RS85 Diagnostic Ultrasound System

• K Number: K173204
• Device Name: RS85 Diagnostic Ultrasound System
• Manufacturer: Samsung Medison Co., Ltd
• Date Cleared: 2018-02-05 ( 126 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 fluid. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative, 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.

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 B mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode: S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging, Tissue Doppler Wave, 3D imaging mode (real time 4D imaging mode), Elastoscan 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 is used to make 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.

Predicate Devices

K171048, K171070, K132274, K163691

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard ultrasound imaging modes and analysis packages.

Therapeutic

No
The device is described as a "diagnostic ultrasound system" used to "obtain ultrasound images and analyze body fluid," and to create "analysis packages that provide information that is used to make a diagnosis." It is not described as providing treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" section states: "The ultrasound diagnostic system..." and the "Device Description" section also clearly states: "The RS85 is a general purpose, mobile, software controlled, diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "diagnostic ultrasound system" and mentions "probes," which are hardware components essential for acquiring ultrasound data. The performance studies also evaluate hardware-related aspects like acoustic output, biocompatibility, and safety standards.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The description clearly states that the device is an "ultrasound diagnostic system and probes" designed to "obtain ultrasound images and analyze body fluid." While it mentions analyzing body fluid, the primary function described is obtaining and displaying ultrasound images of internal anatomical structures.
• Clinical Applications: The listed clinical applications are all related to imaging internal organs and structures using ultrasound technology. These are not typical applications for IVD devices.
• Lack of IVD-Specific Information: The description does not mention any specific tests performed on biological samples, reagents used, or analytical methods commonly associated with IVD devices.

The device is a diagnostic imaging system that uses ultrasound to visualize internal structures, which is distinct from the function of an IVD device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluid. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative, 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 RS85 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.

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

IYN, IYO, ITX

Device Description

The RS85 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode: S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging, Tissue Doppler Wave, 3D imaging mode (real time 4D imaging mode), Elastoscan 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 is used to make 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, Intraoperative, 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.

Indicated Patient Age Range

Adult, pediatric and neonatal patients (in context of Small Organ imaging).

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

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.

K171048, K171070, K132274, K163691

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

Not Found

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

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

February 5, 2018

Re: K173204

Trade/Device Name: RS85 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 29, 2018 Received: February 01, 2018

Dear Ji Yea Lee:

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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

1

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone

(1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

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

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K173204

Device Name RS85 Diagnostic Ultrasound System

Indications for Use (Describe)

The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluid. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative, 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.

Image /page/2/Picture/7 description: The image shows the word "SAMSUNG" in a light blue color. The letters are large and spaced out evenly. The background is white, which makes the light blue letters stand out.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (7/17)

Page 1 of 1

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

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+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C

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

Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

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

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

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

4

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	Note 1	Notes 2,4,7,8,9,11,14
	Abdominal (See Note 10)	P	P	P		P	Note 1	Notes 2,6,7,8,9,11,14,15
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	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 K171070, K171048, K163691; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 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 2: Includes imaging for guidance of biopsy

5

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	Note 1	Notes 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 7, 8, 9, 11
	Small Organ (See Note 5)
	Neonatal Cephalic	P	P	P		P	Note 1	Notes 7, 8, 9, 11
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note 1	Notes 8, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K171070, K171048, K163691; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

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

Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

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

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

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

6

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	Note 1	Notes 2, 4, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P		P	Note 1	Notes 2, 4, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K171070, K171048, K163691; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

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

• Note 4: Color M-mode
  Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

• Note 6: Abdominal organs and peripheral vessel

• Note 7: Tissue Harmonic Imaging (THI)

• Note 8: 3D imaging

• Note 9: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis

• Note 11: Panoramic imaging

• Note 12: ElastoScan

• Note 13: Includes Urology/Prostate

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

7

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	Note 1	Notes 2, 3, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K171070, K171048, K163691; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

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

• Note 4: Color M-mode
  Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

• Note 6: Abdominal organs and peripheral vessel

• Note 7: Tissue Harmonic Imaging (THI)

• Note 8: 3D imaging

• Note 9: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis

• Note 11: Panoramic imaging

• Note 12: ElastoScan

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

• Note 15: S-Shearwave

8

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
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 12
	Trans-vaginal	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 12
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K171070, K171048, K163691; 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+PPH+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-Shearwave

Note 2: Includes imaging for guidance of biopsv

9

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	Specific	B	M	PWD	CWD	Color	Combined*	Other
(Track I only)	(Tracks I & III)					Doppler*	(Spec.)	(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	Laparoscopic
&
Other	Pediatric
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 12, 14
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	b		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 14
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 14
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	b		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 14
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K171070, K171048, K163691; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 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 2: Includes imaging for guidance of biopsy

10

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	Note 1	Note 2, 7, 8, 9
	Abdominal (See Note 12)	b	P	P		P	Note 1	Note 2, 6, 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	Note 1	Note 2, 7, 8, 9, 12
	Trans-vaginal	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	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 K171070, K163691; 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+ID, B+CV, B+C+PW, B+PD+PW, B+PPH+W, B+PPH+PW, B+ID+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

11

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 Imaging
& Other	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.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11,12,15
	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, 11,12,15
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11,12,15
	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, 8, 9, 11
	Other (spec.)

N=new indication; P= previously cleared by FDA K171070, K171048, K163691; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

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

Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

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

12

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	P	Note 1	Note 2, 5, 6, 7, 9, 11, 12
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 9, 11
	Musculo-skel. (Superfic.)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 9, 11
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
	Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	Note 1
Other (spec.)

N=new indication; P= previously cleared by FDA K171070, K171048, K163691; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

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

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

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

• Note 8: 3D imaging
  Note 9: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis

• Note 11: Panoramic imaging

• Note 12: ElastoScan

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

Note 15: S-Shearwave

13

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	Note 1	Note 7, 9, 11
	Intra-operative (Neuro.)	P	P	P		P	Note 1	Note 7, 9, 11
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 7, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 7, 9, 11
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note 1	Note 7, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K171070, K171048, K163691; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

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

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

• Note 6: Abdominal organs and peripheral vessel

• Note 7: Tissue Harmonic Imaging (THI)

• Note 8: 3D imaging

• Note 9: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis

• Note 11: Panoramic imaging

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

• Note 14: S-Fusion

• Note 15: S-Shearwave

14

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)
	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, 14
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 14
	Musculo-skel. (Superfic.)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 14
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 14
	Other (spec.)

N= new indication; P= previously cleared by FDA K171070, K171048, K163691; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

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

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

• Note 6: Abdominal organs and peripheral vessel

• Note 7: Tissue Harmonic Imaging (THI)

• Note 8: 3D imaging

• Note 9: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis

• Note 11: Panoramic imaging

• Note 12: ElastoScan

• Note 13: Includes Urology/Prostate

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

15

510(k) No.: K162094 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)	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
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 12
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K171070, K171048; E=added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

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

• Note 4: Color M-mode
  Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

• Note 6: Abdominal organs and peripheral vessel

• Note 7: Tissue Harmonic Imaging (THI)

• Note 8: 3D imaging

• Note 9: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis

• Note 11: Panoramic imaging

• Note 12: ElastoScan

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

• Note 15: S-Shearwave

16

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 K171070, K171048; E=added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

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

Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

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

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

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

17

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	N	N	N	N	N	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	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 K171070, K171048, K163691; 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+ID, B+CV, B+C+PW, B+PD+PW, B+PPH+W, B+PPH+PW, B+ID+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

18

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 Imaging
& Other	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Note 7
	Small Organ (See Note 5)
	Neonatal Cephalic	N	N	N	N	N	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 K171070, K171048, K163691; 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+CV, B+C+PW, B+PD+PW, B+PPI+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C

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

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

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

19

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 Imaging
& Other	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 12)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) (See Note 13)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)	P	P	P	P	P	Note 1	Note 4, 7
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K171048, K163691; E=added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

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

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

• Note 6: Abdominal organs and peripheral vessel

• Note 7: Tissue Harmonic Imaging (THI)

• Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

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

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

20

510(k) No.:

Device Name: 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
	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 K171070, K171048, K163691; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

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

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

• Note 6: Abdominal organs and peripheral vessel

• Note 7: Tissue Harmonic Imaging (THI)

• Note 8: 3D imaging

• Note 9: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis

• Note 11: Panoramic imaging

• Note 12: ElastoScan

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

• Note 15: S-Shearwave

21

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
& 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 K171070, K171048, K163691; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

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

Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

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

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

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

22

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/Obstetrics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Musculo-skel. (Superfic.)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
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 K171070, K171048, K163691; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

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

Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

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

23

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 K171048, K163691; E=added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

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

Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

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

Note 11: Panoramic imaging

Note 12: ElastoScan

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

Note 15: S-Shearwave

24

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	Specific	B	M	PWD	CWD	Color	Combined*	Other
(Track I only)	(Tracks I & III)					Doppler*	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ (See Note 5)
	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	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K171048, K163691; E=added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

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

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

• Note 6: Abdominal organs and peripheral vessel

• Note 7: Tissue Harmonic Imaging (THI)

• Note 8: 3D imaging

• Note 9: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis

• Note 11: Panoramic imaging

• Note 12: ElastoScan

• Note 13: Includes Urology/Prostate

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

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

25

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	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 K163691; 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+ID, B+CV, B+C+PW, B+PD+PW, B+PPH+W, B+PPH+PW, B+ID+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

26

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
& 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, 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
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K171070; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

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

• Note 4: Color M-mode
  Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

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

• Note 8: 3D imaging
  Note 9: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis

• Note 11: Panoramic imaging

• Note 12: ElastoScan

• Note 13: Includes Urology/Prostate

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

27

6. 510(K) Summary

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

• Date Prepared September 28, 2017 1.
• 2. Manufacturer SAMSUNG MEDISON CO., LTD. 42, Teheran-ro 108-gil, Gangnam-gu, Seoul, Korea
• 3. Primary Contact Person Ji Yea Lee Regulatory Affairs Specialist Phone: [phone] Fax: [phone] Email: [e-mail]
• 4. Secondary Contact Person Ninad Gujar Director of Regulatory & Quality Phone: [phone] Email: [e-mail]
• Proposed Device 5.
  • Common/Usual Name: Diagnostic Ultrasound System and Accessories
  • Proprietary Name: RS85 Diagnostic Ultrasound System
  • Common Name: Diagnostic Ultrasound System
  • Classification Names: system, imaging, pulsed doppler, ultrasonic
  • Product Code: IYN, IYO, ITX
  • Regulation: 892.1550
• Predicate Device 6.
  • RS80A Diagnostic Ultrasound System (K171048) -
  • WS80A Diagnostic Ultrasound System (K171070) ।
  • Aixplorer® Diagnostic Ultrasound System (K132274) -
  • HS70A Diagnostic Ultrasound System (K163691) -
• 7. 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 B mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode: S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging, Tissue Doppler Wave, 3D imaging mode (real time 4D imaging mode), Elastoscan 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 is used to make 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.

• 8. Intended Uses
     The RS85 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal/Obstetrics, Abdominal,

28

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

9. Technology

The RS85 employs the same fundamental scientific technology as its predicate device(s).

10. Determination of Substantial Equivalence

Comparison to Predicates: The RS85 is substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness,

• The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis. ●
• The RS85 and predicates RS80A systems have the same clinical intended use. .
• . The RS85 and predicates RS80A systems have the same imaging modes with the exception of MV-Flow which is substantially equivalent to Samsung Medison RS80A (K171048).
• . The RS85 and predicates RS80A systems have the same imaging modes with the exception of S-Shearwave Imaging which is substantially equivalent to Samsung Medison RS80A (K171048). And SuperSonic Imagine Aixplorer (K132274).
• The RS85 and predicates RS80A, WS80A, HS70A systems transducers are identical.
• The systems are manufactured with materials which have been evaluated and found to be safe . for the intended use of the device.
• . The systems have acoustic power levels which are below the applicable FDA limits.
• . The RS85 and predicate RS80A systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
• The RS85 and predicate systems have been designed in compliance with approved electrical and physical safety standards.

11. Summary of Non-Clinical Test

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, 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.

Reference No.	Title
IEC 60601-1	AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and
A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2	AAMI / ANSI / IEC 60601-1-2:2007(R)2012, Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential performance – Collateral standard:
Electromagnetic compatibility - Requirements and tests (Edition 3)
IEC 60601-2-37	IEC 60601-2-37:2007 Edition 2.0 2007-08, Medical electrical equipment - Part 2-37:
Particular requirements for the basic safety and essential performance of ultrasonic
medical diagnostic and monitoring equipment
ISO10993-1	AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices

• Part 1: Evaluation and testing within a risk management process |
  | ISO14971 | ISO 14971:2007, Medical devices - Application of risk management to medical devices |
  | NEMA UD 2-2004 | NEMA UD 2-2004 (R2009)
  Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
  Revision 3 |
  | NEMA UD 3-2004 | NEMA UD 3-2004 (R2009)
  Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices
  on Diagnostic Ultrasound Equipment, Revision 2 |

29

12. Summary of Clinical Tests

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

• 13. Conclusion
      Intended uses and other key features are consistent with traditional clinical practices and FDA guidelines. The design, development and quality process of the manufacturer confirms with 21 CFR 820 and ISO 13485. The device is designed to conform to applicable medical device safety standards and compliance. Therefore, SAMSUNG MEDISON CO., LTD. considers the RS85 to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

END of 510(K) Summary