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

Device Description

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

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Samsung Medison Co., Ltd. RS85 Diagnostic Ultrasound System.

Important Note: The provided document is a 510(k) summary, which is a premarket notification to the FDA. It declares substantial equivalence to previously cleared devices. Therefore, it primarily compares the new device to predicates rather than presenting de novo acceptance criteria and extensive clinical trial data as might be found in a PMA (Premarket Approval) submission for a novel device or an AI breakthrough.

The document explicitly states: "The subject of this premarket submission, RS85, did not require clinical studies to support substantial equivalence." This means that acceptance criteria for the device's performance in a clinical setting (e.g., diagnostic accuracy) are not detailed within this particular submission. The "acceptance criteria" presented below are inferred from the substantial equivalence claim and the comparison to predicate devices, focusing on technical and functional equivalence rather than clinical performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" largely revolve around demonstrating the new device is functionally, technologically, and safely equivalent to existing cleared devices. The reported device performance is implicitly "meets or is similar to" the predicate devices.

Feature/Criterion	Acceptance Criteria (Implied from Substantial Equivalence)	Reported Device Performance (Implicitly "Met")	Notes
Intended Use	Same as predicate devices	Same as predicate devices	"The Indications for use of the proposed device is same as primary predicate."
Clinical Applications	Same as predicate devices	Same as predicate devices	Listed applications are identical to primary predicate (K191115). New (N) or previously cleared (P) status for specific transducers indicates equivalence to other predicates or prior clearances.
Modes of Operation	Same as predicate devices	Same as predicate devices	All listed modes (B, M, PWD, CWD, Color Doppler, Combined, Other) are present and equivalent to primary predicate.
Scanhead Types	Same types and functionality as predicate devices	Same types and functionality as predicate devices	Linear Array, Curved Linear Array, Endocavity, Phased Array, Static Probes.
Scanhead Frequency	Within range of predicate devices (1.0 ~ 20.0 MHz)	1.0 ~ 20.0 MHz	Identical to predicate devices.
Acoustic Output Display & FDA Limits	Conform to recognized standards (Track 3) and display MI/TI	- Display Feature for Higher Output- Track3 - MI Output Display - TI Output Display	Identical to predicate devices.
Electrical Safety	Conform to ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010 /(R)2012 and IEC 60601-2-37	RS85 evaluated per these standards.	Explicitly stated compliance.
Electromagnetic Compatibility	Conform to IEC60601-1-2: 2014 (4th Edition)	IEC60601-1-2: 2014 (4th Edition)	Explicitly stated compliance.
Biocompatibility	Conform to ISO 10993-1 Fourth edition 2009-10-15	ISO 10993-1 Fourth edition 2009-10-15	Explicitly stated compliance.
Reprocessing Medical Devices	Conform to FDA Guidance issued March 17, 2015, revised June 9, 2017	Evaluated per guidance	Explicitly stated compliance.
Software/Firmware-driven Functionality	Evaluated using same criteria as predicate for image quality	Evaluated for migration into new system design.	"All migrated software functionality was evaluated using the same test criteria as the predicate for all applicable imaging modes to ensure that migration into a new system design did not compromise image quality..."
Ultrasound Safety (Acoustic Output Measurement)	Conform to IEC60601-2-37:2007 + A1:2015 and NEMA UD 2-2004 (R2009)	IEC60601-2-37:2007 + A1:2015, NEMA UD 2-2004 (R2009)	Explicitly stated compliance.
System Characteristics (Channels, Monitor, Power)	Similar to predicate devices	192 Transmit/Receive Channels, 23.8inch (new) / 23inch monitor, 256 gray shades, 100-240VAC, 1100VA, 50/60Hz	Comparison table shows equivalency or slight improvements (e.g., 23.8-inch monitor) that do not alter fundamental safety or effectiveness.
Specific Software Features	Functionally equivalent to corresponding features on predicate/reference devices	New features (EzHRI, QUS, PureVision), predicate features (ShadowHDR, BiometryAssist, IOTA-ADNEX) added, improved features (ElastoScan+ Mode, MV-Flow Mode, S-Fusion, S-Shearwave Imaging, HQ-Vision, Setup&Preference), and name changes (Panoramic -> Panoramic+, MV-Index -> Vascularity Index, NeedleMate -> NeedleMate+)	This implies the new/changed features were tested to ensure they function as intended and do not negatively impact safety or effectiveness compared to predicates they are similar to.
Transducers	Functionally equivalent to previously cleared transducers	Various new (N) and previously cleared (P) transducers listed (e.g., LA2-14A, CA1-7S, PA1-5A, EV2-10A, EA2-11AR, EA2-11AV, EV2-10A) with specific indications.	Each transducer is compared to predicate transducers for substantial equivalence. "SE to predicates; refer to SE Analysis X" indicates supporting data.
Biopsy Guides	Compatible and functionally equivalent to predicate devices	BP-KIT-029 etc. (various models)	Same or functionally equivalent to predicate devices.

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

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

Therefore:

Sample size for test set: Not applicable (no clinical test set as part of this submission for substantial equivalence). The evaluation focused on engineering, software verification, and validation tests comparing the new system to already cleared devices.
Data provenance: Not applicable for clinical data. The comparability data for components and technical specifications are likely derived from internal testing and validation processes by Samsung Medison (South Korea) against industry standards and predicate device specifications.

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

Given the statement that clinical studies were not required, there is no mention of external experts establishing a clinical "ground truth" for a test set in this submission. The "ground truth" for technical and functional validation would be against established engineering specifications, performance standards, and comparison with predicate device outputs. This would involve internal engineering and quality assurance teams.

4. Adjudication Method for the Test Set

Not applicable, as no external clinical test set requiring adjudication by experts is described in this submission.

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

The document explicitly states: "The subject of this premarket submission, RS85, did not require clinical studies to support substantial equivalence." Furthermore, while the device includes new software features like "EzHRI, QUS(TAI, TSI), PureVision" and improvements to "ElastoScan+ Mode, MV-Flow Mode, S-Fusion, S-Shearwave Imaging", these are presented as enhancements or new capabilities whose safety and efficacy are demonstrated through technical equivalence to existing cleared features or algorithms, not through a comparative effectiveness study involving human readers and AI assistance. Therefore, no MRMC study or effect size for AI assistance is reported here.

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

The document doesn't provide specific details on standalone algorithm performance for features like EzHRI, QUS (TAI, TSI), PureVision, ElastoScan+, MV-Flow, S-Fusion, S-Shearwave Imaging, or BiometryAssist. The submission focuses on demonstrating that these software features (whether new or improved) are substantially equivalent to functions on predicate devices or previously cleared equivalents, or meet established performance criteria during internal testing. It implies that these features are integrated into the diagnostic ultrasound system, functioning as tools for a human operator, rather than performing as a standalone diagnostic algorithm.

7. The Type of Ground Truth Used

For this 510(k) submission, the "ground truth" is primarily based on:

Technical and functional specifications: Adherence to established engineering parameters, performance metrics, and compliance with national and international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, NEMA UD 2).
Comparison to predicate devices: The functionality and safety characteristics of the RS85 (including its new and revised features) are demonstrated to be substantially equivalent to those of the predicate devices (RS85 K191115, HERA W10 K182595, HS50/HS60 K181336, and other reference devices like AIXPLORER K173021, Fibroscan K150949, AmCAD-US K162574). This means the performance of the predicate devices implicitly serves as a "ground truth" for what is acceptable.

There is no mention of pathology, expert consensus on clinical cases, or outcomes data as a "ground truth" within this 510(k) summary, as it explicitly states no clinical studies were required.

8. The Sample Size for the Training Set

Not applicable. As no clinical studies were performed, there is no mention of a clinical training set for any AI/software features. If any internal machine learning models are used within the software features (e.g., BiometryAssist, S-Detect), the details of their training data are not provided in this 510(k) summary. The submission focuses on the output of these features being equivalent to predicate devices or meeting internal specifications.

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

Not applicable, as no clinical training set is described in this document.

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

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

January 6, 2020

Re: K192903

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

Dear Ji Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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

Sincerely,

For

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K192903

Device Name RS85 Diagnostic Ultrasound System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) No.:

Device Name: RS85 Diagnostic Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Notes 2, 3, 4, 7, 8, 9, 11, 14
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Notes 2, 4, 5, 6, 7, 8, 9, 11, 12, 14, 15
	Intra-operative (See Note 6)	P	P	P		P	Note 1	Note 7, 9, 11
	Intra-operative (Neuro.)	P	P	P		P	Note 1	Note 7, 9, 11
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 11
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 12, 14, 15
	Neonatal Cephalic	P	P	P		P	Note 1	Notes 8, 9, 11, 16
	Adult Cephalic	P	P	P	P	P	Note 1	Notes 7
	Trans-rectal	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11, 12, 16, 17
	Trans-vaginal	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11, 12, 16
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 12, 14. 16, 17
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 12, 14, 16, 17
	Intra-luminal
	Other (See Note 13)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 12, 16
	Cardiac Adult	P	P	P	P	P	Note 1	Notes 4, 7
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Notes 4, 7
	Trans-esophageal (Cardiac)	P	P	P	P	P	Note 1	Notes 4, 7
	Other (spec.)
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; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Spatial Compound Imaging

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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	P	Note 1	Notes 2, 4, 7, 8, 9, 11, 14
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Notes 2,6,7,8,9,10,11,14,15,16,17
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Notes 2, 6, 7, 8, 9, 11, 14
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P	P	P	Note 1	Notes 2, 6, 7, 8, 9, 11, 14
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	P	P	P	P	P	Note 1	Notes 2, 6, 7, 8, 9, 11, 14
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	Note 1	Notes 2,6, 7, 8, 9, 11, 14
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

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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	P	Note 1	Notes 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Notes 7, 8, 9, 11
	Small Organ (See Note 5)
	Neonatal Cephalic	P	P	P	P	P	Note 1	Notes 7, 8, 9, 11, 16
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	Note 1	Notes 8, 9, 11
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

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

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow Note 17: S-Shearwave Imaging (2D Shearwave)

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

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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	P	Note 1	Notes 2, 3, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 10, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 11, 16
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 11
	Musculo-skel. (Superfic.)	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 11
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 11
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

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

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow Note 17: S-Shearwave Imaging (2D Shearwave)

{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(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 14
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 12, 14,16
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 14,16
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 14,16
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 14
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

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

Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion

Note 15: S-Shearwave

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

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

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

510(k) No.:

Device Name: EA2-11B for use with RS85

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	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 12)	P	P	P		P	Note 1	Note 2, 6, 7, 8, 9, 12
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 12
	Trans-vaginal	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 12
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwaye
Note 16: MV-Flow

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

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

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

510(k) No.:

Device Name: LA2-9A for use with RS85

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11,12,15,17
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11,12,15,17
	Musculo-skel. (Superfic.)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11,12,15,17
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
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 K191115; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel

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

Note 9: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging

Note 12: ElastoScan

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

Note 15: S-Shearwaye

Note 16: MV-Flow

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

Note 2: Includes imaging for guidance of biopsy

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

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

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

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

{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)	N	N	N		N	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	N	N	N		N	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 12, 14,16
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2,5,6,7,8,9,11,14,16
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2,5,6,7,8,9,11,14,16
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 14
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

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

510(k) No.:

Device Name: LM4-15B for use with RS85

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	N	N	N	N	N	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2,5,6,7,8, 9,11,12,16
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
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 K191115; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

{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 K191115; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

{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	P	P	P	P	P	Note 1	Note 7
	Adult Cephalic	P	P	P	P	P	Note 1	Note 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult	P	P	P	P	P	Note 1	Note 4, 7
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

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

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

Note 7: Tissue Harmonic Imaging (THI)

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

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

{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, 10
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

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

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

{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 Imaging& Other	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Musculo-skel. (Superfic.)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
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 K191115; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

{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 K191115; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

Note 7: Tissue Harmonic Imaging (THI)

{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(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult				P
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

{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 Adult				P
Cardiac	Cardiac Pediatric				P
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel				P
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow Note 17: S-Shearwave Imaging (2D Shearwave)

{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	Laparoscopic
&Other	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 11, 12
	Trans-vaginal	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 11, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	P	P	P	P	P	Note 1	Note 2, 7, 8, 9, 11, 12
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow Note 17: S-Shearwave Imaging (2D Shearwave)

Note 7: Tissue Harmonic Imaging (THI)

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

510(k) No.:

Device Name: LA2-14A for use with RS85

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	N	N	N	N	N	Note 1	Notes 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
&Other	Pediatric	N	N	N	N	N	Note 1	Notes 7, 8, 9, 11
	Small Organ (See Note 5)	N	N	N	N	N	Note 1	Notes 7, 8, 9, 11,12,16,17
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	N	N	N	N	N	Note 1	Notes 7, 8, 9, 11,12,16,17
	Musculo-skel. (Superfic.)	N	N	N	N	N	Note 1	Notes 7, 8, 9, 11,12,16,17
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	N	N	N	N	N	Note 1	Notes 7, 8, 9, 11
Vessel	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

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

510(k) No.:

Device Name: CA1-7S for use with RS85

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	N	N	N		N	Note 1	Notes 2, 4, 7, 8, 9, 11, 14
	Abdominal (See Note 10)	N	N	N		N	Note 1	Notes 2,6,7,8,9,10,11,14,15,16,17
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	N	N	N		N	Note 1	Notes 2, 6, 7, 8, 9, 11, 14
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	N	N	N		N	Note 1	Notes 2, 6, 7, 8, 9, 11, 14
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	N	N	N		N	Note 1	Notes 2, 6, 7, 8, 9, 11, 14
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
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; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow Note 17: S-Shearwave Imaging (2D Shearwave)

{29}------------------------------------------------

510(k) No.:

Device Name: EA2-11AR for use with RS85

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal/Obstetrics (See Note 3)	N	N	N	N	N	Note 1	Note 9
	Abdominal (See Note 10)	N	N	N	N	N	Note 1	Note 9, 12
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N	N	N	Note 1	Note 9, 12, 16, 17
	Trans-vaginal	N	N	N	N	N	Note 1	Note 9, 12,16
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	N	N	N	N	N	Note 1	Note 9, 12, 16, 17
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow
Note 17: S-Shearwave Imaging (2D Shearwave)

{30}------------------------------------------------

510(k) No.:

Device Name: EA2-11AV for use with RS85

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	N	N	N	N	N	Note 1	Note 9
	Abdominal (See Note 10)	N	N	N	N	N	Note 1	Note 9, 12
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N	N	N	Note 1	Note 9, 12, 16, 17
	Trans-vaginal	N	N	N	N	N	Note 1	Note 9, 12, 16
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	N	N	N	N	N	Note 1	Note 9, 12, 16, 17
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow Note 17: S-Shearwave Imaging (2D Shearwave)

{31}------------------------------------------------

510(k) No.:

Device Name: EV2-10A for use with RS85

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	N	N	N	N	N	Note 1	Note 8, 9
	Abdominal (See Note 10)	N	N	N	N	N	Note 1	Note 8, 9, 12
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
&Other	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N	N	N	Note 1	Note 8, 9, 12
	Trans-vaginal	N	N	N	N	N	Note 1	Note 8, 9, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	N	N	N	N	N	Note 1	Note 8, 9, 12
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow Note 17: S-Shearwave Imaging (2D Shearwave)

{32}------------------------------------------------

510(k) No.:

Device Name: PA1-5A for use with RS85

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P		P	Note 1	Note 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	Note 1	Note 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult	P	P	P	P	P	Note 1	Note 4, 7
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA 181336; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
Note 16: MV-Flow Note 17: S-Shearwave Imaging (2D Shearwave)

{33}------------------------------------------------

510(K) Summary: K192903

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

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

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

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

{34}------------------------------------------------

modes.

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

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

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

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

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

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

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

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

{35}------------------------------------------------

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

{36}------------------------------------------------

	RS85(Under Review)Proposed Device	RS85(K191115)Primary Predicate	HERA W10(K182595)Predicate	HS50/HS60(K181336)Predicate	Note
Device name	SAMSUNG	SAMSUNG	SAMSUNG	SAMSUNG
Manufacturer	MEDISON.	MEDISON.	MEDISON.	MEDISON.
Regulation No.	892.1550892.1560892.1570	892.1550892.1560892.1570	892.1550892.1560892.1570	892.1550892.1560892.1570
Product Code	IYN, IYO, ITX	IYN, IYO, ITX	IYN, IYO, ITX	IYN, IYO, ITX
Intended Use	The ultrasounddiagnostic system andprobes are designed toobtain ultrasoundimages and analyzebody fluids.	The ultrasounddiagnostic system andprobes are designed toobtain ultrasoundimages and analyzebody fluids.	The ultrasounddiagnostic system andprobes are designed toobtain ultrasoundimages and analyzebody fluids.	The ultrasounddiagnostic system andprobes are designed toobtain ultrasoundimages and analyzebody fluids.
clinicalApplication	- Fetal/Obstetrics- Abdominal- Gynecology- Intra-operative- Pediatric- Small Organ- Neonatal Cephalic- Adult Cephalic- Trans-rectal- Trans-vaginal- Trans-esophageal(Cardiac)- Muscular-Skeletal(Conventional,Superficial)- Urology- Cardiac Adult- Cardiac Pediatric- Peripheral vessel	- Fetal/Obstetrics- Abdominal- Gynecology- Intra-operative- Pediatric- Small Organ- Neonatal Cephalic- Adult Cephalic- Trans-rectal- Trans-vaginal- Trans-esophageal(Cardiac)- Muscular-Skeletal(Conventional,Superficial)- Urology- Cardiac Adult- Cardiac Pediatric- Peripheral vessel	- Fetal/Obstetrics- Abdominal- Gynecology- Pediatric- Small Organ- Neonatal Cephalic- Adult Cephalic- Trans-rectal- Trans-vaginal- Muscular-Skeletal(Conventional,Superficial)- Urology- Cardiac Adult- Cardiac Pediatric- Peripheral vessel	- Fetal/Obstetrics- Abdominal- Gynecology- Pediatric- Small Organ- Neonatal Cephalic- Adult Cephalic- Trans-rectal- Trans-vaginal- Muscular-Skeletal(Conventional,Superficial)- Urology- Cardiac Adult- Cardiac Pediatric- Peripheral vessel	Same to predicates
Scanhead Types	- Linear Array	- Linear Array	- Linear Array	- Linear Array	Same to predicates
	RS85(Under Review)	RS85(K191115)	HERA W10(K182595)	HS50/HS60(K181336)
Device name	Proposed Device	Primary Predicate	Predicate	Predicate	Note
	- Curved Linear Array	- Curved Linear Array	- Curved Linear Array	- Curved Linear Array
	- Endocavity	- Endocavity	- Endocavity	- Endocavity
	- Phased Array	- Phased Array	- Phased Array	- Phased Array
	- Static Probes	- Static Probes	- Static Probes	- Static Probes
ScanheadFrequency	1.0 ~ 20.0 MHz	1.0 ~ 20.0 MHz	1.0 ~ 20.0 MHz	1.0 ~ 20.0 MHz
Acoustic OutputDisplay & FDALimits	- Display Feature forHigher Output-Track3	- Display Feature forHigher Output-Track3	- Display Feature forHigher Output-Track3	- Display Feature forHigher Output-Track3
	- MI Output Display	- MI Output Display	- MI Output Display	- MI Output Display
	- TI Output Display	- TI Output Display	- TI Output Display	- TI Output Display
Modes of Operation	- B-mode	- B-mode	- B-mode	- B-mode
	- M-mode	- M-mode	- M-mode	- M-mode
	- Pulsed wave (PW)Doppler	- Pulsed wave (PW)Doppler	- Pulsed wave (PW)Doppler	- Pulsed wave (PW)Doppler
	- Continuous wave(CW) Doppler	- Continuous wave(CW) Doppler	- Continuous wave(CW) Doppler	- Continuous wave(CW) Doppler
	- Color Doppler	- Color Doppler	- Color Doppler	- Color Doppler
	- Tissue DopplerImaging (TDI)	- Tissue DopplerImaging (TDI)	- Tissue DopplerImaging (TDI)	- Tissue DopplerImaging (TDI)
	- Tissue DopplerWave (TDW)	- Tissue Doppler Wave(TDW)	- Tissue DopplerWave (TDW)	- Tissue DopplerWave (TDW)
	- Power AmplitudeDoppler	- Power AmplitudeDoppler	- Power AmplitudeDoppler	- Power AmplitudeDoppler
	- Pulse Inversion	- Pulse Inversion	- Pulse Inversion	- Pulse Inversion
	- Harmonic Imaging(S-Harmonic)	- Harmonic Imaging(S-Harmonic)	- Harmonic Imaging(S-Harmonic)	- Harmonic Imaging(S-Harmonic)
	- Directional PowerDoppler (S-Flow)	- Directional PowerDoppler (S-Flow)	- Directional PowerDoppler (S-Flow)	- Directional PowerDoppler (S-Flow)
	- Color M-Mode	- Color M-Mode	- Color M-Mode	- Color M-Mode
	- 3D/4D imagingmode	- 3D/4D imaging mode	- 3D/4D imagingmode	- 3D ImagingCombination mode
	- ElastoScan+ Mode	- ElastoScan+ Mode	- ElastoScan+ Mode	- ElastoScan Mode
	- MV-Flow Mode	- MV-Flow Mode	- MV-Flow Mode
RS85 Diagnostic Ultrasound System					Note
Device name	RS85(Under Review)Proposed Device	RS85(K191115)Primary Predicate	HERA W10(K182595)Predicate	HS50/HS60(K181336)Predicate
	- Combined modes	- Combined modes	- Combined modes	- Combined modes	-
#Transmit Channels	192	192	192	128
#Receive Channels	192	192	192	128
SystemCharacteristics:	Beamformer 192	Beamformer 192	Beamformer 192	- Beamformer 128
	Mobile cart	Mobile cart	Mobile cart	- Mobile cart
	LCD Monitor (LEDBacklight unit):23inch, 23.8inch	LCD Monitor (LEDBacklight unit):23inch	LCD Monitor (LEDBacklight unit):23inch	LCD Monitor (LEDBacklight unit):- 21.5inch	SE to predicates; refer to018_Electromagnetic Compatibilityand ElectricalSafety
	256 gray shades onmonitor100-240VAC,1100VA,50/60Hz	256 gray shades onmonitor100-240VAC,1100VA,50/60Hz	256 gray shades onmonitor100-240VAC,1100VA,50/60Hz	- 256 gray shades onmonitor- 100-240VAC,1100VA,- 50/60Hz
Product SafetyCertification	IEC 60601-1CSA C22.2 No.601.1IEC 60601-2-37	IEC 60601-1CSA C22.2 No.601.1IEC 60601-2-37	IEC 60601-1CSA C22.2 No.601.1IEC 60601-2-37	- IEC 60601-1- CSA C22.2 No.601.1- IEC 60601-2-37
EMC Compliance	IEC 60601-1-2	IEC 60601-1-2	IEC 60601-1-2	- IEC 60601-1-2	Same to predicates
Acoustic OutputDisplay Standard	Track 3	Track 3	Track 3	- Track 3
BiocompatibilityCompliance	ISO10993-1	ISO10993-1	ISO10993-1	- ISO10993-1
SoftwareFunctionality	- Q Scan- ClearVision- MultiVision- Panoramic+	- Q Scan- ClearVision- MultiVision- Panoramic	- Q Scan- ClearVision- MultiVision- Panoramic	- Q Scan- ClearVision- MultiVision- Panoramic
Device name	RS85(Under Review)Proposed Device	RS85(K191115)Primary Predicate	HERA W10(K182595)Predicate	HS50/HS60(K181336)Predicate	Note
	- Needle Mate+	- Needle Mate+	- Needle Mate+	- Needle Mate+
	- AutoIMT+	- AutoIMT+	- AutoIMT+	- AutoIMT+
	- Strain+	- Strain+		- Strain+
	- StressEcho	- StressEcho		- StressEcho
	- E-Strain	- E-Strain	- E-Strain	- E-Strain
	- S-Shearwave	- S-Shearwave	- S-Shearwave
	- S-Detect for Breast	- S-Detect for Breast	- S-Detect for Breast	- S-Detect for Breast
	- S-Detect for Thyroid	- S-Detect for Thyroid	- S-Detect for Thyroid	- S-Detect for Thyroid
	- S-Fusion	- S-Fusion
	- Clear Track	- Clear Track
	- Virtual Track	- Virtual Track
	- S-3D ArterialAnalysis	- S-3D ArterialAnalysis	- S-3D ArterialAnalysis
	- ADVR	- ADVR	- ADVR
	-3D Imaging (VolumeData Acquisition)	-3D Imaging (VolumeData Acquisition)	-3D Imaging (VolumeData Acquisition)	-3D Imaging (VolumeData Acquisition)
	3D Imagingpresentation	3D Imagingpresentation	3D Imagingpresentation	- 3D Imagingpresentation	Same to predicates
	-3D Cine/4D Cine	-3D Cine/4D Cine	-3D Cine/4D Cine	- 3D Cine/4D Cine
	-3D Rendering MPR	-3D Rendering MPR	-3D Rendering MPR	- 3D Rendering MPR
	-3D XI MSV/ObliqueView	-3D XI MSV/ObliqueView	-3D XI MSV/ObliqueView	- 3D XI MSV/ObliqueView
	- Volume CT	- Volume CT	- Volume CT	- Volume CT
	-3D MagiCut	-3D MagiCut	-3D MagiCut	- 3D MagiCut
	-Volume Calculation(VOCAL, XIVOCAL)	-Volume Calculation(VOCAL, XI VOCAL)	-Volume Calculation(VOCAL, XIVOCAL)	- Volume Calculation(VOCAL, XIVOCAL)
	- XI STIC	- XI STIC	- XI STIC	- XI STIC
	- HDVI	- HDVI	- HDVI	- HDVI
	- RealisticVue	- RealisticVue	- RealisticVue	- RealisticVue
	- NaturalVue	- NaturalVue	- NaturalVue
RS85 Diagnostic Ultrasound System
Device name	RS85(Under Review)Proposed Device	RS85(K191115)Primary Predicate	HERA W10(K182595)Predicate	HS50/HS60(K181336)Predicate	Note
	- CEUS+	- CEUS+	- CEUS+	- CEUS+
	- MV-Flow	- MV-Flow	- MV-Flow
	- SonoSync	- SonoSync
	- CrystalVue	- CrystalVue	- CrystalVue	- CrystalVue
	- ShadowHDR		- ShadowHDR
	- BiometryAssist		- BiometryAssist	- BiometryAssist
	- IOTA-ADNEX		- IOTA-ADNEX
	- ElastoScan+	- ElastoScan+	- ElastoScan+	- ElastoScan+	Same to predicates
	- E-Thyroid	- E-Thyroid	- E-Thyroid
	- E-Breast	- E-Breast	- E-Breast
	- S-Shearwave Imaging	- S-Shearwave Imaging
	- MV-Flow	- MV-Flow	- MV-Flow
	- HQ-Vision	- HQ-Vision	- HQ-Vision	- HQ-Vision
	- EzHRI				SE to reference;refer to SEAnalysis 1
	- TSI				SE to reference;refer to SEAnalysis 2
	- TAI				SE to reference;refer to SEAnalysis 3
	- PureVision				SE to reference;refer to SEAnalysis 4
Transducer	- CA1-7A	- CA1-7A	- CA1-7A		Same to predicates
	- CF4-9	- CF4-9	- CF4-9	- CF4-9
	- CA2-8A	- CA2-8A	- CA2-8A
	- CA3-10A	- CA3-10A	- CA3-10A	- CA3-10A
	- E3-12A	- E3-12A	- E3-12A
RS85 Diagnostic Ultrasound System
Device name	RS85(Under Review)Proposed Device	RS85(K191115)Primary Predicate	HERA W10(K182595)Predicate	HS50/HS60(K181336)Predicate	Note
	- L3-12A	- L3-12A	- L3-12A
	- EA2-11B	- EA2-11B	- EA2-11B	- EA2-11B
	- LA2-9A	- LA2-9A	- LA2-9A	- LA2-9A
	- LA3-16A	- LA3-16A		- LA3-16A
	- LA3-16AI	- LA3-16AI		- LA3-16AI
	- LA4-18B	- LA4-18B	- LA4-18B
	- LM4-15B	- LM4-15B
	- PM1-6A	- PM1-6A	- PM1-6A
	- PA3-8B	- PA3-8B	- PA3-8B	- PA3-8B
	- PA4-12B	- PA4-12B	- PA4-12B	- PA4-12B
	- MMPT3-7	- MMPT3-7	- MMPT3-7	- MMPT3-7
	- CV1-8A	- CV1-8A	- CV1-8A
	- V5-9	- V5-9		- V5-9
	- LV3-14A	- LV3-14A
	- CW6.0	- CW6.0	- CW6.0
	- DP2B	- DP2B	- DP2B
	- DP8B	- DP8B	- DP8B
	- EV3-10B	- EV3-10B	- EV3-10B
	- LA2-14A				SE to predicates;refer to SEAnalysis 5
	- CA1-7S				SE to predicates;refer to SEAnalysis 6
	- PA1-5A			- PA1-5A	Same to predicate
	- EV2-10A				SE to predicates;refer to SEAnalysis 7
	- EA2-11AR				SE to predicates;refer to SEAnalysis 8 & note
	- EA2-11AV
CompatibleBiopsy Guide	- BP-KIT-029	- BP-KIT-029	- BP-KIT-029	- BP-KIT-029	Same to predicates
	- BP-KIT-030	- BP-KIT-030
Device name	RS85(Under Review)Proposed Device	RS85(K191115)Primary Predicate	HERA W10(K182595)Predicate	HS50/HS60(K181336)Predicate	Note
(Biopsy Needleguide Kit)	BP-KIT-043	- BP-KIT-043	- BP-KIT-043	-BP-KIT-043
	BP-KIT-053	- BP-KIT-053	- BP-KIT-053	-BP-KIT-053
	BP-KIT-054	- BP-KIT-054	- BP-KIT-054	-BP-KIT-054
	BP-KIT-055	- BP-KIT-055		-BP-KIT-055
	BP-KIT-057	- BP-KIT-057	- BP-KIT-057
	BP-KIT-058	- BP-KIT-058	- BP-KIT-058
	BP-KIT-059	- BP-KIT-059	- BP-KIT-059
	BP-KIT-060	- BP-KIT-060	- BP-KIT-060	- BP-KIT-060
	BP-KIT-065	- BP-KIT-065	- BP-KIT-065
	BP-KIT-066	- BP-KIT-066	- BP-KIT-066
	BP-KIT-067	- BP-KIT-067	- BP-KIT-067
	BP-KIT-068	- BP-KIT-068		-BP-KIT-068
	BP-KIT-069	- BP-KIT-069	- BP-KIT-069
	BP-KIT-071	- BP-KIT-071	- BP-KIT-071
	BP-KIT-075	- BP-KIT-075	- BP-KIT-075
	BP-KIT-076	- BP-KIT-076	- BP-KIT-076
	BP-KIT-077	- BP-KIT-077	- BP-KIT-077
	BP-KIT-078	- BP-KIT-078	- BP-KIT-078
	BP-KIT-079
	BP-KIT-080				Cleared (K970514)
	BP-KIT-081				Cleared (K875240)
	BP-KIT-082				Cleared (K875128)
	BP-KIT-083	- BP-KIT-083			Cleared (K191115)
	BP-KIT-085
	BP-KIT-086
	BP-KIT-088				Cleared (K971722)
	BP-KIT-089
	BP-KIT-090
	BP-KIT-094				Cleared (K970514)
DigitalStorage/TransferStation	- Foot Switch- ECG (defibrillationproof)	- Foot SwitchECG (defibrillationproof)	- Foot Switch- ECG (defibrillationproof)	- Foot Switch- ECG (defibrillationproof)	Same to predicates
Device name	RS85(Under Review)Proposed Device	RS85(K191115)Primary Predicate	HERA W10(K182595)Predicate	HS50/HS60(K181336)Predicate	Note
	- Gel Warmer	- Gel Warmer	- Gel Warmer	- Gel Warmer
	- Clear Track/ VirtualTrack	- Clear Track/ VirtualTrack	- Clear Track/ VirtualTrack	- Clear Track/ VirtualTrack
	System Stand	System Stand	System Stand	System Stand
	WLAN Card	- WLAN Card	- WLAN Card	- WLAN Card

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510(k) Summary

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RS85 Diagnostic Ultrasound S10(k)
RS85 Diagnostic Ultrasound System

510(k) Summary

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RS85 Diagnostic Ultrasound System

510(k) Summary

Section 6. Page 9/12

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RS85 Diagnostic Ultrasound S10(k)
RS85 Diagnostic Ultrasound System

510(k) Summary

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Traditional 510(k) RS85 Diagnostic Ultrasound System

10. Summary of Non-Clinical Test

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

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

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

11. Summary of Clinical Tests

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

12. Conclusion

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

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.