The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

Device Description

The RS80A 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, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode.Harmonic imaging. Tissue Doppler imaging. Tissue Doppler Wave. 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The RS80A 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 RS80A 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

The provided 510(k) summary for the RS80A Diagnostic Ultrasound System does not contain information related to acceptance criteria or a study proving the device meets specific acceptance criteria for AI/CAD performance. The document is a premarket notification for a general-purpose diagnostic ultrasound system and its various transducers.

The "study" discussed in this document is a demonstration of substantial equivalence to predicate devices. This is a regulatory pathway in the US for medical devices that are substantially equivalent in terms of intended use, technological characteristics, and safety and effectiveness to a legally marketed predicate device. This type of submission relies on comparisons to existing devices rather than a standalone clinical study to validate novel performance claims against specific acceptance criteria.

Therefore, the requested information cannot be fully provided from the given text. However, based on the document, here's what can be extracted and what is explicitly stated as not applicable:

Non-AI / Non-CAD Acceptance Criteria and Performance (Based on Substantial Equivalence)

The document asserts that the RS80A Diagnostic Ultrasound System is "substantially equivalent with respect to safety, effectiveness, and functionality" to several predicate ultrasound systems (UGEO WS80A, UGEO HM70A, ACCUVIX A30, ACCUVIX XG). This means that the device is deemed to meet the same implicit "acceptance criteria" through comparison.

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

The document does not specify quantitative acceptance criteria. Instead, it relies on a qualitative comparison to predicate devices, asserting equivalence across various features and functionalities. The "reported device performance" is implicitly represented by the "√" (check mark) indicating that the RS80A possesses the same features as the predicate devices.

Feature / Characteristics	Subject Device (RS80A) Reported Performance (Implicitly meets predicate performance)	Predicate Devices (Implicit Acceptance Criteria)
Indication for Use (Fetal/Obstetrics, Abdominal, Gynecology, etc.)	√ (All listed indications)	UGEO WS80A (K133329), ACCUVIX A30 (K112339), UGEO HM70A (K130803), ACCUVIX XG (K103397), LOGIQ E9 (K123564), B-CAD (K050846)
Scanhead Types (Linear Array, Curved Linear Array, Endocavity, Phased Array, Static Probes)	√ (All listed types)	Same as above
Scanhead Frequency (1.0~20.0 MHz)	√	Same as above
Modes of Operation (B-mode, M-mode, PW Doppler, CW Doppler, Color Doppler, Power Amplitude Doppler, Tissue Harmonic Imaging, 3D/4D imaging mode, Combined modes)	√ (All listed modes)	Same as above
Safety & EMC Compliance (IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2)	√ (All listed standards)	Same as above
Acoustic Output Display Standard (Track 3)	√	Same as above
Patient Contact Materials (Tested to ISO 10993-1)	√	Same as above
Functionality (Quick Scan, Spatial Compound Imaging, Auto IMT+, Elastoscan, Panoramic, 3D Imaging, Volume Slice, 3D MagiCut, Volume Calculation, XI STIC, HDVI, ADVR, Clear Track, S-Detect)	√ (All listed functions, with noted name changes for some)	Same as above (specific predicates for Clear Track and S-Detect)

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

Not applicable. The document explicitly states: "Summary of Clinical Tests: Not applicable. The subject of this submission, RS80A, did not require clinical studies to support substantial equivalence." The evaluation was based on bench and non-clinical tests.

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

Not applicable. No clinical studies were conducted, thus no expert-established ground truth for a test set was required for this submission.

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

Not applicable.

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

Not applicable. No MRMC study was conducted. The "S-Detect" feature is mentioned as being substantially equivalent to "B-CAD (K050846)," which is likely a Computer-Aided Detection (CAD) system. However, the document does not include a comparative effectiveness study or report an effect size for human reader improvement with this feature.

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

Not applicable. The document does not describe standalone algorithm performance studies for any features. The comparison for "S-Detect" is to an existing CAD system, implying its functionality is similar, but no specific performance metrics are provided.

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

Not applicable. As no clinical studies or performance studies requiring ground truth were conducted for this substantial equivalence submission, no ground truth types are mentioned. The ground truth for proving safety and effectiveness primarily relies on meeting engineering and safety standards (e.g., IEC, UL, NEMA, ISO standards) and demonstrating functional equivalence to predicate devices.

8. The sample size for the training set

Not applicable. The document does not describe any specific training sets as no "AI" or "CAD" algorithms in the modern sense of requiring extensive training data are discussed in terms of their development or validation. The "S-Detect" feature is likely a rule-based or classic image processing CAD system from its predicate date (K050846), which typically would not involve machine learning training sets in the same way modern AI does.

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

Not applicable.

In summary: K141620 is a 510(k) submission based on substantial equivalence to predicate diagnostic ultrasound systems. It focuses on demonstrating that the RS80A Diagnostic Ultrasound System has similar intended uses, technological characteristics, and meets safety standards, thereby not requiring de novo clinical studies with specific acceptance criteria, test sets, or ground truth establishment for novel AI/CAD performance claims. The mention of "S-Detect" is a comparison to an existing CAD system (B-CAD K050846), but no performance data, either standalone or human-in-the-loop, is provided for this feature within this document.

Summary

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K141620
page 1 of 5

RS80ADiagnostic 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: March 24, 2013

Name of the device:

Common/Usual Name:

. Diagnostic Ultrasound System and Accessories

Proprietary Name:

RS80A Diagnostic Ultrasound System

Classification Names:	FR Number	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	IYN
Ultrasound Pulsed Echo Imaging System	892.1560	IYO
Diagnostic Ultrasound Transducer	892.1570	ITX

3. Identification of the predicate or legally marketed device:

UGEO WS80A Diagnostic Ultrasound System (K133329) 1

UGEO HM70A Diagnostic Ultrasound System (K130803)

ACCUVIX A30 Diagnostic Ultrasound Svstem(K112339) -

ACCUVIX XG Diagnostic Ultrasound System (K 103397) -

LOGIQ E9Diagnostic Ultrasound System (K123564) -

-B-CAD (K050846)

The proprietary name of predicate device (K130803)was changedto UGEO HM70A Diagnostic ※ Ultrasound System from UGEO H70c Diagnostic Ultrasound System on FDADatabases.

510(k) Summary / Statement Certification

ATTACHEMENT I

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4. Device Description:

5. Intended Uses:

The RS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

6. Technological Characteristics:

The RS80Ais substantially equivalent with respect to safety, effectiveness, and functionality to the UGEO WS80A Diagnostic Ultrasound System (K133329), UGEO HM70A Diagnostic Ultrasound System (K130803), ACCUVIX A30 Diagnostic Ultrasound System (K112339)and ACCUVIX XG Diagnostic Ultrasound System (K103397).

It is substantially equivalent with respect to safety, effectiveness, and functionality to the Volume Navigation™(Needle Tracking) of GE's LOGIQ E9 (K123564) in regards to the device with Clear Track. It is substantially equivalent with respect to safety, effectiveness, and functionality to theMadipattern's B-CAD30System (K050846) in regards to the device with S-Detect.

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.

510(k) Summary / Statement Certification

ATTACHEMENT 1

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RS80ADiagnostic Ultrasound System

Feature /Characteristics	The subjectdeviceRS80A	The predicate devicesUGEOWS80A(K133329)	ACCUVIXA30(K112339)	UGEOHM70A(K130803)	ACCUVIXXG(K103397)	LOGIQ E9(K123564)	B-CAD(K050846)
Indication for Use
- Fetal/Obstetrics	√	√	√	√	√	√	-
- Abdominal	√	√	√	√	√	√	-
- Gynecology	√	√	√	√	√	√	-
- Pediatric	√	√	√	√	√	√	-
- Small Organ	√	√	√	√	√	√	-
- Neonatal Cephalic	√	√	√	√	√	√	-
- Adult Cephalic	√	√	√	√	√	√	-
- Trans-rectal	√	√	√	√	√	√	-
- Trans-vaginal	√	√	√	√	√	√	-
- Musculo-skeletal(Conventional)	√	√	√	√	√	√	-
- Musculo-skeletal(Superficial)	√	√	√	√	√	√	-
- Urology	√	√	√	√	√	√	-
- 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 AmplitudeDoppler	√	√	√	√	√	√	-
- Tissue HarmonicImaging	√	√	√	√	√	√	-
- 3D/4D imaging mode	√	√	√	√	√	√	-
- Combined modes	√	√	√	√	√	√	-
Safety & EMCCompliance
- IEC 60601-1	√	√	√	√	√	√	-
- UL 60601-1

510(k) Summary / Statement Certification

ATTACHEMENT I

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RS80ADiagnostic Ultrasound System

Feature /Characteristics	The subjectdeviceRS80A	The predicate devices
		UGEOWS80A(K133329)	ACCUVIXA30(K112339)	UGEOHM70A(K130803)	ACCUVIXXG(K103397)	LOGIQ E9(K123564)	B-CAD(K050846)
- IEC 60601-2-37	√	√	√	√	√	√	-
- IEC 60601-1-2	√	√	√	√	√	√	-
Acoustic Output DisplayStandard
Track 3	√	√	√	√	√	√	-
Patient ContactMaterials
Tested to ISO 10993-1	√	√	√	√	√	√	-
Functionality
- Quick Scan (Q Scan)	√	√	√	√	√	-	-
- Spatial CompoundImaging	√	√	√	√	√	-	-
- SMDR (SMDR evo)	(1)	√	√	√	√	-	-
- Auto IMT+(Auto IMT)	√	√	√	√	√	-	-
- Elastoscan	√	√	√	√	√	-	-
- Panoramic	√	√	√	√	√	-	-
- 3D Imaging(Volume DataAcquisition)	√	√	√	√	√	-	-
- 3D Imagingpresentation						-	-
3D Cine/4D Cine	√	√	√	√	√	-	-
- 3D RenderingMPR(Multi PlanerRender)	√	√	√	√	√	-	-
- 3D XI
MSV(Multi SliceView)Oblique View	√	√	√	√	√	-	-
- 3D MXI
Volume Slice, MirrorView	√	√	√	√	√	-	-
- Volume CT	√	√	√	√	√	-	-
- 3D MagiCut	√	√	√	√	√	-	-
- Volume Calculation(VOCAL, XIVOCAL)	√	√	√	√	√	-	-
- XI STIC	√	√	√	√	√	-	-
- HDVI	√	√	√	√	√	-	-
- FRV	(2)	√	√
- ADVR	√	√	√	√	√	-	-
- Clear Track	√					√(3)
- S-Detect	√						√(4)

l ) The name of the feature is changed to ClearVision.

The name of the feature is changed to Realistic Vue.
Volume Navigation (Needle Tracking)
B-CAD

510(k) Summary / Statement Certification

ATTACHEMENT 1

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RS80ADiagnostic Ultrasound System

1. 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 RS80A 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. RS80A, 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 RS80Ato be as safe, as effective, and performance is substantially equivalent to the predicate devices.

END of 510(K) Summary

510(k) Summary / Statement Certification

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Image /page/5/Picture/0 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbol in the center consists of three curved lines that resemble a stylized human figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Flealth Service

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

July 2, 2014

Samsung Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313

Re: K141620

Trade/Device Name: RS80A Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: 1YN, IYO, ITX Dated: June 16, 2014 Received: June 17, 2014

Dear Mr. Job:

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

This determination of substantial equivalence applies to the following transducers intended for use with the Rs80a Diagnostic Ultrasound System, as described in your premarket notification: Transducer Model Number

CA1A. /------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	ﻟ7-16-4 -	V5-9
1999-100	tiﺗ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	141J-----
144	1.42-9A	~W6.6A & AND LEASE COLLECT
r oft:-----	DE7.4 - 4 Hourd
11lAS measure	DM' -{}/

If your device is classified (see above) into cither class 11 (Special Controls) or class 111 (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.

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

Page 2-Mr. Job

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of 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,

Michael D. O'Hara

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)

K141620

Device Name

RS80A Diagnostic Ultrasound System

Indications for Use (Describe)

The RS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal/Obsterics, Abdominal. Gynecology, Pediatric, Small Organ, Neonatal Cephalic. Adult Cephalic. Trans-rectal, Trans-vaginal. Muscular-Skeletal (Conventional. Superficial), Urology. Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

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)

Michael D. O'Hara

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."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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

510(k) No.:

Device Name: RS80ADiagnostic 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.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	N	N	N		N	Note 1	Notes 2, 4, 7, 8, 9, 11, 14
	Abdominal (See Note 10)	N	N	N	N	N	Note 1	Notes 2, 5, 6, 7, 8, 9, 11, 12, 14
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	N	N	N		N	Note 1	Notes 8, 9, 11
	Small Organ (See Note 5)	N	N	N		N	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 12. 14
	Neonatal Cephalic	N	N	N		N	Note 1	Notes 8, 9
	Adult Cephalic	N	N	N	N	N	Note 1	Notes 7
	Trans-rectal	N	N	N		N	Note 1	Notes 2,7, 8, 9, 11, 12
	Trans-vaginal	N	N	N		N	Note 1	Notes 2, 7, 8, 9, 11, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	N	N	N		N	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 14
	Musculo-skel. (Superfic.)	N	N	N		N	Note 1	Note 2, 5, 6. 7, 8. 9, 11, 14
	Intra-luminal
	Other (See Note 13)	N	N	N		N	Note 1	Notes 2,7, 8, 9, 12
	Cardiac Adult	N	N	N	N	N	Note 1	Notes 4, 7
Cardiac	Cardiac Pediatric	N	N	N	N	N	Note 1	Notes 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	N	N	N	N	N	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 14
	Other (spec.)

N= new indication. P= previously cleared by FDA. F= added under Appendix F.

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Coldr Dopper includes Power (Amplinder) Dopper
Nate 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+C+PW, B+PL+PW, B+PD+PW, B+C+M,Dusl/Quad, B+C+CW, B+PD+CW, B+E, B+B/C

Note 2: Includes imaging for guidance of biopsy

Note 3; Includes infersility monitoring of follicle development

Note 4 Color M-mode

Note 5 : For example: thyroid, breast, scrowm and penis in adult, pediatic and nennalal palients

Note 6: Abdominal organs and peripheral vessel
Note 7 Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis

Note | 1: Panoramic imaging

Note 11: Panoramic
Note 12: Chauffeur

Note 12: FlastoScan

Note 13: Includes Urology/Prostate

Note 14: Cicar Track

Concurrence of Center for Devices und Radiological Heulth (CDRH) Prescription Use (Por 21 CFR 801 109)

Indication for use

page 2 of 15

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

510(k) No.:

Device Name: CA !-7A for use with RS80A

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/Obstetrics (See Note 3)	N	N	N		N	Note 1	Notes 2,4,7,8,9,11,14
	Abdominal (See Note 10)	N	N	N		N	Note 1	Notes 2,6,7,8,9,11,14
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	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 (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

ittonal Comments:
Colar Doppler includes Power (Anuplinde) Dopler
Nove : B+M, B+PW, B+C, B+DD, B+DPD, B+C'+PW, B+C+PW, B+C+PD+PW, B+PD+PW, B+C+M,I>xlV,Nxl/Qhad, B+C+CW, B+PD+CW. B+E, B+B/C

Note 2: Includes imaging for guidance of biopsy

Note 3. Includes inferiility monitoring of fullicle development

Nose 4: Calor M-mode

Note 4: Color M-hiode

Note 6 Abdominal organs and peripheral vessel
Note 7: Tissue Hamionic Imaging (THI)

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9. Spanal Compound Imaging

Note 10 Includes Renal, Gynecology/Pelvis

Note i 1 Panoramic imaging

Note | 2: ElastoScan

Note 13: Includes Urology/Prostate Note 14: Clenr Track

Concurrence of Center for Devices and Radiological Health (CDRH) Preseription Use (Per 21 CFR 801 109)

Indication for use

page 3 of 15

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

510(k) No.:

Device Name: C2-6 for use with RS80A

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/Obstetrics (See Note 3)	P	P	P		P	Note 1	Notes 2, 4, 7, 8, 9, 11
	Abdominal(See Note 10)	P	P	P		P	Note 1	Notes 2,6, 7, 8, 9, 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
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K 130803. I = added under Appendix Li

Additional Comments:

thouar Connineludes Power (Amplitude) Doppler

Color Dopper Includes Powel (Angliade) Dripler
Note 1: B+M, B+PW, B+C, B+PD, B+DY!), B+I'D, B+C+PW, B+PI>+PW, B+PID+PW, B+C+M.Iball(Xiad, B+C+CW, B+PD+CW. B+F. B+B/C

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infectibity monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, scrown and penis in adult, pediative and nevealal patients

Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Spatial Compound Imaging Note 10: Includes Renal, Gynecology/Pelvis

Nolc 11: Ponoramic imaging

Nolc 12: FlastoScan

Note 13: Includes Urology/Prostate

Note 14: Clear Track

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801 109)

Indication for use

page 4 of 15

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

510(k) No.:

Device Name: CF4-9for use with RS80A

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/Obstetrics (See Note 3)
	Abdominal(See Note 10)	P	P	P		P	Note 1	Notes 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 8, 9, 11
	Small Organ (See Note 5)
	Neonatal Cephalic	P	P	P		P	Note 1	Notes 8, 9, 11
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1	Notes 8, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K I 30803; L= added under Appendix L

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Dopper includes Power (Ampliude) Doper
Note I: B+M, B+PW, B+C, B+PD, B+DPD, B+C+PW, B+PD+PW, B+PD+PW, B+TD+PW, B+C+M,Izual/Quad, B+C+CW. B+PD+CW, B+E., B+B/C

Note 2: Includes imaging for guidance of biopsy

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 neonalal patients

Note 6: Abdominal organs and peripheral vesse!

Note 7: Tissue Harmonic Imaging {THI)

Nole 8: 3D imaging
Note 9: Spanial Compound Imaging
Note 10: Includes Renal, Gynecolugy/Pelvis

Note 10: Includes Renal, Gynecology/Pelvis

Note I I Panoranic unaging
Note 12. FlastoScan

Note 13. Includes Urology/Prostate

Note 14 Clear Track

Concurrence of Center for Devices and Radiological Health {CDRH} Prescription Use (Per 21 CFR 801.109)

Indication for use

page 5 of 15

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

510(k) No.:

Device Name: E3-12Afor use with RS80A

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/Obstetrics (See Note 3)	P	P	P		P	Note I	Notes 2, 7, 8, 9
	Abdominal(See Note 10)	P	P	P		P	Note I	Notes 2, 7, 8, 9, 12
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 3)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note I	Notes 2, 7, 8, 9, 12
	Trans-vaginal	P	P	P		P	Note I	Notes 2, 7, 8, 9, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	P	P	P		P	Note I	Notes 2, 7, 8, 9, 12
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication: P= previously cleared by FDA K133329; E= added under Appendix E

Additional Comments:

Colar Doppler includes Power (Amplitude) Doppler

Cold Llopper Includes Power (Amplude) Lopper
Note I: B+M, B+PW, B+C, B+PD, B+DPI), B+TD, B+C'W, B+C+PW, B+PD+PW, B+TIX+PW, B+C+M,Dual/Quad. B+C+CW, B+PD+CW, B+E, B+B/C

Note 2: Includes imaging for guidance of biopsy

Note 2: Includes interior for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathytoid, breast, scroum and penis in adult, pediatic and necessar patiens

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Hannonic Imaging (THI)

Note 8: 3D imaging
Note 9: Spatial Compound Imaging

Note 10: Includes Renal. Ginecology/Pelvis

Note II. Panoramic imaging
Note 12: ElastoScan

Note 13. Includes Urology:140state Note 14 Clear Track

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801 109)

Indication for use

page 6 of 15

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

510(k) No.:

Device Name: L3-12A for use with RS80A

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/Obstetrics (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)	P	P	P		P	Note I	Note 2, 5, 6, 7, 8, 9, 11, 12,14
	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, 8, 9, 11, 14
	Musculo-skel. (Superfic.)	P	P	P		P	Note I	Note 2, 5, 6, 7, 8, 9, 11, 14
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note I	Note 2, 5, 6. 7, 8, 9, 11. 14
	Other (spec.)

N= new indication; P= previously cleared by:FDA K133329; L=added under Appendix L

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Colar Dopper includes Power (Amplinde) Dopper B+PD+CW. B+E, B+B/C

Note 2: Includes imaging for guidance of biopsy

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertitity montoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrolum and penis in adult, pediativ and neonalal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging
Note 9: Spatial Compound linaging

Note 10: Includes Renal, Gynecology/Pelvis

Note II: Panoranic imaging
Note 12: ElastoScan

Note 13. Includes Urology/Prostate Note 14: Clear Track

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801 109)

Indication for use

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

510(k) No .:

Device Name: L5-13 for use with RS80A

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/Obstetrics (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)	P	P	P		P	Note 1	Note 2, 5, 6, 8, 7, 9, 11, 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, 8, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDAK 130803; L= added under Appendix L

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Dopper includes Power (Amphide) Dopper
Note I: B+M, B+PW, B+C, B+DPD, B+ID, B+C+PW, B+C+PW, B+PD+PW, B+DM)>+PW, B+C+M,Inal/Qhad, B+C+CW, B+PD+CW, B+E. B+B/C

Note 2: Includes imaging for guidance of biopsy.

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 neonalal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Nole 8: 3D imaging

Note 9: Spatial Compound Imaging

Nole 10: Includes Renal, Gynecology/Pelvis Note II: Panoramic imaging

Note 12: ElastoScan
Note 13: Includes Urology/Prostate

Note 14: Clear Track

Concurrence of Center for Devices and Radiological I Iralih (CDRH) Prescription Use (Per 21 CFR 801 109)

Indication for use

page 8 of 15

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

510(k) No.:

Device Name: L7-16 for use with RS80A

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)						Other(Spec.)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal/Obstetrics (See Note 3)
	Abdominal(See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	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, 8, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

itional Comments:
Color Dopler includes Power (Ampliude) Doppler
Nue 1 B+M, B+PW, B+C, B+I1), B+ID!1), B+I'D, B+C'W, B+C+IVW, B+CDPD-I'W, B+C+M,Mall(Viad, B+C+CW, H-PD-CW, B-F., B+BK

Note 3. Includes imaging for gindance of biopsy

Note 3. Includes infertility montoring of folliate development

Note 4: Color M-mode

Note 5 For example: Untuid, parathyroid, breast, scrown and penis in adult, pediatre and newatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging
Note 9: Spaijal Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13 Includes Urology/Prostale

Note 14: Clear Track

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Usc (Per 21 CFR 801.109)

Indication for use

page 9 of 15

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

510(k) No .:

Device Name: LA2-9A for use with RS80A

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)	ਰ	M	PWD	CWD	ColorDoppler	Combined"(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	FetaliObsteiries (See Note 3)
	Abdominal(Sec Note 10)	19	P	p		p	Note I	Note 2, 5, 6, 7, 8, 9, 11
	Intra-operative (Sec Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
Otherધ	Pediatric
	Small Organ (Ser Note 3)	]>	P	p		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Neonatal Cephalic
	Adult Cephalic
	Trans-reclal
	Trans-vagnal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent)	P	P	P		P	Note 1	Note 2. 5. 6. 7. 8. 9. 11
	Musculo-skel (Superfic.)	P	P	p		P	Note I	Note 2, 5, 6, 7, 8, 9, 11
	Intra-luminal
	Other (Sec Note 13)
	Cardiac Adult
Cardiac	Cardiac Pedialric
	Trans-csophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	P	િ	p		p	Note 1	Note 2, 5. 6, 7, 8, 9, 11
Vessel	Other (spec.)

N= new indication: P= previously cleared by FDA K 130803; I = added under Appendix 1:

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Cold Dopper intudies Povel (Anghiboer) Ropper
Note 1 B+M, B+PW, B+C, B+(1), B+DPL), B+C'+PW, R+P(1)-PW, B+(1)PD+PW, B+TD+PW, B+C+M,Lhall()xiad, B+C+CW, B+PD-CW.B+E. B+B/C

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 neconatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging
Note 9: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoraniic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prosiate Note 14: Clear Track

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801. 109)

Indication for use

page 10 of 15

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

510(k) No.:

Device Name: PE2-4 for use with RS80A

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/Obstetrics (See Note 3)
	Abdominal(See Note 10)	P	P	P	P	P	Note 1	Note 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 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
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 K 130803; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Dopper includes Power (Amplitude) Dolpter
Note I: B+M, B+PW, B+C, B+PD, B+DPD, B+C+PW, B+PD+PW, B+PD+PW, B+PD+PW, B+C+M.Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C

Note 2: Includes imaging for guidance of biopsy

Note 2: Includes infertility monitoring of biopsy
Note 3: Includes infertility monitoring of Follscle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, scrolum and penis in adult, pediation and neconatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI) .

Note 8: 3D imaging

Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoranic imaging

Note 12: FlastoScan

Note 13: Includes UrologyProstate Note 14: Clear Track

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801 109)

Indication for use

page 11 of 15

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

510(k) No.:

Device Name: PM1-6A for use with RS80A

Intended Use. Diagnostic ultrasound imaging or third 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 Imaging& Other	Fetal Obstetrics (See Note 5)
	Abdominal(See Note 10)	N	N	N	N	N	Note 1	Note 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 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel (Convent.)
	Musculo-skel (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult	N	N	N	N	N	Note 1	Note 4, 7
Cardiac	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) Dopplet

Cood Copier memors Power (video) B-DN), B-C-PM, B-HD-PW, B-DND-PW, B-C-M,Dual Oual Dual R-C-CW, B+PD+CW B+E, B+B4C

Note 2: Includes maging for guidance of bropsy

Note 3 Includes infertifity momtoring of folhele development

Note 4 Color M-mode

Nate 5 For example thytonit, parathyroid, breast, scrothim and penis in adult, pediative and nearens

Note 6: Abdominal organs and peripheral vessel

Note 7 Tissue Hamnonse Imaging (TIH)

Note S 3D maging
Note 9 Spanal Compound Imaging

Note 10 Includes Renal. GynecologyPelsis

Note 11 Panorame imaging

Note 12 FilastaScan

Note 13: Includes UrologyProstate

Note 14 Clear Track

Conventence of Center for Devices and Radiological Health (CDRH) Preserspuon Use (Per 21 CFR S01.109)

Indication for use

page 12 of 15

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

510(k) No .;

Device Name: V5-9for use with RS80A

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/Obstetrics (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
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Note 2, 7, 8, 9
	Trans-vaginal	P	P	P		P	Note 1	Note 2, 7, 8, 9
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	P	P	P		P	Note 1	Note 2, 7, 8, 9
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K133329; E= added under Appendix L

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Cold Dopper includes Power (Amplinac) Lopper
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+C+PW, B+C+PW, B+PD+PW, B+DPD+PW, B+C+M,Dial/Quad, B+C+CW, B+PD+CW, B+F., B+B/C

Note 2: Includes imaging for guidance of biopsy

Note 2. Includes inferility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediator and necenatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Nole 8: 3D imaging

Note 9: Spatial Compound Imaging
Note ID: Includes Renal, Gynecology/Pelvis

Note II: Panoranic imaging

Noic 12: ElastoScan

Nov. 12. Enskede
11-17. Includer 11%

Note 13: Includes Urology/Prostate Note 14: Clear Track

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

Indication for use

page 13 of 15

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

510(k) No.:

Device Name: LV3-14Afor use with RS80A

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 Obstetrics (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)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	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, 8, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Other (spec.)

N= new indication: P= previously cleared by FDA K103397: L= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Doppler includes Pover (Amphiude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+C'+PW, B+PU+PW, B+PD+PW, B+PD+PW, B+C+M,Ixlal/Quad, B+C+CW. B+PD+CW, B+E, R+R/C

Note 2: Includes imaging for guidance of biopsy

Note 2 : Includes infertility monitoring of follich development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, scrown and penis in adult, pediatric and neverstal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Spatial Compound Imaging

Note 10: Includes Renal. Gynecology:Pelvis

Note || Panoranic imaging Nule 12: ElastoScan

Note 12: PlastoScan
Note 13: Includes Use

Note 13. Includes Urology Prostate Note 14 Clear Track

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

Indication for use

page 14 of 15

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

510(k) No.:

Device Name: CW6.0 for use with RS80A

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 Obstetrics (See Note 3)
	Abdominal(See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	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 (See Note 13)
Cardiac	Cardiac Adult				P
	Cardiac Pediatric				P
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel				P
	Other (spec.)

N= new indication; P= previously cleared by ['DAK 112339; L= added under Appendix L

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Cold Libert includes Power (Anipinde) Loppier
Novel : B+M, B+DV, B+C, B+PD, B+DPD, B+ID, B+C++W, B+PD+PW, B+PD+PW, B+C+M,InaliQuad, B+C+CW,
Novel : B+M, B+DPD, B+DPD, B+ID, B+PD+CW.B+E. B+B/C

Note 2. Includes imaging for guidance of biopsy

Note 3. Includes inferritity monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyrord, parathyroid, breast, scrolum and penis in adult, pediative and neconatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging
Note 9: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology:Pelvis

Note II Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prosiate

Note 14: Clear Track

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Pcr 21 C'FR 80). 109)

Indication for use

page 15 of 15

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.