Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging modes and analysis packages, but does not mention AI, ML, or deep learning. The performance studies focus on comparing measurements and classifications to predicate devices using traditional methods, not AI/ML-based performance metrics.

Therapeutic

No
The device is described as a "Diagnostic Ultrasound System" intended for "diagnostic ultrasound imaging and fluid analysis," and its function is to "acquire ultrasound data and to display the data" for making a diagnosis. There is no mention of treating or preventing diseases.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "The RS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body." The "Device Description" also mentions that the system "offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals."

SaMD (Software as a Medical Device)

No

The device is described as a "general purpose, mobile, software controlled, diagnostic ultrasound system" and its function is to "acquire ultrasound data". This indicates the device includes hardware components (transducers, system for acquiring data) in addition to the software control and processing.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states "diagnostic ultrasound imaging and fluid analysis of the human body." This describes a device that uses physical principles (ultrasound waves) to create images and analyze properties within the body, not a device that analyzes samples outside the body (in vitro).
Device Description: The description details how the system acquires ultrasound data and displays it in various imaging modes. This is consistent with an in vivo imaging device.
Mentions image processing: The mention of post-processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body further supports its function as an in vivo imaging device.
Input Imaging Modality: The input modality is Ultrasound, which is an in vivo imaging technique.
Anatomical Site: The listed anatomical sites are all locations within the human body.
Summary of Performance Studies: The performance studies describe evaluations using phantoms and clinical data to assess the accuracy of measurements and comparisons to predicate ultrasound systems. This is typical for an in vivo imaging device.
Key Metrics: The key metrics (sensitivity, AUC, specificity, accuracy) are applied to the performance of the ultrasound system's measurement and analysis capabilities, not to the performance of a test on a biological sample.

In vitro diagnostic devices are designed to examine specimens, such as blood, urine, or tissue, that have been taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on ex vivo samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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-reginal, Trans-esoph. (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

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, M 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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

Indicated Patient Age Range

Adult, Pediatric, Neonatal (implied)

Intended User / Care Setting

Competent health care professionals (implied)

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

Not Found

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

Not Found

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

Summary of Non-Clinical Test

The E-Strain has been evaluated using phantom to demonstrate measuring two average strain values within two average strain values with two separate regions of interest. Using the clinical data, we were able to directly compared values of sensitivity, AUC quantitatively. Although specificity rate was slightly lower than one of predicate, however, accuracy value was within the scope of the predicate statically and therefore, performance of E-Strain is substantially equivalent to the predicate.
The S-3D Arterial Analysis has been evaluated by comparison of plaque volume value quantitatively to the predicate using clinical data that allows demonstrating of substantial equivalence to the predicate. The functionality and predicate use similar segmentation method to obtain plaque information and user interface is the same.
The S-Detect for Thyroid has been evaluated to demonstrate measurement of lesion size using phantom that is an essential and basic method of measurement provided in Diagnostic Ultrasound System and workflow is the same as the predicate. The lexicon classification is provided in the predicate. Although lexicon item is different from the predicate, it is the same method for user to select item of best description to their diagnosis decision. Therefore, providing user to select lexicon item and allow printing out their selection is substantially equivalent to the predicate.
The S-Detect for Breast has been evaluated to demonstrate measurement of lesion size by direct comparison to the predicate and has shown substantial equivalent value to the predicate.

Summary of Clinical Tests
Not applicable. The subject of this submission, RS80A, did not require clinical studies to support substantial equivalence.

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

Sensitivity, AUC, Specificity, Accuracy (for E-Strain)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K162094, K121223, K142160, K142368

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus symbol is composed of three human profiles facing to the right.

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

August 24, 2017

SAMSUNG MEDISON CO., LTD. % Ji Yea Lee Regulatory Affairs Specialist 42. Teheran-ro 108-gil Gangnam-gu. Seoul 06176 REPUBLIC OF KOREA

Re: K171048

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: August 7, 2017 Received: August 9, 2017

Dear Ji Yea Lee:

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 of medical device

1

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 (DICE) 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 (DICE) 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.

Sincerely,

Michael D. O'Hara

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

Enclosure

2

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K171048

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-reginal, 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)

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)

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."

3

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	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	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)	P	P	P		P	Note 1	Note 7, 9, 11
	Intra-operative (Neuro.)	P	P	P		P	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	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)	P	P	P	P	P	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 Adult	P	P	P	P	P	Note 1	Notes 4, 7
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Notes 4, 7
	Trans-esophageal (Cardiac)	P	P	P	P	P	Note 1	Note 4, 7
	Other (spec.)
Peripheral
Vessel	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+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

4

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	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P	P	P	Note 1	Notes 2,4,7,8,9,11,14
	Abdominal (See Note 10)	P	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.)
Peripheral
Vessel	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+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

5

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	Color
Doppler*	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	Laparoscopic
&
Other	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 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

6

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	Color
Doppler*	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.)
Peripheral
Vessel	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

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	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)		P	P	P		P	Note 1	Notes 2, 7, 8, 9
	Abdominal (See Note 10)		P	P	P		P	Note 1	Notes 2, 7, 8, 9, 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	Note 1	Notes 2, 7, 8, 9, 12
	Trans-vaginal		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	Note 1	Notes 2, 7, 8, 9, 12
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	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+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 biopsv
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)

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	Color
Doppler*	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.)
Peripheral
Vessel	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+DPL, B+CW, 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

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	Color
Doppler*	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.)
Peripheral
Vessel	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)

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	Color
Doppler*	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.)
Peripheral
Vessel	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+DPL, B+CW, 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

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) | | | | | | Other
(Spec.) |
|---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|---------------------------|
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined*
(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 |
| | 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.) | | | | | | | |
| Peripheral
Vessel | 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

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	Color
Doppler*	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.)
Peripheral
Vessel	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+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, 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

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	Color
Doppler*	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
Vessel	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, 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)

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	Color
Doppler*	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.)
Peripheral
Vessel	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

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	Color
Doppler*	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.)
Peripheral
Vessel	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 | (Spec.) |
|---------------------------|--------------- | General
(Track I only) | Specific
(Tracks I & III) | B Doppler | Combined*
(Spec.) | |
| Ophthalmic | Ophthalmic | Fetal Imaging
& Other | Fetal/Obstetrics (See Note 3) | | | Abdominal (See Note 10) | | Intra-operative | | 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 | | Cardiac Pediatric | | Trans-esophageal (Cardiac) | | Other (spec.) | Peripheral
Vessel | Peripheral vessel | | | Other (spec.) | Mode of Operation (includes simultaneous B-mode) | | | | | | Other
----------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| M | PWD | CWD | Color
| | | | | | | |
| | | | | | |
| | | | | | | |
(See Note 6) | | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | P | | | |
| | | | P | | | |
| | | | | | | |
| | | | | | | |
| | | P | | | |
| | | | | | | |

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

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 Color
Doppler* 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.)
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+DPD, B+DPI, 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, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

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

Note 7: Tissue Harmonic Imaging (THI)

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 Color
Doppler* 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+CV, B+C+PW, B+PD+PW, B+DPD+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, 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

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 Color
Doppler* Combined*
(Spec.) Other
(Spec.)
Ophthalmic Ophthalmic
Fetal/Obstetrics (See Note 3)
Abdominal (See Note 10)
Intra-operative (See Note 6) P P P P Note 1 Note 7, 9, 11
Intra-operative (Neuro.) 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 Note 1 Note 7, 9, 11
Musculo-skel. (Superfic.) 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.)
Peripheral
Vessel Peripheral vessel 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+CV, B+C+PW, B+PD+PW, B+DPD+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: 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 Color
Doppler* 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, 12, 14
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, 14
Musculo-skel. (Superfic.) P 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
Vessel 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+DPD, B+PPI, B+CV, B+C+PW, B+PD+PW, B+DPD+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: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

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 Color
Doppler* 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.)
Peripheral
Vessel 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+DPD+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, 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 Color
Doppler* 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+DPI, 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, 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 Color
Doppler* Combined*
(Spec.) Other
(Spec.)
Ophthalmic Ophthalmic
Fetal Imaging
& Other 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.)
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
Cardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
Vessel 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+DPD+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, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

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 7: Tissue Harmonic Imaging (THI)

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 Color
Doppler* Combined*
(Spec.) Other
(Spec.)
Ophthalmic Ophthalmic
Fetal Imaging
& Other 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.)
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
Cardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
Vessel 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+DPD+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: 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 Color
Doppler* 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.)
Peripheral
Vessel 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+DPD+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, 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 Color
Doppler* Combined*
(Spec.) Other
(Spec.)
Ophthalmic Ophthalmic
Fetal Imaging
& Other Fetal/Obstetrics (See Note 3) P P P P Note 1 Notes 2, 3, 7, 8, 9, 11
Abdominal (See Note 10) P P P P Note 1 Notes 2, 7, 8, 9, 11
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Laparoscopic
Pediatric 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.) P P P P Note 1 Notes 2, 7, 8, 9, 11
Musculo-skel. (Superfic.) P P P P Note 1 Notes 2, 7, 8, 9, 11
Intra-luminal
Other (See Note 13)
Cardiac Adult
Cardiac Cardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
Vessel Peripheral vessel 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+CV, B+C+PW, B+PD+PW, B+DPD+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: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

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
(Track I only) Specific
(Tracks I & III) B M PWD CWD Color
Doppler* 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, 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.)
Peripheral
Vessel 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; 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+DPD+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: 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 Color
Doppler* Combined*
(Spec.) Other
(Spec.)
Ophthalmic Ophthalmic
Fetal Imaging
&
Other Fetal/Obstetrics (See Note 3)
Abdominal (See Note 12)
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) P P P P P Note 1 Note 4, 7
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.) (See Note 13)
Cardiac Cardiac Adult
Cardiac Pediatric
Trans-esophageal (Cardiac) P P P P P Note 1 Note 4, 7
Other (spec.)
Peripheral
Vessel Peripheral 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+CV, B+C+PW, B+PD+PW, B+DPD+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, 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

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

29

6. 510(K) Summary

RS80A Diagnostic Ultrasound System

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

Date Prepared: August 7, 2017

Manufacturer:

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

Primary Contact Person:

Ji Yea Lee Regulatory Affairs Specialist Phone: +82.2.2194.1594 Fax: +82.2.556.3974 Email: jiyea722.lee@samsungmedison.com

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

Predicate Device (K-Number):

RS80A Diagnostic Ultrasound System (K162094) QLAB WITH FHN AND VPQ PLUG-IN (K121223) LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM (K142160) NOBLUS DIAGNOSTIC ULTRASOUND SCANNER (K142368)

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, M 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.

30

Intended Uses:

The RS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imging and fluid analysis of the human body. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Trans-rectal, Trans-vaginal, Transesoph. (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.

Technological Characteristics:

The RS80A is substantially equivalent with respect to safety, effectiveness, and functionality to the RS80A Diagnostic Ultrasound System (K162094), QLAB (K121223), LOGIQ (K142160), and NOBLUS (K142368).

It is substantially equivalent with respect to safety, effectiveness, and functionality to the ElastoScan of -RS80A (K162094) and Strain Ratio of NOBLUS (K142368) in regards to the device with E-Strain.

It is substantially equivalent with respect to safety, effectiveness, and functionality to the VPQ" of Philips's -OLAB (K121223) in regards to the device with S-3D Arterial Analysis.

It is substantially equivalent with respect to safety, effectiveness, and functionality to the S-Detect of RS80A -(K162094) and Thyroid Productivity package' of GE's LOGIQ E9 (K142160) in regards to the device with S-3D Arterial Analysis.

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.

See Table 1 below for technological characteristics comparison to the predicate devices.

RS80A Addition of V3.00 Remarks
Clinical
application • No addition
Operation of
modes • No addition
Applied
transducers • No addition
SW Features • Adding the new S/W features
: E-Strain, S-3D Arterial Analysis, S-
Detect for Thyroid

• Improving the previous S/W feature
: S-Detect for Breast (old name: S-
Detect) | • Description of S/W Features
• E-Strain: This is the function for breast,
prostate or gynecology lesion exam.
Calculates the strain between the areas of the
suspected lesion (ROI A) and reference
tissue area (ROI B, reference) and displays
the results.

• S-3D Arterial Analysis: The purpose is to
display the highly comprehensible vessel
structure through the 3D vessel and plaque
analysis with the ultrasound equipment and
help to diagnose cardiovascular by
calculating clinically useful indicators.

• S-Detect for Thyroid: It is a set of
functionalities for conducting ultrasound
thyroid exams. It assists the entire process of
locating a lesion in an ultrasound image and
making a diagnosis. |

Table 1. Change Applied to the previously cleared RS80A (K162094)

31

RS80A Addition of V3.00 Remarks
HW Features - No addition

| Feature /
Characteristics | The subject device
RS80A | RS80A
(K162094) | The predicate devices
QLAB
(K121223) | LOGIQ E9
(K142160) | NOBLUS
(K142368) |
|--------------------------------------------------|-----------------------------|-----------------------|--------------------------------------------|-----------------------|---------------------|
| | | | | | |
| 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 | √ | √ | | √ | √ |
| Feature /
Characteristics | The subject device | The predicate devices | | | |
| | RS80A | RS80A
(K162094) | QLAB
(K121223) | LOGIQ E9
(K142160) | NOBLUS
(K142368) |
| Imaging | | | | | |
| - 3D/4D imaging
mode | √ | √ | | √ | √ |
| - Combined modes | √ | √ | | √ | |
| Safety & EMC
Compliance | | | | | |
| - IEC 60601-1 | | | | √ | |
| - UL 60601-1 | √ | √ | | | |
| - CSA C22.2
No.601.1 | | | | √ | |
| - IEC 60601-2-37 | √ | √ | | √ | |
| - IEC 60601-1-2 | √ | √ | | √ | |
| Acoustic Output
Display Standard | | | | | |
| Track 3 | √ | √ | | | |
| Patient Contact
Materials | | | | | |
| Tested to ISO
10993-1 | √ | √ | | √ | |
| Functionality | | | | | |
| - Q Scan | √ | √ | | | |
| - ClearVision | √ | √ | | | |
| - MultiVision | √ | √ | | | |
| - Panoramic | √ | √ | | | |
| - Needle Mate | √ | √ | | | |
| - Auto IMT+ | √ | √ | | | |
| - Strain+ | √ | √ | | | |
| - Stress Echo | √ | √ | | | |
| - Elastoscan | √ | √ | | √ | |
| - E-Thyroid | √ | √ | | | |
| - E-Breast | √ | √ | | | |
| - E-Strain | √ | | | | √ |
| - S-Shearwave | √ | √ | | √ | |
| - S-Detect for
Breast | √1) | √ | | | |
| - S-Detect for
Thyroid | √ | | | √3) | |
| - S-Fusion | √ | √ | | | |
| - Clear Track | √ | √ | | √ | |
| - Virtual Track | √ | √ | | √ | |
| - S-3D Arterial
Analysis | √ | | √2) | | |
| - ADVR | √ | √ | √ | | |
| - 3D Imaging
(Volume Data
Acquisition) | √ | √ | √ | √ | |
| - 3D Imaging
presentation | | | | | |
| 3D Cine/4D Cine | √ | √ | | | |
| Feature /
Characteristics | The subject device
RS80A | The predicate devices | | | |
| | RS80A | RS80A
(K162094) | QLAB
(K121223) | LOGIQ E9
(K142160) | NOBLUS
(K142368) |
| 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 | √ | √ | | | |
| - CEUS+ | √ | √ | | | |
| - HQ Vision | √ | √ | | | |

32

33

The name of the feature is changed to S-Detect for Breast from S-Detect.

VPQ (Vascular Plaque Quantification)

Thyroid Productivity Package

34

Safety, EMC, and Performance Data

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 and
A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General
requirements 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 ultrasonic
medical 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 Equipment
Revision 3 |
| NEMA UD 3-2004 | NEMA UD 3-2004 (R2009)
Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices
on Diagnostic Ultrasound Equipment, Revision 2 |

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

Summary of Non-Clinical Test

The E-Strain has been evaluated using phantom to demonstrate measuring two average strain values within two average strain values with two separate regions of interest. Using the clinical data, we were able to directly compared values of sensitivity, AUC quantitatively. Although specificity rate was slightly lower than one of predicate, however, accuracy value was within the scope of the predicate statically and therefore, performance of E-Strain is substantially equivalent to the predicate.

The S-3D Arterial Analysis has been evaluated by comparison of plaque volume value quantitatively to the predicate using clinical data that allows demonstrating of substantial equivalence to the predicate. The functionality and predicate use similar segmentation method to obtain plaque information and user interface is the same.

The S-Detect for Thyroid has been evaluated to demonstrate measurement of lesion size using phantom that is an essential and basic method of measurement provided in Diagnostic Ultrasound System and workflow is the same as the predicate. The lexicon classification is provided in the predicate. Although lexicon item is different from the predicate, it is the same method for user to select item of best description to their diagnosis decision. Therefore, providing user to select lexicon item and allow printing out their selection is substantially equivalent to the predicate.

The S-Detect for Breast has been evaluated to demonstrate measurement of lesion size by direct comparison to the predicate and has shown substantial equivalent value to the predicate.

Summary of Clinical Tests

Not applicable. The subject of this submission, RS80A, did not require clinical studies to support substantial equivalence.

35

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

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

RS80A	Addition of V3.00	Remarks
Clinical
application	• No addition
Operation of
modes	• No addition
Applied
transducers	• No addition
SW Features	• Adding the new S/W features
: E-Strain, S-3D Arterial Analysis, S-
Detect for Thyroid

Reference No.	Title
IEC 60601-1	AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and
A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General
requirements 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 ultrasonic
medical diagnostic and monitoring equipment
ISO10993-1	AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices