(116 days)
RS85 Diagnostic Ultrasound System (K173204)
No
The summary does not mention AI, ML, or related terms, and the device description focuses on standard ultrasound imaging modes and analysis packages.
No.
The device is described as a "diagnostic ultrasound system" used to "obtain ultrasound images and analyze body fluid," and to "aid in making a diagnosis." There is no mention of treating or curing any conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluid." Additionally, the "Device Description" section describes the RS85 as a "diagnostic ultrasound system" whose analysis packages "aid in making a diagnosis." The "Predicate Device(s)" also refers to the device as a "Diagnostic Ultrasound System".
No
The device description explicitly states it is a "diagnostic ultrasound system" and mentions "probes" in the intended use, indicating it includes hardware components for image acquisition.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is designed to "obtain ultrasound images and analyze body fluid." While it mentions analyzing body fluid, the primary function described is obtaining and displaying ultrasound images for diagnostic purposes.
- Device Description: The description focuses on the imaging capabilities (2D, Doppler modes, 3D/4D, Elastoscan) and measurement/analysis packages that aid in diagnosis based on these images.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device operates in vivo (within the body) using ultrasound waves.
While the system can analyze body fluid, this analysis is likely related to the ultrasound imaging itself (e.g., assessing fluid accumulation or characteristics within the body), not performing laboratory-style tests on collected samples.
Therefore, the RS85 is a diagnostic ultrasound system, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluid. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
- Fetal/Obstetrics (See Note 3). Note 3: Includes infertility monitoring of follicle development
- Abdominal (See Note 10). Note 10: Includes Renal, Gynecology/Pelvis
- Intra-operative (See Note 6). Note 6: Abdominal organs and peripheral vessel
- Intra-operative (Neuro.)
- Pedal Imaging & Other
- Laparoscopic
- Pediatric
- Small Organ (See Note 5). Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
- Neonatal Cephalic
- Adult Cephalic
- Trans-rectal
- Trans-vaginal
- Trans-urethral
- Trans-esoph. (non-Cardiac)
- Musculo-skeletal (Convent.)
- Musculo-skeletal (Superfic.)
- Intra-luminal
- Other (See Note 13). Note 13: Includes Urology/Prostate
- Cardiac Adult
- Cardiac Pediatric
- Trans-esophageal (Cardiac)
- Peripheral vessel
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The RS85 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 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 imaging, Tissue Doppler Wave, 3D imaging mode (real-time 4D imaging mode), Elastoscan* Mode or as a combination of these modes. The RS85 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that may aid in making a diagnosis by competent health care professionals. The RS85 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/Obstetrics, Abdominal, Gynecological, Intraoperative, Small Organ (e.g., thyroid, parathyroid, breast, scrotum and penis), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac), Peripheral vessel.
Indicated Patient Age Range
Adult, Pediatric, Neonatal (implied from clinical applications)
Intended User / Care Setting
Competent health care professionals (implied from safety information)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission, RS85, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
RS85 Diagnostic Ultrasound System (K173204)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
LOGIQ E9 Diagnostic Ultrasound System (K142160), Aplio i900/i800/i700/i600 Diagnostic Ultrasound System (K182679)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
February 15, 2019
Image /page/0/Picture/1 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 and Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name reads "U.S. Food & Drug Administration" with the word "Administration" on the second line.
SAMSUNG MEDISON CO., LTD. % Ji Yea Lee Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA
Re: K182932
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: January 11, 2019 Received: January 15, 2019
Dear Ji Yea Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K182932
Device Name RS85 Diagnostic Ultrasound System
Indications for Use (Describe)
The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluid. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.
Type of Use (Select one or both, as applicable) |
---|
------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) No.:
Device Name: RS85 Diagnostic Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
---|---|---|---|---|---|---|---|---|---|
General | |||||||||
(Track I only) | Specific | ||||||||
(Tracks I & III) | B | M | PWD | CWD | Color | ||||
Doppler* | Combined* | ||||||||
(Spec.) | Other | ||||||||
(Spec.) | |||||||||
Ophthalmic | Ophthalmic | ||||||||
Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Notes 2, 3, 4, 7, 8, 9, 11, 14 | ||
Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Notes 2, 4, 5, 6, 7, 8, 9, 11, 12, 14, 15 | ||
Intra-operative (See Note 6) | P | P | P | P | Note 1 | Note 7, 9, 11 | |||
Intra-operative (Neuro.) | P | P | P | P | Note 1 | Note 7, 9, 11 | |||
Fetal Imaging | |||||||||
& Other | Laparoscopic | ||||||||
Pediatric | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11 | ||
Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 12, 14 | |||
Neonatal Cephalic | P | P | P | P | Note 1 | Notes 8, 9, 11 | |||
Adult Cephalic | P | P | P | P | P | Note 1 | Notes 7 | ||
Trans-rectal | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11, 12 | |||
Trans-vaginal | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11, 12 | |||
Trans-urethral | |||||||||
Trans-esoph. (non-Cardiac) | |||||||||
Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 | |||
Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 | |||
Intra-luminal | |||||||||
Other (See Note 13) | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12 | |||
Cardiac Adult | P | P | P | P | P | Note 1 | Notes 4, 7 | ||
Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Notes 4, 7 | |
Trans-esophageal (Cardiac) | P | P | P | P | P | Note 1 | Notes 4, 7 | ||
Other (spec.) | |||||||||
Peripheral | |||||||||
Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 | |
Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
4
510(k) No.:
Device Name: CA1-7A for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
---|---|---|---|---|---|---|---|---|
General | ||||||||
(Track I only) | Specific | |||||||
(Tracks I & III) | B | M | PWD | CWD | Color | |||
Doppler* | Combined* | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
Ophthalmic | Ophthalmic | |||||||
Fetal/Obstetrics (See Note 3) | P | P | P | P | Note 1 | Notes 2,4,7,8,9,11,14 | ||
Abdominal (See Note 10) | P | P | P | P | Note 1 | Notes 2,6,7,8,9,11,14,15 | ||
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& Other | Laparoscopic | |||||||
Pediatric | 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 | Note 1 | Notes 2,6,7,8,9,11,14 | ||
Musculo-skel. (Superfic.) | ||||||||
Intra-luminal | ||||||||
Other (See Note 13) | P | P | P | P | Note 1 | Notes 2,6,7,8,9,11,14 | ||
Cardiac Adult | ||||||||
Cardiac | Cardiac Pediatric | |||||||
Trans-esophageal (Cardiac) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | P | P | P | P | Note 1 | Notes 2,6,7,8,9,11,14 | |
Other (spec.) |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPL, B+CW, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion Note 15: S-Shearwave
5
510(k) No.:
Device Name: CF4-9 for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
---|---|---|---|---|---|---|---|---|
General | ||||||||
(Track I only) | Specific | |||||||
(Tracks I & III) | B | M | PWD | CWD | Color | |||
Doppler* | Combined* | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
Ophthalmic | Ophthalmic | |||||||
Fetal/Obstetrics (See Note 3) | ||||||||
Abdominal (See Note 10) | P | P | P | P | Note 1 | Notes 7, 8, 9, 11 | ||
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& Other | Laparoscopic | |||||||
Pediatric | P | P | P | P | Note 1 | Notes 7, 8, 9, 11 | ||
Small Organ (See Note 5) | ||||||||
Neonatal Cephalic | P | P | P | P | Note 1 | Notes 7, 8, 9, 11 | ||
Adult Cephalic | ||||||||
Trans-rectal | ||||||||
Trans-vaginal | ||||||||
Trans-urethral | ||||||||
Trans-esoph. (non-Cardiac) | ||||||||
Musculo-skel. (Convent.) | ||||||||
Musculo-skel. (Superfic.) | ||||||||
Intra-luminal | ||||||||
Other (See Note 13) | ||||||||
Cardiac Adult | ||||||||
Cardiac | Cardiac Pediatric | |||||||
Trans-esophageal (Cardiac) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | P | P | P | P | Note 1 | Notes 8, 9, 11 | |
Other (spec.) |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion Note 15: S-Shearwave
6
510(k) No.:
Device Name: CA2-8A for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
---|---|---|---|---|---|---|---|---|
General | ||||||||
(Track I only) | Specific | |||||||
(Tracks I & III) | B | M | PWD | CWD | Color | |||
Doppler* | Combined* | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
Ophthalmic | Ophthalmic | |||||||
Fetal/Obstetrics (See Note 3) | P | P | P | P | Note 1 | Notes 2, 4, 7, 8, 9, 11 | ||
Abdominal (See Note 10) | P | P | P | P | Note 1 | Notes 2, 4, 7, 8, 9, 11 | ||
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& Other | Laparoscopic | |||||||
Pediatric | ||||||||
Small Organ (See Note 5) | ||||||||
Neonatal Cephalic | ||||||||
Adult Cephalic | ||||||||
Trans-rectal | ||||||||
Trans-vaginal | ||||||||
Trans-urethral | ||||||||
Trans-esoph. (non-Cardiac) | ||||||||
Musculo-skel. (Convent.) | ||||||||
Musculo-skel. (Superfic.) | ||||||||
Intra-luminal | ||||||||
Other (See Note 13) | ||||||||
Cardiac Adult | ||||||||
Cardiac | Cardiac Pediatric | |||||||
Trans-esophageal (Cardiac) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | |||||||
Other (spec.) |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+DPI, B+CW, B+C+PW, B+PD+PW, B+PPF+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients -
Note 6: Abdominal organs and peripheral vessel
-
Note 7: Tissue Harmonic Imaging (THI)
-
Note 8: 3D imaging
-
Note 9: MultiVision (Spatial Compound Imaging)
-
Note 10: Includes Renal, Gynecology/Pelvis
-
Note 11: Panoramic imaging
-
Note 12: ElastoScan
-
Note 13: Includes Urology/Prostate
-
Note 14: S-Fusion Note 15: S-Shearwave
7
510(k) No.:
Device Name: CA3-10A for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
---|---|---|---|---|---|---|---|---|---|
General | |||||||||
(Track I only) | Specific | ||||||||
(Tracks I & III) | B | M | PWD | CWD | Color | ||||
Doppler* | Combined* | ||||||||
(Spec.) | Other | ||||||||
(Spec.) | |||||||||
Ophthalmic | Ophthalmic | ||||||||
Fetal/Obstetrics (See Note 3) | P | P | P | P | 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, 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 | ||
Small Organ (See Note 5) | |||||||||
Neonatal Cephalic | |||||||||
Adult Cephalic | |||||||||
Trans-rectal | |||||||||
Trans-vaginal | |||||||||
Trans-urethral | |||||||||
Trans-esoph. (non-Cardiac) | |||||||||
Musculo-skel. (Convent.) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11 | ||
Musculo-skel. (Superfic.) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11 | ||
Intra-luminal | |||||||||
Other (See Note 13) | |||||||||
Cardiac Adult | |||||||||
Cardiac | Cardiac Pediatric | ||||||||
Trans-esophageal (Cardiac) | |||||||||
Other (spec.) | |||||||||
Peripheral | |||||||||
Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11 | |
Other (spec.) |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CV, B+C+PW, B+PD+PW, B+DPD+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients -
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) -
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging) -
Note 10: Includes Renal, Gynecology/Pelvis
-
Note 11: Panoramic imaging
-
Note 12: ElastoScan
-
Note 13: Includes Urology/Prostate Note 14: S-Fusion
Note 15: S-Shearwave
8
510(k) No.:
Device Name: E3-12A for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
---|---|---|---|---|---|---|---|---|---|
General | |||||||||
(Track I only) | Specific | ||||||||
(Tracks I & III) | B | M | PWD | CWD | Color | ||||
Doppler* | Combined* | ||||||||
(Spec.) | Other | ||||||||
(Spec.) | |||||||||
Ophthalmic | Ophthalmic | ||||||||
Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 | ||
Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12 | ||
Intra-operative (See Note 6) | |||||||||
Intra-operative (Neuro.) | |||||||||
Fetal Imaging | |||||||||
& Other | Laparoscopic | ||||||||
Pediatric | |||||||||
Small Organ (See Note 5) | |||||||||
Neonatal Cephalic | |||||||||
Adult Cephalic | |||||||||
Trans-rectal | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12 | ||
Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12 | ||
Trans-urethral | |||||||||
Trans-esoph. (non-Cardiac) | |||||||||
Musculo-skel. (Convent.) | |||||||||
Musculo-skel. (Superfic.) | |||||||||
Intra-luminal | |||||||||
Other (See Note 13) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12 | ||
Cardiac Adult | |||||||||
Cardiac | Cardiac Pediatric | ||||||||
Trans-esophageal (Cardiac) | |||||||||
Other (spec.) | |||||||||
Peripheral | |||||||||
Vessel | Peripheral vessel | ||||||||
Other (spec.) |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+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
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 | Color | |||
Doppler* | Combined* | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
Ophthalmic | Ophthalmic | |||||||
Fetal/Obstetrics (See Note 3) | ||||||||
Abdominal (See Note 10) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 | ||
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& Other | Laparoscopic | |||||||
Pediatric | ||||||||
Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 12, 14 | ||
Neonatal Cephalic | ||||||||
Adult Cephalic | ||||||||
Trans-rectal | ||||||||
Trans-vaginal | ||||||||
Trans-urethral | ||||||||
Trans-esoph. (non-Cardiac) | ||||||||
Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 | ||
Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 | ||
Intra-luminal | ||||||||
Other (See Note 13) | ||||||||
Cardiac Adult | ||||||||
Cardiac | Cardiac Pediatric | |||||||
Trans-esophageal (Cardiac) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 | |
Other (spec.) |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPL, B+CW, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion Note 15: S-Shearwave
10
510(k) No.:
Device Name: EA2-11B for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
---|---|---|---|---|---|---|---|---|
General | ||||||||
(Track I only) | Specific | |||||||
(Tracks I & III) | B | M | PWD | CWD | Color | |||
Doppler* | Combined* | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
Ophthalmic | Ophthalmic | |||||||
Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9 | |
Abdominal (See Note 12) | P | P | P | P | P | Note 1 | Note 2, 6, 7, 8, 9, 12 | |
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& Other | Laparoscopic | |||||||
Pediatric | ||||||||
Small Organ (See Note 5) | ||||||||
Neonatal Cephalic | ||||||||
Adult Cephalic | ||||||||
Trans-rectal | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | |
Trans-vaginal | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | |
Trans-urethral | ||||||||
Trans-esoph. (non-Cardiac) | ||||||||
Musculo-skel. (Convent.) | ||||||||
Musculo-skel. (Superfic.) | ||||||||
Intra-luminal | ||||||||
Other (See Note 13) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | |
Cardiac Adult | ||||||||
Cardiac | Cardiac Pediatric | |||||||
Trans-esophageal (Cardiac) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | |||||||
Other (spec.) |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CV, B+C+PW, B+PD+PW, B+PPH+W, B+PPH+PW, B+ID+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients -
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) -
Note 8: 3D imaging
-
Note 9: MultiVision (Spatial Compound Imaging)
-
Note 10: Includes Renal, Gynecology/Pelvis
-
Note 11: Panoramic imaging
-
Note 12: ElastoScan
-
Note 13: Includes Urology/Prostate
-
Note 14: S-Fusion
-
Note 15: S-Shearwave
11
510(k) No.:
Device Name: LA2-9A for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
---|---|---|---|---|---|---|---|---|
General | ||||||||
(Track I only) | Specific | |||||||
(Tracks I & III) | B | M | PWD | CWD | Color | |||
Doppler* | Combined* | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
Ophthalmic | Ophthalmic | |||||||
Fetal/Obstetrics (See Note 3) | ||||||||
Abdominal (See Note 10) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | ||
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& Other | Laparoscopic | |||||||
Pediatric | ||||||||
Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11,12,15 | ||
Neonatal Cephalic | ||||||||
Adult Cephalic | ||||||||
Trans-rectal | ||||||||
Trans-vaginal | ||||||||
Trans-urethral | ||||||||
Trans-esoph. (non-Cardiac) | ||||||||
Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11,12,15 | ||
Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11,12,15 | ||
Intra-luminal | ||||||||
Other (See Note 13) | ||||||||
Cardiac Adult | ||||||||
Cardiac | Cardiac Pediatric | |||||||
Trans-esophageal (Cardiac) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | |
Other (spec.) |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion Note 15: S-Shearwave
12
510(k) No.:
Device Name: LA3-16A for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
---|---|---|---|---|---|---|---|---|
General | Specific | B | M | PWD | CWD | Color | ||
Doppler* | Combined* | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
(Track I only) | (Tracks I & III) | |||||||
Ophthalmic | Ophthalmic | |||||||
Fetal/Obstetrics (See Note 3) | ||||||||
Abdominal (See Note 10) | ||||||||
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& | ||||||||
Other | Laparoscopic | |||||||
Pediatric | ||||||||
Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 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 Adult | ||||||||
Cardiac | Cardiac Pediatric | |||||||
Trans-esophageal (Cardiac) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | |
Other (spec.) |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CV, B+C+PW, B+PD+PW, B+DPD+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients -
Note 6: Abdominal organs and peripheral vessel
-
Note 7: Tissue Harmonic Imaging (THI)
-
Note 8: 3D imaging
-
Note 9: MultiVision (Spatial Compound Imaging)
-
Note 10: Includes Renal, Gynecology/Pelvis
-
Note 11: Panoramic imaging
-
Note 12: ElastoScan
-
Note 13: Includes Urology/Prostate
-
Note 14: S-Fusion Note 15: S-Shearwave
13
510(k) No.:
Device Name: LA3-16AI for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
---|---|---|---|---|---|---|---|---|
General | ||||||||
(Track I only) | Specific | |||||||
(Tracks I & III) | B | M | PWD | CWD | Color | |||
Doppler* | Combined* | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
Ophthalmic | Ophthalmic | |||||||
Fetal Imaging | ||||||||
& Other | Fetal/Obstetrics (See Note 3) | |||||||
Abdominal (See Note 10) | ||||||||
Intra-operative (See Note 6) | P | P | P | P | Note 1 | Note 7, 9, 11 | ||
Intra-operative (Neuro.) | P | P | P | P | Note 1 | Note 7, 9, 11 | ||
Laparoscopic | ||||||||
Pediatric | ||||||||
Small Organ (See Note 5) | ||||||||
Neonatal Cephalic | ||||||||
Adult Cephalic | ||||||||
Trans-rectal | ||||||||
Trans-vaginal | ||||||||
Trans-urethral | ||||||||
Trans-esoph. (non-Cardiac) | ||||||||
Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Note 7, 9, 11 | ||
Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 7, 9, 11 | ||
Intra-luminal | ||||||||
Other (See Note 13) | ||||||||
Cardiac | Cardiac Adult | |||||||
Cardiac Pediatric | ||||||||
Trans-esophageal (Cardiac) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | P | P | P | P | Note 1 | Note 7, 9, 11 | |
Other (spec.) |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CV, B+C+PW, B+PD+PW, B+DPD+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients -
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) -
Note 8: 3D imaging
-
Note 9: MultiVision (Spatial Compound Imaging)
-
Note 10: Includes Renal, Gynecology/Pelvis
-
Note 11: Panoramic imaging
-
Note 12: ElastoScan
-
Note 13: Includes Urology/Prostate Note 14: S-Fusion
-
Note 15: S-Shearwave
14
510(k) No.:
Device Name: LA4-18B for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
---|---|---|---|---|---|---|---|---|---|
General | |||||||||
(Track I only) | Specific | ||||||||
(Tracks I & III) | B | M | PWD | CWD | Color | ||||
Doppler* | Combined* | ||||||||
(Spec.) | Other | ||||||||
(Spec.) | |||||||||
Ophthalmic | Ophthalmic | ||||||||
Fetal/Obstetrics (See Note 3) | |||||||||
Abdominal (See Note 10) | |||||||||
Intra-operative (See Note 6) | |||||||||
Intra-operative (Neuro.) | |||||||||
Fetal Imaging | |||||||||
& Other | Laparoscopic | ||||||||
Pediatric | |||||||||
Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 12, 14 | |||
Neonatal Cephalic | |||||||||
Adult Cephalic | |||||||||
Trans-rectal | |||||||||
Trans-vaginal | |||||||||
Trans-urethral | |||||||||
Trans-esoph. (non-Cardiac) | |||||||||
Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 | |||
Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 | |||
Intra-luminal | |||||||||
Other (See Note 13) | |||||||||
Cardiac Adult | |||||||||
Cardiac | Cardiac Pediatric | ||||||||
Trans-esophageal (Cardiac) | |||||||||
Other (spec.) | |||||||||
Peripheral | |||||||||
Vessel | Peripheral vessel | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 | ||
Other (spec.) |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CV, B+C+PW, B+PD+PW, B+DPD+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients -
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) -
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging) -
Note 10: Includes Renal, Gynecology/Pelvis
-
Note 11: Panoramic imaging
-
Note 12: ElastoScan
-
Note 13: Includes Urology/Prostate
Note 14: S-Fusion Note 15: S-Shearwave
15
510(k) No.: K162094 Device Name: LM4-15B for use with RS85 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
---|---|---|---|---|---|---|---|---|---|
General | |||||||||
(Track I only) | Specific | ||||||||
(Tracks I & III) | B | M | PWD | CWD | Color | ||||
Doppler* | Combined* | ||||||||
(Spec.) | Other | ||||||||
(Spec.) | |||||||||
Ophthalmic | Ophthalmic | ||||||||
Fetal/Obstetrics (See Note 3) | |||||||||
Abdominal (See Note 10) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | |||
Intra-operative (See Note 6) | |||||||||
Intra-operative (Neuro.) | |||||||||
Fetal Imaging | |||||||||
& Other | Laparoscopic | ||||||||
Pediatric | |||||||||
Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 12 | |||
Neonatal Cephalic | |||||||||
Adult Cephalic | |||||||||
Trans-rectal | |||||||||
Trans-vaginal | |||||||||
Trans-urethral | |||||||||
Trans-esoph. (non-Cardiac) | |||||||||
Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | |||
Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | |||
Intra-luminal | |||||||||
Other (See Note 13) | |||||||||
Cardiac Adult | |||||||||
Cardiac | Cardiac Pediatric | ||||||||
Trans-esophageal (Cardiac) | |||||||||
Other (spec.) | |||||||||
Peripheral | |||||||||
Vessel | Peripheral vessel | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | ||
Other (spec.) |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CV, B+C+PW, B+PD+PW, B+DPD+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients -
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) -
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging) -
Note 10: Includes Renal, Gynecology/Pelvis
-
Note 11: Panoramic imaging
-
Note 12: ElastoScan Note 13: Includes Urology/Prostate
-
Note 14: S-Fusion
-
Note 15: S-Shearwave
16
510(k) No.:
Device Name: PM1-6A for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
---|---|---|---|---|---|---|---|---|
General | ||||||||
(Track I only) | Specific | |||||||
(Tracks I & III) | B | M | PWD | CWD | Color | |||
Doppler* | Combined* | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
Ophthalmic | Ophthalmic | |||||||
Fetal Imaging | ||||||||
& Other | Fetal/Obstetrics (See Note 3) | |||||||
Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Note 7 | |
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Laparoscopic | ||||||||
Pediatric | ||||||||
Small Organ (See Note 5) | ||||||||
Neonatal Cephalic | ||||||||
Adult Cephalic | P | P | P | P | P | Note 1 | Note 7 | |
Trans-rectal | ||||||||
Trans-vaginal | ||||||||
Trans-urethral | ||||||||
Trans-esoph. (non-Cardiac) | ||||||||
Musculo-skel. (Convent.) | ||||||||
Musculo-skel. (Superfic.) | ||||||||
Intra-luminal | ||||||||
Other (See Note 13) | ||||||||
Cardiac | Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7 |
Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 | |
Trans-esophageal (Cardiac) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | |||||||
Other (spec.) |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion Note 15: S-Shearwave
17
510(k) No.:
Device Name: PA3-8B for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
General | ||||||||||
(Track I only) | Specific | |||||||||
(Tracks I & III) | B | M | PWD | CWD | Color | |||||
Doppler* | Combined* | |||||||||
(Spec.) | Other | |||||||||
(Spec.) | ||||||||||
Ophthalmic | Ophthalmic | |||||||||
Fetal/Obstetrics (See Note 3) | ||||||||||
Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Note 7 | |||
Intra-operative (See Note 6) | ||||||||||
Intra-operative (Neuro.) | ||||||||||
Fetal Imaging | ||||||||||
& Other | Laparoscopic | |||||||||
Pediatric | P | P | P | P | P | Note 1 | Note 7 | |||
Small Organ (See Note 5) | ||||||||||
Neonatal Cephalic | P | P | P | P | P | Note 1 | Note 7 | |||
Adult Cephalic | P | P | P | P | P | Note 1 | Note 7 | |||
Trans-rectal | ||||||||||
Trans-vaginal | ||||||||||
Trans-urethral | ||||||||||
Trans-esoph. (non-Cardiac) | ||||||||||
Musculo-skel. (Convent.) | ||||||||||
Musculo-skel. (Superfic.) | ||||||||||
Intra-luminal | ||||||||||
Other (See Note 13) | ||||||||||
Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7 | |||
Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 | ||
Trans-esophageal (Cardiac) | ||||||||||
Other (spec.) | ||||||||||
Peripheral | ||||||||||
Vessel | Peripheral vessel | |||||||||
Other (spec.) |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CV, B+C+PW, B+PD+PW, B+PPH+W, B+PPH+PW, B+ID+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
- Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
- Note 9: MultiVision (Spatial Compound Imaging)
- Note 10: Includes Renal, Gynecology/Pelvis
- Note 11: Panoramic imaging
- Note 12: ElastoScan
- Note 13: Includes Urology/Prostate
- Note 14: S-Fusion
- Note 15: S-Shearwave
18
510(k) No.:
Device Name: PA4-12B for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
---|---|---|---|---|---|---|---|---|
General | ||||||||
(Track I only) | Specific | |||||||
(Tracks I & III) | B | M | PWD | CWD | Color | |||
Doppler* | Combined* | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
Ophthalmic | Ophthalmic | |||||||
Fetal/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 Adult | P | P | P | P | P | Note 1 | Note 4, 7 | |
Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 |
Trans-esophageal (Cardiac) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | |||||||
Other (spec.) |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+TD, B+CV, B+C+PW, B+PD+PW, B+PPI+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients -
Note 6: Abdominal organs and peripheral vessel
-
Note 7: Tissue Harmonic Imaging (THI)
-
Note 8: 3D imaging
-
Note 9: MultiVision (Spatial Compound Imaging)
-
Note 10: Includes Renal, Gynecology/Pelvis
-
Note 11: Panoramic imaging
-
Note 12: ElastoScan
-
Note 13: Includes Urology/Prostate
-
Note 14: S-Fusion
-
Note 15: S-Shearwave
19
510(k) No.:
Device Name: MMPT3-7 for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
---|---|---|---|---|---|---|---|---|---|
General | |||||||||
(Track I only) | Specific | ||||||||
(Tracks I & III) | B | M | PWD | CWD | Color | ||||
Doppler* | Combined* | ||||||||
(Spec.) | Other | ||||||||
(Spec.) | |||||||||
Ophthalmic | Ophthalmic | ||||||||
Fetal Imaging | |||||||||
& Other | Fetal/Obstetrics (See Note 3) | ||||||||
Abdominal (See Note 12) | |||||||||
Intra-operative (See Note 6) | |||||||||
Intra-operative (Neuro.) | |||||||||
Laparoscopic | |||||||||
Pediatric | |||||||||
Small Organ (See Note 5) | |||||||||
Neonatal Cephalic | |||||||||
Adult Cephalic | |||||||||
Trans-rectal | |||||||||
Trans-vaginal | |||||||||
Trans-urethral | |||||||||
Trans-esoph. (non-Cardiac) | |||||||||
Musculo-skel. (Convent.) | |||||||||
Musculo-skel. (Superfic.) | |||||||||
Intra-luminal | |||||||||
Other (spec.) (See Note 13) | |||||||||
Cardiac | Cardiac Adult | ||||||||
Cardiac Pediatric | |||||||||
Trans-esophageal (Cardiac) | P | P | P | P | P | Note 1 | Note 4, 7 | ||
Other (spec.) | |||||||||
Peripheral | |||||||||
Vessel | Peripheral vessel | ||||||||
Other (spec.) |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CV, B+C+PW, B+PD+PW, B+DPD+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients -
Note 6: Abdominal organs and peripheral vessel
-
Note 7: Tissue Harmonic Imaging (THI)
-
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)
- Note 10: Includes Renal, Gynecology/Pelvis
- Note 11: Panoramic imaging
- Note 12: ElastoScan
- Note 13: Includes Urology/Prostate
- Note 14: S-Fusion Note 15: S-Shearwave
20
510(k) No.:
Device Name: CV1-8A for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
General | ||||||||||
(Track I only) | Specific | |||||||||
(Tracks I & III) | B | M | PWD | CWD | Color | |||||
Doppler* | Combined* | |||||||||
(Spec.) | Other | |||||||||
(Spec.) | ||||||||||
Ophthalmic | Ophthalmic | |||||||||
Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Note 2, 4, 7, 8, 9, 11 | |||
Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Note 2, 4, 7, 8, 9 | |||
Intra-operative (See Note 6) | ||||||||||
Intra-operative (Neuro.) | ||||||||||
Fetal Imaging | ||||||||||
& Other | Laparoscopic | |||||||||
Pediatric | ||||||||||
Small Organ (See Note 5) | ||||||||||
Neonatal Cephalic | ||||||||||
Adult Cephalic | ||||||||||
Trans-rectal | ||||||||||
Trans-vaginal | ||||||||||
Trans-urethral | ||||||||||
Trans-esoph. (non-Cardiac) | ||||||||||
Musculo-skel. (Convent.) | ||||||||||
Musculo-skel. (Superfic.) | ||||||||||
Intra-luminal | ||||||||||
Other (See Note 13) | ||||||||||
Cardiac Adult | ||||||||||
Cardiac | Cardiac Pediatric | |||||||||
Trans-esophageal (Cardiac) | ||||||||||
Other (spec.) | ||||||||||
Peripheral | ||||||||||
Vessel | Peripheral vessel | |||||||||
Other (spec.) |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CV, B+C+PW, B+PD+PW, B+DPD+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients -
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) -
Note 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging) -
Note 10: Includes Renal, Gynecology/Pelvis
-
Note 11: Panoramic imaging
-
Note 12: ElastoScan
-
Note 13: Includes Urology/Prostate Note 14: S-Fusion
Note 15: S-Shearwave
21
510(k) No.:
Device Name: V5-9 for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
---|---|---|---|---|---|---|---|---|---|
General | |||||||||
(Track I only) | Specific | ||||||||
(Tracks I & III) | B | M | PWD | CWD | Color | ||||
Doppler* | Combined* | ||||||||
(Spec.) | Other | ||||||||
(Spec.) | |||||||||
Ophthalmic | Ophthalmic | ||||||||
Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9 | ||
Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | ||
Intra-operative (See Note 6) | |||||||||
Intra-operative (Neuro.) | |||||||||
Fetal Imaging | |||||||||
& Other | Laparoscopic | ||||||||
Pediatric | |||||||||
Small Organ (See Note 5) | |||||||||
Neonatal Cephalic | |||||||||
Adult Cephalic | |||||||||
Trans-rectal | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | ||
Trans-vaginal | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | ||
Trans-urethral | |||||||||
Trans-esoph. (non-Cardiac) | |||||||||
Musculo-skel. (Convent.) | |||||||||
Musculo-skel. (Superfic.) | |||||||||
Intra-luminal | |||||||||
Other (See Note 13) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | ||
Cardiac Adult | |||||||||
Cardiac | Cardiac Pediatric | ||||||||
Trans-esophageal (Cardiac) | |||||||||
Other (spec.) | |||||||||
Peripheral | |||||||||
Vessel | Peripheral vessel | ||||||||
Other (spec.) |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion Note 15: S-Shearwave
22
510(k) No.:
Device Name: LV3-14A for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
---|---|---|---|---|---|---|---|---|---|
General | Specific | B | M | PWD | CWD | Color | Combined* | Other | |
(Track I only) | (Tracks I & III) | Doppler* | (Spec.) | (Spec.) | |||||
Ophthalmic | Ophthalmic | ||||||||
Fetal/Obstetrics (See Note 3) | |||||||||
Abdominal (See Note 10) | |||||||||
Intra-operative (See Note 6) | |||||||||
Intra-operative (Neuro.) | |||||||||
Fetal Imaging | Laparoscopic | ||||||||
& | |||||||||
Other | Pediatric | ||||||||
Small Organ (See Note 5) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | ||
Neonatal Cephalic | |||||||||
Adult Cephalic | |||||||||
Trans-rectal | |||||||||
Trans-vaginal | |||||||||
Trans-urethral | |||||||||
Trans-esoph. (non-Cardiac) | |||||||||
Musculo-skel. (Convent.) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | ||
Musculo-skel. (Superfic.) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | ||
Intra-luminal | |||||||||
Other (See Note 13) | |||||||||
Cardiac Adult | |||||||||
Cardiac | Cardiac Pediatric | ||||||||
Trans-esophageal (Cardiac) | |||||||||
Other (spec.) | |||||||||
Peripheral | Peripheral vessel | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | |
Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion
Note 15: S-Shearwave
23
510(k) No.:
Device Name: CW6.0 for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
---|---|---|---|---|---|---|---|---|
General | ||||||||
(Track I only) | Specific | |||||||
(Tracks I & III) | B | M | PWD | CWD | Color | |||
Doppler* | Combined* | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
Ophthalmic | Ophthalmic | |||||||
Fetal Imaging | ||||||||
& Other | Fetal/Obstetrics (See Note 3) | |||||||
Abdominal (See Note 10) | ||||||||
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Laparoscopic | ||||||||
Pediatric | ||||||||
Small Organ (See Note 5) | ||||||||
Neonatal Cephalic | ||||||||
Adult Cephalic | ||||||||
Trans-rectal | ||||||||
Trans-vaginal | ||||||||
Trans-urethral | ||||||||
Trans-esoph. (non-Cardiac) | ||||||||
Musculo-skel. (Convent.) | ||||||||
Musculo-skel. (Superfic.) | ||||||||
Intra-luminal | ||||||||
Other (See Note 13) | ||||||||
Cardiac | Cardiac Adult | P | ||||||
Cardiac Pediatric | P | |||||||
Trans-esophageal (Cardiac) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | P | ||||||
Other (spec.) |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion Note 15: S-Shearwave
24
510(k) No.:
Device Name: DP2B for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
---|---|---|---|---|---|---|---|---|
General | ||||||||
(Track I only) | Specific | |||||||
(Tracks I & III) | B | M | PWD | CWD | Color | |||
Doppler* | Combined* | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
Ophthalmic | Ophthalmic | |||||||
Fetal Imaging | ||||||||
& Other | Fetal/Obstetrics (See Note 3) | |||||||
Abdominal (See Note 10) | ||||||||
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Laparoscopic | ||||||||
Pediatric | ||||||||
Small Organ (See Note 5) | ||||||||
Neonatal Cephalic | ||||||||
Adult Cephalic | ||||||||
Trans-rectal | ||||||||
Trans-vaginal | ||||||||
Trans-urethral | ||||||||
Trans-esoph. (non-Cardiac) | ||||||||
Musculo-skel. (Convent.) | ||||||||
Musculo-skel. (Superfic.) | ||||||||
Intra-luminal | ||||||||
Other (See Note 13) | ||||||||
Cardiac | Cardiac Adult | P | ||||||
Cardiac Pediatric | ||||||||
Trans-esophageal (Cardiac) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | |||||||
Other (spec.) |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CV, B+C+PW, B+PD+PW, B+DPD+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients -
Note 6: Abdominal organs and peripheral vessel
-
Note 7: Tissue Harmonic Imaging (THI)
-
Note 8: 3D imaging
-
Note 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 9: MultiVision (Spatial Compound Imaging)
25
510(k) No.:
Device Name: DP8B for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
---|---|---|---|---|---|---|---|---|
General | ||||||||
(Track I only) | Specific | |||||||
(Tracks I & III) | B | M | PWD | CWD | Color | |||
Doppler* | Combined* | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
Ophthalmic | Ophthalmic | |||||||
Fetal Imaging | ||||||||
& Other | Fetal/Obstetrics (See Note 3) | |||||||
Abdominal (See Note 12) | ||||||||
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Laparoscopic | ||||||||
Pediatric | ||||||||
Small Organ (See Note 5) | ||||||||
Neonatal Cephalic | ||||||||
Adult Cephalic | ||||||||
Trans-rectal | ||||||||
Trans-vaginal | ||||||||
Trans-urethral | ||||||||
Trans-esoph. (non-Cardiac) | ||||||||
Musculo-skel. (Convent.) | ||||||||
Musculo-skel. (Superfic.) | ||||||||
Intra-luminal | ||||||||
Other (See Note 13) | ||||||||
Cardiac | Cardiac Adult | P | ||||||
Cardiac Pediatric | P | |||||||
Trans-esophageal (Cardiac) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | P | ||||||
Other (spec.) |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CV, B+C+PW, B+PD+PW, B+PPH+W, B+PPH+PW, B+ID+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients -
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) -
Note 8: 3D imaging
-
Note 9: MultiVision (Spatial Compound Imaging)
-
Note 10: Includes Renal, Gynecology/Pelvis
-
Note 11: Panoramic imaging
-
Note 12: ElastoScan
-
Note 13: Includes Urology/Prostate
-
Note 14: S-Fusion
-
Note 15: S-Shearwave
26
510(k) No.:
Device Name: EV3-10B for use with RS85
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
---|---|---|---|---|---|---|---|---|
General | ||||||||
(Track I only) | Specific | |||||||
(Tracks I & III) | B | M | PWD | CWD | Color | |||
Doppler* | Combined* | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
Ophthalmic | Ophthalmic | |||||||
Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 11 | |
Abdominal (See Note 10) | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 11, 12 | ||
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& Other | Laparoscopic | |||||||
Pediatric | ||||||||
Small Organ (See Note 5) | ||||||||
Neonatal Cephalic | ||||||||
Adult Cephalic | ||||||||
Trans-rectal | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 11, 12 | ||
Trans-vaginal | 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 | Note 1 | Note 2, 7, 8, 9, 11, 12 | ||
Cardiac Adult | ||||||||
Cardiac | Cardiac Pediatric | |||||||
Trans-esophageal (Cardiac) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | |||||||
Other (spec.) |
N= new indication; P= previously cleared by FDA K173204; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CV, B+C+PW, B+PD+PW, B+DPD+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients -
Note 6: Abdominal organs and peripheral vessel
-
Note 7: Tissue Harmonic Imaging (THI)
-
Note 8: 3D imaging
-
Note 9: MultiVision (Spatial Compound Imaging)
-
Note 10: Includes Renal, Gynecology/Pelvis
-
Note 11: Panoramic imaging
-
Note 12: ElastoScan
-
Note 13: Includes Urology/Prostate Note 14: S-Fusion
-
Note 15: S-Shearwave
27
510(K) Summary: K182932
In accordance with 21 CFR 807.92 the following summary of information is provided:
- Date Prepared January 13, 2019 1.
-
- Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, REPUBLIC OF KOREA
-
- Primary Contact Person Ji Yea Lee Regulatory Affairs Specialist Phone: +82.2.2.2194.1594 Fax: +82. 31.8017.9573 Email: jiyea722.lee@samsungmedison.com
-
- Proposed Device
- Common/Usual Name: Diagnostic Ultrasound System and Accessories
- Proprietary Name: RS85 Diagnostic Ultrasound System
- Common Name: Diagnostic Ultrasound System
- Classification Names: system, imaging, pulsed doppler, ultrasonic
- Product Code: IYN, IYO, ITX
- Regulation: 892.1550, 892.1560, 892.1570
-
- Predicate Device
-Aplio i900/i800/i700/i600 Diagnostic Ultrasound System (K182679)
-
- 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 imaging, Tissue Doppler Wave, 3D imaging mode (real-time 4D imaging mode), Elastoscan* Mode or as a combination of these modes. The RS85 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that 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.
- Device Description
-
- Indications for Use
The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids.
- Indications for Use
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 the same as predicates.
28
8. Technology
The RS85 employs the same fundamental scientific technology as its predicate device(s).
-
- Determination of Substantial Equivalence
The proposed RS85 is substantially equivalent to the predicate devices with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness.
- Determination of Substantial Equivalence
A comparison of the proposed device to the currently marketed predicates is provided in the table below.
Feature | Subject Device | Predicate Device |
---|---|---|
Device name | ||
(510(k) clearance) | RS85 | |
(Proposed Device) | RS85 | |
(K173204) | ||
Primary | ||
Manufacturer | Samsung Medison, Co.,LTD | Samsung Medison, Co.,LTD |
Clinical | ||
Application | - Fetal/Obstetrics |
- Abdominal
- Gynecology
- Intra-operative
- Pediatric
- Small Organ,
- Neonatal Cephalic
- Adult Cephalic
- Trans-rectal
- Trans-vaginal
- Trans-esoph. (non-Cardiac)
- Muscular-Skeletal (Conventional,
Superficial) - Urology
- Cardiac Adult
- Cardiac Pediatric
- Trans-esophageal (Cardiac)
- Peripheral vessel | - Fetal/Obstetrics
- Abdominal
- Gynecology
- Intra-operative
- Pediatric
- Small Organ,
- Neonatal Cephalic
- Adult Cephalic
- Trans-rectal
- Trans-vaginal
- Trans-esoph. (non-Cardiac)
- Muscular-Skeletal (Conventional,
Superficial) - Urology
- Cardiac Adult
- Cardiac Pediatric
- Trans-esophageal (Cardiac)
- Peripheral vessel |
| Scanhead Types | - Linear Array - Curved Linear Array
- Endocavity
- Phased Array
- Static Probes | - Linear Array
- Curved Linear Array
- Endocavity
- Phased Array
- Static Probes |
| Scanhead
Frequency | 1.0 ~ 20.0 MHz | 1.0 ~ 20.0 MHz |
| Acoustic Output
Display & FDA
Limits | - Display Feature for Higher Output-
Track3 - MI Output Display
TI Output Display | - Display Feature for Higher Output-
Track3 - MI Output Display
TI Output Display |
| Modes of Operation | - B-mode - M-mode
- Pulsed wave (PW) Doppler
- Continuous wave (CW) Doppler
- Color Doppler | - B-mode
- M-mode
- Pulsed wave (PW) Doppler
- Continuous wave (CW) Doppler
- Color Doppler |
| | - Tissue Harmonic Imaging | - Tissue Harmonic Imaging |
| | - 3D/4D imaging mode | - 3D/4D imaging mode |
| | - Combined modes | - Combined modes |
| #Transmit Channels | 192 | 192 |
| #Receive Channels | 192 | 192 |
| System | - Beamformer 192 | - Beamformer 192 |
| Characteristics: | - Mobile cart | - Mobile cart |
| | - LCD Monitor (LED Backlight unit) | - LCD Monitor (LED Backlight unit) |
| | - 256 gray shades on monitor | - 256 gray shades on monitor |
| | - 100-240VAC, 1100VA, 50/60Hz | - 100-240VAC, 1100VA, 50/60Hz |
| Acoustic Output | Track 3 | Track 3 |
| Display Standard | | |
| Software | - Q Scan | - Q Scan |
| Functionality | - ClearVision | - ClearVision |
| | - MultiVision | - MultiVision |
| | - Panoramic | - Panoramic |
| | - Needle Mate | - Needle Mate |
| | - Auto IMT+ | - Auto IMT+ |
| | - Strain+ | - Strain+ |
| | - Stress Echo | - Stress Echo |
| | - Elastoscan | - Elastoscan |
| | - E-Thyroid | - E-Thyroid |
| | - E-Breast | - E-Breast |
| | - E-Strain | - E-Strain |
| | - S-Shearwave | - S-Shearwave |
| | - S-Detect for Breast | - S-Detect for Breast |
| | - S-Detect for Thyroid | - S-Detect for Thyroid |
| | - HQ Vision | - HQ Vision |
| | - S-Fusion | - S-Fusion |
| Transducer | - Clear Track - Virtual Track
- S-3D Arterial
Analysis - ADVR
- 3D Imaging
- (Volume Data Acquisition)
- 3D Imaging presentation
- 3D Cine/4D Cine
- 3D Rendering MPR
- 3D XI MSV/Oblique View
- Volume CT
- 3D MagiCut
- Volume Calculation
- (VOCAL, XI VOCAL)
- XI STIC
- HDVI
- Realistic Vue
- Natural Vue
- CEUS+
- MV-Flow
- S-Shearwave Imaging
- CA1-7A
- CF4-9
- CA2-8A
- CA3-10A
- E3-12A
- L3-12A
- EA2-11B
- LA2-9A
- LA3-16A
- LA3-16AI
- LA4-18B
- LM4-15B
- PM1-6A
- PA3-8B
- PA4-12B
- MMPT3-7
- CV1-8A
- V5-9
- LV3-14A
- CW6.0
- DP2B
- DP8B
- EV3-10B | - Clear Track
- Virtual Track
- S-3D Arterial
Analysis - ADVR
- 3D Imaging
- (Volume Data Acquisition)
- 3D Imaging presentation
- 3D Cine/4D Cine
- 3D Rendering MPR
- 3D XI MSV/Oblique View
- Volume CT
- 3D MagiCut
- Volume Calculation
- (VOCAL, XI VOCAL)
- XI STIC
- HDVI
- Realistic Vue
- Natural Vue
- CEUS+
- MV-Flow
- S-Shearwave Imaging
- CA1-7A
- CF4-9
- CA2-8A
- CA3-10A
- E3-12A
- L3-12A
- EA2-11B
- LA2-9A
- LA3-16A
- LA3-16AI
- LA4-18B
- LM4-15B
- PM1-6A
- PA3-8B
- PA4-12B
- MMPT3-7
- CV1-8A
- V5-9
- LV3-14A
- CW6.0
- DP2B
- DP8B
- EV3-10B |
| Biopsy Guide | - BP-KIT-029 - BP-KIT-030
- BP-KIT-043 | - BP-KIT-029
- BP-KIT-030
- BP-KIT-043 |
| | | |
| | - BP-KIT-053 | - BP-KIT-053 |
| | - BP-KIT-054 | - BP-KIT-054 |
| | - BP-KIT-055 | - BP-KIT-055 |
| | - BP-KIT-057 | - BP-KIT-057 |
| | - BP-KIT-058 | - BP-KIT-058 |
| | - BP-KIT-059 | - BP-KIT-059 |
| | - BP-KIT-060 | - BP-KIT-060 |
| | - BP-KIT-067 | - BP-KIT-067 |
| | - BP-KIT-068 | - BP-KIT-068 |
| | - BP-KIT-069 | - BP-KIT-069 |
| | - BP-KIT-071 | - BP-KIT-071 |
| | - BP-KIT-075 | - BP-KIT-075 |
| | - BP-KIT-083 | |
| Digital | - Foot Switch | - Foot Switch |
| Storage/Transfer | - ECG (defibrillation proof) | - ECG |
| Station | - Gel Warmer | - Gel Warmer |
| | - Clear Track/ Virtual Track | - Clear Track/ Virtual Track |
| | - System Stand | System Stand |
| | - WLAN Card | - WLAN Card |
29
30
31
-
The PET/CT modality of the S-Fusion feature is substantially equivalent to PET/CT modality of Volume Navigation feature of the reference device, LOGIQ E9 (K142160).
-
The MV Index is substantially equivalent to Vascularity Index of the reference device, Aplio i900/i800/i700/i600 (K182679).
10. Summary of Non-Clinical Test
The proposed device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The RS85 and its applications comply with voluntary standards.
Test | Standards and FDA Guidance |
---|---|
Risk Management | ISO 14971 Second edition 2007 Medical devices - Application of risk management to |
medical devices | |
Electrical Safety | The RS85 Ultrasound System with defibrillation-proof ECG electrode was evaluated per |
the following standards. | |
ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010 | |
/(R)2012 | |
Medical Electrical Equipment - Part 1: General Requirements for basic safety and | |
essential performance. | |
Electromagnetic | |
Compatibility | IEC60601-1-2: 2014(4th Edition) Medical Electrical Equipment -- Part 1-2: General |
Requirements For Basic Safety And Essential Performance -- Collateral Standard: | |
Electromagnetic Disturbances -- Requirements And Tests | |
Biocompatibility | ISO 10993-1 Fourth edition 2009-10-15 Biological evaluation of medical devices - Part |
1: Evaluation and testing within a risk management process. |
32
| Reprocessing
Medical Devices | FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation
Methods and Labeling issued on March 17, 2015, revised June 9, 2017. |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software/Firmware-
driven Functionality | All migrated software functionality was evaluated using the same test criteria as the
predicate for all applicable imaging modes to ensure that migration into a new system
design did not compromise image quality with respect to the intended use of each
feature. |
| Software/Firmware-
driven Functionality | Guidance for the Content of Premarket Submissions for Software Contained in Medical
Devices issued on May 11, 2005 |
| Ultrasound Safety | Information for Manufacturers Seeking Marketing Clearance of
Diagnostic Ultrasound Systems and Transducers issued September 9, 2008 |
| | IEC60601-2-37:2007 + A1:2015, Particular requirements for the safety of ultrasonic
medical diagnostic and monitoring equipment |
| | NEMA UD 2-2004 (R2009)
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision
3 |
| | NEMA UD 3-2004 (R2009)
Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on
Diagnostic Ultrasound Equipment, Revision 2 |
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 RS85 to be as safe, as effective, and performance is substantially equivalent to the predicate device.
END of 510(K) Summary