Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, deep learning, or any related terms, nor does it describe any training or test sets typically associated with AI/ML models. The focus is on the system's hardware and software for image acquisition and display using "zone technology."

Therapeutic

No
The device is described as a "diagnostic ultrasound system" intended for "ultrasound evaluation" and acquiring "high-resolution, real-time ultrasound data," which are diagnostic rather than therapeutic functions.

Diagnostic

Yes.
The Device Description explicitly states that the ZS3 and z.one Ultrasound Systems are "diagnostic ultrasound systems".

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "full-featured, general purpose, software controlled, diagnostic ultrasound system," indicating it includes hardware components (the ultrasound system itself) in addition to software. The performance studies also include hardware-related testing like Mechanical Verification, Electrical Safety, EMC Testing, Thermal and Acoustic Output, Biocompatibility, and Cleaning & Disinfection.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the ZS3 and z.onepro Ultrasound Systems are for "ultrasound evaluation" of various anatomical sites. This involves using ultrasound technology to visualize internal structures and assess their characteristics.
Device Description: The device is described as a "diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data." This aligns with the function of an ultrasound machine, which is an imaging modality.
Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. This device operates in vivo (within the body) by emitting and receiving ultrasound waves.
Performance Studies: The performance studies listed focus on the technical and safety aspects of the ultrasound system itself (mechanical, electrical, thermal, acoustic, biocompatibility, cleaning, software validation), not on the analytical or clinical performance of a test performed on a specimen.

In summary, the ZS3 and z.onepro Ultrasound Systems are diagnostic imaging devices, not in vitro diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ZS3 and z.onepro Ultrasound Systems are 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-vaginal, Trans-esophageal (non-cardiac and cardiac); Musculoskeletal (conventional & superficial); 3D/4D; Cardiac - Adult/ Pediatric/ Fetal; Echo, Intra-Cardiac; Peripheral vascular; harmonic tissue and contrast imaging and Tissue elasticity.

Product codes

IYN, IYO, ITX

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.

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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-esophageal (non-cardiac and cardiac); Musculoskeletal (conventional & superficial); Cardiac (Adult/ Pediatric/ Fetal; Echo, Intra-Cardiac); Pelvic; Peripheral vascular

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal

Intended User / Care Setting

Qualified physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The 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:

Mechanical Verification: In accordance with device performance specifications, Result: PASS
Electrical Safety: In accordance with IEC 60601-1, Result: PASS
EMC Testing: In accordance with IEC 60601-1-2, Result: PASS
Thermal and Acoustic Output: In accordance with IEC 60601-2-37, Result: PASS
Biocompatibility: In accordance with ISO 10993, Result: PASS
Cleaning & Disinfection: In accordance with FDA Guidance Document, Result: PASS
Software Validation & Verification: In accordance with 62304 and FDA Guidance Document Principles of Software Validation, Result: PASS

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

ZONARE's ZS3 Ultrasound System K120703, ZONARE's z.one ultra Ultrasound System K101091

Reference Device(s)

St. Jude K031066, K073709, Shenzhen Mindray K123185

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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 Avenue
Mountain View, CA 94043 | | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|-------------------------------------|
| Contact Person: | Dan Bradford
Vice President, Operations
Phone: (650) 316-3113
Facsimile: (650) 967-9056
E-mail: dbradford@zonare.com | | |
| Date Prepared: | April 24, 2014 | | |
| Trade Name(s): | ZS3 Ultrasound System
z.onepro Ultrasound System | | |
| Common Name: | Diagnostic Ultrasound System with Accessories | | |
| Classification: | II | | |
| Classification
Name(s): | Ultrasonic Pulsed
Doppler Imaging
System | Ultrasonic Pulsed
Echo Imaging System | Diagnostic Ultrasound
Transducer |
| Regulation
Number: | 21 CFR 892.1550 | 892.1560 | 892.1570 |
| Product Code: | IYN | IYO | ITX |
| Classification
Panel: | Radiology | | |
| Predicate Devices: | ZONARE's ZS3 Ultrasound System K120703
ZONARE's z.one ultra Ultrasound System K101091 | | |

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.

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 Platform
ZS3 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 flow
analysis of the human body. | Same | Same |
| Indications for
Use | The z.onepro 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-
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 contrast
imaging and Tissue elasticity. | Same | Same |
| Design | Diagnostic zone technology ultrasound based
platform | Same | Same |
| Safety Standards | IEC 60601-1
IEC 60601-2-37
IEC 60601-1-2
ISO 10993-1, -5, 10, -12
AIUM, NEMA UD 2, NEMA UD3 | Same | Same |
| Patient Contact
Materials | Complies with ISO 10993 | Same | Same |
| Mode of
Operations | 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 | | | |
| Rechargeable
Battery | Yes (up to 3.0 hour operation per charge) | Same | same |
| Wireless
Capability | 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

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·

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

:

i

:

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 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

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)

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.

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	Color
Doppler	Combined
Modes	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	Color
Doppler1	Combined
Modes4	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. 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	Color
Doppler	Combined
Modes¹	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/ trans
cranial	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 #V11-3BE
Transducer (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	Color
Doppler	Combined
Modes	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	Color
Doppler	Combined
Modes	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	Color
Doppler	Combined
Modes	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	Color
Doppler	Combined
Modes¹	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	Color
Doppler1	Combined
Modes1
	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	Color
Doppler	Combined
Modes	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	Color
Doppler	Combined
Modes	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	Color
Doppler	Combined
Modes	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	Color
Doppler	Combined
Modes'	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

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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	Color
Doppler	Combined
Modes'	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)

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