RS80A Diagnostic Ultrasound System

• K Number: K162094
• Device Name: RS80A Diagnostic Ultrasound System
• Manufacturer: Samsung Medison Co., Ltd
• Date Cleared: 2016-08-26 ( 29 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K151663 , K153529 , K153408 , K142160 , K131267
• Predicate For: K163691 , K170493 , K171048 , K171070

Intended Use

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/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-raginal, Trans-esoph, (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) 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 text describes a 510(k) premarket notification for the SAMSUNG MEDISON RS80A Diagnostic Ultrasound System. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its effectiveness through new clinical trials. Therefore, the document does not contain acceptance criteria, a study proving device meeting acceptance criteria, or information on AI/standalone performance.

Here's an analysis of the requested information based on the provided text, highlighting what is present and what is not applicable to a 510(k) submission for this device:

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Analysis of Acceptance Criteria and Study for RS80A Diagnostic Ultrasound System (K162094)

The provided document is a 510(k) Premarket Notification for the SAMSUNG MEDISON RS80A Diagnostic Ultrasound System. In a 510(k) submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, not to establish new clinical effectiveness or safety based on acceptance criteria or a dedicated clinical performance study with human readers and AI assistance in the way a PMA (Premarket Approval) might require for novel devices.

Therefore, many of the requested details regarding acceptance criteria, performance metrics, and clinical study designs (especially those involving AI-assisted human readers or standalone AI performance) are not applicable or not present in this type of submission for this particular device.

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable in a 510(k) for this device.
A 510(k) submission for an ultrasound system like the RS80A typically focuses on demonstrating that its technological characteristics, intended use, and safety/EMC performance are equivalent to predicate devices. It does not typically define specific clinical performance acceptance criteria (e.g., sensitivity, specificity for a particular pathology) that the device must meet, nor does it report device performance against such criteria. The "performance" demonstrated is primarily technical capability and compliance with safety standards.

The document states: "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." This is the primary "performance" being demonstrated for substantial equivalence in a 510(k).

Technological Characteristics Comparison Table (from pages 32-33):
This table compares features of the RS80A (V3.00) to its predicate devices, demonstrating equivalence in functionality, scanhead types, frequency ranges, and modes of operation. This acts as the "performance data" in the context of substantial equivalence, showing that the new device offers comparable features and safety.

Feature / Characteristics	RS80A (V3.00) (Subject Device)	RS80A (K151663) (Predicate)	WS80A (K153529) (Predicate)	HM70A (K130803) (Predicate)	LOGIQ E9 (K123564) (Predicate)	Voluson E10 (K131267) (Predicate)
Indication for Use
- Fetal/Obstetrics	√	√	√	√	√	√
- Abdominal	√	√	√	√	√	√
- Gynecology	√	√	√	√	√	√
- Intraoperative	√	√	√	√	√	√
- Pediatric	√	√	√	√	√	√
- Small Organ	√	√	√	√	√	√
- Neonatal Cephalic	√	√	√	√	√	√
- Adult Cephalic	√	√	√	√	√	√
- Trans-rectal	√	√	√	√	√	√
- Trans-vaginal	√	√	√	√	√	√
- Trans-esoph. (non-Cardiac)	√	√	√	√	√	√
- Musculo-skeletal (Conventional)	√	√	√	√	√	√
- Musculo-skeletal (Superficial)	√	√	√	√	√	√
- Urology	√	√	√	√	√	√
- Cardiac Adult	√	√	√	√	√	√
- Cardiac Pediatric	√	√	√	√	√	√
- Trans-esophageal (Cardiac)	√	√	√	√	√
- 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 Doppler	√	√	√	√	√	√
- Tissue Harmonic Imaging	√	√	√	√	√	√
- 3D/4D imaging mode	√	√	√	√	√	√
- Combined modes	√	√	√	√	√	√
Safety & EMC Compliance
- IEC 60601-1 / UL 60601-1	√	√	√		√	√
- IEC 60601-2-37	√	√	√	√	√	√
- IEC 60601-1-2	√	√	√	√	√	√
- Acoustic Output Display Std (Track 3)	√	√	√	√	√	√
- Patient Contact Materials (ISO 10993-1)	√	√	√	√	√	√
Functionality
- Q Scan	√	√	√	√
- ClearVision	√	√	√	√
- MultiVision	√	√	√	√
- Panoramic	√	√	√	√
- Needle Mate	√	√	√	√
- Auto IMT+	√	√	√	√
- Strain+	√	√		√
- Stress Echo	√	√		√
- Elastoscan	√	√	√	√	√	√
- E-Thyroid	√	√
- E-Breast	√	√
- S-Shearwave	√	√			√
- S-Detect	√(1)	√	√	√		√
- S-Fusion	√	√
- Clear Track	√	√			√
- Virtual Track	√	√			√
- ADVR	√	√	√	√		-
- 3D Imaging (Volume Data Acquisition)	√	√	√	√	√	√
- 3D Imaging presentation (3D Cine/4D Cine)	√	√	√	√
- 3D Rendering MPR	√	√	√	√
- 3D XI MSV/Oblique View	√	√	√	√
- 3D MXI Volume Slice/Mirror View	√	√	√
- Volume CT	√	√	√
- 3D MagiCut	√	√	√	√
- Volume Calculation (VOCAL, XI VOCAL)	√	√	√	√
- XI STIC	√	√	√	√
- HDVI	√	√	√	√
- Realistic Vue	√	√	√
- Natural Vue	√	√
- HQ Vision	√

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

Not Applicable for this specific 510(k) submission.
The document states "Summary of Clinical Tests: Not applicable. The subject of this submission, RS80A, did not require clinical studies to support substantial equivalence." This means there was no specific test set of patient data used for an effectiveness study in the usual sense. The testing performed was primarily non-clinical (bench tests) for safety and performance against standards.

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

Not Applicable.
As no clinical effectiveness study was required, there was no ground truth for a test set established by experts in the context of clinical performance (e.g., for diagnostic accuracy).

4. Adjudication Method for the Test Set

Not Applicable.
Since no test set with expert ground truth was established for a clinical effectiveness study, no adjudication method was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Readers Improvement with AI vs. without AI Assistance

Not Applicable.
The document does not mention any AI functionality in the context of diagnostic interpretation or a human-in-the-loop study comparing human readers with and without AI assistance. The features listed are image enhancement, processing, and visualization capabilities (e.g., HQ Vision, 3D imaging, ElastoScan, S-Fusion, S-Shearwave, S-Detect). While "S-Detect" might imply some level of automated detection, the submission does not describe it as an AI-driven diagnostic aid requiring an MRMC study or reporting an effect size on human readers. The purpose of this 510(k) filing is to demonstrate substantial equivalence, not superior effectiveness through such comparative studies.

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

Not Applicable.
There is no mention of a standalone algorithm performance evaluation in the provided document. The device is a diagnostic ultrasound system intended for use by a "competent health care professional."

7. The Type of Ground Truth Used

Not Applicable (for clinical effectiveness).
As no clinical effectiveness study requiring ground truth (e.g., pathology, outcomes data) was conducted for this 510(k) submission, this information is not available. The "truth" evaluated was compliance with safety standards and equivalence to predicate device specifications.

8. The Sample Size for the Training Set

Not Applicable.
Since this is not an AI/machine learning device undergoing a clinical performance study that would typically involve a "training set" for an algorithm to learn, this information is not relevant to this 510(k) submission.

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

Not Applicable.
As there was no training set for an algorithm, the method for establishing its ground truth is not relevant or provided.

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Summary of what the K162094 510(k) demonstrates:

The 510(k) for the RS80A Diagnostic Ultrasound System (K162094) demonstrates substantial equivalence to previously cleared predicate devices (RS80A Diagnostic Ultrasound System (K151663), WS80A Diagnostic Ultrasound System (K153529), HM70A Diagnostic Ultrasound System (K153408), LOGIQ E9 Diagnostic Ultrasound System (K142160), Voluson E10 Diagnostic Ultrasound System (K131267), AmCAD-UT (K122536), QLAB (K121223)). This equivalence is based on:

• Identical Intended Uses: The RS80A and its transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body for various clinical applications.
• Similar Technological Characteristics: The device utilizes standard ultrasound imaging modes (B-mode, M-mode, Doppler modes, harmonic imaging, 3D/4D imaging) and offers advanced features (e.g., Elastoscan, S-Detect, S-Fusion, HQ Vision) similar to or improved upon those in the predicate devices.
• Compliance with Recognized Standards: The device has been evaluated for acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety, conforming to international and national medical device safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, NEMA UD 2-2004, NEMA UD 3-2004).

The document explicitly states that clinical studies were not required to support substantial equivalence for this submission because it falls under the scope of demonstrating technical and safety equivalence to existing devices.

Summary

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

SAMSUNG MEDISON CO., LTD. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO MN 55313

August 26, 2016

Re: K162094

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: IYN, IYO, ITX Dated: July 26, 2016 Received: August 3, 2016

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.

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.

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Page 2-Mr. Job

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 [phone] or [phone] 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" (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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jeff Rodges

For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162094

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/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-raginal, Trans-esoph, (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) 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)

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510(k) No.:

Device Name: RS80A 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.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P	P	P	Note 1	Notes 2, 3, 4, 7, 8, 9, 11, 14
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Notes 2, 4, 5, 6, 7, 8, 9, 11, 12, 14, 15
	Intra-operative (See Note 6)	N	N	N	N	N	Note 1	Note 7, 9, 11
	Intra-operative (Neuro.)	N	N	N	N	N	Note 1	Note 7, 9, 11
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 11
	Small Organ (See Note 5)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 12, 14
	Neonatal Cephalic	P	P	P		P	Note 1	Notes 8, 9, 11
	Adult Cephalic	P	P	P	P	P	Note 1	Notes 7
	Trans-rectal	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11, 12
	Trans-vaginal	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)	N	N	N	N	N	Note 1	Note 4, 7
	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 1	Note 2, 5, 6, 7, 8, 9, 11, 14
	Intra-luminal
	Other (See Note 13)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 12
Cardiac	Cardiac Adult	P	P	P	P	P	Note 1	Notes 4, 7
	Cardiac Pediatric	P	P	P	P	P	Note 1	Notes 4, 7
	Trans-esophageal (Cardiac)	N	N	N	N	N	Note 1	Note 4, 7
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 14
	Other (spec.)

N= new indication; P= previously cleared by FDA K151663; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+TD, B+CW, B+C+PW, B+PD+PW, B+PPI+PW, B+PPI+PW, B+TD+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 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: Spatial Compound Imaging
• Note 10: Includes Renal, Gynecology/Pelvis
• Note 11: Panoramic imaging
• Note 12: ElastoScan
• Note 13: Includes Urology/Prostate
• Note 14: S-Fusion
• Note 15: S-Shearwave

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510(k) No.:

Device Name: CA1-7A 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)	P	P	P		P	Note 1	Notes 2,4,7,8,9,11,14
	Abdominal (See Note 10)	P	P	P		P	Note 1	Notes 2,6,7,8,9,11,14,15
	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 K151663; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+CW, B+CW, B+C+PW, B+PD+PW, B+PPH+PW, B+PPH+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 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: Spatial Compound Imaging
• Note 10: Includes Renal, Gynecology/Pelvis
• Note 11: Panoramic imaging
• Note 12: ElastoScan
• Note 13: Includes Urology/Prostate
• Note 14: S-Fusion
• Note 15: S-Shearwave

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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	P	Note 1	Notes 2, 4, 7, 8, 9, 11
	Abdominal (See Note 10)	P	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 K151663; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+TD, B+CW, B+C+PW, B+PD+PW, B+PPH+PW, B+PPH+PW, B+TD+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 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 9: Spatial Compound Imaging
• Note 10: Includes Renal, Gynecology/Pelvis
• Note 11: Panoramic imaging
• Note 12: ElastoScan
• Note 13: Includes Urology/Prostate
• Note 14: S-Fusion
• Note 15: S-Shearwave

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

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510(k) No.:

Device Name: CF4-9 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)	P	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	P	Note 1	Notes 8, 9, 11
	Small Organ (See Note 5)
	Neonatal Cephalic	P	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 Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	Note 1	Notes 8, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K151663; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+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 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 vessel

Note 7: Tissue Harmonic Imaging (THI)

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

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: S-Fusion

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

510(k) No.:

Device Name: E3-12A 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 I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 12
	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	P	Note 1	Notes 2, 7, 8, 9, 12
	Trans-vaginal	P	P	P	P	P	Note 1	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	P	Note 1	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 K151663; 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+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+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 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 vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: S-Fusion Note 15: S-Shearwave

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

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 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	Note 2, 5, 6, 7, 8, 9, 11, 14
	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, 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 1	Note 2, 5, 6, 7, 8, 9, 11, 14
	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, 14
	Other (spec.)

N= new indication; P= previously cleared by FDA K153529; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+CW, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+TD+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 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 vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: S-Fusion

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

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	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	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Musculo-skel. (Superfic.)	P	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	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K151663; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+DPD+PW, B+DPD+PW, B+PPI+PW, B+TD+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 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: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: S-Fusion Note 15: S-Shearwave

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

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

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)
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)	P	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	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Musculo-skel. (Superfic.)	P	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.)
Peripheral	Peripheral vessel	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K151663; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+TD, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C

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 vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: S-Fusion

Note 2: Includes imaging for guidance of biopsy

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

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)						Combined*(Spec.)	Other(Spec.)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	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 K151663; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+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 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: Spatial Compound Imaging
• Note 10: Includes Renal, Gynecology/Pelvis
• Note 11: Panoramic imaging
• Note 12: ElastoScan
• Note 13: Includes Urology/Prostate
• Note 14: S-Fusion Note 15: S-Shearwave

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

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

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/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.)
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 (See Note 13)
	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.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K151663; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+TD+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 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 vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: S-Fusion

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

510(k) No.:

Device Name: PM1-6A 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)	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 (See Note 13)
	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 K151663; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+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 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: Spatial Compound Imaging
• Note 10: Includes Renal, Gynecology/Pelvis
• Note 11: Panoramic imaging
• Note 12: ElastoScan
• Note 13: Includes Urology/Prostate Note 14: S-Fusion
• Note 15: S-Shearwave

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

510(k) No.:

Device Name: V5-9 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	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 K151663; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+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 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: Spatial Compound Imaging
• Note 10: Includes Renal, Gynecology/Pelvis
• Note 11: Panoramic imaging
• Note 12: ElastoScan
• Note 13: Includes Urology/Prostate
• Note 14: S-Fusion Note 15: S-Shearwave

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

510(k) No.:

Device Name: LV3-14A 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, 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 K151663; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+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 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 vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: S-Fusion Note 15: S-Shearwave

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

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

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.)
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 FDA K151663; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+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 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 vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate Note 14: S-Fusion

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

510(k) No.:

Device Name: CA2-8A 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	P	Note 1	Notes 2, 4, 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
	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 K151663; 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+PPI, B+CV, B+C+PW, B+PD+PW, B+PPI+PW, B+PPI+PW, B+TD+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 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 vessel

• Note 7: Tissue Harmonic Imaging (THI)
• Note 8: 3D imaging
• Note 9: MultiVision (Spatial Compound Imaging)
• Note 10: Includes Renal, Gynecology/Pelvis
• Note 11: Panoramic imaging
• Note 12: ElastoScan
• Note 13: Includes Urology/Prostate
• Note 14: S-Fusion Note 15: S-Shearwave

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

510(k) No.:

Device Name: LA3-16A 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	Laparoscopic
&Other	Pediatric
	Small Organ (See Note 5)	P	P	P	P	P	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.)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 9, 11
	Musculo-skel. (Superfic.)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 9, 11
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 9, 11
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K151663; 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+PPI, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+PW, B+TD+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 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 10: Includes Renal, Gynecology/Pelvis
• Note 11: Panoramic imaging
• Note 12: ElastoScan
• Note 13: Includes Urology/Prostate Note 14: S-Fusion

Note 9: MultiVision (Spatial Compound Imaging)

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

510(k) No.:

Device Name: LA3-16AI 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)	P	P	P	P	P	Note 1	Note 7, 9, 11
	Intra-operative (Neuro.)	P	P	P	P	P	Note 1	Note 7, 9, 11
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.)	P	P	P	P	P	Note 1	Note 7, 9, 11
	Musculo-skel. (Superfic.)	P	P	P	P	P	Note 1	Note 7, 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	P	Note 1	Note 7, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K153529; 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+PPI, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+PW, B+TD+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 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: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

• Note 11: Panoramic imaging
  Note 12: ElastoScan

• Note 13: Includes Urology/Prostate
  Note 14: S-Fusion Note 15: S-Shearwave

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

510(k) No.:

Device Name: LA4-18B 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	Laparoscopic
&Other	Pediatric
	Small Organ (See Note 5)	P	P	P		P	Note 1	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 1	Note 2, 5, 6, 7, 8, 9, 11, 14
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 14
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K151663; 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+PPI, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+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 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 vessel

• Note 7: Tissue Harmonic Imaging (THI)

• Note 8: 3D imaging

• Note 9: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis

• Note 11: Panoramic imaging

• Note 12: ElastoScan Note 13: Includes Urology/Prostate

• Note 14: S-Fusion

• Note 15: S-Shearwave

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

510(k) No.:

Device Name: PA3-8B 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)	P	P	P	P	P	Note 1
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	Note 1
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	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 K151663; 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+PPI, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+PW, B+TD+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 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: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis

• Note 11: Panoramic imaging

• Note 12: ElastoScan Note 13: Includes Urology/Prostate

• Note 14: S-Fusion

• Note 15: S-Shearwave

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

510(k) No.:

Device Name: PA4-12B 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)	P	P	P	P	P	Note 1	Note 2
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Note 2
	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	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 K151663; 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+PPI, B+CW, B+C+PW, B+PD+PW, B+PPF+PW, B+PPI+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 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: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

• Note 11: Panoramic imaging
• Note 12: ElastoScan
• Note 13: Includes Urology/Prostate

Note 14: S-Fusion Note 15: S-Shearwave

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

510(k) No.:

Device Name: CV1-8A 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	P	Note 1	Note 2, 4, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 2, 4, 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
	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 K151663; 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+PPI, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+PW, B+TD+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 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: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis

• Note 11: Panoramic imaging

• Note 12: ElastoScan Note 13: Includes Urology/Prostate

• Note 14: S-Fusion

• Note 15: S-Shearwave

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

510(k) No.:

Device Name: V4-8 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	P	Note 1	Note 2, 4, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 2, 4, 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
	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 K151663; 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+PPI, B+CW, B+C+PW, B+PD+PW, B+PPI+PW, B+PPI+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 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: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis

• Note 11: Panoramic imaging

• Note 12: ElastoScan Note 13: Includes Urology/Prostate

• Note 14: S-Fusion

• Note 15: S-Shearwave

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

510(k) No.:

Device Name: DP2B 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)
	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
	Other (spec.)

N= new indication; P= previously cleared by FDA K151663; 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+PPI, B+CW, B+C+PW, B+PD+PW, B+PPI+PW, B+PPI+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 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 vessel

• Note 7: Tissue Harmonic Imaging (THI)

• Note 8: 3D imaging

• Note 9: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis

• Note 11: Panoramic imaging

• Note 12: ElastoScan

• Note 13: Includes Urology/Prostate Note 14: S-Fusion

• Note 15: S-Shearwave

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

510(k) No.:

Device Name: CA3-10A 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	P	Note 1	Notes 2, 3, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 11
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	N	N	N	N	N	Note 1	Notes 2, 7, 8, 9, 11
	Musculo-skel. (Superfic.)	N	N	N	N	N	Note 1	Notes 2, 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	P	Note 1	Notes 2, 7, 8, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K153529; 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+PPI, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+PW, B+TD+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 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 vessel

• Note 7: Tissue Harmonic Imaging (THI)
• Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis
• Note 11: Panoramic imaging
• Note 12: ElastoScan
• Note 13: Includes Urology/Prostate Note 14: S-Fusion

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

510(k) No.:

Device Name: LM4-15B 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	Specific	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
(Track I only)	(Tracks I & III)Ophthalmic
Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
&Other	Pediatric
	Small Organ (See Note 5)	N	N	N	N	N	Note 1	Note 2, 5, 6, 7 8, 9, 11, 12
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	N	N	N	N	N	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Musculo-skel. (Superfic.)	N	N	N	N	N	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.)
Peripheral	Peripheral vessel	N	N	N	N	N	Note 1	Note 2, 5, 6, 7, 8, 9, 11
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA; 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+PPI, B+CW, B+C+PW, B+PD+PW, B+PPI+PW, B+PPI+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 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 vessel

• Note 7: Tissue Harmonic Imaging (THI)

• Note 8: 3D imaging

• Note 9: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis

• Note 11: Panoramic imaging

• Note 12: ElastoScan

• Note 13: Includes Urology/Prostate Note 14: S-Fusion

• Note 15: S-Shearwave

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

510(k) No.:

Device Name: MMPT3-7 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 12)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
&Other	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)	P	P	P	P	P	Note 1	Note 4, 7
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)	P	P	P	P	P	Note 1	Note 4, 7
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K153408; 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+PPI, B+CW, B+C+PW, B+PD+PW, B+PPI+PW, B+PPI+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 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: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

• Note 11: Panoramic imaging
• Note 12: ElastoScan
• Note 13: Includes Urology/Prostate Note 14: S-Fusion

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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)

SAMSUNG MEDISON 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: April 25, 2016

2. 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

3. Identification of the predicate or legally marketed device:

• RS80A Diagnostic Ultrasound System (K151663) -
• -WS80A Diagnostic Ultrasound System (K153529)
• -HM70A Diagnostic Ultrasound System (K153408)
• -LOGIQ E9 Diagnostic Ultrasound System (K142160)
• -Voluson E10 Diagnostic Ultrasound System (K131267)
• -AmCAD-UT (K122536)
• QLAB (K121223) -

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4. 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.

5. Intended Uses:

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/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Trans-esoph, (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.

6. Technological Characteristics:

The RS80A is substantially equivalent with respect to safety, effectiveness, and functionality to the RS80A Diagnostic Ultrasound System (K151663), WS80A Diagnostic Ultrasound System (K153529), HM70A Diagnostic Ultrasound System (K153408), LOGIQ E9 Diagnostic Ultrasound System (K142160) and Voluson E10 Diagnostic Ultrasound System (K131267)

• It is substantially equivalent with respect to safety, effectiveness, and functionality to the Clear Vision of RS80A (K151663) in regards to the device with HQ Vision.
  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.

RS80A	Addition of V3.00	Remarks
Clinicalapplication	• Addition of clinical applications.: Intra-operative, Trans-esoph (non-Cardiac) and Trans-esoph (Cardiac)
Operation ofmodes	• No addition

---------------------------	--

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RS80A	Addition of V3.00	Remarks
Appliedtransducers	• Addition of 3 transducers: CA3-10A, LM4-15B and MMPT3-7.	Transducers The previouslycleared transducers CA3-10A K153529 LM4-15B None MMPT3-7 K153408
SW Features	• Adding the new S/W features: HQ Vision• Improving the S/W feature that waspreviously cleared in RS80A(K151663): Needle Mate, S-Fusion	Description of S/W Features• HQ Vision: It provides real-time imageenhancement algorithms that improve spatialresolution. This feature shows the finerdetails in the image.
HW Features	• No addition

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	The subject device			The predicate devices
Feature /Characteristics	RS80A(V3.00)	RS80A(K151663)	WS80A(K153529)	HM70A(K130803)	LOGIQ E9(K123564)	Voluson E10(K131267)
Indication for Use
- Fetal/Obstetrics	√	√	√	√	√	√
- Abdominal	√	√	√	√	√	√
- Gynecology	√	√	√	√	√	√
- Intraoperative	√	√	√	√	√	√
- Pediatric	√	√	√	√	√	√
- Small Organ	√	√	√	√	√	√
- Neonatal Cephalic	√	√	√	√	√	√
- Adult Cephalic	√	√	√	√	√	√
- Trans-rectal	√	√	√	√	√	√
- Trans-vaginal	√	√	√	√	√	√
- Trans-esoph.(non-Cardiac)	√	√	√	√	√	√
- Musculo-skeletal(Conventional)	√	√	√	√	√	√
- Musculo-skeletal(Superficial)	√	√	√	√	√	√
- Urology	√	√	√	√	√	√
- Cardiac Adult	√	√	√	√	√	√
- Cardiac Pediatric	√	√	√	√	√	√
- Trans-esophageal(Cardiac)	√	√	√	√	√	√
- Peripheral vessel	√	√	√	√	√	√
Scanhead Types
- Linear Array	√	√	√	√	√	√
- Curved LinearArray	√	√	√	√	√	√
- 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 imagingmode	√	√	√	√	√	√
- Combined modes	√	√	√	√	√	√
Safety & EMC
Feature /Characteristics	The subject device			The predicate devices
	RS80A(V3.00)	RS80A(K151663)	WS80A(K153529)	HM70A(K130803)	LOGIQ E9(K123564)	Voluson E10(K131267)
Complianceg
- IEC 60601-1
- UL 60601-1	√	√	√		√	√
- CSA C22.2No.601.1
- IEC 60601-2-37	√	√	√	√	√	√
- IEC 60601-1-2	√	√	√	√	√	√
Acoustic OutputDisplay Standard
Track 3	√	√	√	√	√	√
Patient ContactMaterials
Tested to ISO10993-1	√	√	√	√	√	√
Functionality
- Q Scan	√	√	√	√
- ClearVision	√	√	√	√
- MultiVision	√	√	√	√
- Panoramic	√	√	√	√
- Needle Mate	√	√	√	√
- Auto IMT+	√	√	√	√
- Strain+	√	√		√
- Stress Echo	√	√		√
- Elastoscan	√	√	√	√	√	√
- E-Thyroid	√	√
- E-Breast	√	√
- S-Shearwave	√	√			√
- S-Detect	√(1)	√	√	√		√
- S-Fusion	√	√
- Clear Track	√	√			√
- Virtual Track	√	√			√
- ADVR	√	√	√	√		-
- 3D Imaging(Volume DataAcquisition)	√	√	√	√	√	√
- 3D Imagingpresentation
3D Cine/4D Cine	√	√	√	√
- 3D RenderingMPR	√	√	√	√
- 3D XIMSV/ObliqueView	√	√	√	√
- 3D MXIVolume Slice/MirrorView	√	√	√
Feature /Characteristics	The subject device			The predicate devices
	RS80A(V3.00)	RS80A(K151663)	WS80A(K153529)	HM70A(K130803)	LOGIQ E9(K123564)	Voluson E10(K131267)
- Volume CT	√	√	√
- 3D MagiCut	√	√	√	√
- VolumeCalculation(VOCAL, XI VOCAL)	√	√	√	√
- XI STIC	√	√	√	√
- HDVI	√	√	√	√
- Realistic Vue	√	√	√
- Natural Vue	√	√
- HQ Vision	√

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510(k) Premarket Notification

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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.

Reference No.	Title
IEC 60601-1	AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 andA2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2	AAMI / ANSI / IEC 60601-1-2:2007(R)2012, Medical electrical equipment - Part 1-2:General requirements for basic safety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests (Edition 3)
IEC 60601-2-37	IEC 60601-2-37:2007 Edition 2.0 2007-08, Medical electrical equipment – Part 2-37:Particular requirements for the basic safety and essential performance of ultrasonicmedical diagnostic and monitoring equipment
ISO10993-1	AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process
ISO14971	ISO 14971:2007, Medical devices - Application of risk management to medical devices
NEMA UD 2-2004	NEMA UD 2-2004 (R2009)Acoustic Output Measurement Standard for Diagnostic Ultrasound EquipmentRevision 3
NEMA UD 3-2004	NEMA UD 3-2004 (R2009)Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indiceson Diagnostic Ultrasound Equipment, Revision 2

The RS80A and its application comply with voluntary standards as below:

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

END of 510(K) Summary

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.