The ZS3 and z.onepro Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal/obsteric, gynccological; Abdominal (renal, GYN/Pelvic; Intracter and vascular), Intra-operative neurological; Pediatric: small organ (thyroid, breast, testes, etc.), Adult & Neonatal Cephalic; Trans-rectal, Trans-vaginal, Trans-esophageal (non-cardiac and cardiac); Musculoskeletal (conventional & superficial); 3D/4D; Cardiac - Adult/ Pediatric/ Fetal; Echo, Intra-Cardiac; Peripheral vascular; hamonic tissue and contrast imaging and Tissue elasticity.

Device Description

The ZS3 and z.one, Ultrasound Systems (hereafter referred to as "ZS3 Ultrasound Platform" or "ZS3" for simplicity) are full-featured, general purpose, software controlled, diagnostic ultrasound systems used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. The platform utilizes ZONARE's patented zone technology which allows the system to collect more data at one time, thereby optimizing image quality.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ZS3 and z.onepro Ultrasound Systems.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with performance metrics in the typical sense of a diagnostic algorithm. Therefore, many of the requested items related to AI/algorithm performance (like effect size, training set details, ground truth for training) are not applicable or not provided in this type of submission.

Acceptance Criteria and Device Performance

The acceptance criteria for the ZS3 and z.onepro Ultrasound Systems are based on compliance with various safety and performance standards for diagnostic ultrasound systems, as well as demonstrating substantial equivalence to predicate devices (ZONARE's ZS3 Ultrasound System K120703 and ZONARE's z.one ultra Ultrasound System K101091).

The "reported device performance" in this context refers to the outcomes of the non-clinical testing performed to show compliance with these standards and specifications.

Acceptance Criteria (Based on Compliance with Standards/Specifications)	Reported Device Performance
Mechanical Verification (In accordance with device performance specifications)	PASS
Electrical Safety (In accordance with IEC 60601-1)	PASS
EMC Testing (In accordance with IEC 60601-1-2)	PASS
Thermal and Acoustic Output (In accordance with IEC 60601-2-37)	PASS
Biocompatibility (In accordance with ISO 10993)	PASS
Cleaning & Disinfection (In accordance with FDA Guidance Document)	PASS
Software Validation & Verification (In accordance with 62304 and FDA Guidance Document Principles of Software Validation)	PASS
Substantial Equivalence to Predicate Devices for Intended Use, Indications for Use, Design, Safety Standards, Patient Contact Materials, Mode of Operations, Measurements, Principle of Operation, Acoustic Output, Transducer Types, Transducer Frequency, DICOM Compliant, Special Procedures User Interface, Display Monitor/Monitor Arm, Scanner, Transducer Port(s), Dimensions/Weight, Power, Rechargeable Battery, Wireless Capability	Met (as concluded by FDA determination of substantial equivalence, K141641)

Study Details (Non-Clinical Testing for Substantial Equivalence)

Sample size used for the test set and the data provenance:
- The document describes non-clinical testing which typically does not involve a "test set" of patient data in the same way an AI algorithm study would. Instead, it involves testing the hardware and software against engineering specifications and regulatory standards.
- No specific sample sizes for image data or patient cases are mentioned, as this is not a clinical performance study. The "test set" consists of the physical device components and software.
- Data provenance: N/A for this type of non-clinical testing. The "testing" is conducted on the manufactured device itself or its components.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable (N/A). The "ground truth" for non-clinical engineering and regulatory compliance testing is established by the specifications and standards themselves, not by expert interpretation of medical images. For example, the ground truth for "Electrical Safety" is whether the device meets the specified limits in IEC 60601-1, which is measured by test equipment, not human experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are relevant for studies involving human interpretation where consensus is needed to establish ground truth for medical conditions. This document details engineering compliance testing.
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:
- No MRMC study was done. This submission is for a diagnostic ultrasound system, not an AI-assisted diagnostic tool. There is no mention of AI assistance for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance was done in the context of diagnostic interpretation. This is a medical imaging device, not a standalone AI diagnostic algorithm.
The type of ground truth used:
- For the non-clinical testing, the "ground truth" is defined by established engineering standards (e.g., IEC 60601-1, IEC 60601-2-37, ISO 10993) and the device's internal performance specifications. For instance, the ground truth for "Acoustic Output" is the maximum derated ISPTA and Mechanical Index values allowed by the standard, and the device is tested to ensure it operates within these limits.
The sample size for the training set:
- N/A. This is a hardware and software system, not an AI/machine learning model that requires a "training set" of data in the common sense. The software validation refers to standard software development lifecycle testing, not AI model training.
How the ground truth for the training set was established:
- N/A, as there is no "training set" in the context of AI.

Summary of the Study:

The "study" described in the provided document is a comprehensive set of non-clinical, engineering, and regulatory compliance tests. The purpose of these tests is to demonstrate that the ZS3 and z.onepro Ultrasound Systems meet all applicable safety, electrical, mechanical, and performance standards for diagnostic ultrasound devices. This type of submission (510(k)) relies heavily on showing that the new device is "substantially equivalent" to predicate devices already cleared for market, meaning it operates in a similar way, has similar intended uses and indications for use, and meets the same safety and effectiveness standards, without raising new questions of safety or effectiveness. No clinical efficacy studies or AI-related performance metrics are presented or required for this type of device clearance.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the word "ZONARE" in a bold, sans-serif font. Above the word is a stylized graphic that resembles a bird in flight or a stylized eye. The graphic is composed of several curved lines that create a sense of movement.

K141641
Page 1 of 4

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92 510(k).

General Information

Applicant:	ZONARE Medical Systems, Inc.420 N. Bernardo AvenueMountain View, CA 94043
Contact Person:	Dan BradfordVice President, OperationsPhone: (650) 316-3113Facsimile: (650) 967-9056E-mail: dbradford@zonare.com
Date Prepared:	April 24, 2014
Trade Name(s):	ZS3 Ultrasound Systemz.onepro Ultrasound System
Common Name:	Diagnostic Ultrasound System with Accessories
Classification:	II
ClassificationName(s):	Ultrasonic PulsedDoppler ImagingSystem	Ultrasonic PulsedEcho Imaging System	Diagnostic UltrasoundTransducer
RegulationNumber:	21 CFR 892.1550	892.1560	892.1570
Product Code:	IYN	IYO	ITX
ClassificationPanel:	Radiology
Predicate Devices:	ZONARE's ZS3 Ultrasound System K120703ZONARE's z.one ultra Ultrasound System K101091

Device Description

The exam dependent default settings for the ZS3 allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control enables the advanced user to set the system

420 N. Bernardo Avenue Mountain View, CA 94043 Corporate 877-966-2731 Service 877-913-9663 Fax 650-230-2828 www.zonare.com

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

based on image appearance preference. The architecture of the ZS3 Ultrasound Platform supports system integration to a variety of upgradable options and features. Up to three ZONARE transducers can be connected to the multi-transducer port permitting easy transducer transition. The ZS3 Ultrasound Platform can be operated on either battery or AC power.

Intended 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 and cardiac); Musculosketal (conventional & superficial); 3D/4D; Cardiac - Adult/ Pediatric/ Fetal; Echo, Intra-Cardiac; Pelvic; Peripheral vascular; harmonic tissue and contrast imaging and Tissue elasticity,

Item	ZS3 Ultrasound PlatformZS3 and z.onepro Ultrasound Systems(ZONARE Medical Systems)	ZS3(ZONARE Medical Systems)	z.one ultra and z.one ultra SP(ZONARE Medical Systems)
510(k) Number	Current Submission	K120703	K101091
Intended Use	Diagnostic ultrasound imaging or fluid flowanalysis of the human body.	Same	Same
Indications forUse	The z.onepro is intended for use by a qualifiedphysician 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-vaginal, Trans-cranial, Trans-esophageal (non-cardiac and cardiac); Musculoskeletal(conventional & superficial); 3D/4D: Cardiac -Adult/ Pediatric/ Fetal: Echo, Intra-Cardiac: Pelvic;Peripheral vascular; harmonic tissue and contrastimaging and Tissue elasticity.	Same	Same
Design	Diagnostic zone technology ultrasound basedplatform	Same	Same
Safety Standards	IEC 60601-1IEC 60601-2-37IEC 60601-1-2ISO 10993-1, -5, 10, -12AIUM, NEMA UD 2, NEMA UD3	Same	Same
Patient ContactMaterials	Complies with ISO 10993	Same	Same
Mode ofOperations	B-Mode, M-Mode, PWD Mode, CWD, CD Mode.Elastorgraphy, Contrast Enhanced, 3D/4D, ECG(for cardiac cycle referenced timing only)Combined Modes include B+CD, B+PW.	Same	Same
Item	ZS3 Ultrasound Platform	ZS3	z.one ultra and z.one ultra SP
	ZS3 and z.onepro Ultrasound Systems(ZONARE Medical Systems)	(ZONARE Medical Systems)	(ZONARE Medical Systems)
	B+CD+PW, B+M, M+CM, B+CD+M+CM,
	B+Elastorgraphy, B+CEUS, and + ECG Trace
	B-Mode (2D): Depth, Distance, Circ/Arca/ Volume	Same	Same
Measurements
	M-Mode: Depth, Distance, HR
	PWD (Manual): Velocity. Velocity Pairs, RI, Accl.
	S/D, A/B, PI, HR/ PWD (AutoTrace: RI, PI, Accl,
	S/D, HR, AT, TAMX and TAMN
Principle of	Applying high voltage burst to the Piezoelectric	Same	Same
Operation	material in the transducer and detect reflected echo
	to construct the diagnostic image
Acoustic Output	Track 3:MI, TIS, TIC, TIB (TI Range 0-6.0)	Same	Same
	Derated ISPTA: 720mW/cm2 maximum,
	Mechanical Index ≤ 1.9 maximum or Derated ISPPA
	≤ 190 W/cm2 max
	Ophthalmic use:
	TI = Max (TISas. TIC) ≤ 1;
	ISPTA.3 ≤ 50mW/cm2: and MI ≤ 0.23
Transducer Types	Linear Array	Same	Same
	Curved Linear Array
	Phased Array
	Trans-esophageal
	Pencil Probe
	Intracavitary
Transducer	1.0 - 20.0 MHz	Same	1.0-14.0 MHz
Frequency

DICOM	Yes	Same	Same
Compliant
Special	Yes	Same	Same
Procedures User
Interface
Display Monitor/	ZS3: Color 19" Liquid Crystal Display (LCD)/ 2	Color 19" Liquid Crystal	Cart: Same
	arm articulation plus tilt and swivel	Display (LCD)/ 2 arm	Scan Engine: 5.8" Liquid
Monitor Arm	z.onepro: Color 17" Liquid Crystal Display (LCD)/	articulation plus tilt and	Crystal Display (LCD)

	Tilt and swivel	swivel
Scanner	Integrated	Same	Portable
Transducer	Multi-Transducer Port (Three)	Same	Cart: same
Port(s)			Scanner/ Scan Module: One
Dimensions/	Height, max (in operational use) 157.5cm (62in)	Same	Cart: Same
Weight	Height, min (in operational use) 128cm (50.5in)
	Height min (displayed lower for transport) 104cm		Scanner/ Scan Module:
	(41in)		Height: 7.3cm (2.9in)/ 5.4cm
	Width: 51cm (21.1in)		(2.1in)
	Depth: 72cm (28.2)		Width: 25.7cm
	Weight: 65.3kg (144lb)		(10.1in)/22.0cm (8.7)
			Depth: 25cm (9.8in)/ 25cm
			(9.8in)
			Weight: 2.5kg (5.6lb)/ 1.6kg
			(3.5lb)
Power	100-240V options, ~ 50-60Hz, 6A max.	Same	same
Item	ZS3 Ultrasound Platform	ZS3	z.one ultra and zone ultra SP
	ZS3 and z.onepro Ultrasound Systems(ZONARE Medical Systems)	(ZONARE Medical Systems)	(ZONARE Medical Systems)
Requirements
RechargeableBattery	Yes (up to 3.0 hour operation per charge)	Same	same
WirelessCapability	Yes (IEEE 802.11b/g. Wi-Fi compliant)	Same	Same

Comparison of ZONARE ZS3 Ultrasound Platform to the Predicate Devices

420 N. Bernardo Avenue Mountain View, CA 94043 Corporate 877-966-2731 Service 877-913-9663 Fax 650-230-2828 www.zonare.com

{2}------------------------------------------------

420 N. Bernardo Avenue Mountain View, CA 94043 Corporate 877-966-2731 Service 877-913-9663 Fax 650-230-2828 www.zonare.com

{3}------------------------------------------------

Summary of Non-Clinical Testing Performed:

The ZS3 and z.onewo Ultrasound Systems were tested in accordance with FDA Guidance Document -Manufacturer's Seeking Clearance for Ultrasound Systems and Transducers. The following testing was completed:

Test	Method	Result
Mechanical Verification	In accordance with deviceperformance specifications	PASS
Electrical Safety	In accordance with IEC 60601-1	PASS
EMC Testing	In accordance with IEC 60601-1-2	PASS
Thermal and Acoustic Output	In accordance with IEC 60601-2-37	PASS
Biocompatibility	In accordance with ISO 10993	PASS
Cleaning & Disinfection	In accordance with FDAGuidance Document	PASS
Software Validation &Verification	In accordance with 62304 andFDA Guidance DocumentPrinciples of SoftwareValidation	PASS

NOTE: ZONARE's ZS3 Ultrasound Platform and transducers do not require clinical studies to support the determination of substantial equivalence.

Conclusion

The ZS3 and z.one, Ultrasound Systems are substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to ZONARE's ZS3 and z.one ultra Ultrasound Systems. There are no new no new issues of safety and/or effectiveness introduced by the modification proposed when used as instructed.

420 N. Bernardo Avenue Mountain View, CA 94043 Corporate 877-966-2731 Service 877-913-9663 Fax 650-230-2828 www.zonare.com

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

==============================================================================================================================================================================

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

July 18, 2014

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

Rc: K141641

Trade/Device Name: ZS3 and z.onepro Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: 1YN. 1Y(), ITX Dated: June 17, 2014 Received: June 19, 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 10 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 ZS3 and 2.0nepro Ultrasound System, as described in your premarket notification:

	Transducer Model Number
C4-1	C6-2	C9-3
C10-3	C8-3(3D)	P4-1c
V11-3BE Transducer (off-the-shelf) (Endo-Cavity Transducer E9-3)
E9-4	E9-3 (3D)	L10-5
L8-3	L14-5sp	L14-5v
L20-5	P8-3TEE
VF-PM Part #09-2005 (off the shelf) (P9-3ic)
A2CW	A5CW

{5}------------------------------------------------

Page 2—Mr. Job

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statules 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 Industry and Consumer Education 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. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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

{6}------------------------------------------------

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) K141641

Device Name

ZS3 and z.onepro Ultrasound System

Indications for Use (Describe)

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) (Signature)

Sm.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."

{7}------------------------------------------------

System:	ZS3 and z.onc Ultrasound System
Transducer:	System Union of all Transducer Types
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic	P	P	P	P	P	P	P
Fetal Imaging &Other	Fetal	P	P	P	P	P	P	P5
	Abdominal	P	P	P	P	P	P	P5
	Intra-operative(Specify)	P	P	P	P	P	P	P4
	Intra-operative (Neuro)	P	P	P	P	P	P	P4
	Laparoscopic	P	P	P	P	P	P	P4
	Pediatric	P	P	P	P	P	P	P4
	Small Organ (Thyroid,Breast, Testes, etc.)	P	P	P	P	P	P	P5,8
	Neonatal Cephalic	P	P	P	P	P	P	P4
	Adult Cephalic	P	P	P	P	P	P	P5
	Trans-rectal	P	P	P	P	P	P	P5
	Trans-vaginal	P	P	P	P	P	P	P4
	Trans-urethral
	Trans-esoph. (non-Card.)	P	P	P	P	P	P	P5
	Musculo-skel.(Conventional)	P	P	P	P	P	P	P5,8
	Musculo-skel.(Superficial)	P	P	P	P	P	P	P5,8
	Intravascular
	Other(3D/4D and Contrast)	P	P	P	P	P	P	P
Cardiac	Cardiac Adult	P1	P	P	P	P	P	P4
	Cardiac Pediatric	P1	P	P	P	P	P	P4
	Intravascular (Cardiac)
	Trans-esoph (Cardiac)	P1	P	P	P	P	P	P4
	Intra-cardiac	P1	P	P	N	P	N
	(Other (3D/4D))	P	P	P	P	P	P
Peripheral Vessel	Peripheral Vessel	P	P	P	P	P	P	P5,8
	Other (3D/4D)	P	P	P	P	P	P

Table 1.3-1: Diagnostic Ultrasound Indications for Use Form - ZONARE's ZS3 and z.onenro Ultrasound System

N - new system indication: P - previously cleared by FDA 510(k) K10109) or K120703. (S1 Jude K031066 & K073709) and (Sherzhen

Mindray K123185), E=Added under Appendix E

' Includes B-Mode and Humonic (contrast) imaging (HI)

2 Includes PWD-Mode imaging and I ligh Pulse Repetition Rate PWD-Mode (IIPRF)

meludes it william in the ringing and Pright and Roponial (DPD), and Power Doppler (PD)

4 Includes B+CD. B-PW. B+CD+PW. B+M, M+CM, B+CD-M+CM, B+Elassorgraphy, B+CEUS, and + ECG Trace

' Color M-Modc (CM)

" Abdominal includes renal, G Y N/Pelvic

Intra operative include abdominal. Ihoracic (cardiac) and vascular (PV)

Freehand tissue clasticity

Prescription Use (Per 21 CFR 80) Subpart 12)

Page 2 of 20

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

C4-1
System:		ZS3 and z.one... Ultrasound System
Transducer:		Curvilinear Transducer C4-1
Intended Use:		Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General(Tracks I Only)	Specific(Track 1 & III)	B	M	PWD	CWD	ColorDoppler1	CombinedModes4	Other,*
Ophthalmic	Ophthalmic
	Fetal	P	P	P	N	P	P
	Abdominal2	P	P	P	N	P	P
	Intra-operative(Specify)3
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P
Fetal Imaging &Other	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)	P	P	P		P
	Musculo-skel.(Superficial)
	Intravascular
	Other(3D/4D and Contrast)	P	P	P		P	P
Cardiac	Cardiac Adult	P	P	P	N	P	P
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral Vessel	Peripheral Vessel
	Other (Specify)

Table 1.3-2: Diagnostic Ultrasound Indications for Use Form - Curvilinear Transducer CA 1

N = new indication; P previously cleared by FDA 510(k) K 10)091 & K 120703, E=Added under Appendix E

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

2 Includes PWD-Mode maging and High Pulse Repention Rate PWD-Mode (HIPRF)

' Includes Color Doppler (CD), Directional Power Doppler (DMD), und Power Doppler (PD)

4 Includes B · CD, H · PW, B · CD · PW, B · CD, M · CM, B · Elastorgraphy. B · CEUS, and · ECG Trace

' Color M-Mode (L'M)

^ Abdominal includes renal. <i Y N Pelvic

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

Freehand ussue classicaly

Prescription Use (Per 21 CFR 801 Subpan D)

Page 3 of 20

{9}------------------------------------------------

System:	ZS3 and z.one Ultrasound System
Transducer:	Curvilinear Transducer C6-2
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P¹
	Abdominal	P	P	P		P	P	P¹
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P¹
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel(Conventional)
	Musculo-skel.(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
	Peripheral Vascular	P	P	P		P	P	P¹
Peripheral Vessel	Other (Specify)

Table 1.3-3: Diagnostic Ultrasound Indications for Use Form - Curvilinear Transducer C6-2

N = new indication: P=previously cleared by FDA $10(k) K101091 & K120703, E=Added under Appendix E

' includes B-Mode and Harmonic (contrast) imaging (HI)

' Includes B-Mode and Hunnonic (contrast) imaging (HJ)
² Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HIPRF)

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

includes i w E Winderlig Martigi Tale Tigh The Propine (1970), and Power Dopler (PD)
Includes Color Doppler (CD), Directional Power Dopler (DPD), and Power Doppler (PD)
1

' Color M-Mode (CM)

Abdominal includes renal. GYN/Petric

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

Frechand tissue classicus

Preseription Use (Per 21 CT'R 801 Subpart Di

Page 4 of 20

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

System:			7.S.3 and z.onem, Ultrasound System
Transducer:			Curvilinear Transducer C9-3
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 1 & 3)	B	M	PWD	CWD	ColorDoppler	CombinedModes	Otherx
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	P	P	P		P	P	P1
	Abdominal	P	P	P		P	P	P1
	Intra-operative(Specify)	P	P	P		P	P	P1
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P1
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skel.(Conventional)	P	P	P		P	P	P1
	Musculo-skel.(Superficial)	P	P	P		P	P	P1
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
	Peripheral Vascular	P	P	P		P	P	P1
Peripheral Vessel	Other (Specify)

Table 1.3-4: Diagnostic Ultrasound Indications for Use Form - Curvilinear Transducer ro_t

N = new indication: 11 previously cleared by FDA 311/k ) K 10/091 & K 120703, 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)

therades Color Doppler (CD). Directional Power Doppler (DPD), and Power (PD)

Theludes Color 120pplet (CD), Oncentable Parter (17) 19), and Pontaction (1) 1978)
1 Includes B+CD, B+PW, B+CD+PW, M+CM. B+CD+M+CM, B+Classorgephy, B+CT:US, and + FCG Trace

' Color M-Mode (CM)

6 Abdominal includes renal, GYN/Pelvic

7 Intra operative include abdominat and vascular (PV)

" Frechand lissue clasticity

Prescription Use (Per 21 CFR 801 Subpart D)

Page 5 of 20

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

C10-3
System:	ZS3 and z.one Ultrasound System
Transducer:	Curvilinear Transducer C10-3
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General(Track 1)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	CombinedModes	Other*,5
Ophthalmic	Ophthalmic	N	N	N		N	N
	Fetal	P	P	P	N	P	P	P5
	Abdominal*	P	P	P	N	P	P	P5
	Intra-operative(specify)	P	P	P		P	P	P5
	Intra-operative (Neuro)	P	P	P		P	P	P5
	Laparoscopic
	Pediatric	P	P	P	N	P	P	P5
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic	P	P	P	N	P	P	P5
Fetal Imaging &Other	Adult Cephalic trans-cranial	P	P	P	N	P	P	P5
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)
	Musculo-skel.(Superficial)
	Intravascular
	Other (Specify)
	Cardiac Adult	P	P	P	N	P	P	P5
	Cardiac Pediatric	P	P	P	N	P	P	P5
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
	Peripheral Vascular	P	P	P	N	P	P	P5
Peripheral Vessel	Other (Specify)

Table 1.3-5: Diagnostic Ultrasound Indications for Use Form - Curvilinear Transducer C10-3

N = new indication: P=previously cleared by the FDA 5101k) K120703. E=Added under Appendix E

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

N = hew indiculon; P=previously the PDA : hors; it itsering (HD)
' tncludes B-Mode and Humonic (contrast it integing (HD)
1 theludes BWD-Mode imaging and High Pulse Repeilly

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

" Reludes PM L-Mode maging and right Pase Kepenhol Kate P W Privince HTF T
" Includes Color Dopler (CD). Drections) Power Dopler (DPD). and Power Doppler (IP))
" Includes Is

ا Color M-Mode (CM)

Abdominal includes renal. G Y N Telvic

' Intra operative melude abdominal, thoracic (cardiac) and vascular (PV)

Freehand ussue classicits

Prescription Use (Per 21 CFR 801 Subpart D)

Page 6 of 20

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

System:		ZS3 and z.onc., Ultrasound System
Transducer:		Curvilinear Transducer C8-3(3D)
Intended Use:		Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Clinical Application		Mode of Operation
General(Track 1)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P3
	Abdominal	P	P	P		P	P	P3
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P3
	Small Organ (Thyroid,Breast. Testes, etc.)
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph (non-Card)
	Musculo-skel(Conventional)
	Musculo-skel(Superficial)
	Intravascular
	Other (3D/4D)	P	P	P		P	P	P3
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
	Peripheral Vascular	P	P	P		P	P	P3
Peripheral Vessel	Other (Specify)

Table 1.3-6: Diagnostic Ultrasound Indications for Use Form - Curvilinear Transducer C8-3(3D)

N = new indication: P = previously cleared by FDA $10(k) K101091 & K120703, E=Added under Appendix E

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

2 Includes PWI>Mode imaging and High Pulse Repetition Rate PWI>Mode (HPRF)

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

Theludes Child Taiplier (CT), Titlethand Priver (CA) PAGME PHIlastorgraphy, R+C!EUS, and + FCG Trace

Color M-Mode ((M)

" Abdominal includes renal, G Y N Pelvic

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

*Freehand lissue clasticily

Prescription Use (Per 21 CFR 801 Subpart D)

Page 7 of 20

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

System:	ZS3 and z.one,... Ultrasound System
Transducer:	Phase (Sector) Array Transducer P4-1c
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	CombinedModes¹	Other*,²
	Ophthalmic
	Fetal	P	P	P	P	P	P	P¹
	Abdominal¹	P	P	P	P	P	P	P¹
	Intra-operative(Specify)²
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P¹
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic	P	P	P	P	P	P	P¹
Fetal Imaging &Other	Adult Cephalic/ transcranial	P	P	P	P	P	P	P¹
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)
	Musculo-skel.(Superficial)
	Intravascular
	Other (Specify)
	Cardiac Adult	P¹	P	P	P	P	P	P¹
Cardiac	Cardiac Pediatric	P¹	P	P	P	P	P	P¹
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Contrast)	P¹	P	P	P	P	P	P¹
	Peripheral Vascular	P¹	P	P	P	P	P	P¹
Peripheral Vessel	Other (Specify)

Table 1.3-7; Diagnostic Ultrasound Indications for Use Form - Phase (Sector) Array Transducer P4-1c

N = new indication: P=previously cleared by the FDA 510(k) K10109) or K120703. E+Added under Appendix E

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

3 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+CD. B+PW. B+CD+PW. B+CM, M+CM, B+CD+M+CM, B+Elastorgraphy, B+CEUS, and + ECG Trace

' Color M-Mode (CM)

Abdominal includes renal. G Y N/Pelvic

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

Freehand Inssue classicity

Prescription Use (Per 21 CFR 801 Subpart D)

Page 8 of 20

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

Table 1.3-8: Diagnostic Ultrasound Indications for Use Form - Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Model #V11-3BE Transducer (off-the-shelf) (Endo-Cavity Transducer E9-3)

System:		ZS3 and z.one... Ultrasound System
Transducer:		Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Model #V11-3BETransducer (off-the-shelf) (Endo-Cavity Transducer E9-3)

Intended Use:		Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application						Mode of Operation
General	Specific	B	M	PWD	CWD	Color	Combined	Other *
(Track I Only)	(Track 1 & III)				Aux	Doppler	Modes'
Ophthalmic	Ophthalmic
	Fetal	N	N	N		N	N	N³
	Abdominal
	Intra-operative
	(Specify)'
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid,
	Breast, Testes, etc.)
	Neonatal Cephalic
	Adult Cephalic
General	Trans-rectal	N	N	N		N	N	N³
application	Trans-vaginal	N	N	N		N	N	N³
	Trans-urethral
	Trans-esoph. (non-
	Card.)
	Musculo-skel.
	(Conventional)
	Musculo-skel.
	(Superficial)
	Intravascular
	Intra-luminal
	Other (Specify)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph (Cardiac)
	Intra-cardiac
	Other (Specify)
	Peripheral vascular
Peripheral vascular	Other (Specify)

N = new indication: P previously cleared by F12A Shenzhen Mindray 310(k) K123185, I * Added under Appendix 1,

Includes 13-Mode and Harmonic (contrast) imaging (111)

Includes PWD-Mode maging and High Pulse Repeinton Rate PWI)-Mode (IIIPRF)

" Includes Color Doppler (CI)). Directional Power Doppler (DPD), and Power Doppler (PD)

theludes B+CD, B+PW, B+CD+M+CM, B+CD+M -CM, B+CD+M -CM, B+Elustorgraphy, B+CE/S, and + ECG Trace

` Color M-Mode (CM)

" Abdominal includes renal. G Y N:Pelvic

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

" Freehund tissue clasticity

Prescription Use (Per 21 CFR 801 Subpart D)

Page 9 of 20

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

System:		ZS3 and z one, Ultrasound System
Transducer:		Endo-Cavity Transducer E9-4
Intended Use:		Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
Fetal Imaging &Other	Pediatric
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P
	Trans-vaginal	P	P	P		P	P	P
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)
	Musculo-skel(Superficial)
	Intravascular
	Other (Specify)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-Cardiac
	Other (Specify)
	Peripheral vascular
	Other (Specify)
Peripheral Vessel

Table 1.3-9: Diagnostic Ultrasound Indications for Use Form - Endo-Cavity Transducer F9-4

N = new indication: P-previously cleared by FDA 510(k) K101091 & K120703. 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 in Perinoce maging alle Reported (1970). and Pover Doppler (1974)
Includes Color Doppler (CD). Directional Power Doppler (19PD). and Pover Doppler (PD)
1 includes

´ Color M-Mode (CM)

^d Abdominal includes renal, GYN/Pelvic

" Color in Throudes renal. G Y N/Pelvic
" Inita operative include abdominal, Ihoracic (cardiac) and vascular (PV)

Frechand lissue classicity

Prescription Use (Per 21 CFR 801 Subpan Di

Page 10 of 20

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

E9-3 (3D)	ZS3 and z one, Ultrasound System
System:	Endo-Cavity Transducer F9-3 (3D)
Transducer:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Intended Use:
Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	CombinedModes	Other*
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P*
	Abdominal
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid.Breast, Testes, etc.)
	Neonatal Cephalic
Fetal Imaging &Other	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P*
	Trans-vaginal	P	P	P		P	P	P*
	Trans-urethral
	Trans-esoph (non-Card)
	Musculo-skel(Conventional)
	Musculo-skel(Superficial)
	Intravascular
	Other (3D/4D)	P	P	P		P	P	P*
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
	Peripheral vascular
Peripheral Vessel	Other (Specify)

Table 1.3-10: Diagnostic Ultrasound Indications for Use Form - Endo-Cavity Transducer R9-3 (3D)

N = new indication; P-previously cleared by FDA 510(k) K101091 & K120703, E-Added under Appendix E

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

11 - new manaka - Harmonic (contrast) imaging (H)

Includes B-Mode and High Pulse Repelition Rate PWD-Mode (HPRF)

meludes Color Doppler (CD). Directional Power Doppler (DPI). and Power Doppler (PD)

1 Includes B + CD B + PW. B + M. M - CM. B + CD M · CM. B + Elastorgraphy. B ICEUS, and + ECG Trace

' Color M-Mode (C.M)

Abdominal includes renal. G Y N/Pelvic

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

4 Frechand tissue clasticuly

Prescription Use (Per 21 CFR 801 Subpart D)

Page 11 ol 20

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

System:		ZS3 and z.one,,, Ultrasound System
Transducer:		Linear Transducer L10-5
Intended Use:		Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	CombinedModes	Other
General(Track 1 Only)
Ophthalmic	Ophthalmic	P	P	P		P	P	P
	Fetal	P	P	P		P	P	P1
	Abdominal	P	P	P		P	P	P1
	Intra-operative(Specify)	P	P	P		P	P	P1
	Intra-operative (Neuro)	P		P		P	P	P1
	Laparoscopic
	Pediatric	P	P	P		P	P	P1
	Small Organ (Thyroid,Breast, Testes, etc.)	P	P	P		P	P	P1,4
	Neonatal Cephalic	P1	P1	P1		P	P	P1
Fetal Imaging &Other	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
	Intravascular
	Other (Specify)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph (Cardiac)
	Intra-cardiac
	Other (Specify)
	Peripheral Vascular	P	P	P		P	P	P1,x
	Other (Specify)
Peripheral Vessel

Table 1.3-11: Diagnostic Ultrasound Indications for Use Form - Linear Transducer L10-5

N - new indication: P - previously cleared by the FDA $10(k) K (0)(09) & K120703, F: Added under Appendix F.

Includes B-Mode and Harmonic (contrast) เทเลยูเกต (III)

Includes PWD-Mode imaging and I ligh Pulse Repention Rate PWD-Mode (fIPRF)

' Includes Color Doppler (CD). Directional Power Duppler (DPD), und Power Doppler (PD)

includes B+CD. B+CD+PW. B+M, M+CM, B+CD+M+CM, B+CD+M+CM, B+Elastorgraphy, B+CEJS, and + ECG Trace

' Color M-Mode (CM)

Cold, No Mass (C.N.M.)

Abdominal includes renal &

" monades b" CDT P = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = = " = = =

Freehand tissue elasticity

Prescription Use (Per 21 CFR 801 Subpart D)

Page 12 ol 20

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

System:	ZS3 and z.one, Ultrasound System
Transducer:	Linear Transducer L.8-3
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 1 & 3)	B	M	PWD	CWD	Color Doppler	Combined Modes	Other*.x
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	P	P	P		P	P	P3
	Abdominal	P	P	P		P	P	P3
	Intra-operative(Specify)	P	P	P		P	P	P3
	Intra-operative (Neuro)	P	P	P		P	P	P3
	Laparoscopic
	Pediatric	P	P	P		P	P	P3
	Small Organ (Thyroid,Breast, Testes, etc.)	P	P	P		P	P	P3.x
	Neonatal Cephalic	P	P	P		P	P	P3
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card)
	Musculo-skel.(Conventional)	P	P	P		P	P	P3.x
	Musculo-skel(Superficial)	P	P	P		P	P	P3.x
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral Vessel	Peripheral Vascular	P	P	P		P	P	P3.x
	Other (Specify)

Table 1.3-12; Diagnostic Ultrasound Indications for Use Form - Linear Transducer L8-3

N - new indication: P-previously cleared by the FDA 510(k) K 101091 & K 120703, E=Added under Appendix F.

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

2 Includes PWD-Mode imaging and High Putse Repeition Rate PWI>Mode (HPRF)

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

4 Includes B+CD. B · PW. B · C D · PW. B · CD · M+ CM. B · Elastorgraphy. B+CEUS. and + ECG Trace

'Color M-Mode (CM)

' Color M-Mode (CM)
^ Abdominal includes renal. (i Y N Pelvic

' Intra operative include abdominal. Ihoracte (cardiac) and vascular ((V)

" Freehand Inssur classiculy

Prescription Use (Per 21 CFR 801 Subpart Di

Page 13 v1 20

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

System:			ZS3 and z one... Ultrasound System
Transducer:		Linear Transducer 1.14-5sp
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWI	CWD	ColorDoppler	CombinedModes¹	Other⁵
Ophthalmic	Ophthalmic	N		N		N	N
	Fetal	P	P	P		P	P	P¹
	Abdominal"	P	P	P		P	P	P¹
	Intra-operative(Specify)	P	P	P		P	P	P¹
	Intra-operative (Neuro)	P	P	P		P	P	P¹
	Laparoscopic
	Pediatric	P	P	P		P	P	P¹
	Small Organ (Thyroid.Breast, Testes, etc.)	P	P	P		P	P	P⁵,⁸
	Neonatal Cephalic	P	P	P		P	P	P¹
Fetal Imaging &Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)	P	P	P		P	P	P³, ⁸
	Musculo-skel(Superficial)	P	P	P		P	P	P³, ᴷ
	Intravascular
	Other (Specify)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph (Cardiac)
	Intra-cardiac
	Other (Specify)
	Peripheral Vascular	P	P	P		P	P	P³, ᴷ
Peripheral Vessel	Other (Specific)

Table 1.3-13: Diagnostic Ultrasound Indications for Use Form - Linear Transducer L14-Sso

N = new indication: P-previously cleared by the FDA 510(k) K101091 & K120703. I:+Added under Appendix E

Includes 8-Mode and Harmonic (contrast) imaging (H1)

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

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

4 Includes B+CD, B+PW, B+CD+PW, B+M, M+CM, B+CD+M+CM, B+Clastorgraphy, B+Cl:US, and + ECG Trace

' Color M-Mode (CM)

Abdominal includes renal, GYN/Pelv

Abdominal includes renal. G YN!Pelvic
' Intra operative include abdominal, thoracic (cardiac) and vascular (PV)

4 Frechand lissue classicity

Prescription Use (Per 21 CFR 801 Subpart 1))

Page 14 of 20

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

System:			ZS3 and z.onepm Ultrasound System
Transducer:		Linear Transducer L14-5w
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
	General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler1	CombinedModes1
	Ophthalmic	N		N		N	N
Fetal Imaging &Other	Fetal	P	P	P		P	P	P1
	Abdominalm	P	P	P		P	P	P1
	Intra-operative(Specify)	P	P	P		P	P	P1
	Intra-operative (Neuro)	P		P		P		P3
	Laparoscopic
	Pediatric	P	P	P		P	P	P1
	Small Organ (Thyroid,Breast, Testes, etc.)	P	P	P		P	P	P5,k
	Neonatal Cephalic	P	P	P		P	P	P1
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel.(Conventional)	P	P	P		P	P	P5,k
	Musculo-skel.(Superficial)	P	P	P		P	P	P5,n
Cardiac	Intravascular (Cardiac)
	Other (Specify)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph (Cardiac)
	Intra-cardiac
	Other (Specify)
	Peripheral Vascular	P	P	P		P	P	P5,k
Peripheral Vessel	Other (Specify)

Table 1.3-14: Diagnostic Ultrasound Indications for Use Form - Linear Transducer L14-스바

N = new indication: P=previously cleared by the I'DA 510(k) K 101091 & K 120703. E=Added under Appendix E

Includes B-Mode and Harmonic (contrast) imaging (H1)

1 Includes PWD-Mode imaging and High Pulse Repeition Rate PWI)-Mode (HIPRF)

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

the loces in of the maging and may of the may of the may be news Doppler (PD)
1 includes Color Doppler (C1), Directions) Purver (DPD), and Power Doppler (PD)
1 includes B+C1

' Color M-Mode (CM)

" Abdominal includes renal. GYN Pelvic

' Intra operative include abdominal, thoracte (cardiac) and vascular (PV)

" Freehand fissue clasticus

Prescription Use (Per 21 CFR 801 Subpart Di

Page 15 of 20

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

System:	ZS3 and z.one, Ultrasound System
Transducer:	Linear Transducer L20-5
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic	N	N	N	N	N	N
Fetal Imaging &Other	Fetal	E	E	E	E	E	E	E2
	Abdominal	E	E	E	E	E	E	E2
	Intra-operative (Specify)	E	E	E	E	E	E	E2
	Intra-operative (Neuro)	E	E	E	E	E	E	E2
	Laparoscopic
	Pediatric	E	E	E	E	E	E	E2
	Small Organ (Thyroid,Breast, Testes, etc.)	E	E	E	E	E	E	E3, *
	Neonatal Cephalic	E	E	E	E	E	E	E2
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph (non-Card)
	Musculo-skel(Conventional)	E	E	E	E	E	E	E3, *
	Musculo-skel. (Superficial)	E	E	E	E	E	E	E3, *
	Intravascular
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)

Peripheral Vessel	Peripheral Vascular	E	E	E	E	E	E	E3, *
	Other (Specify)

Table 1.3-15: Diagnostic Ultrasound Indications for Use Form - Linear Transducer L20-5

N = new indication. P=per rously cleared by the FDA. E= Added under Appendix E

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

³ Includes PWD-Mode imaging and High Pulse Repetition Rate PWL>Mode (HPRF)

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

Includes TW Divide Mizens and Then Liber Hose Noor Home Provinces Provins Provinces Provinces
' Includes Color Dopler (C D). Directional Power Loppler (DPD), and Pover Doppl

S Color M-Mode (CM)

Abdominal includes renal, G Y N/Pelvic

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

Freehand tissue elastıcılıy

Prescription Use (Per 21 (FK 80) Subpart 1))

l'age 16 of 20

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

System:		ZS3 and z.oneno. Ultrasound System
Transducer:		Trans-esophageal Transducer P8-3TEE
Intended Use:		Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General(Truck 1 Only )	Specific(tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Thyroid,Breast, Testes, etc.)
	Neonatal Cephalic
Fetal Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card. )	P	P	P	P	P	P	P5
	Musculo-skel.(Conventional)
	Musculo-skel.(Superficial)
	Intravascular
	Other (Specify)
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
Cardiac	Trans-esoph. (Cardiac)	P	P	P	P	P	P	P5
	Intra-cardiac
	Other (Specify)
	Peripheral Vessel
Peripheral Vessel	Other (Specify)

Table 1.3-15: Diagnostic Ultrasound Indications for Use Form - Trans-esophageal Transducer P8-3TEE

N = new indication: P=previously cleared by FDA $10(k) K101091 & K120703, E=Added under Appendix E

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

2 Includes PWD-Mode imaging and High Pulse Reperition Rate PWD-Mode (HIPRF)

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

1 Includes B+CD, B+PW, R+CD+PW, B+M, M+CM, B+CD+M+CM, B+Filassorgraphy, B+CF.US, and + FCG Trace

' Color M-Mode (CM)

Abdominal includes renal, G Y N/Pelvic

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

Freehand lissue classicity

Prescription Use IPer 21 CFK 801 Subpart D)

Page 17 of 20

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

System:		ZS3 and z.one, Ultrasound System
Transducer:		St Jude F.P ViewFlex PLUS ICE Catheter model # VF-PM Part #09-2005 (off the
		shelf) (P9-31c)
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 1 & 3)	B	M	PWD	CWD	ColorDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
Fetal Imaging &Other	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)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph (Cardiac)
	Intra-cardiac	P	P	P	N	P	N
	Other (Specify)
Peripheral Vessel	Peripheral vascular
	Other (Specify)

Table 1.3-16: Diagnostic Ultrasound Indications for Use Form - St. Jude EP ViewFlex PLUS ICE Catheter model # VF-PM Part #09-2005 (off the shelf) (P9-3ic)

N - new industrially cleared by FDA 510(k) K101091 & K120703. IST Jude K011066 & K073709): E-Added under Appendix E 10 - new Mizerians - - Harmone (contrast) imaging (HD)

Includes PWD-Mode muging and High Pulse Reperition Rate PWD-Mode (HPRF)
Includes PWD-Mode muging and High Pulse Rep

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

¹Includes Color Doppler (CD1, Directional Power Doppler (OPD), and Power Doppler (PD

michdes i VV-Frinte Million Micr Cheminal Province (1977), and Piwer Library)
Includes Color Dopplet (CD), Directional Power (Dopper (19PD), and Pwer Doppler (192)
1 Inclu

' Color M-Mode ( ' 'M )

� Abdominal includes renal. (¡ Y N: Pelvic

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

" Frechand tissue classicus

Prescription Use (Per 21 CFR 801 Subpart D)

Page 18 01 20

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

System:		ZS3 and z.one, Ultrasound System
Transducer:		A2CW (Common name Pencil Probe)
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 1 & 3)	B	M	PWD	CWD	ColorDoppler	CombinedModes'	Other*.
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric				P
	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)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult				P
	Cardiac Pediatric				P
	Intravascular (Cardiac)
	Trans-esoph (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral Vessel	Peripheral vascular
	Other (Specify)

Table 1.3-17: Diagnostic Ultrasound Indications for Use Form - A2CW (Common name Pencil Probe)

N = new indication: P = previously cleared by FDA 510(k) K101091: E-Added under Appendix E

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

2 Includes PWI>Mode imaging and High Pulse Repetition Rate PWIJ-Mode (HPRF)

Includes Color Doppler (CD). Directional Power Doppler (DPD), und Power Doppler (PD)

thelodes Color Dopper (CD) Cheering) (CD) M . M . CM, B . Elastorgraphy, B . CEUS, and . ECG Trace

'Color M-Mode' ('CM')

` Color M-Mode (C'M)

Abdominal includes renal. (i Y N/Pelvic

7 Intro operative include abdominal. Thoracic (cardiac) and vascular (PV)

Frechand tissue classicity

Prescription Use (Per 21 CFR 801 Subpart Di

Page 18 of 20

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

Pencil Probe)
System:		ZS3 and zone, Ultrasound System
Transducer:		ASCW (Common name Pencil Probe)
Intended Use:		Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	CombinedModes'	Other"
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative(Specify)'
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric				P
	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)
	Intravascular
	Other (Specify)
	Cardiac	Cardiac Adult
		Cardiac Pediatric
		Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral Vessel	Peripheral vascular				P
	Other (Specify)

Table 1.3-18: Diagnostic Ultrasound Indications for Use Form - A5CW (Common name Pencil Probe)

N - new indication. P -previously cleared by FDA 510(k) K101091: E-Added under Appendix E

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

" ficibucs D-MOOC into riamione (connelly mise Repention Rate PWI)-Mode (HPRF)

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

meludes - W Dinise maging and right disc Relation Nation (1977) - 1977 - 1977
Includes Color Doppler (CD). Directional Power Loppler (DVD) and Power Doppler (PD)
1 include

'Color M-Mode (CM)

' Color M-Mode (CM)

Abdominal includes renal, G Y N/Pelvic

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

" Frechand tissue clasticuty

Prescription Use (Per 21 CFR 801 Subpart D)

Page 20 of 20

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.