applicable to this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since no clinical tests or dedicated test sets were used, there were no experts required for establishing ground truth from such a set.

4. Adjudication Method for the Test Set

Not applicable, as no dedicated clinical test set was used.

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

Not applicable. This is a 510(k) submission for an ultrasound system, not an AI-powered diagnostic device. The application does not mention any AI components or MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical imaging system, not an algorithm being submitted for standalone performance evaluation.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not describe the use of specific ground truth types (like pathology or outcomes data) in a clinical study context for this submission, as no clinical studies were deemed necessary. The ground truth for demonstrating safety and effectiveness relied on the established performance of the predicate devices and the compliance with engineering and safety standards.

8. The Sample Size for the Training Set

Not applicable. Given that "Clinical Tests" were "Not Required" and there's no mention of an algorithm or AI being developed, there would be no training set in the context of device performance evaluation. The device development process would have involved engineering testing and verification, but not "training data" in the sense of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set (for an algorithm/AI) was mentioned or used in this submission.

Summary

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510(k) Summary of Safety & Effectiveness
-----------------------------------------------------

Prepared in accordance with 21 CFR Part 807.92(c)

The assigned 510(k) number is:	K101091
--------------------------------	---------

Applicant Information:

Date Prepared:	June 14, 2010
Name:	ZONARE Medical Systems, Inc.420 North Bernardo AvenueMountain View, CA 94043
Contact Persons:	Linda J. MooreDirector, Regulatory Affairs & Quality Assurance
Telephone Numbers:	650-230-2724
Fax Number:	650-967-9036
Email	lmoore@zonare.com

Device Information:

Trade Name:	ZONARE z.one Ultra Ultrasound System
-------------	--------------------------------------

JUN 2 5 2010Device Name: ZONARE Diagnostic Ultrasound System

	FR Number	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
Diagnostic Ultrasound Transducer	892.1570	90-ITX

Marketed Device(s): The ZONARE z.one Ultra Ultrasound System (K022858), (K082326), EPMed Systems (St. Jude. K031066) (K073709), Philips HD11 (K062247), and Sonosite, Inc. (K053069) devices currently in commercial distribution.

Device Description: The z.one Ultra is a general purpose diagnostic ultrasound system which consists of a combination of portable scanner(s) less than 10 inches wide and 3 inches high, embedded in the cart, or that can be held by the user in one hand. They include buttons for controlling the system and may have a screen that display ultrasound mages and user interface or be without the screen (monitor) and user interface. The portable scanner can be held by the user in one hand accommodates a removable transducer module. Signals received from the transducer module are digitized and preprocessed. The transducer module comes into contact with the patient and both transmit and receive ultrasound energy.

{1}------------------------------------------------

Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal/obstetric, gynecological; Abdominal (renal, GYN/Pelvic; Intra-operative (abdominal, thoracic, and vascular). Intra-operative neurological; Pediatric; Small organ (thyroid, breast, testes, etc), Adult & Neonatal Cephalic; Trans-rectal, Trans-cranial, Trans-cranial, Trans-esophageal (non-cardiac); Musculoskeletal (conventional & superficial); 3D/4D; Cardiac - Adult/Pediatric/Fetal; Intra-Cardiac; Pelvio; Peripheral vascular; harmonic tissue and contrast imaging and Tissue elasticity.

Comparison with Predicate Device: With respect to features and applications, the ZONARE z.one Ultra with the new ophthalmic indication for use and the off the shelf intra-cardiac echo catheter (View-Flex) is comparable and substantially equivalent to the currently marketed ZONARE z.one and the predicate devices listed in predicate devices section in terms of portability, features and functionality, they have the same important safety and effectiveness features, as well as design, materials, and construction.

Non-clinical tests: The device has been evaluated according to the applicable medical device quality systems, safety standards for acoustic output, biocompatibility, verification, cleaning, and disinfection effectiveness as well as for thermal, electrical, and mechanical safety, those applicable to ZONARE's ultrasound product are:

ISO 14971	Medical Devices – applications of risk management to medical devices
IEC/UL 60601-1	Medical Electrical Equipment (MEE) – General Requirements for Safety
IEC 60601-1-1	Medical Electrical Equipment for Systems
IEC 60601-1-2	EMC
IEC 60601-1-4	MEE – Programmable electrical medical systems
IEC 60601-2-37	Safety of ultrasonic medical diagnostic and monitoring equipment
IEC 62304	Medical Device software – software life cycle processes
ISO 10993	Biological evaluation of medical devices
AIUM	Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (2002)

Clinical Tests: Non Required

Conclusion: The device conforms to applicable medical device safety standards and compliance for safety and effectiveness is verified through defined evaluation and market surveillance. The ZONARE z.one Ultra Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices current cleared for market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 2 5 2010

ZONARE Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K101091

Trade/Device Name: The z.one Ultra Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: TYN, IYO, and ITX Dated: June 9, 2010 Received: June 10, 2010

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with The z.one Ultra Ultrasound System, as described in your premarket notification:

Transducer Model Number

Curvilinear Transducer C4-1 Curvilinear Transducer C5-2 Curvilinear Transducer C6-2 Curvilinear Transducer C9-3 Curvilinear Transducer C8-3 (3D/4D) Curvilinear Transducer C9-4t Phase (Sector) Array Transducer P4-1 Phase (Sector) Array Transducer P4-1c Phased (Sector) Array Transducer P10-4 Endo-Cavity Transducer E9-4 Endo-Cavity Transducer E9-4 (3D) Linear Transducer L10-5

Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

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Linear Transducer L8-3 Linear Transducer L12-4v Linear Transducer L14-5sp Linear Transducer L14-5w Tran-Esophageal Transducer P8-3T St. Jude EP ViewFlex PLUS ICE Catheter model # VF-PM Part #09-2005 A2CW (Common name Pencil Probe) A5CW (Common name Pencil Probe)

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.

Sincerely vours.

Robert Becker (for)
Donald St. Pierre

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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Image /page/4/Picture/0 description: The image shows a logo with a stylized letter 'Z' inside a black square. The letter 'Z' is white and appears to be made of thick, overlapping lines. Below the square, the word 'ZONARE' is written in a simple, blocky font. The logo has a slightly pixelated or grainy appearance, suggesting it may be a low-resolution image or a scan of an older print.

Indications for Use Statement

510(K) Number (if known): K101091

Device Name: The z.one Ultra Ultrasound system

Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal/obstetric, gynecological; Abdominal (renal, GYN/Pelvic ; Intra-operative (abdominal, thoracic, and vascular), Intra-operative neurological; Pediatric; Small organ (thyroid, breast, testes, etc), Adult & Neonatal Cephalic; Trans-vaginal, Trans-vaginal, Trans-esophageal (non-cardiac and cardiac); Musculoskeletal (conventional & superficial); 3D/4D; Cardiac -Adult/Pediatric/Fetal; Intra-Cardiac; Peripheral vascular; harmonic tissue and contrast imaging and Tissue elasticity. .

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Robert P. Becker
Division Sign-Off.

Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety

510(K) K101091

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Diagnostic Ultrasound Indications for use 1.3.

510(K) Number (if known):

System Name: ZONARE z.one Ultra Ultrasound Diagnostic System Device Name: Union of all Transducer Types

Indications for Use: This device is intended for use by a qualified physician for ultrasound evaluation of the following: Feal, Abdominal, Intraoperative, Pediatric, Ophthalmic, Small organ/parts (breast/estest thyroid, ecc), Transvaginal, Transrectal, Transcranial, Trans-esoph, Trans-urethral, OB/GYN, Cardiac, Pelvic, Neonatal/Adult cephalic, Vascular, 3D/4D, Tissue elasticity, Musculoskeletal, cardiac, Superficial Musculoskeletal, and Peripheral Vascular applications and others as shown below.

Clinical Application	Specific	B	M	PWD2	CWDCWDAux	ColorDoppler3	CombinedModes4	Other5, 8
Ophthalmic	Ophthalmic	N		N		N
	Fetal	P	P	P	P	P	P	p5
	Abdominal	P	P	P	P	P	P	p5
	Intra-operative(Specify)6	P	P	P		P	P	p5
	Intra-operative (Neuro)	P		P		P	P	p5
	Laparoscopic
	Pediatric	P	P	P	P	P	P	p5
	Pediatric Aux				P
	Small Organ (Thyroid,Breast, Testes, etc.)	P	P	P		P	P	p5
	Neonatal Cephalic	P	P	P	P	P	P	p5
General	Adult Cephalic	P	P	P	P	P	P	p5
Application	Trans-rectal	P	P	P		P	P	p5
	Trans-vaginal	P	P	P		P	P	p5
	Trans-urethral
	Trans-esoph. (non-Card.)	P	P	P	P	P	P	p5
	Musculo-skel.(Conventional)	P	P	P		P	P	p5, 8
	Musculo-skel.(Superficial)	P	P	P		P	P	p5, 8
	Intra-luminal
	Other (Specify)(3D/4D)	P	P	P		P	P
	Cardiac Adult	P1	P	P	P	P	P	p5
	Cardia Adult Aux				P
	Cardiac Pediatric	P	P	P	P	P	P	p5
Cardiac	Cardiac Pediatric Aux				P
	Trans-esoph. (Cardiac)	P	P	P	P	P	P	p5
	Other (Specify)(3D/4D)	P	P	P	P	P	P
	Other (Intra-Cardiac)*	P	P	P		P	P	p5
Peripheral vascular	Peripheral Vessel	P	P	P	P	P	P	p5
	Peripheral Vessel Aux				P
	Other (Specify)(3D/4D)	P	P	P		P	P

N = new indication; P = previously cleared by FDA 510(k) K022858 & K082326, *ST. Jude # 073709 E=Added under Appendix E Includes B-Mode and Harmonic (contrast) imaging (HI)

2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)

3 Color M-Mode (CM)

Abdominal includes renal, GYN/Pelvic Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

Freehand tissue elasticity

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Devices Evaluation and Safety 510(K)

Page 1 of

510k Submittal ZONARE Medical Systems, Inc.

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System Name: ZONARE z.one Ultra Ultrasound Diagnostic System Device Name: Curvilinear Transducer C4-1

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

	Clinical Application
General(Track I Only)	Specific(Track I & III)	B	M	PWD²	CWD	ColorDoppler³	CombinedModes⁴	Other⁸
Ophthalmic	Ophthalmic
	Fetal	E	E	E		E	E
	Abdominal	E	E	E		E	E
	Intra-operative(Specify)
	Intra-operative(Neuro)
	Laparoscopic
	Pediatric	E	E	E		E	E
	Small Organ(Thyroid, Breast,Testes, etc.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)	E	E	E		E
	Musculo-skel.(Superficial)
	Intra-luminal
	Other (Specify)(3D/4D)contrast	E	E	E		E	E
	Cardiac Adult	E	E	E		E	E
Cardiac	Cardiac Pediatric
	Trans-esoph.(Cardiac)
	Other (Specify)
Peripheral	Peripheral vascular
vascular	Other (Specify)

N = new indication; P=previously cleared by FDA 510(k), E=Added under Appendix E

1 Includes B-Mode and Harmonic (contrast) imaging (HI)

2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)

S Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Concurre

Division Sign Off

Office of In Vitro Diagnostic Devices Evaluation and Safety

510(K) K101091

Page 1 of

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System Name: ZONARE z.one Ultra Ultrasound Diagnostic System Device Name: Curvilinear Transducer C5-2

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

Clinical Application		Mode of Operation
General	Specific(Track I & III)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other8
Ophthalmic	Ophthalmic
Generalapplications	Fetal	P	P	P		P	P	P5
	Abdominal6	P	P	P		P	P	P5
	Intra-operative(Specify)
	Intra-operative(Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P5
	Small Organ(Thyroid, Breast,Testes, etc.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)
	Musculo-skel.(Superficial)
	Intra-luminal
	Other (Specify)(3D/4D)
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Trans-esoph.(Cardiac)
	Other (Specify)
	Peripheral Vascular	P	P	P		P	P	P5
Peripheral	Other (Specify)

N = new indication; P=previously cleared by FDA 510(k) K022858 & K082326, E=Added under Appendix E

1 Includes B-Mode and Harmonic (contrast) imaging (HI)

2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD) 5 Color M-Mode (CM)

Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Robert A. Becklof
Division Sign-Off

Office of In Vitro Diagnostic Devices Evaluation and Safety

510(K) 101091

{8}------------------------------------------------

System Name: ZONARE z.one Ultra Ultrasound Diagnostic System Device Name: Curvilinear Transducer C6-2

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

	Clinical Application	Mode of Operation
General	Specific(Track I & III)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other8
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P5
	Abdominal6	P	P	P		P	P	P5
	Intra-operative(Specify)
	Intra-operative(Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P5
	Small Organ(Thyroid, Breast,Testes, etc.)
	Neonatal Cephalic
Generalapplications	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)
	Musculo-skel.(Superficial)
	Intra-luminal
	Other (Specify)(3D/4D)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph.(Cardiac)
	Other (Specify)
PeripheralVascular	Peripheral Vascular	P	P	P		P	P	P5
	Other (Specify)

N = new indication; P=previously cleared by FDA 510(k) K022858 & K082326, E=Added under Appendix E

1 Includes B-Mode and Harmonic (contrast) imaging (HI)

2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

RolaRBeeted
Division Sign-Off

Office of In Vitro Diagnostic Devices Evaluation and Safety

510(K) K101091

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System Name: ZONARE z.one Ultra Ultrasound Diagnostic System

Device Name: Curvilinear Transducer C9-3

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

	Clinical Application			Mode of Operation
General	Specific(Track I & III)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other8
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P5
	Abdominal6	P	P	P		P	P	P5
	Intra-operative(Abdominal)	P	P	P	P	P	P	P5
	Intra-operative(Vascular)	P	P	P	P	P	P	P5
	Laparoscopic
	Pediatric	P	P	P		P	P	P5
	Small Organ(Thyroid, Breast,Testes, etc.)
	Neonatal Cephalic
General	Adult Cephalic
applications	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)	P	P	P	P	P	P	P5
	Musculo-skel.(Superficial)	P	P	P	P	P	P	P5
	Intra-luminal
	Other (Specify)(3D/4D)
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Trans-esoph.(Cardiac)
	Other (Specify)
PeripheralVascular	Peripheral Vascular	P	P	P		P	P	P5
	Other (Specify)

N = new indication: P=previously cleared by FDA 510(k) K082326, E=Added under Appendix E

Includes B-Mode and Harmonic (contrast) imaging (HI)

2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Robert Beckerf
Division Sign-Off

Office of In Vitro Diagnostic Devices Evaluation and Safety

510(K) K101091

{10}------------------------------------------------

System Name: ZONARE z.one Ultra Ultrasound Diagnostic System

Device Name: Curvilinear Transducer C8-3 (3D/4D)

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

Clinical Application	Mode of Operation
General	Specific(Track I & III)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other5
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P5
	Abdominal6	P	P	P		P	P	P5
Generalapplications	Intra-operative(Specify)
	Intra-operative(Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P5
	Small Organ(Thyroid, Breast,Testes, etc.)
	Peonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)
	Musculo-skel.(Superficial)
	Intra-luminal
	Other (Specify)(3D/4D)	P	P	P		P	P	P5
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph.(Cardiac)
	Other (Specify)
PeripheralVascular	Peripheral Vascular	P	P	P		P	P	P5

N = new indication; P=previously cleared by FDA 510(k) K082326, E=Added under Appendix E

1 Includes B-Mode and Harmonic (contrast) imaging (HI)

2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Zolul Beckuf
Division Sign-Off

Office of In Vitro Diagnostic Devices Evaluation and Safety

510(K) K101091

{11}------------------------------------------------

System Name: ZONARE z.one Ultra Ultrasound Diagnostic System Device Name: Curvilinear Transducer C9-4t

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

	Clinical Application		Mode of Operation
	General(Track I Only)	Specific(Track I & III)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other8
Ophthalmic		Ophthalmic
		Fetal
		Abdominal	E	E	E		E	E
		Intra-operative(Specify)7
		Intra-operative(Neuro)
		Laparoscopic
		Pediatric	E	E	E		E	E
		Small Organ(Thyroid, Breast,Testes, etc.)
		Neonatal Cephalic	E	E	E		E	E
Generalapplication		Adult Cephalic
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Trans-esoph. (non-Card.)
		Musculo-skel.(Conventional)	E	E	E		E	E
		Musculo-skel.(Superficial)	E	E	E		E	E
		Intra-luminal
		Other (Specify)(3D/4D)	E	E	E		E	E
		Vet abdominal
		Cardiac Adult
		Cardiac Pediatric	E	E	E		E	E
Cardiac		Trans-esoph.(Cardiac)
		Other (Specify) vetcardiac	E	E	E		E	E
Peripheralvascular		Peripheral vascular
		Other (Specify)

N = new indication; P=previously cleared by FDA E=Added under Appendix E

1 Includes B-Mode and Harmonic (contrast) imaging (HI)

2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Concur

Division Sign-Off

Office of In Vitro Diagnostic Devices Evaluation and Safety

510(K) K101091

{12}------------------------------------------------

System Name: ZONARE z.one Ultra Ultrasound Diagnostic System

Device Name: Phase (Sector) Array Transducer P4-1

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

	Clinical Application	Mode of Operation
General	Specific(Track I & III)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other8
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P5
	Abdominal6	P	P	P	P	P	P	p5
	Intra-operative(Specify)7
	Intra-operative(Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	p5
	Small Organ(Thyroid, Breast,Testes, etc.)
	Neonatal Cephalic	P	P	P	P	P	P	p5
Generalapplication	Adult Cephalic/ transcranial	P	P	P	P	P	P	p5
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)
	Musculo-skel.(Superficial)
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult	P	P	P	P	P	P	p5
	Cardiac Pediatric	P	P	P	P	P	P	p5
	Trans-esoph.(Cardiac)
	Other (Specify)(3D/4D)
Peripheralvascular	Peripheral Vascular	P	P	P	P	P	P	p5
	Other (Specify)

N = new indication; P=previously cleared by the FDA 510(k) K082326, E=Added under Appendix E

1 Includes B-Mode and Harmonic (contrast) imaging (HI)

2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrer

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

ivision Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety

510(K) K101091

{13}------------------------------------------------

System Name: ZONARE z.one Ultra Ultrasound Diagnostic System

Device Name: Phase (Sector) Array Transducer P4-1c

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

	Clinical Application	Mode of Operation
General	Specific(Track I & III)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other8
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P5
	Abdominal6	P	P	P	P	P	P	P5
	Intra-operative(Specify)7
	Intra-operative(Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P5
	Small Organ(Thyroid, Breast,Testes, etc.)
	Neonatal Cephalic	P	P	P	P	P	P	P5
Generalapplication	Adult Cephalic/ transcranial	P	P	P	P	P	P	P5
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)
	Musculo-skel.:(Superficial)
	Intra-luminal
	Other (Specify)
	Cardiac Adult	P1	P	P	P	P	P	P5
	Cardiac Pediatric	P	P	P	P	P	P	P5
Cardiac	Trans-esoph.(Cardiac)
	Other (Specify)(3D/4D)contrast	E	E	E	E	E	E	E5
Peripheral	Peripheral Vascular	P	P	P	P	P	P	P5
vascular	Other (Specify)

N = new indication; P=previously cleared by the FDA 510(k) K082326, E=Added under Appendix E

Includes B-Mode and Harmonic (contrast) imaging (HI)

2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety

510(K) K101091

{14}------------------------------------------------

System Name: ZONARE z.one Ultra Ultrasound Diagnostic System Device Name: Phased (Sector) Array Transducer P10-4

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

Clinical Application	Mode of Operation
General	Specific(Track I & III)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other8
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	P5
	Abdominal6	P	P	P	P	P	P	P5
	Intra-operative(Specify)7	P	P	P		P	P	P5
	Intra-operative(Peuro)	P	P	P		P	P	P5
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P5
	Small Organ(Thyroid, Breast,Testes, etc.)
	Neonatal Cephalic	P	P	P	P	P	P	P5
Generalapplication	Adult Cephalic/ transcranial	P	P	P	P	P	P	P5
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)
	Musculo-skel.(Superficial)
	Intra-luminal
	Other (Specify)
	Cardiac Adult	P	P	P	P	P	P	P5
	Cardiac Pediatric	P	P	P	P	P	P	P5
Cardiac	Trans-esoph.(Cardiac)
	Other (Specify)(3D/4D)
Peripheralvascular	Peripheral Vascular	P	P	P	P	P	P	P5
	Other (Specify)

N = new indication; P=previously cleared by the FDA 510(k) K082326, E=Added under Appendix E

1 Includes B-Mode and Harmonic (contrast) imaging (HI)

2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)

5 Color M-Mode (CM)

Abdominal includes renal, GYN/Pelvic

7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Robert T. Becker

Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety

510(K) 101091

{15}------------------------------------------------

System Name: ZONARE z.one Ultra Ultrasound Diagnostic System Device Name: Endo-Cavity Transducer E9-4

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

	Clinical Application	Mode of Operation
General(Track I Only)	Specific(Track I & III)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other58
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P5
	Abdominal
	Intra-operative(Specify)7
	Intra-operative(Neuro)
	Laparoscopic
	Pediatric
	Small Organ(Thyroid, Breast,Testes, etc.)
	Neonatal Cephalic
	Adult Cephalic
Generalapplication	Trans-rectal	P	P	P		P	P	P5
	Trans-vaginal	P	P	P		P	P	P5
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.
	(Conventional)
	Musculo-skel.
	(Superficial)
	Intra-luminal
	Other (Specify)(3D/4D)
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Trans-esoph.(Cardiac)
	Other (Specify)
Peripheral	Peripheral vascular
vascular	Other (Specify)

N = new indication; P=previously cleared by FDA 510(k) K022858 & K082326, E=Added under Appendix E

1 Includes B-Mode and Harmonic (contrast) imaging (HI)

2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)

5 Color M-Mode (CM)

్ Abdominal includes renal, GYN/Pelvic

7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Concurre

Division Sign-Off

Office of In Vitro Diagnostic Devices Evaluation and Safety

510(K) 10101091

{16}------------------------------------------------

System Name: ZONARE Z.one Ultra Ultrasound Diagnostic System Device Name: Endo-Cavity Transducer E9-4 (3D)

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

Clinical Application		Mode of Operation
General(Track I Only)	Specific(Track I & III)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other8
Ophthalmic	Ophthalmic
Generalapplication	Fetal	P	P	P		P	P	P5
	Abdominal
	Intra-operative(Specify)7
	Intra-operative(Neuro)
	Laparoscopic
	Pediatric
	Small Organ(Thyroid, Breast,Testes, etc.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P5
	Trans-vaginal	P	P	P		P	P	P5
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)
	Musculo-skel.(Superficial)
	Intra-luminal
	Other (Specify)(3D/4D)	P	P	P		P	P	P5
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph.(Cardiac)
	Other (Specify)
Peripheralvascular	Peripheral vascular
	Other (Specify)

N = new indication; P=previously cleared by FDA 510(k) K082326, E=Added under Appendix E

1 Includes B-Mode and Harmonic (contrast) imaging (HI)

2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)

S Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Darn Becked
Division Sign-Off

Office of In Vitro Diagnostic Devices Evaluation and Safety

510(K) K101091

{17}------------------------------------------------

System Name: ZONARE z.one Ultra Ultrasound Diagnostic System Device Name: Linear Transducer L10-5

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

Clinical Application	Mode of Operation
General(Track I Only)	Specific(Track I & III)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other5
Ophthalmic	Ophthalmic	N		N		N
Generalapplication	Fetal	P	P	P		P	P	P5
	Abdominal6	P	P	P		P	P	P5
	Intra-operative(Specify)7	P	P	P		P	P	P5
	Intra-operative(Neuro)	P		P			P	P5
	Laparoscopic
	Pediatric	P	P	P		P	P	P5
	Small Organ(Thyroid, Breast,Testes, etc.)	P	P	P		P	P	P5P8
	Neonatal Cephalic	P	P	P		P	P	P5
Generalapplication	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)	P	P	P		P	P	P5,8
	Musculo-skel.(Superficial)	P	P	P		P	P	P5,8
	Intra-luminal
	Other (Specify)8(3D/4D)
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Trans-esoph.(Cardiac)
	Other (Specify)
PeripheralVascular	Peripheral Vascular	P	P	P		P	P	P5P8
	Other (Specify)

N = new indication; P=previously cleared by the FDA 510(k) K022858 & K082326, E=Added under Appendix E

1 Includes B-Mode and Harmonic (contrast) imaging (HI)

2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off
ke

Office of In Vitro Diagnostic Devices Evaluation and Safety

510(K) K101091/

{18}------------------------------------------------

System Name: ZONARE z.one Ultra Ultrasound Diagnostic System

Device Name: Linear Transducer L8-3

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

Clinical Application	Mode of Operation
General(Track I Only)	Specific(Track I & III)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other8
Ophthalmic	Ophthalmic
Generalapplication	Fetal	P	P	P		P	P	P5
	Abdominal6	P	P	P		P	P	P5
	Intra-operative(Specify)7	P	P	P		P	P	P5
	Intra-operative(Neuro)	P		P		P	P	P5
	Laparoscopic
	Pediatric	P	P	P		P	P	P5
	Small Organ(Thyroid, Breast,Testes, etc.)	P	P	P		P	P	P5P8
	Neonatal Cephalic	P	P	P		P	P	P5
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)	P	P	P		P	P	P5,8
	Musculo-skel.(Superficial)	P	P	P		P	P	P5,8
	Intra-luminal
	Other (Specify)83D/4D
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph.(Cardiac)
	Other (Specify)

PeripheralVascular	Peripheral Vascular	P	P	P		P	P	P5P8
	Other (Specify)

N = new indication; P=previously cleared by the FDA 510(k) K082326, E=Added under Appendix E

I Includes B-Mode and Harmonic (contrast) imaging (HI)

2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)

్ Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

Examples may include A-mode, Amplitude Doppler, 3-D insging, Tissue Motion Doppler, Color velocity imaging

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Devices Evaluation and Safety

510(K) Kiona I

{19}------------------------------------------------

System Name: ZONARE z.one Ultra Ultrasound Diagnostic System Device Name: Linear Transducer L12-4v

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

Clinical Application	Mode of Operation
General(Track I Only)	Specific(Track I & III)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other5
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Specify)7
	Intra-operative(Neuro)
	Laparoscopic
	Pediatric	E	E	E		E	E
	Small Organ(Thyroid, Breast,Testes, etc.)	E	E	E		E	E
	Neonatal Cephalic
Generalapplication	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)	E	E	E		E	E	E
	Musculo-skel.(Superficial)	E	E	E		E	E	E
	Intra-luminal
	Other (Specify)(3D/4D)(vet use too)	E	E	E		E	E	E
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph.(Cardiac)
	Other (Specify)
Peripheralvascular	Peripheral vascular	E	E	E		E	E	E
	Other (Specify)

N = new indication; P=previously cleared by FDA, E=Added under appendix E,

I Includes B-Mode and Harmonic (contrast) imaging (HI)

4 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

4 Includes BHM, B+M+CM, B+CD+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
5 C. Lock Late M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Concur

Division Sign-Off

Office of In Vitro Diagnostic Devices Evaluation and Safety

510(K) K101091

{20}------------------------------------------------

510(K) Number (if known): System Name: ZONARE z.one Ultra Ultrasound Diagnostic System Device Name: Linear Transducer L14-5sp

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

Clinical Application	Mode of Operation
General(Track I Only)	Specific(Track I & III)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other8
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P5
	Abdominal6	P	P	P		P	P	P5
	Intra-operative(Specify)7	P	P	P		P	P	P5
	Intra-operative(Neuro)	P		P		P	P	P5
	Laparoscopic
	Pediatric	P	P	P		P	P	P5
	Small Organ(Thyroid, Breast,Testes, etc.)	P	P	P		P	P	P5P8
Generalapplication	Neonatal Cephalic	P	P	P		P	P	P5
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)	P	P	P		P	P	P5,8
	Musculo-skel.(Superficial)	P	P	P		P	P	P5,8
	Intra-luminal
	Other (Specify)8
	3D/4D
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph.(Cardiac)
	Other (Specify)
PeripheralVascular	Peripheral Vascular	P	P	P		P	P	P5P8
	Other (Specify)
	3D/4D

N = new indication; P=previously cleared by the FDA 510(k) K082326, E=Added under Appendix E

1 Includes B-Mode and Harmonic (contrast) imaging (HI)

2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

. Examples may include A-mode, Amplitude Doppler, 3-D imaging, Tissue Motion Doppler, Color velocity imaging

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Congurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

on Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety

510(K) K101091

{21}------------------------------------------------

System Name ZONARE Z.one Ultra Ultrasound Diagnostic System Device Name: Linear Transducer L14-5w

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

Clinical Application	Mode of Operation
General(Track I Only)	Specific(Track I & III)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other8
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P5
	Abdominal6	P	P	P		P	P	P5
	Intra-operative(Specify)7	P	P	P		P	P	P5
	Intra-operative(Neuro)	P		P		P	P	P5
	Laparoscopic
	Pediatric	P	P	P		P	P	P5
	Small Organ(Thyroid, Breast,Testes, etc.)	P	P	P		P	P	P5P8
	Neonatal Cephalic	P	P	P		P	P	P5
General	Adult Cephalic
application	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)	P	P	P		P	P	P5,8
	Musculo-skel.(Superficial)	P	P	P		P	P	P5,8
	Intra-luminal
	Other (Specify)83D/4D
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Trans-esoph.(Cardiac)
	Other (Specify)
Peripheral	Peripheral Vascular	P	P	P		P	P	P5P8
Vascular	Other (Specify)3D/4D

N = new indication; P=previously cleared by the FDA 510(k) K082326, E=Added under Appendix E

1 Includes B-Mode and Harmonic (contrast) imaging (HI)

2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

4 Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)

3 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

Examples may include A-mode, Amplinde Doppler, 3-D imaging, Tissue Motion Doppler, Color velocity imaging

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

oncurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

NarARedds
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Page 1 of

{22}------------------------------------------------

System Name: ZONARE z.one Ultra Ultrasound Diagnostic System

Device Name: Tran-Esophageal Transducer: P8-3T

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

Clinical Application	Mode of Operation
General(Track I Only)	Specific(Track I & III)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other5
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Specify)7
	Intra-operative(Neuro)
	Laparoscopic
	Pediatric
	Small Organ(Thyroid, Breast,Testes, etc.)
	Neonatal Cephalic
Generalapplications	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)	P	P	P	P	P	P	P5
	Musculo-skel.(Conventional)
	Musculo-skel.(Superficial)
	Intra-luminal
	Other (Specify)(3D/4D)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph.(Cardiac)	P	P	P	P	P	P	P5
	Other (Specify)
PeripheralVessel	Peripheral Vessel
	Other (Specify)

N = new indication; P=previously cleared by FDA 510(k) K082326, E=Appendix E

1 Includes B-Mode and Harmonic (contrast) imaging (HI)

2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Peter Becker

ision Sign Office of In Vitro Diagnostic Devices Evaluation and Safety

510(K) K161091

{23}------------------------------------------------

System Name: ZONARE z.one Ultra Ultrasound Diagnostic System

Device Name: St. Jude EP ViewFlex PLUS ICE Catheter model # VF-PM Part #09-2005 Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track I Only)	Specific(Track I & III)	B	M	PWD2	CWD	ColorDoppler	CombinedModes4	Other8
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Specify)7
	Intra-operative(Neuro)
	Laparoscopic
	Pediatric
	Small Organ(Thyroid, Breast,Testes, etc.)
	Neonatal Cephalic
Generalapplication	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)
	Musculo-skel.(Superficial)
	Intra-luminal
	Other (Specify)(3D/4D)
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Trans-esoph.(Cardiac)
	Other (Intra-Cardiac)	P	P	P		P
	Peripheral vascular
Peripheralvascular	Other (Specify)

N = new indication; P=previously cleared by FDA 510(k) K031066 & K073709, E=Added under Appendix E

1 Includes B-Mode and Harmonic (contrast) imaging (HI)

2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD) 5 Color M-Mode (CM)

Color M-Mode (CM)
6. Additional help

6 Abdominal includes renal, GYN/Pelvic

7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Concurren

Robert Beck

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{24}------------------------------------------------

System Name: ZONARE z.one Ultra Ultrasound Diagnostic System

Device Name: A2CW (Common name Pencil Probe)

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

Clinical Application	Mode of Operation
General(Track I Only)	Specific(Track I & III)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other5
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Specify)7
	Intra-operative(Neuro)
	Laparoscopic
	Pediatric				P
	Small Organ(Thyroid, Breast,Testes, etc.)
	Neonatal Cephalic
Generalapplication	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)
	Musculo-skel.(Superficial)
	Intra-luminal
	Other (Specify)(3D/4D)
	Cardiac Adult				P
	Cardiac Pediatric				P
Cardiac	Trans-esoph.(Cardiac)
	Other (Specify)
Peripheralvascular	Peripheral vascular
vascular	Other (Specify)

N = new indication; P=previously cleared by FDA 510(k) K082326, E=Appendix E

I Includes B-Mode and Harmonic (contrast) imaging (HI)

2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

3 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

4 Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)

5 Color M-Mode (CM)

Abdominal includes renal, GYN/Pelvic

7 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

N. Becker
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Office of In Vitro Diagnostic Devices Evaluation and Safety

510(K) K101091'

{25}------------------------------------------------

System Name: ZONARE z.one Ultra Ultrasound Diagnostic System

Device Name: A5CW (Common name Pencil Probe)

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

Clinical Application		Mode of Operation
General(Track I Only)	Specific(Track I & III)	B	M	PWD2	CWD	ColorDoppler3	CombinedModes4	Other8
Ophthalmic	Ophthalmic
Generalapplication	Fetal
	Abdominal
	Intra-operative(Specify)7
	Intra-operative(Neuro)
	Laparoscopic
	Pediatric
	Small Organ(Thyroid, Breast,Testes, etc.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)
	Musculo-skel.(Superficial)
	Intra-luminal
	Other (Specify)(3D/4D)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph.(Cardiac)
	Other (Specify)
Peripheralvascular	Peripheral vascular			P
	Other (Specify)

N = new indication; P=previously cleared by FDA 510(k) K082326, E=Appendix E

Includes B-Mode and Harmonic (contrast) imaging (HI)

2 Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)

1 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)
1 Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)

Entinces B+M, B+M+CM, B+CD+M+CM, B+CD+DWF(DPD), and Power Doppler (PD)

Includes B+M, B+M+CM, B+CD+M+CM, B+CD+PWD where CD could represent (CD, DPD, PD, or BD)
Color M-M

5 Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

1 Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

8 Freehand tissue elasticity

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Dorret Becker
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Office of In Vitro Diagnostic Devices Evaluation and Safety

510(K) K101091

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.