K Number

Device Name

RS85 Diagnostic Ultrasound System

Manufacturer

Samsung Medison Co., Ltd

Date Cleared

2020-01-06

(83 days)

Product Code

IYN ITX IYO

Regulation Number

892.1550

Intended Use

The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-raginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.

Device Description

The RS85 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D 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 Wave, 3D imaging mode (real-time 4D imaging mode), Elastoscan* Mode, MV-Flow Mode or as a combination of these modes. The RS85 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that may aid in making a diagnosis by competent health care professionals. The RS85 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K191115, K182595, K181336

Reference Devices

K173021, K150949, K162574

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, and the description focuses on standard ultrasound imaging modes and analysis packages without indicating advanced learning capabilities.

Therapeutic

No
The device is described as a "diagnostic ultrasound system" and its function is to "acquire ultrasound data and to display the data" and "aid in making a diagnosis," which indicates a diagnostic rather than a therapeutic purpose.

Diagnostic

Yes

The "Device Description" explicitly states, "The RS85 is a general purpose, mobile, software controlled, diagnostic ultrasound system." Additionally, the "Intended Use / Indications for Use" section lists various clinical applications, and the device "offers analysis packages that provide information that may aid in making a diagnosis by competent health care professionals."

SaMD (Software as a Medical Device)

The device description explicitly states it is a "general purpose, mobile, software controlled, diagnostic ultrasound system," indicating it includes hardware components (the ultrasound system and probes) in addition to the software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states that the system is designed to "obtain ultrasound images and analyze body fluids." While it analyzes body fluids, the primary function described is obtaining images for diagnostic purposes.
Device Description: The description focuses on the various ultrasound imaging modes and analysis packages that aid in diagnosis by competent healthcare professionals. It does not describe any in vitro testing of samples outside the body.
Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device operates in vivo (within the body) using ultrasound waves.

The analysis of body fluids mentioned in the intended use is likely related to the ultrasound imaging itself, such as assessing fluid accumulation or characteristics within the body, rather than performing laboratory-style tests on collected samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

IYN, IYO, ITX

Device Description

The RS85 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that may aid in making a diagnosis by competent health care professionals.

The RS85 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

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal/Obstetrics, Abdominal, Gynecology, Neonatal Cephalic, Adult Cephalic, Muscular-Skeletal, Peripheral vessel.
Specific examples: thyroid, parathyroid, breast, scrotum, penis, Renal, Prostate

Indicated Patient Age Range

Adult, Pediatric, Neonatal.

Intended User / Care Setting

Competent health care professionals.

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

Not Found

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

Not Found

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

The proposed device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The RS85 and its applications comply with voluntary standards.

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

Not Found

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.

K191115, K182595, K181336

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.

K173021, K150949, K162574

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

Samsung Medison Co., Ltd Ji Lee Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, 25108 Kr

January 6, 2020

Re: K192903

Trade/Device Name: RS85 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: December 16, 2019 Received: December 16, 2019

Dear Ji 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K192903

Device Name RS85 Diagnostic Ultrasound System

Indications for Use (Describe)

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: RS85 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, 15
	Neonatal Cephalic	P	P	P		P	Note 1	Notes 8, 9, 11, 16
	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, 16, 17
	Trans-vaginal	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11, 12, 16
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 12, 14. 16, 17
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 12, 14, 16, 17
	Intra-luminal
	Other (See Note 13)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 12, 16
	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	Notes 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; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, 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 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 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Spatial Compound Imaging

510(k) No.:

Device Name: CA1-7A for use with RS85

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 2,6,7,8,9,10,11,14,15,16,17
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Notes 2, 6, 7, 8, 9, 11, 14
	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	Notes 2, 6, 7, 8, 9, 11, 14
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	P	P	P	P	P	Note 1	Notes 2, 6, 7, 8, 9, 11, 14
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	Note 1	Notes 2,6, 7, 8, 9, 11, 14
	Other (spec.)

N= new indication: P= previously cleared by FDA K191115; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPL, 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
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

510(k) No.:

Device Name: CF4-9 for use with RS85

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 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 7, 8, 9, 11
	Small Organ (See Note 5)
	Neonatal Cephalic	P	P	P	P	P	Note 1	Notes 7, 8, 9, 11, 16
	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 K191115; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPL, 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, 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
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

510(k) No.:

Device Name: CA2-8A for use with RS85

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, 10, 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
Vessel	Peripheral vessel
	Other (spec.)

N= new indication: P= previously cleared by FDA K191115; 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+C+PW, B+PD+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 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
Note 16: MV-Flow Note 17: S-Shearwave Imaging (2D Shearwave)

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

510(k) No.:

Device Name: CA3-10A for use with RS85

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, 3, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 10, 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, 16
	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	Notes 2, 7, 8, 9, 11
	Musculo-skel. (Superfic.)	P	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	P	Note 1	Notes 2, 7, 8, 9, 11
	Other (spec.)

N= new indication: P= previously cleared by FDA K191115; 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+C+PW, B+PD+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 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
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

510(k) No.:

Device Name: E3-12A for use with RS85

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, 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	Laparoscopic
&
Other	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.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K191115; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, 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
Note 16: MV-Flow Note 17: S-Shearwave Imaging (2D Shearwave)

510(k) No.:

Device Name: L3-12A for use with RS85

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*	Combine
d*
(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, 14,16
	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, 14,16
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 14,16
	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 K191115; 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, 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

Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

Prescription Use (Per 21 CFR 801.109) DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: EA2-11B for use with RS85

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	Note 2, 7, 8, 9
	Abdominal (See Note 12)	P	P	P		P	Note 1	Note 2, 6, 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	Note 2, 7, 8, 9, 12
	Trans-vaginal	P	P	P	P	P	Note 1	Note 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	Note 2, 7, 8, 9, 12
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication: P= previously cleared by FDA K191115; 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+PPI+PW, B+PY+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-Shearwaye
Note 16: MV-Flow

Note 17: S-Shearwave Imaging (2D Shearwave)

Prescription Use (Per 21 CFR 801.109) DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: LA2-9A for use with RS85

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, 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	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11,12,15,17
	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, 11,12,15,17
	Musculo-skel. (Superfic.)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11,12,15,17
	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
	Other (spec.)

N= new indication: P= previously cleared by FDA K191115; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+CW, 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 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-Shearwaye

Note 16: MV-Flow

Note 17: S-Shearwave Imaging (2D Shearwave)

Note 2: Includes imaging for guidance of biopsy

510(k) No.:

Device Name: LA3-16A for use with RS85

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

N= new indication: P= previously cleared by FDA K191115; 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+C+PW, B+PD+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 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
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

510(k) No.:

Device Name: LA3-16AI for use with RS85

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	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.)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	Note 1	Note 7, 9, 11
	Other (spec.)

N= new indication: P= previously cleared by FDA K191115; 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+C+PW, B+PD+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 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
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

510(k) No.:

Device Name: LA4-18B for use with RS85

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)	N	N	N		N	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	N	N	N		N	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 12, 14,16
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2,5,6,7,8,9,11,14,16
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2,5,6,7,8,9,11,14,16
	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 K191115; 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+C+PW, B+PD+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 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
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

510(k) No.:

Device Name: LM4-15B for use with RS85

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
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	N	N	N	N	N	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2,5,6,7,8, 9,11,12,16
	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 K191115; 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+C+PW, B+PD+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 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
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

510(k) No.:

Device Name: PM1-6A for use with RS85

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 K191115; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPL, 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
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

510(k) No.:

Device Name: PA3-8B for use with RS85

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	P	P	P	P	P	Note 1	Note 7
	Small Organ (See Note 5)
	Neonatal Cephalic	P	P	P	P	P	Note 1	Note 7
	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 K191115; 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+C+PW, B+PD+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 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
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

510(k) No.:

Device Name: PA4-12B for use with RS85

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	P	P	P	P	P	Note 1	Note 7
	Small Organ (See Note 5)
	Neonatal Cephalic	P	P	P	P	P	Note 1	Note 7
	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	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 K191115; 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+C+PW, B+PD+PW, B+PPH+PW, B+C+M, Dual/Ouad. 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 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 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

Note 7: Tissue Harmonic Imaging (THI)

510(k) No.:

Device Name: MMPT3-7 for use with RS85

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 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
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	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
Vessel	Peripheral vessel
	Other (spec.)

N= new indication: P= previously cleared by FDA K191115; 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+C+PW, B+PD+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 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
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

510(k) No.:

Device Name: CV1-8A for use with RS85

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	Note 2, 4, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 2, 4, 7, 8, 9, 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
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication: P= previously cleared by FDA K191115; 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+C+PW, B+PD+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 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
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

510(k) No.:

Device Name: V5-9 for use with RS85

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	Note 2, 7, 8, 9
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 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	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 12
	Trans-vaginal	P	P	P	P	P	Note 1	Note 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	Note 2, 7, 8, 9, 12
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication: P= previously cleared by FDA K191115; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPL, 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
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

510(k) No.:

Device Name: LV3-14A for use with RS85

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
	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	Cardiac Adult
	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
	Other (spec.)

N= new indication: P= previously cleared by FDA K191115; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPL, 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
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

510(k) No.:

Device Name: CW6.0 for use with RS85

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				P
	Other (spec.)

N= new indication: P= previously cleared by FDA K191115; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPL, 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 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
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

Note 7: Tissue Harmonic Imaging (THI)

510(k) No.:

Device Name: DP2B for use with RS85

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)
	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
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication: P= previously cleared by FDA K191115; 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+C+PW, B+PD+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 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
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

510(k) No.:

Device Name: DP8B for use with RS85

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 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
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult				P
Cardiac	Cardiac Pediatric				P
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel				P
	Other (spec.)

N= new indication: P= previously cleared by FDA K191115; 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+C+PW, B+PD+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 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
Note 16: MV-Flow Note 17: S-Shearwave Imaging (2D Shearwave)

510(k) No.:

Device Name: EV3-10B for use with RS85

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	Note 2, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 11, 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	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 11, 12
	Trans-vaginal	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 11, 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	Note 2, 7, 8, 9, 11, 12
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication: P= previously cleared by FDA K191115; 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+C+PW, B+PD+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 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 16: MV-Flow Note 17: S-Shearwave Imaging (2D Shearwave)

Note 7: Tissue Harmonic Imaging (THI)

510(k) No.:

Device Name: LA2-14A for use with RS85

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)	N	N	N	N	N	Note 1	Notes 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
&
Other	Pediatric	N	N	N	N	N	Note 1	Notes 7, 8, 9, 11
	Small Organ (See Note 5)	N	N	N	N	N	Note 1	Notes 7, 8, 9, 11,12,16,17
	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 7, 8, 9, 11,12,16,17
	Musculo-skel. (Superfic.)	N	N	N	N	N	Note 1	Notes 7, 8, 9, 11,12,16,17
	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	Notes 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+PPI, 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
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

510(k) No.:

Device Name: CA1-7S for use with RS85

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)	N	N	N		N	Note 1	Notes 2, 4, 7, 8, 9, 11, 14
	Abdominal (See Note 10)	N	N	N		N	Note 1	Notes 2,6,7,8,9,10,11,14,15,16,17
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	N	N	N		N	Note 1	Notes 2, 6, 7, 8, 9, 11, 14
	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	Note 1	Notes 2, 6, 7, 8, 9, 11, 14
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	N	N	N		N	Note 1	Notes 2, 6, 7, 8, 9, 11, 14
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	N	N	N		N	Note 1	Notes 2,6, 7, 8, 9, 11, 14
	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+PD+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
Note 16: MV-Flow Note 17: S-Shearwave Imaging (2D Shearwave)

510(k) No.:

Device Name: EA2-11AR for use with RS85

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)	N	N	N	N	N	Note 1	Note 9
	Abdominal (See Note 10)	N	N	N	N	N	Note 1	Note 9, 12
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N	N	N	Note 1	Note 9, 12, 16, 17
	Trans-vaginal	N	N	N	N	N	Note 1	Note 9, 12,16
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	N	N	N	N	N	Note 1	Note 9, 12, 16, 17
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+CW, 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: 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 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

510(k) No.:

Device Name: EA2-11AV for use with RS85

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)	N	N	N	N	N	Note 1	Note 9
	Abdominal (See Note 10)	N	N	N	N	N	Note 1	Note 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	N	N	N	N	N	Note 1	Note 9, 12, 16, 17
	Trans-vaginal	N	N	N	N	N	Note 1	Note 9, 12, 16
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	N	N	N	N	N	Note 1	Note 9, 12, 16, 17
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+CW, 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: 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 16: MV-Flow Note 17: S-Shearwave Imaging (2D Shearwave)

510(k) No.:

Device Name: EV2-10A for use with RS85

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)	N	N	N	N	N	Note 1	Note 8, 9
	Abdominal (See Note 10)	N	N	N	N	N	Note 1	Note 8, 9, 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	N	N	N	N	N	Note 1	Note 8, 9, 12
	Trans-vaginal	N	N	N	N	N	Note 1	Note 8, 9, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	N	N	N	N	N	Note 1	Note 8, 9, 12
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, 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
Note 16: MV-Flow Note 17: S-Shearwave Imaging (2D Shearwave)

510(k) No.:

Device Name: PA1-5A for use with RS85

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 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 181336; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, 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
Note 16: MV-Flow Note 17: S-Shearwave Imaging (2D Shearwave)

510(K) Summary: K192903

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date Prepared October 11, 2019 1.
1. Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, REPUBLIC OF KOREA
1. Primary Contact Person Ji Yea Lee Regulatory Affairs Specialist Phone: +82.2.2.2194.1594 Fax: +82.31.8017.9576 Email: jiyea722.lee@samsungmedison.com

Secondary Contact Person Ninad Gujar Director of Regulatory & Quality Phone: +1.978.564.8632 Fax: +1.978.564.8677 Email: ngujar@neurologica.com

1. Proposed Device
  Common Name: Trade/Device Name: Additional Marketing Name: Regulation Name: Panel/ Regulatory Class: Product Code: Regulation No./Product Code Diagnostic Ultrasound System and Accessories RS85 Diagnostic Ultrasound System RS85 Prestige Diagnostic Ultrasound System Ultrasound pulsed Doppler imaging system Radiology / II IYN, IYO, ITX 892.1550, 892.1560, 892.1570
1. Predicate Device
- . Predicates
  - RS85 Diagnostic Ultrasound System (K191115) ; Primary -
  - HERA W10 Diagnostic Ultrasound System (K182595) -
  - HS50/HS60 Diagnostic Ultrasound System (K181336) -
- Reference
  - AIXPLORER & AIXPLORER Ultimate Ultrasound Diagnostic Systems (K173021) -
  - -Fibroscan (K150949)
  - AmCAD-US (K162574) -
1. Device Description

modes.

The RS85 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

1. Indications for Use
  The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids.

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

The Indications for use of the proposed device is same as primary predicate.

1. Technology
  The RS85 employs the similar fundamental scientific technology as its predicate device(s).
1. Determination of Substantial Equivalence
  The proposed RS85 is similar to the predicate devices with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness.

A comparison of the proposed device to the currently marketed predicates is provided in the table below.

RS85	Addition of V2.00 (RS85 Prestige)	Remarks
Clinical
application	• No addition
Operation of
modes	• No addition
Applied
transducers	• LA2-14A
• CA1-7S
• PA1-5A
• EV2-10A
• EA2-11AR
• EA2-11AR	Transducer 510(k)
Clearance LA2-14A NEW CA1-7S NEW PA1-5A K181336 EV2-10A NEW EA2-11AR NEW EA2-11AR NEW
SW Features	• Addition of new S/W feature:
: EzHRI, QUS(TAI, TSI), PureVision
• Addition of predicate S/W features
: ShadowHDR, BiometryAssist, IOTA-ADNEX
• Improvement of cleared S/W feature
: ElastoScan+ Mode(E-Thyroid), MV-Flow Mode,
S-Fusion, S-Shearwave Imaging,
HQ-Vision, Setup&Preference(EzPrep)
• Name change of cleared S/W feature:
: Panoramic → Panoramic+
MV-Index → Vascularity Index	SW Features 510(k)
clearance EzHRI NEW TAI NEW TSI NEW PureVision NEW ShadowHDR, K182595 BiometryAssist K182595 IOTA-ADNEX K182595

RS85	Addition of V2.00 (RS85 Prestige)	Remarks
	NeedleMate → NeedleMate+
HW Features	• Addition of 23.8inch Monitor

| | RS85
(Under Review)
Proposed Device | RS85
(K191115)
Primary Predicate | HERA W10
(K182595)
Predicate | HS50/HS60
(K181336)
Predicate | Note |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Device name | SAMSUNG | SAMSUNG | SAMSUNG | SAMSUNG | |
| Manufacturer | MEDISON. | MEDISON. | MEDISON. | MEDISON. | |
| Regulation No. | 892.1550
892.1560
892.1570 | 892.1550
892.1560
892.1570 | 892.1550
892.1560
892.1570 | 892.1550
892.1560
892.1570 | |
| Product Code | IYN, IYO, ITX | IYN, IYO, ITX | IYN, IYO, ITX | IYN, IYO, ITX | |
| Intended Use | The ultrasound
diagnostic system and
probes are designed to
obtain ultrasound
images and analyze
body fluids. | The ultrasound
diagnostic system and
probes are designed to
obtain ultrasound
images and analyze
body fluids. | The ultrasound
diagnostic system and
probes are designed to
obtain ultrasound
images and analyze
body fluids. | The ultrasound
diagnostic system and
probes are designed to
obtain ultrasound
images and analyze
body fluids. | |
| clinical
Application | - Fetal/Obstetrics

Abdominal
Gynecology
Intra-operative
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-esophageal
(Cardiac)
Muscular-Skeletal
(Conventional,
Superficial)
Urology
Cardiac Adult
Cardiac Pediatric
Peripheral vessel | - Fetal/Obstetrics
Abdominal
Gynecology
Intra-operative
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-esophageal
(Cardiac)
Muscular-Skeletal
(Conventional,
Superficial)
Urology
Cardiac Adult
Cardiac Pediatric
Peripheral vessel | - Fetal/Obstetrics
Abdominal
Gynecology
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Muscular-Skeletal
(Conventional,
Superficial)
Urology
Cardiac Adult
Cardiac Pediatric
Peripheral vessel | - Fetal/Obstetrics
Abdominal
Gynecology
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Muscular-Skeletal
(Conventional,
Superficial)
Urology
Cardiac Adult
Cardiac Pediatric
Peripheral vessel | Same to predicates |
| Scanhead Types | - Linear Array | - Linear Array | - Linear Array | - Linear Array | Same to predicates |
| | RS85
(Under Review) | RS85
(K191115) | HERA W10
(K182595) | HS50/HS60
(K181336) | |
| Device name | Proposed Device | Primary Predicate | Predicate | Predicate | Note |
| | - Curved Linear Array | - Curved Linear Array | - Curved Linear Array | - Curved Linear Array | |
| | - Endocavity | - Endocavity | - Endocavity | - Endocavity | |
| | - Phased Array | - Phased Array | - Phased Array | - Phased Array | |
| | - Static Probes | - Static Probes | - Static Probes | - Static Probes | |
| Scanhead
Frequency | 1.0 ~ 20.0 MHz | 1.0 ~ 20.0 MHz | 1.0 ~ 20.0 MHz | 1.0 ~ 20.0 MHz | |
| Acoustic Output
Display & FDA
Limits | - Display Feature for
Higher Output-
Track3 | - Display Feature for
Higher Output-
Track3 | - Display Feature for
Higher Output-
Track3 | - Display Feature for
Higher Output-
Track3 | |
| | - MI Output Display | - MI Output Display | - MI Output Display | - MI Output Display | |
| | - TI Output Display | - TI Output Display | - TI Output Display | - TI Output Display | |
| Modes of Operation | - B-mode | - B-mode | - B-mode | - B-mode | |
| | - M-mode | - M-mode | - M-mode | - M-mode | |
| | - Pulsed wave (PW)
Doppler | - Pulsed wave (PW)
Doppler | - Pulsed wave (PW)
Doppler | - Pulsed wave (PW)
Doppler | |
| | - Continuous wave
(CW) Doppler | - Continuous wave
(CW) Doppler | - Continuous wave
(CW) Doppler | - Continuous wave
(CW) Doppler | |
| | - Color Doppler | - Color Doppler | - Color Doppler | - Color Doppler | |
| | - Tissue Doppler
Imaging (TDI) | - Tissue Doppler
Imaging (TDI) | - Tissue Doppler
Imaging (TDI) | - Tissue Doppler
Imaging (TDI) | |
| | - Tissue Doppler
Wave (TDW) | - Tissue Doppler Wave
(TDW) | - Tissue Doppler
Wave (TDW) | - Tissue Doppler
Wave (TDW) | |
| | - Power Amplitude
Doppler | - Power Amplitude
Doppler | - Power Amplitude
Doppler | - Power Amplitude
Doppler | |
| | - Pulse Inversion | - Pulse Inversion | - Pulse Inversion | - Pulse Inversion | |
| | - Harmonic Imaging
(S-Harmonic) | - Harmonic Imaging
(S-Harmonic) | - Harmonic Imaging
(S-Harmonic) | - Harmonic Imaging
(S-Harmonic) | |
| | - Directional Power
Doppler (S-Flow) | - Directional Power
Doppler (S-Flow) | - Directional Power
Doppler (S-Flow) | - Directional Power
Doppler (S-Flow) | |
| | - Color M-Mode | - Color M-Mode | - Color M-Mode | - Color M-Mode | |
| | - 3D/4D imaging
mode | - 3D/4D imaging mode | - 3D/4D imaging
mode | - 3D Imaging
Combination mode | |
| | - ElastoScan+ Mode | - ElastoScan+ Mode | - ElastoScan+ Mode | - ElastoScan Mode | |
| | - MV-Flow Mode | - MV-Flow Mode | - MV-Flow Mode | | |
| RS85 Diagnostic Ultrasound System | | | | | Note |
| Device name | RS85
(Under Review)
Proposed Device | RS85
(K191115)
Primary Predicate | HERA W10
(K182595)
Predicate | HS50/HS60
(K181336)
Predicate | |
| | - Combined modes | - Combined modes | - Combined modes | - Combined modes | - |
| #Transmit Channels | 192 | 192 | 192 | 128 | |
| #Receive Channels | 192 | 192 | 192 | 128 | |
| System
Characteristics
: | Beamformer 192 | Beamformer 192 | Beamformer 192 | - Beamformer 128 | |
| | Mobile cart | Mobile cart | Mobile cart | - Mobile cart | |
| | LCD Monitor (LED
Backlight unit):
23inch, 23.8inch | LCD Monitor (LED
Backlight unit):
23inch | LCD Monitor (LED
Backlight unit):
23inch | LCD Monitor (LED
Backlight unit):
21.5inch | SE to predicates
; refer to
018_Electromagne
tic Compatibility
and Electrical
Safety |
| | 256 gray shades on
monitor
100-240VAC,
1100VA,
50/60Hz | 256 gray shades on
monitor
100-240VAC,
1100VA,
50/60Hz | 256 gray shades on
monitor
100-240VAC,
1100VA,
50/60Hz | - 256 gray shades on
monitor
100-240VAC,
1100VA,
50/60Hz | |
| Product Safety
Certification | IEC 60601-1
CSA C22.2 No.601.1
IEC 60601-2-37 | IEC 60601-1
CSA C22.2 No.601.1
IEC 60601-2-37 | IEC 60601-1
CSA C22.2 No.601.1
IEC 60601-2-37 | - IEC 60601-1
CSA C22.2 No.601.1
IEC 60601-2-37 | |
| EMC Compliance | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | - IEC 60601-1-2 | Same to predicates |
| Acoustic Output
Display Standard | Track 3 | Track 3 | Track 3 | - Track 3 | |
| Biocompatibility
Compliance | ISO10993-1 | ISO10993-1 | ISO10993-1 | - ISO10993-1 | |
| Software
Functionality | - Q Scan
ClearVision
MultiVision
Panoramic+ | - Q Scan
ClearVision
MultiVision
Panoramic | - Q Scan
ClearVision
MultiVision
Panoramic | - Q Scan
ClearVision
MultiVision
Panoramic | |
| Device name | RS85
(Under Review)
Proposed Device | RS85
(K191115)
Primary Predicate | HERA W10
(K182595)
Predicate | HS50/HS60
(K181336)
Predicate | Note |
| | - Needle Mate+ | - Needle Mate+ | - Needle Mate+ | - Needle Mate+ | |
| | - AutoIMT+ | - AutoIMT+ | - AutoIMT+ | - AutoIMT+ | |
| | - Strain+ | - Strain+ | | - Strain+ | |
| | - StressEcho | - StressEcho | | - StressEcho | |
| | - E-Strain | - E-Strain | - E-Strain | - E-Strain | |
| | - S-Shearwave | - S-Shearwave | - S-Shearwave | | |
| | - S-Detect for Breast | - S-Detect for Breast | - S-Detect for Breast | - S-Detect for Breast | |
| | - S-Detect for Thyroid | - S-Detect for Thyroid | - S-Detect for Thyroid | - S-Detect for Thyroid | |
| | - S-Fusion | - S-Fusion | | | |
| | - Clear Track | - Clear Track | | | |
| | - Virtual Track | - Virtual Track | | | |
| | - S-3D Arterial
Analysis | - S-3D Arterial
Analysis | - S-3D Arterial
Analysis | | |
| | - ADVR | - ADVR | - ADVR | | |
| | -3D Imaging (Volume
Data Acquisition) | -3D Imaging (Volume
Data Acquisition) | -3D Imaging (Volume
Data Acquisition) | -3D Imaging (Volume
Data Acquisition) | |
| | 3D Imaging
presentation | 3D Imaging
presentation | 3D Imaging
presentation | - 3D Imaging
presentation | Same to predicates |
| | -3D Cine/4D Cine | -3D Cine/4D Cine | -3D Cine/4D Cine | - 3D Cine/4D Cine | |
| | -3D Rendering MPR | -3D Rendering MPR | -3D Rendering MPR | - 3D Rendering MPR | |
| | -3D XI MSV/Oblique
View | -3D XI MSV/Oblique
View | -3D XI MSV/Oblique
View | - 3D XI MSV/Oblique
View | |
| | - Volume CT | - Volume CT | - Volume CT | - Volume CT | |
| | -3D MagiCut | -3D MagiCut | -3D MagiCut | - 3D MagiCut | |
| | -Volume Calculation
(VOCAL, XI
VOCAL) | -Volume Calculation
(VOCAL, XI VOCAL) | -Volume Calculation
(VOCAL, XI
VOCAL) | - Volume Calculation
(VOCAL, XI
VOCAL) | |
| | - XI STIC | - XI STIC | - XI STIC | - XI STIC | |
| | - HDVI | - HDVI | - HDVI | - HDVI | |
| | - RealisticVue | - RealisticVue | - RealisticVue | - RealisticVue | |
| | - NaturalVue | - NaturalVue | - NaturalVue | | |
| RS85 Diagnostic Ultrasound System | | | | | |
| Device name | RS85
(Under Review)
Proposed Device | RS85
(K191115)
Primary Predicate | HERA W10
(K182595)
Predicate | HS50/HS60
(K181336)
Predicate | Note |
| | - CEUS+ | - CEUS+ | - CEUS+ | - CEUS+ | |
| | - MV-Flow | - MV-Flow | - MV-Flow | | |
| | - SonoSync | - SonoSync | | | |
| | - CrystalVue | - CrystalVue | - CrystalVue | - CrystalVue | |
| | - ShadowHDR | | - ShadowHDR | | |
| | - BiometryAssist | | - BiometryAssist | - BiometryAssist | |
| | - IOTA-ADNEX | | - IOTA-ADNEX | | |
| | - ElastoScan+ | - ElastoScan+ | - ElastoScan+ | - ElastoScan+ | Same to predicates |
| | - E-Thyroid | - E-Thyroid | - E-Thyroid | | |
| | - E-Breast | - E-Breast | - E-Breast | | |
| | - S-Shearwave Imaging | - S-Shearwave Imaging | | | |
| | - MV-Flow | - MV-Flow | - MV-Flow | | |
| | - HQ-Vision | - HQ-Vision | - HQ-Vision | - HQ-Vision | |
| | - EzHRI | | | | SE to reference;
refer to SE
Analysis 1 |
| | - TSI | | | | SE to reference;
refer to SE
Analysis 2 |
| | - TAI | | | | SE to reference;
refer to SE
Analysis 3 |
| | - PureVision | | | | SE to reference;
refer to SE
Analysis 4 |
| Transducer | - CA1-7A | - CA1-7A | - CA1-7A | | Same to predicates |
| | - CF4-9 | - CF4-9 | - CF4-9 | - CF4-9 | |
| | - CA2-8A | - CA2-8A | - CA2-8A | | |
| | - CA3-10A | - CA3-10A | - CA3-10A | - CA3-10A | |
| | - E3-12A | - E3-12A | - E3-12A | | |
| RS85 Diagnostic Ultrasound System | | | | | |
| Device name | RS85
(Under Review)
Proposed Device | RS85
(K191115)
Primary Predicate | HERA W10
(K182595)
Predicate | HS50/HS60
(K181336)
Predicate | Note |
| | - L3-12A | - L3-12A | - L3-12A | | |
| | - EA2-11B | - EA2-11B | - EA2-11B | - EA2-11B | |
| | - LA2-9A | - LA2-9A | - LA2-9A | - LA2-9A | |
| | - LA3-16A | - LA3-16A | | - LA3-16A | |
| | - LA3-16AI | - LA3-16AI | | - LA3-16AI | |
| | - LA4-18B | - LA4-18B | - LA4-18B | | |
| | - LM4-15B | - LM4-15B | | | |
| | - PM1-6A | - PM1-6A | - PM1-6A | | |
| | - PA3-8B | - PA3-8B | - PA3-8B | - PA3-8B | |
| | - PA4-12B | - PA4-12B | - PA4-12B | - PA4-12B | |
| | - MMPT3-7 | - MMPT3-7 | - MMPT3-7 | - MMPT3-7 | |
| | - CV1-8A | - CV1-8A | - CV1-8A | | |
| | - V5-9 | - V5-9 | | - V5-9 | |
| | - LV3-14A | - LV3-14A | | | |
| | - CW6.0 | - CW6.0 | - CW6.0 | | |
| | - DP2B | - DP2B | - DP2B | | |
| | - DP8B | - DP8B | - DP8B | | |
| | - EV3-10B | - EV3-10B | - EV3-10B | | |
| | - LA2-14A | | | | SE to predicates;
refer to SE
Analysis 5 |
| | - CA1-7S | | | | SE to predicates;
refer to SE
Analysis 6 |
| | - PA1-5A | | | - PA1-5A | Same to predicate |
| | - EV2-10A | | | | SE to predicates;
refer to SE
Analysis 7 |
| | - EA2-11AR | | | | SE to predicates;
refer to SE
Analysis 8 & note |
| | - EA2-11AV | | | | |
| Compatible
Biopsy Guide | - BP-KIT-029 | - BP-KIT-029 | - BP-KIT-029 | - BP-KIT-029 | Same to predicates |
| | - BP-KIT-030 | - BP-KIT-030 | | | |
| Device name | RS85
(Under Review)
Proposed Device | RS85
(K191115)
Primary Predicate | HERA W10
(K182595)
Predicate | HS50/HS60
(K181336)
Predicate | Note |
| (Biopsy Needle
guide Kit) | BP-KIT-043 | - BP-KIT-043 | - BP-KIT-043 | -BP-KIT-043 | |
| | BP-KIT-053 | - BP-KIT-053 | - BP-KIT-053 | -BP-KIT-053 | |
| | BP-KIT-054 | - BP-KIT-054 | - BP-KIT-054 | -BP-KIT-054 | |
| | BP-KIT-055 | - BP-KIT-055 | | -BP-KIT-055 | |
| | BP-KIT-057 | - BP-KIT-057 | - BP-KIT-057 | | |
| | BP-KIT-058 | - BP-KIT-058 | - BP-KIT-058 | | |
| | BP-KIT-059 | - BP-KIT-059 | - BP-KIT-059 | | |
| | BP-KIT-060 | - BP-KIT-060 | - BP-KIT-060 | - BP-KIT-060 | |
| | BP-KIT-065 | - BP-KIT-065 | - BP-KIT-065 | | |
| | BP-KIT-066 | - BP-KIT-066 | - BP-KIT-066 | | |
| | BP-KIT-067 | - BP-KIT-067 | - BP-KIT-067 | | |
| | BP-KIT-068 | - BP-KIT-068 | | -BP-KIT-068 | |
| | BP-KIT-069 | - BP-KIT-069 | - BP-KIT-069 | | |
| | BP-KIT-071 | - BP-KIT-071 | - BP-KIT-071 | | |
| | BP-KIT-075 | - BP-KIT-075 | - BP-KIT-075 | | |
| | BP-KIT-076 | - BP-KIT-076 | - BP-KIT-076 | | |
| | BP-KIT-077 | - BP-KIT-077 | - BP-KIT-077 | | |
| | BP-KIT-078 | - BP-KIT-078 | - BP-KIT-078 | | |
| | BP-KIT-079 | | | | |
| | BP-KIT-080 | | | | Cleared (K970514) |
| | BP-KIT-081 | | | | Cleared (K875240) |
| | BP-KIT-082 | | | | Cleared (K875128) |
| | BP-KIT-083 | - BP-KIT-083 | | | Cleared (K191115) |
| | BP-KIT-085 | | | | |
| | BP-KIT-086 | | | | |
| | BP-KIT-088 | | | | Cleared (K971722) |
| | BP-KIT-089 | | | | |
| | BP-KIT-090 | | | | |
| | BP-KIT-094 | | | | Cleared (K970514) |
| Digital
Storage/Transfer
Station | - Foot Switch
ECG (defibrillation
proof) | - Foot Switch
ECG (defibrillation
proof) | - Foot Switch
ECG (defibrillation
proof) | - Foot Switch
ECG (defibrillation
proof) | Same to predicates |
| Device name | RS85
(Under Review)
Proposed Device | RS85
(K191115)
Primary Predicate | HERA W10
(K182595)
Predicate | HS50/HS60
(K181336)
Predicate | Note |
| | - Gel Warmer | - Gel Warmer | - Gel Warmer | - Gel Warmer | |
| | - Clear Track/ Virtual
Track | - Clear Track/ Virtual
Track | - Clear Track/ Virtual
Track | - Clear Track/ Virtual
Track | |
| | System Stand | System Stand | System Stand | System Stand | |
| | WLAN Card | - WLAN Card | - WLAN Card | - WLAN Card | |

510(k) Summary

RS85 Diagnostic Ultrasound S10(k)
RS85 Diagnostic Ultrasound System

510(k) Summary

RS85 Diagnostic Ultrasound System

510(k) Summary

Section 6. Page 9/12

RS85 Diagnostic Ultrasound S10(k)
RS85 Diagnostic Ultrasound System

510(k) Summary

Traditional 510(k) RS85 Diagnostic Ultrasound System

10. Summary of Non-Clinical Test

Test	Standards and FDA Guidance
Risk Management	ISO 14971 Second edition 2007 Medical devices - Application of risk management to medical devices
Electrical Safety	The RS85 Ultrasound System with defibrillation-proof ECG electrode was evaluated per the
following standards.
	ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010 /(R)2012
Medical Electrical Equipment - Part 1: General Requirements for basic safety and essential
performance.
Electromagnetic
Compatibility	IEC60601-1-2: 2014(4th Edition) Medical Electrical Equipment -- Part 1-2: General Requirements
For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances --
Requirements And Tests
Biocompatibility	ISO 10993-1 Fourth edition 2009-10-15 Biological evaluation of medical devices - Part 1: Evaluation
and testing within a risk management process.
Reprocessing
Medical Devices	FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and
Labeling issued on March 17, 2015, revised June 9, 2017.
Software/Firmware-
driven
Functionality	All migrated software functionality was evaluated using the same test criteria as the predicate for all
applicable imaging modes to ensure that migration into a new system design did not compromise
image quality with respect to the intended use of each feature.

| | Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
issued on May 11, 2005 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------|
| Ultrasound Safety | Information for Manufacturers Seeking Marketing Clearance of |
| | Diagnostic Ultrasound Systems and Transducers issued September 9, 2008 |
| | IEC60601-2-37:2007 + A1:2015, Particular requirements for the safety of ultrasonic medical |
| | diagnostic and monitoring equipment |
| | NEMA UD 2-2004 (R2009) |
| | Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 |

11. Summary of Clinical Tests

The subject of this premarket submission, RS85, did not require clinical studies to support substantial equivalence.

12. Conclusion

SAMSUNG MEDISON considers the RSS5 to be as safe, as effective, and performance is substantially equivalent to the predicate device.