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
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K171048 , K171070 , K132274 , K163691
• Predicate For: K181336 , K182595 , K182932

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the SAMSUNG MEDISON CO., LTD. RS85 Diagnostic Ultrasound System, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed clinical study report with specific acceptance criteria and performance metrics for the new device itself. As such, direct numerical acceptance criteria for performance (e.g., sensitivity, specificity) and a study proving the device meets those specific performance acceptance criteria are not explicitly stated in this document. Instead, the document relies on the equivalence of the RS85 to existing cleared devices and compliance with relevant standards.

Therefore, the tables below will reflect what is inferable from the document, which primarily focuses on demonstrating equivalence rather than establishing new performance benchmarks.

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1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence and Standards)	Reported Device Performance (as stated or implied)
Intended Use: Consistent with diagnostic ultrasound imaging and fluid flow analysis of the human body for specified clinical applications.	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. 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.
Technological Characteristics: Employs the same fundamental scientific technology as predicate devices.	The RS85 employs the same fundamental scientific technology as its predicate device(s).
Imaging Modes: Same as predicate RS80A systems, with the exception of MV-Flow and S-Shearwave Imaging deemed substantially equivalent to relevant predicates.	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), and S-Shearwave Imaging which is substantially equivalent to Samsung Medison RS80A (K171048) and SuperSonic Imagine Aixplorer (K132274).
Transducers: Identical to predicates RS80A, WS80A, HS70A systems.	The RS85 and predicates RS80A, WS80A, HS70A systems transducers are identical.
Materials: Evaluated and found to be safe for the intended use.	The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
Acoustic Power Levels: Below applicable FDA limits.	The systems have acoustic power levels which are below the applicable FDA limits.
Capability: Similar measurements, digital image capturing, reviewing, and reporting to predicate RS80A systems.	The RS85 and predicate RS80A systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
Safety and Performance Standards: Compliance with electrical, physical safety standards, and various IEC, ISO, and NEMA standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, NEMA UD 2-2004, NEMA UD 3-2004).	The RS85 and predicate systems have been designed in compliance with approved electrical and physical safety standards. 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 (listed in the document).
Quality Process: Conformance with 21 CFR 820 and ISO 13485.	The design, development and quality process of the manufacturer conforms with 21 CFR 820 and ISO 13485.

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Study Proving Acceptance Criteria:

The document clearly states:

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

This indicates that no dedicated clinical study was performed with the RS85 device to prove specific performance acceptance criteria in human patients. Instead, the FDA clearance for this device, a 510(k), is based on demonstrating substantial equivalence to already legally marketed predicate devices. The arguments for substantial equivalence are based on:

• Similar intended uses.
• Similar technological characteristics.
• Similar imaging capabilities and modes (with new features shown to be equivalent to features in existing cleared devices).
• Compliance with recognized performance standards (acoustic output, biocompatibility, electrical safety, etc.).

Therefore, the following points address the questions based on this underlying premise of substantial equivalence, rather than a new performance study:

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable, as no dedicated clinical test set from human subjects was used for a performance study. Non-clinical testing would have involved engineering samples and simulated environments.
• Data Provenance: Not applicable for a clinical test set. The data presented relates to engineering and bench testing, and comparisons to legally marketed predicate devices (K171048, K171070, K132274, K163691).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable, as no clinical test set requiring expert ground truth establishment for performance evaluation was conducted.

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

• Not applicable, as no clinical test set requiring adjudication was conducted.

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

• No MRMC comparative effectiveness study was done or reported in this 510(k) summary. The device is a diagnostic ultrasound system, and while it may incorporate advanced features, it is presented as substantially equivalent to existing non-AI predicate devices in its fundamental technology and clinical applications. There is no mention of AI assistance for human readers or any associated effect sizes.

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

• Not applicable. The RS85 is a diagnostic ultrasound system, not an AI-driven algorithm intended for standalone performance evaluation without human-in-the-loop. Its performance is assessed through its output in imaging modes.

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

• For the non-clinical tests (acoustic output, biocompatibility, safety standards), the "ground truth" would be the specifications and requirements of the referenced standards (e.g., IEC 60601-1, NEMA UD 2-2004). For demonstrating substantial equivalence, the "ground truth" is established by the performance and safety profiles of the legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. This document does not describe the development or training of an AI algorithm necessitating a training set. The device is a traditional ultrasound system.

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

• Not applicable, as no training set for an AI algorithm is mentioned in this submission.

Summary

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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.

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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

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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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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	ColorDoppler*	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
PeripheralVessel	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

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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	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Notes 2,4,7,8,9,11,14
	Abdominal (See Note 10)	P	P	P		P	Note 1	Notes 2,6,7,8,9,11,14,15
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	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.)
PeripheralVessel	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

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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	ColorDoppler*	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.)
PeripheralVessel	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

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

N= new indication; P= previously cleared by FDA 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

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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	ColorDoppler*	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.)
PeripheralVessel	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

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

N= new indication; P= previously cleared by FDA 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	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Note 2, 7, 8, 9
	Abdominal (See Note 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	ColorDoppler*	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.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Other (spec.)

N=new indication; P= previously cleared by FDA 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	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 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.)
	PeripheralVessel	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	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)	P	P	P		P	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.)
PeripheralVessel	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	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)	P	P	P	P	P	Note 1	Note 2, 5, 6, 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.)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 14
	Other (spec.)

N= new indication; P= previously cleared by FDA 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	ColorDoppler*	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.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA 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	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	Note 1	Note 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult	P	P	P	P	P	Note 1	Note 4, 7
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA 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	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	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.)
PeripheralVessel	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	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	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.)
PeripheralVessel	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	ColorDoppler*	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.)
PeripheralVessel	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	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P	P	P	Note 1	Note 2, 4, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 2, 4, 7, 8, 9
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	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	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P	P	P	Note 1	Note 2, 7, 8, 9
	Abdominal (See Note 10)	P	P	P	P	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.)
PeripheralVessel	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	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)	P	P	P	P	P	Note 1	Note 2, 5, 6, 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.)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Other (spec.)

N=new indication; P= previously cleared by FDA 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	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult				P
	Cardiac Pediatric				P
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel				P
	Other (spec.)

N= new indication; P= previously cleared by 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	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 12)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging&Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult				P
	Cardiac Pediatric				P
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel				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	ColorDoppler*	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.)
PeripheralVessel	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 andA2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2	AAMI / ANSI / IEC 60601-1-2:2007(R)2012, Medical electrical equipment - Part 1-2:General requirements for basic safety and essential performance – Collateral standard:Electromagnetic compatibility - Requirements and tests (Edition 3)
IEC 60601-2-37	IEC 60601-2-37:2007 Edition 2.0 2007-08, Medical electrical equipment - Part 2-37:Particular requirements for the basic safety and essential performance of ultrasonicmedical diagnostic and monitoring equipment
ISO10993-1	AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process
ISO14971	ISO 14971:2007, Medical devices - Application of risk management to medical devices
NEMA UD 2-2004	NEMA UD 2-2004 (R2009)Acoustic Output Measurement Standard for Diagnostic Ultrasound EquipmentRevision 3
NEMA UD 3-2004	NEMA UD 3-2004 (R2009)Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indiceson Diagnostic Ultrasound Equipment, Revision 2

{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

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.