The clinical applications include:Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial),Cardiac Adult, Cardiac Pediatricand Peripheral vessel.

Device Description

The SONOACE R7 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color Doppler imaging, Power Doppler imaging(including Directional Power Doppler mode), PW/CWSpectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, 3D imaging mode (real time 4D imaging mode) or as a combination of these modes. The SONOACE R7 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The SONOACE R7 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes used, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, type of ground truth used, or sample size/ground truth establishment for training sets.

The document is a 510(k) Premarket Notification for the SONOACE R7 Diagnostic Ultrasound System. It primarily focuses on:

Device Description and Intended Uses: Explaining what the device is and its clinical applications.
Technological Characteristics Comparison with Predicates: Demonstrating substantial equivalence to previously cleared devices by comparing features and compliance with standards.
Bench and Non-Clinical Tests: Stating that the device underwent evaluations for acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety, conforming to applicable standards.
Conclusion: Asserting the device's safety, effectiveness, and substantial equivalence to predicate devices.
Indications for Use Statements for various transducers: Listing the specific body parts and modes of operation for each transducer.

The document explicitly states: "Summary of Clinical Tests: Not applicable. The subject of this submission, SONOACE R7, did not require clinical studies to support substantial equivalence." This means no clinical studies, and therefore no acceptance criteria or performance data, were generated for this submission. The substantial equivalence argument relies on the inherent safety and performance of the predicate devices and the new device's adherence to relevant safety and performance standards.

Summary

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

K133506

DEC 2 7 2013

510(k) Premarket Notification

SONOACE R7 Diagnostic Ultrasound System

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.

1. Submitter's Information: 21 CFR 807.92(a)(1)

SAMSUNGMEDISON CO., LTD. 42, Teheran-ro 108-gil, Gangnam-gu, Seoul, Korea

Contact Person: . Kyeong-Mi, Park

Regulatory Affairs Manager

Telephone:	82.2.2194.1373
Facsimile:	82.2.556.3974

Data Prepared:September 9, 2013

2. Name of the device:

Common/Usual Name: Diagnostic Ultrasound System and Accessories Proprietary Name: SONOACE R7 Diagnostic Ultrasound System Product Code FR Number Classification Names: Ultrasonic Pulsed Doppler Imaging System 892.1550 IYN IYO Ultrasound Pulsed Echo Imaging System 892.1560 ITX 892.1570 Diagnostic Ultrasound Transducer

3. Identification of the predicate or legally marketed device:

SONOACE R7 Diagnostic Ultrasound System(K112646) -
UGEO HM70A Diagnostic Ultrasound System (K130803) -
ACCUVIX A30 Diagnostic Ultrasound System(K112339) -
EKO 7 Diagnostic Ultrasound System (K101455) .
UGEO H60 Diagnostic Ultrasound System (K122583) -
UGEO PT60A Diagnostic Ultrasound System (K132228) -
MySono U6 Diagnostic Ultrasound System (K113381) ﮯ
The proprietary names of predicate devices (K130803 / K122583) have been changed to UGEO HM70A / ※ UGEO H60 Diagnostic Ultrasound System from UGEO H70c / UGEO G60 Diagnostic Ultrasound System on FDA Databases.

510(k) Summary

Page 1 of 6

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4. Device Description:

5. Intended Uses:

The SONOACE R7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

6. Technological Characteristics:

The SONOACE R7is substantially equivalent with respect to safety, effectiveness, and functionality to the SONOACE R7 Diagnostic Ultrasound System (K112646) and ACCUVIX A30 Diagnostic Ultrasound System (K112339).

It is substantially equivalent with respect to safety, effectiveness, and functionality to the Bodymarker of SONOACE R7(K112646) in regards to the device with e-Motion Marker.

All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All system allow for specialized measurements of structures and flow, and calculations.

These are described in detail in the technological characteristics comparison table as below.

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0NOACE R7 Diagnostic Ultrasound System

Feature/Characteristics	The subject deviceSONOACE R7	SONOACE R7(K112646)	ACCUVIX A30(K112339)	EKO 7(K101455)	UGEO HM70A(K130803)	UGEO H60(K122583)	MySono U6(K113381)	UGEO PT60A(K132228)
Indication for Use
- Fetal	√	√	√	√	√	√	√	√
- Abdominal	√	√	√	√	√	√	√	√
- Pediatric	√	√	√	√	√	√	√	√
- Small Organ	√	√	√	√	√	√	√	√
- Neonatal Cephalic	√	√	√	√	√	√	√	√
- Adult Cephalic	√	√	√	√	√	√	√	√
- Trans-rectal	√	√	√	√	√	√	√	√
- Trans-vaginal	√	√	√	√	√	√	√	√
- Musculo-skeletal(Conventional)	√	√	√	√	√	√	√	√
- Musculo-skeletal(Superficial)	√	√	√	√	√	√	√	√
- Cardiac Adult	√	√	√	√	√	√	√	√
- Cardiac Pediatric	√	√	√	√	√	√	√	√
- Peripheral vessel	√	√	√	√	√	√	√	√
Scanhead Types
- Linear Array	√	√	√	√	√	√	√	√
- Curved Linear Array	√	√	√	√	√	√	√	√
- Endocavity	√	√	√	√	√	√	√	√
- Phased Array	√	√	√	√	√	√	√	√
- Static Probes	√	√	√	√	√	√	√	√
Scanhead Frequency
- 1.0 - 20.0 MHz	√	√	√	√	√	√	√	√
Modes of Operation
- B-mode	√	√	√	√	√	√	√	√
- M-mode	√	√	√	√	√	√	√	√
- Pulsed wave (PW) Doppler	√	√	√	√	√	√	√	√
- Continuous wave (CW) Doppler	√	√	√	√	√	√	√	√
- Color Doppler	√	√	√	√	√	√	√	√
- Power Amplitude	√	√	√	√	√	√	√	√
Feature / Characteristics	The subject deviceSONOACE R7	SONOACE R7(K112646)	ACCUVIX A30(K112339)	EKO 7(K101455)	UGEO HM70A(K130803)	UGEO H60(K122583)	MySono U6(K113381)	UGEO PT60A(K132228)
Doppler	√	√	√	√	√	√	√	√
Tissue HarmonicImaging	√	√	√	√	√	√	√	√
3D/4D imaging mode	√	√	√	√	√	√	√	√
Combined modes	√	√	√	√	√	√	√	√
Safety & EMC Compliance
IEC60601-1	√	√	√	√	√	√	√	√
UL 60601-1
CSA C22.2 No.601.1
IEC 60601-2-37	√	√	√	√	√	√	√	√
IEC 60601-1-2
Acoustic Output Display Standard	√	√	√	√	√	√	√	√
Track 3
Patient Contact Materialstested to ISO 10993-1	√	√	√	√	√	√	√	√
Functionality
Quick Scan (Q Scan)	√	√	√	√	√	√	√	√
Spatial CompoundImaging	√	√	√	√	√	√	√	√
SMDR (Dynamic MRPlus)	√	√	√	√	√	√	√	√
Auto IMT+(Auto IMT)	√	√	√	√	√	√	√	√
Strain	√	√	√	√	√	√	√	√
Stress Echo	√	√	√	√	√	√	√	√
Panoramic	√	√	√	√	√	√	√	√
Elastoscan	√	√	√	√	√	√	√	√
3D Imaging(Volume DataAcquisition)	√	√	√	√	√	√	√	√
3D Imaging presentation(3D Cine/4D Cine)	√	√	√	√	√	√	√	√
3D Rendering	√	√	√	√	√	√	√	√
MPR(Multi PlanerRender)	√	√	√	√	√	√	√	√
3D XI	√	√	√	√	√	√	√	√

fechnological Characteristics Comparison Table>

510(k) Summary

Page 3 of 6

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SONOACE R7 Diagnostic Ultrasound System

510(k) Summary

Page 4 of 6

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KONOACE R7 Diagnostic Ultrasound System

Feature / Characteristics	The subjectdevice	The predicate devices
	SONOACE R7	SONOACE R7(K112646)	ACCUVIX A30(K112339)	EKO 7(K101455)	UGEO HM70A(K130803)	UGEO H60(K122583)	MySono U6(K113381)	UGEO PT60A(K132228)
MSV(Multi Slice View)		V	V	V	V	V	V	V
Oblique View		V	V	V	V	V	V	V
- 3D MagiCut		V	V	V	V	V	V	V
- e-Motion Marker

BodyMarker

510(k) Summary

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

7. A brief discussion of the bench and non-clinical tests conducted on the subject device

The device has been evaluated for acoustic output, biocompatibility effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform to applicable medical device safety standards.

The SONOACE R7 and its application comply with voluntary standards as below:

UL 60601-1. Safety requirements for Medical Equipment
CSA C22.2 No. 601.1, Safety requirements for Medical Equipment
IEC60601-2-37, Diagnostic Ultrasound Safety Standards
EN/IEC60601-1,Safety requirements for Medical Equipment
EN/IEC60601-1-2,EMC requirements for Medical Equipment
NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
ISO10993-1, Biocompatibility
ISO14971, Application of risk management to medical devices

Summary of Clinical Tests:

Not applicable. The subject of this submission, SONOACE R7, did not require clinical studies to support substantial equivalence.

8. Conclusion

Intended uses and other key features are consistent with traditional clinical practices and FDA guidelines. The design, development and quality process of the manufacturer confirms with 21 CFR 820 and ISO 13485. The device is designed to conform to applicable medical device safety standards and compliance. Therefore, SAMSUNG MEDISON CO., LTD. considers the SONOACE R7to be as safe, as effective, and performanceis substantially equivalent to thepredicate devices.

END of 510(K) Summary

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

December 27, 2013

SAMSUNG MEDISON CO., LTD C/O MARK JOB RESPONSIBLE THIRD PARTY OFFICIAL REGULATORY TECHNOLOGY SERVICES LLC 1394 25TH STREET NW BUFFALO MN 55313

Re: K133505

Trade/Device Name: SONOACE R7 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 13, 2013 Received: November 14, 2013

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

This determination of substantial equivalence applies to the following transducers intended for use with the SONOACE R7 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number
C2-5	C2-8	C4-9/10ED
ER4-9/10ED	EV4-9/10ED	L3-8
L5-12/50EP	LN5-12	HL5-12ED
P2-4AH	P3-7AC	3DC2-6
3D4-8ET	3D4-9ES	C4-9
CF4-9	ER4-9	EVN4-9
L5-12/50	P2-4	PN2-4 SP3-8

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

.	3D4-8	3D4-9	VN4-8
		CW2.0

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

FDA

For

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K133505

Device Name

SONOACE R7 Diagnostic Ultrasound System

Indications for Use (Describe)

The SONOACE R7 Diagnostic Ultrasound System and transcheers are intended for disgnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Trans-recal, Transvaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Pediatic and Peripheral vessel.

Type of Use (Select one or both, as applicable)

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)

Michael D. O'Hara

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last pege.

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

510(k) No.:

Device Name: SONOACE R7 Diagnostic Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Abdominal(See Note 10)	P	P	P	P	P	Note 1	Notes 2, 4, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 12
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 12
	Neonatal Cephalic	P	P	P		P	Note 1	Notes 2,8, 9
	Adult Cephalic	P	P	P	P	P	Note I	Note 4, 7
	Trans-rectal	P	P	P		P	Note 1	Note 2, 7, 8, 11
	Trans-vaginal	P	P	P		P	Note 1	Note 2, 7, 8, 11
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note I	Note 2, 5, 6, 7, 9, 12
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 12
	Intra-luminal
	Other (spec.)
	Cardiac Adult	P	P	P	P	P	Note I	Note 4, 7
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note I	Note 4. 7
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 12
	Other (spec.)

N= new indication; P= previously cleared by FDA K112646; E= added under Appendix E

Additional Comments:

Color Doppler includes Power ( Amplitude) Doppler

Color Doppler includes Power (Amplinude) Dopler
Note I : B-M, B+PW, B+C, B+PD, B+CW, B+CW, B+C+PW, B+C+PW, B+DPD+PW, B+C+M, B+C+CW, B+PD+CW, B+PD-CW, Dual(B. B+C, B+PD, B+TD, B+PD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example; thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9; Panoramic imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note I I : ElastoScan

Notel 2; Spatial Compound Imaging .

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indications for Use

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. 510(k) Premarket Notification :

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: C2-5 for use with SONOACE R7 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	P	P	P		P	Note 1	Notes 2, 7, 8, 9
	Abdominal(See Note 10)	P	P	P		P	Note 1	Notes 2, 7, 8, 9
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 2, 7, 8, 9
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared byFDA K112646; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+C+PW, B+PD+PW, B+DPD+PW, B+C+M, B+C+CW, B+C+CW, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Note 10: Includes Renal, Gynecology Petvis

Note 11: ElastoScan

Note 12: Spatial Compound Imaging

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801 109)

Indications for Use

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... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: C2-8 for use with SONOACE R7

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	P	P	P		P	Note 1	Notes 2, 7, 8, 9
	Abdominal(See Note 10)	P	P	P		P	Note 1	Notes 2, 7, 8, 9
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 2, 7, 8, 9
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared byFDA K112646; E= added under Appendix E

Additional Comments:

・

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+C+PW, B+DPD+PW, B+DPD+PW, B+TD+PW, B+C+M, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5; For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vesse!

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: ElastoScan

Note 12: Spatial Compound Imaging

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indications for Use

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

510(k) No.:

Device Name: C4-9/10ED for use with SONOACE R7 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	P	P	P	P	P	Note 1	Notes 2,8, 9
	Abdominal(See Note 10)	P	P	P	P	P	Note 1	Notes 2,8, 9
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Notes 2,8, 9
	Small Organ (See Note 5)	P	P	P	P	P	Note 1	Notes 2,8, 9
	Neonatal Cephalic	P	P	P	P	P	Note 1	Notes 2,8, 9
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	Note 1	Notes 2,8, 9
	Other (spec.)

N= new indication; P= previously cleared byFDA K112646; E= added under Appendix E

. Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Collar Dopper Interest one ( milipinate) Dopper
Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+C+PW, B+C+PW, B+PD+PW, B+C+M, B+C+CW, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color Momode

Note 5: For example: thyroid, parathyroid, breast, serotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: ElastoScan

Note 12: Spatial Compound Imaging

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

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

510(k) No .:

Device Name: ER4-9/10ED for use with SONOACE R7 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	P	P	P		P	Note 1	Notes 2, 8
	Abdominal(See Note 10)	P	P	P		P	Note 1	Notes 2, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Notes 2, 8
	Trans-vaginal	P	P	P		P	Note 1	Notes 2, 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K112646; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Nate I: B+M, B+PW, B+C, B+PD, B+DPD, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+TD+PW, B+C+M, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatic and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Note 10: Includes Renal, Gynecology/Pelvis Note 11: ElastoScan

Note 12: Spatial Compound Imaging

Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indications for Use

. -

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

510(k) No .:

Device Name: EV4-9/10ED for use with SONOACE R7 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal ( See Note 3 )	P	P	P		P	Note 1	Notes 2, 8
	Abdominal ( See Note 10 )	P	P	P		P	Note 1	Notes 2, 8
	Intra-operative ( See Note 6 )
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ ( See Note 5 )
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Notes 2, 8
	Trans-vaginal	P	P	P		P	Note 1	Notes 2, 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication: P= previously cleared by FDAK112646; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Dopper Mellaus Front (Timpinson Boppia
Note 1: B+M, B+C+PD, B+C, B+PD, B+CW, B+C+PW, B+C+PW, B+PD+PW, B+PD+PW, B+C+M, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: ElastoScan

Note 12: Spatial Compound Imaging

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indications for Use

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

510(k) No.:

Device Name: L3-8 for use with SONOACE R7

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

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal ( See Note 3 )
	Abdominal ( See Note 10 )
	Intra-operative ( See Note 6 )
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	N	N	N		N	Note I	Note 2, 5, 6, 7, 9, 12
	Small Organ ( See Note 5 )	N	N	N		N	Note I	Note 2, 5, 6, 7, 9, 12
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9, 12
	Musculo-skel. (Superfic.)	N	N	N		N	Note 1	Note 2. 5, 6. 7, 9, 12
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	N	N	N		N	Note I	Note 2, 5, 6, 7, 9, 12
	Other (spec.)

N= new indication; P= previously cleared by FDA K112646; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+C+M, B+C+CW, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: ElastoScan

Note 12: Spatial Compound Imaging

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801 109)

Indications for Use

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

510(k) No .:

Device Name: L5-12/50EP for use with SONOACE R7 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal(See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 12
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 12
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 12
	Musculo-skel. (Superfic.)	P	P	P	-	P	Note 1	Note 2, 5, 6, 7, 9, 12
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 12
	Other (spec.)

N= new indication; P= previously cleared by FDA K 12646; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+C+M, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note II: ElastoScan

Note 12: Spatial Compound Imaging

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indications for Use

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

510(k) No .:

Device Name: LN5-12 for use with SONOACE R7

	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation (* includes simultaneous B-mode)
General(Track I only)	Specific(Tracks 1 & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal(See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note I	Notes 2,5.6, 9, 11, 12
	Small Organ (See Note 5)	P	P	P		P	Note I	Notes 2,5,6, 9, 12
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note I	Notes 2,5,6, 9, 12
	Musculo-skel. (Superfic.)	P	P	P		P	Note I	Notes 2,5,6, 9, 12
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P		P	Note I	Notes 5,6, 9, 12
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K112646; E= added under Appendix E

Additional Comments:

Color Doppier includes Power (Amplitude) Doppler

Color Dopper Mitiades Port (mipinale) Boppia
Nota 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+C+PW, B+PD+PW, B+PD+PW, B+C+M, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6; Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: ElastoScan

Note 12: Spatial Compound Imaging

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indications for Use

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

510(k) No.:

Device Name: HLS-12ED for use with SONOACE R7 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal ( See Note 3 )
	Abdominal ( See Note 10 )
	Intra-operative ( See Note 6 )
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 12
	Small Organ ( See Note 5 )	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 12
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 12
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 12
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 12
	Other (spec.)

N= new indication; P= previously cleared by FDA K112646; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Nota I: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+C+PW, B+PD+PW, B+PD+PW, B+C+M, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)

Note 2; Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: ElastoScan

Note 12: Spatial Compound Imaging

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indications for Use

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

510(k) No.:

Device Name: P2-4AH for use with SONOACE R7 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 4, 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro )
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	Note 1	Note 4, 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult	P	P	P	P	P	Note 1	Note 4, 7
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K 112646; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Coll Dopper Minister only (rispinser) Dopping Dual(B, B+C, B+PD, B+TD, B+PD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: ElastoScan

Note 12: Spatial Compound Imaging

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indications for Use

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

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

510(k) No .:

Device Name: P3-7AC for use with SONOACE R7

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal(See Note 10)	P	P	P	P	P	Note 1	Note 4, 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	Note 1	Note 4, 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult	P	P	P	P	P	Note 1	Note 4, 7
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication: P= previously cleared by FDA K112646; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Dopper alchades rone («mphade) Boppiel
Note 1: B+M, B+PW, B+C, B+PD, B+DD, B+C+PW, B+C+PW, B+C+PW, B+C+PW, B+C+M, B+C+CW, B+C+CW, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example; thyroid, parathyoid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: ElastoScan

Note 12: Spatial Compound Imaging

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indications for Use

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

510(k) No .:

Device Name: 3DC2-6 for use with SONOACE R7 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler .	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (Sec Note 3)	P	P	P		P	Note l	Note 2, 7, 8, 9
	Abdominal(See Note 10)	P	P	P		P	Note I	Note 2, 7, 8, 9
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
&Other	Pediatric	P	b	P		P	Note I	Note 2, 7, 8, 9
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans esoph (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA KI12646; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Nate I: B+M, B+PW, B+C, B+PD, B+DPD, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+C+M, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: ElastoScan

Note 12: Spatial Compound Imaging

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indications for Use

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

510(k) No .:

Device Name: 3D4-8ET for use with SONOACE R7

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	P	P	P		P	Note 1	Note 2, 7, 8, 9
	Abdominal (See Note 10)	P	P	P		P	Note 1	Note 2, 7, 8, 9
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Note 2, 7, 8, 9
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

. N= new indication; P= previously cleared by FDA K112646; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Dopper Motions Port (1.miphiles) Dopper D, B+C+PW, B+PD+PW, B+PD+PW, B+C+M, B+C+CW, B+C+CW, B+C+CW, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note II: ElastoScan

Note 12: Spatial Compound Imaging

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indications for Use

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No .:

Device Name: 3D4-9ES for use with SONOACE R7 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (* includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler *	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	P	P	P		P	Note 1	Note 2, 7, 8
	Abdominal (See Note 10)	P	P	P		P	Note 1	Note 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Note 2, 7, 8
	Trans-vaginal	P	P	P		P	Note 1	Note 2, 7, 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K112646; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Doppier netdas Forect (Antipliade) Dopper
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+C+M, B+C+M, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)

Note 2; Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thytoid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: ElastoScan

Note 12: Spatial Compound Imaging

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

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

510(k) No .:

Device Name: C4-9for use with SONOACE R7

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as tollows:

Clinical Application			Mode of Operation (* includes simultaneous B-mode)
General(Track 1 only)	Specific(Tracks I & II)	B	M	PWD	CWD	ColorDoppler *	Combined *(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal (See Note 3)	P	P	P		P	Note 1	Notes 8, 9
	Abdominal (See Note 10)	P	P	P		P	Note 1	Notes 8, 9
	Intra-operative (See Note 6)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 8, 9
	Small Organ (See Note 5)	P	P	P		P	Note 1	Notes 8, 9
	Neonatal Cephalic	P	P	P		P	Note 1	Notes 8, 9
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Supertic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1	Notes 8, 9
	Other (spec.)

No new mdreation: P : previously cleared byFDA K113381, E= added under Appendry E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Cool respectionals Pare (respirition) (1892) BeCW, B-C-PW, B-PD-PW, R-ITD+PW, B-C-M, B+C+M, B+C+CW, B+PD><W Dual B, B+C, B+PD, B+TD, B+PD]

Note 2 Includes maging for guidance of bropsy

Note 3 Includes infertify monitoring of follicle development

Note 4. Color M-mode

Note 5 For example thyroid, parathyroid, breast, serotum and pens in addit, pediative and neonatal patients

Note 6 Abdominal organs and peripheral vessel

Note 7 Tissue Harmanic Imaging ( 1711)

Note 8: 3D maging

Note 9 Panoramic maging

Note 16 Includes Renal, Gynecology Pelvis

Note 11: Elastoscan

Note 12 Spatial Compound Imaging

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

510(k) No.:

Device Name: CF4-9 for use with SONOACE R7

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

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks 1 & II)	B	M	PWD	CWD	ColorDoppler *	Combined *(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal (See Note 3)	P	P	P		P	Note 1	Notes 8, 6
	Abdominal(See Note 10)	P	P	P		P	Note 1	Notes 8, 9
	Intra-operative (See Note 6)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 8, 9
	Small Organ (See Note 5)	P	P	P		P	Note 1	Notes 8, 9
	Neonatal Cephalic	P	P	P		P	Note 1	Notes 8, 9
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent)
	Musculo-skel. (Supertic)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1	Notes 8, 9
	Other (spec.)

N new mdreation: Previously cleared byFDA K122583. I = added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

E BOT Poppeditionals Fores (Angles) BeCW, B-C-PW, B-PD-PW, B-PDFD-PW, B-C-M, B-C-CW, B-PD-CW, Dual B, B-C, R+PD, B+1D, B+PD)

Note 2 includes una ung for guidance of propsy

Note 3 Includes infertility manitoring of folliele development

Note 4 Color M-mode

Note 5 For example thyroid, parathyroid, breast, scrotum and pens in adalt, pediatric and neconatal patterns

Note 6. Abdominal organs and peripheral vessel

Note 7. Tissue Harmonic Imaging (THI)

Note 8 3D macing

Note 9 Panoramic maging

Note in Includes Renal, Gynecology Peters

Note 11. Elastoscan

Note 12 Spanal Compound Imaging

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (GRT Preseription Use (Per 21 CFR 801.109)

{26}------------------------------------------------

510(k) No.:

Device Name: ER4-9 for use with SONOACE R7

Intended Use: Diagnostic ultrasound imaging or tluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & II)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	P	P	P		P	Note 1	Notes 2, 7, 8, 11
	Abdominal(See Note 10)	P	P	P		P	Note 1	Notes 2, 7, 8, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Notes 2, 7, 8, 11
	Trans-vaginal	P	P	P		P	Note 1	Notes 2, 7, 8, 11
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel (Convent)
	Musculo-skel (Supertic)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N new indication: P - previously cleared by FDA K 122583. E= added under Appendix E

Additional Comments:

Color Doppler meludes Power (Amplitude) Doppler

Color Department (Angliade Propider)
Note I Read, Robert, Replice, Recom, Belling, BeC-PW, B-PD-PW, B+DMD+PW, B+C-M, B+C+CW, B+C+M, B+C+CW, B+C+CW, B+C+CW, B+C+CW, B+C+CW Dual(B, B+C, B-PD, B+TD, B+PD)

Note 2 Includes imaging for guidance of biopsy

Note 3 Includes infertility monitoring of follicle development

Note 4 Color M-mode

Note 5 For example thyroid, parathytoid, breast, serotum and penis in adult, pediatic and neonatal patients

Note 6 Abdominal organs and peripheral vessel

Note 7 Tissue Harmonic Imaging (THII)

Note 8: 3D manng

Note 9 Panoramic imaging

Note 16 Includes Renal, Gynecology Petris

Note 11 Elastoscan Note 12: Spana! Compound Imaging

Concurrence of CDRH, Oftice of In Vitro Diagnostics and Radiological Health (GIR) Preseription Use (Per 21 CFR 801,109)

{27}------------------------------------------------

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

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

510(k) No.:

Device Name: EVN4-9 for use with SONOACE R7

Clinical Application		Mode of Operation (* includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic

Fetal Imaging& Other	Fetal (See Note 3)	P	P	P		P	Note 1	Notes 2, 7, 8
	Abdominal (See Note 10)	P	P	P		P	Note 1	Notes 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Notes 2, 7, 8
Trans-vaginal	P	P	P		P	Note 1	Notes 2, 7, 8
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)
Musculo-skel. (Supertic.)
Intra-luminal
Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N=new indication: P= previously cleared by FDA K122583: E=added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B=M, B+PW, B+C, B+PD, B+DPD, B+CW, B+C+PW, B+DY>PW, B+DYD+PW, B+C+M, B+C+CW, B+PD-CW, Dual(B, B+C. B+PD, B+TD, B+PD, B+PD)

Note 2: Includes imaging for guidance of bropsy

Note 3; Includes infertility monitoring of folliele development

Note 4: Color M-mode

Note 5: For example: thyroid, preast, scrotum and penis in adult, pediatric and nearmall patients

Note 6: Abdominal organs and peripheral vessel

Note 7; Tissue Harmonic Imaging (1711)

Note 8: 3D imaging

Note 9: Panoranic imaging

Note 10: Includes Remal, Gyuecology/Pelvis

Note 11: ElastoScan

Note 12: Spatial Compound Imaging

Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (CJR) Prescription Use (Per 21 CFR 801.109)

Indications for Use

{28}------------------------------------------------

510(k) No.:

Device Name: L5-12/50 for use with SONOACE R7

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track 1 only)	Specific(Tracks I & II)	B	M	PWD	CWD	ColorDoppler *	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal(See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9, 12
	Small Organ (See Note 5)	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9, 11, 12
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent)	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9, 12
	Musculo-skel (Supertic.)	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9, 12
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9, 12
	Other (spec.)

N=new indication: P=previously cleared by FDA: E= added under Appendix E

Additional Comments:

Color Doppier includes Power (Ampliude) Doppler

Cool ropper metable from (calphiae) rapper
Note 1: R+M, R+PW, R+C, R+PD, B+CW, B+C+PW, B+C+PW, B+111+PW, R+TD+PW, B+C+M, B+C+CW, B+C+CW, B+C+CW, B+C+CW, B+C+CW, B+0D+CW, Dual(B, B+C, B+PD, B+TD, B+PD)

Note 2: Includes imaging for guidance of broysy

Note 3: Includes infertifity monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, serotom and penis in addle, pediatic and neonalal patients

Note 6; Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8; 3D imaging

Note 9: Panoranne imaging

Note 10; Includes Renal, Gynecology/Pelvis

Note II: ElastoScan

Note 12: Spatial Compound Imaging

Concurrence of CDRH, Office of In Fitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801, 109)

Indications for Use

{29}------------------------------------------------

510(k) No.:

Device Name: P2-4 for use with SONOACE R7

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

Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal (See Note 3)
	Abdominal/See Note 10	P	P	P	P	P	Note 1	Note 4, 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	Note 1	Note 4, 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult	P	P	P	P	P	Note 1	Note 4, 7
	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K113381; E= added under Appendis E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Nae I: B+M, R+PW, B+C, B+PD, B+DM), B+CW, B+CW, B+C+PW, B+DPD+PW, B+TD>PW, B+C+M, B+C+CW, B+PD+CW, Daa(B, B+C, B=PD, B+TD, B+PD)

Note 2: Includes inaging for guidance of biopsy

Note 3: Includes infectility monitoring at tollicle development

Note 4: Color M-mode

Note 5: For example: thywid, preast, scrotum and penis in adult, pediatin and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harnonic Imaging (THD)

Note S: 3D imaging

Note 9: Panoramic imaging

Note 10; Includes Renal. Gynecology:Pelvis Note 11: ElastoScan

Note 12: Spatial Compound Imaging

Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR) Preseription Use (Per 21 CFR 801,109)

Indications for Use

{30}------------------------------------------------

510(k) No.:

Device Name: PN2-4 for use with SONOACE R7 Imended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & II)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	Note 1	Note 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult	P	P	P	P	P	Note 1	Note 4, 7
	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

: N= new indication; P= previously cleared byFDA K 132228; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Dopplet

Note i Ball BePW Hoc, 8-19, B-DPD, B+CW, B+C+PW, B+DPDPW, B-TDPW, B+C+M, B+C-CW, B+PD-CW, Dual(B, B:C, B:PD, B+TD, B+PD)

None 2: Includes imaging for guidance of biopsy

Note 3: Includes infertifity monitoring of tollicle development

Note 4: Color M-mode

Note 5: For example: thytoid, garathyroid, breast, sciolum and periis in adult, pediative and nequatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonie Imaging (THI)

Note 8: 3D imaging

Note 9: Panoranic imaging

Note 10 Includes Renal, Gynecology/Pelvis

Note 11: ElastoScan Note 12: Spatial Compound Imaging

Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indications for Use

{31}------------------------------------------------

510(k) No.:

Device Name: SP3-8 for use with SONOACE R7

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

	Clinical Application		Mode of Operation (*includes simultaneous B-mode)
	General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler *	Combined *(Spec.)	Other(Spec.)
	Ophthalmic	Ophthalmic
	Fetal Imaging& Other	Fetal (See Note 3)
		Abdominal(See Note 10)	N	N	N	N	N	Note 1	Note 4, 7
		Intra-operative (See Note 6)
		Intra-operative (Neuro)
		Laparoscopic
		Pediatric
		Small Organ (See Note 5)
		Neonatal Cephalic
		Adult Cephalic	N	N	N	N	N	Note 1	Note 4, 7
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Trans-esoph. (non-Cardiac)
		Musculo-skel. (Convent.)
		Musculo-skel (Supertic.)
		Intra-luminal
		Other (spec.)
Cardiac		Cardiac Adult	N	N	N	N	N	Note 1	Note 4, 7
		Cardiac Pediatric	N	N	N	N	N	Note 1	Note 4, 7
		Trans-esophageal (Cardiac)
		Other (spec.)
PeripheralVessel		Peripheral vessel
		Other (spec.)

N= new indication: P= previously cleared by FDA: E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Nate 1: Boat, Bopw, Bed, Repo, Retw, BeCw, BeCw, BeCarw, B-PD-PW, B+DYD-PW, B+C+M, B+C+CW, B-PD+CW, Dual(B, B+C. I3+PD, B+TD, B+PD) 1

Note 2: Includes imaging for guidance of bropsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

・

Note 5; For example: thyroid, preast, scrotum and genis in adult, pediatic and neonatal patients

Note b: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panorame imaging

Note 16: Includes Renal, Gynecology/Pelvis

Note 11: ElastoScan

Note 12: Spatial Compound Imaging

Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (GR) Prescription Use (Per 21 CFR 801.109)

Indications for Use

{32}------------------------------------------------

510(k) No .:

Device Name: 3D4-8 for use with SONOACE R7 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (* includes simultaneous B-mode)
General(Track 1 only)	Specific(Tracks 1 & III)	B	M	PWD	CWD	ColorDoppler *	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal (See Note 3)	P	P	P		P	Note 1	Note 2, 7, 8, 9
	Abdominal(See Note 10)	P	P	P		P	Note 1	Note 2, 7, 8, 9
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Note 2, 7, 8, 9
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent)
	Musculo-skel (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication: P= previously cleared by FDA K 12646; E=added under Appendix E

Additional Comments:

Color Doppier includes Power (Amplitude) Doppler

Cold Dapper action of the (Angliade) Dognet
Nate 1: ReMA Replier (Angliade) Bell), BeCW, B-C-PW, B-ID-PW, B-IDPD-PW, B+C-M, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+TD, B+PD)

Note 2: Includes imaging for goidance of bropsy

Note 3; Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example; ahyroid, breast, scrotum and penis in addly, pediative and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 31) imaging

Note 9: Panoramic imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note II : ElastoScan

Note 12: Spatial Compound Imaging

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OR) Prescription Use tPer 21 CFR 801.109)

Indications for Use

{33}------------------------------------------------

510(k) No.:

Device Name: 3D4-9 for use with SONOACE R7

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

Clinical Application		Mode of Operation (* includes simultaneous B-mode)
General(Track only)	Specific(Tracks I & II)	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	P	P	P		P	Note 1	Note 2, 7, 8
	Abdominal(See Note 10)	P	P	P		P	Note 1	Note 2, 7, 8
Fetal Imaging& Other	Intra-operative (See Note 6)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Note 2, 7, 8
	Trans-vaginal	P	P	P		P	Note 1	Note 2, 7, 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Supertic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N=new indication: P= previously cleared by FDA K122583: E= added under Appendix 13

Additional Comments:

(_olor Doppler includes Power (Amplitude) Doppler

Cool request and Port (ruiphisos) roopics
Note 1: 14-M, B=PW, B+C, R+PD, B+CW, B+C+PW, B+C+PW, B+P1)+PW, B+C+N+ B+C+N+ B+C+CW, B+YD+CW, DualqB, B+C, R+PD, B+TD, B+PD)

Note 2, Includes imaging for guidance of bropsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5; For example: thyroid, breast, serotum and penis in adult, pediatic and neonatal parients

Note 6: Abdominal organs and peripheral vessel

Note 7. Tissue Harmonie Imaging (THI)

Note 8: 31) imaging

Note 9; Panorame imaging

Note 10: Includes Rena), GynecologyPelvis

Note 11: ElastoScan

Note 12: Spatial Compound Imaging

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (ORS Prescription Use (Per 21 CFR 801,109)

Indications for Use

{34}------------------------------------------------

510(k) No.:

Device Name: VN4-8 for use with SONOACE R7

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

Clinical Application		Mode of Operation (* includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	N	N	N		N	Note 1	Note 2, 7, 8, 9
	Abdominal(See Note 10)	N	N	N		N	Note 1	Note 2, 7, 8, 9
	Intra-operative (See Note 6)
	Intra-operative (Neuro)
Fetal Imaging& Other	Laparoscopic
	Pediatric	N	N	N		N	Note 1	Note 2, 7, 8, 9
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent)
	Musculo-skel (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication: P= previously cleared by FDA K130803: E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Nate 1: BoM, B-PW, B-C, FFPD, B-DPD, B+CW, B+C+PW, B-PD-PW, B+DPD+PW, B+C+M, B+C+CW, B+C+CW, B+YD+CW, Dual(B, B+C. B=PD, B=TD. B+PD)

Note 2: Includes imaging for guidance of bropsy

Note 3: Includes inferrility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example; thyroid, parathyroid, breast, scrotum and penis in adult, pediatic and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonie Imaging (THI)

Note 8: 3D imaging

Note 9: Paneramic imaging

Note 10: Includes Renal, Gynecology:Pelvis

Note 11: ElastoScan

Note 12: Spatial Compound Imaging

Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indications for Use

{35}------------------------------------------------

510(k) No.:

Device Name: CW2.0 for use with SONOACE R7 Intended Use. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (* includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & II)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro )
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic				P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult				P
Cardiac	Cardiac Pediatric				P
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel				P
	Other (spec.)

N= new indication: P= previously cleared by FDA K 130803: E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppter

Cood Depper licidues Pakel (ruipintue) Propped
Naie 1: B+M, R+PW, B+C, B+PD, B+D1, B+CW, B+CW, B+C+PW, B+CW, B+CPD+PW, B+C+M, B+C+CW, B+C+CW, B+PD+CW, Dual(B, B+C, B+PD, B+7D, B+PD)

Note 2: Includes imaging for guidance of bropsy

Note 3; Includes intentifity monitoring of follicle development

Note 4: Calor M-mode

Note 5: For example; thereoid, breast, scrotum and penis in addla pediatic and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 10: Includes Renal. Gynecology/Petvis

Nole 11: ElastoScan

Note 12: Spatial Compound Imaging

Image /page/35/Figure/20 description: The image shows text that states "Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)". The text also states "Prescription Use (Per 21 CFR 801,109)". The text is centered on the page.

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.