(54 days)
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 clearly stated as a "Diagnostic Ultrasound System" for "diagnostic ultrasound imaging and fluid analysis", and its function is to "acquire ultrasound data and to display the data" for making a diagnosis. There is no mention of treating or ameliorating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The RS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body." Additionally, the "Device Description" calls it a "diagnostic ultrasound system" and states it "offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals."
No
The device description explicitly states it is a "general purpose, mobile, software controlled, diagnostic ultrasound system," indicating it includes hardware components for acquiring ultrasound data.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging and fluid analysis of the human body." This describes an imaging system used to visualize internal structures and potentially analyze fluids within the body, not to perform tests on samples outside the body.
- Device Description: The description focuses on acquiring and displaying ultrasound data in various modes (B mode, Doppler, etc.) and providing measurement and analysis packages for diagnosis. This aligns with the function of an imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) in vitro (outside the body). The device's function is based on emitting and receiving ultrasound waves to create images.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This ultrasound system does not fit that description.
N/A
Intended Use / Indications for Use
The RS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
Product codes
IYN, IYO and ITX
Device Description
The RS80A is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The RS80A also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The RS80A 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, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel. (Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients; Note 6: Abdominal organs and peripheral vessel)
Indicated Patient Age Range
Adult, Pediatric, Neonatal.
Intended User / Care Setting
Competent health care professionals. Not Found for care setting.
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)
Not applicable. The subject of this submission, RS80A, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K141620, K150478, K143089, K130803, K142466
Reference Device(s)
K142160, K132274, K131164, K130881, K021966
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three figures facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 12, 2015
SAMSUNG MEDISON CO., LTD. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K151663
Trade/Device Name: RS80A Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO and ITX Dated: July 29, 2015 Received: July 30, 2015
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael O'Hara
For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
RS80A Diagnostic Ultrasound System
Indications for Use (Describe)
The RS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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: RS80A Diagnostic Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetrics (See Note 3) | P | P | P | P | Note 1 | Notes 2, 4, 7, 8, 9, 11, 14 | ||
| Abdominal (See Note 10) | P | P | P | P | Note 1 | Notes 2, 4, 5, 6, 7, 8, 9, 11, 12, 14, 15 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | P | P | P | N | P | Note 1 | Notes 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) | ||||||||
| 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 K141620; 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+PPH+PW, B+PPI+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, 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
Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)
4
510(k) No.:
Device Name: CA1-7A for use with RS80A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler* | Combined* | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Notes 2,4,7,8,9,11,14 | ||
| Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Notes 2,6,7,8,9,11,14,15 | ||
| 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 K141620; 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+PD+PW, B+DPD+PW, B+PPI+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, 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
5
510(k) No.:
Device Name: C2-6 for use with RS80A
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) | 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, 6, 7, 8, 9, 11 | |||
| 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 | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K141620; 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+PPH+PW, B+PPI+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, 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: CF4-9 for use with RS80A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal/Obstetrics (See Note 3) | |||||||
| Abdominal (See Note 10) | P | P | P | P | Note 1 | Notes 8, 9, 11 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| & Other | Pediatric | P | P | P | P | Note 1 | Notes 8, 9, 11 | |
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | P | P | P | P | Note 1 | Notes 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 | Cardiac Adult | |||||||
| 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 K141620; 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+PPH+PW, B+PPI+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, 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
Image /page/6/Figure/24 description: The image contains text that states "Concurrence of Center for Devices and Radiological Health (CDRH)". The image also states "Prescription Use (Per 21 CFR 801.109)". The text is centered on the page.
7
510(k) No.:
Device Name: E3-12A for use with RS80A
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 | |||
| Fetal Imaging | ||||||||||
| & Other | Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | ||||||||||
| 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 | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Trans-esophageal (Cardiac) | ||||||||||
| Other (spec.) | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | |||||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K141620; 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+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: Spatial Compound Imaging
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 13: Includes Urology/Prostate
Note 14: S-Fusion Note 15: S-Shearwave
Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)
Indication for use
8
510(k) No.:
Device Name: L3-12A for use with RS80A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal/Obstetrics (See Note 3) | |||||||
| Abdominal (See Note 10) | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 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 | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA K141620; 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+PD+PW, B+DPD+PW, B+PPI+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, 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
9
510(k) No.:
Device Name: L5-13 for use with RS80A
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, 8, 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, 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 | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | ||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K141620; 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
10
510(k) No.:
Device Name: L7-16 for use with RS80A
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 | 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 K141620; 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+PD+PW, B+DPD+PW, B+PPI+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: 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
11
510(k) No.:
Device Name: LA2-9A for use with RS80A
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 | ||
| 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 K141620; 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
12
510(k) No.:
Device Name: PE2-4 for use with RS80A
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) | P | P | P | P | P | Note 1 | Note 7 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | P | P | P | P | Note 1 | Note 7 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (See Note 13) | ||||||||
| Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K141620; 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+PPH+PW, B+PPI+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, 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
13
510(k) No.:
Device Name: PM1-6A for use with RS80A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetrics (See Note 3) | ||||||||
| Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Note 7 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | P | P | P | P | Note 1 | Note 7 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (See Note 13) | ||||||||
| Cardiac | 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 K141620; 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
Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)
14
510(k) No.:
Device Name: V5-9 for use with RS80A
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 | |
| 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 | |
| Trans-vaginal | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9 | |
| 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 | |
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K141620; 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, 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
15
510(k) No.:
Device Name: LV3-14A for use with RS80A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler* | Combined* | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal/Obstetrics (See Note 3) | |||||||||
| Abdominal (See Note 10) | |||||||||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging | |||||||||
| & Other | Laparoscopic | ||||||||
| Pediatric | |||||||||
| Small Organ (See Note 5) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | ||
| Intra-luminal | |||||||||
| Other (See Note 13) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA K141620; 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, 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
16
510(k) No.:
Device Name: CW6.0 for use with RS80A
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 K141620; 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, 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
17
510(k) No.:
Device Name: CA2-8A for use with RS80A
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 K143089 ; 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+ID, B+CV, B+C+PW, B+PD+PW, B+DPD+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: LA3-16A for use with RS80A
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 | Laparoscopic | ||||||||
| & | |||||||||
| Other | Pediatric | ||||||||
| Small Organ (See Note 5) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11, 12 | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | ||
| Intra-luminal | |||||||||
| Other (See Note 13) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | |
| Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA K150478; 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+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+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, 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
19
510(k) No.:
Device Name: LA3-16AI for use with RS80A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetrics (See Note 3) | ||||||||
| Abdominal (See Note 10) | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & | ||||||||
| Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | P | Note 1 | Note 7, 9, 11 | |
| Musculo-skel. (Superfic.) | P | P | P | P | P | Note 1 | Note 7, 9, 11 | |
| Intra-luminal | ||||||||
| Other (See Note 13) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Note 7, 9, 11 |
| Other (spec.) |
N= new indication; P= previously cleared by FDA K150478 (LS6-15); 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+PD+PW, B+PPI+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, 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: LA4-18B for use with RS80A
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) | N | N | N | N | N | 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.) | N | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | |
| Musculo-skel. (Superfic.) | N | N | N | N | N | 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 | N | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 |
| 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+ID, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+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
21
510(k) No.:
Device Name: PA3-8B for use with RS80A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | Combined* | Other | |
| (Track I only) | (Tracks I & III) | Doppler* | (Spec.) | (Spec.) | |||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal/Obstetrics (See Note 3) | |||||||||
| Abdominal (See Note 10) | P | P | P | P | P | Note 1 | |||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging | Laparoscopic | ||||||||
| & | |||||||||
| Other | Pediatric | P | P | P | N | P | Note 1 | ||
| Small Organ (See Note 5) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | P | P | P | P | P | Note 1 | |||
| 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 | Peripheral vessel | ||||||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA K130803 (P3-8); 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+PD+PW, B+PPI+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, 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
22
510(k) No.:
Device Name: PA4-12B for use with RS80A
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 2 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | N | P | Note 1 | Note 2 | |
| 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 | 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 K142466 (P4-12); 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+ID, B+CV, B+C+PW, B+PD+PW, B+DPD+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
23
510(k) No.:
Device Name: CV1-8A for use with RS80A
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 1 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 K150478; 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+PD+PW, B+PPI+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, 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
24
510(k) No.:
Device Name: V4-8 for use with RS80A
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 K150478; 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+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, 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
25
510(k) No.:
Device Name: DP2B for use with RS80A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetrics (See Note 3) | ||||||||
| Abdominal (See Note 10) | ||||||||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (See Note 13) | ||||||||
| Cardiac | Cardiac Adult | P | ||||||
| Cardiac Pediatric | P | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K150478; 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+PD+PW, B+PPI+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, 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
26
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
1. Submitter's Information: 21 CFR 807.92(a)(1)
SAMSUNG MEDISON CO., LTD. 42, Teheran-ro 108-gil, Gangnam-gu, Seoul. Korea
Contact Person:
Kyeong-Mi, Park Regulatory Affairs Manager
| Telephone: | 82.2.2194.1373 |
|---|---|
| Facsimile: | 82.2.556.3974 |
Data Prepared: March 24, 2013
2. Name of the device:
| Common/Usual Name: | ||
|---|---|---|
| Diagnostic Ultrasound System and Accessories | ||
| Proprietary Name: | ||
| RS80A Diagnostic Ultrasound System | ||
| Classification Names: | FR Number | Product Code |
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | IYN |
| Ultrasound Pulsed Echo Imaging System | 892.1560 | IYO |
3. Identification of the predicate or legally marketed device:
- RS80A Diagnostic Ultrasound System (K141620) -
- A35 Diagnostic Ultrasound System (K150478) -
- -WS80A Diagnostic Ultrasound System (K143089)
- HM70A Diagnostic Ultrasound System (K130803) -
- -PT60A Diagnostic Ultrasound System (K142466)
- -LOGIQ E9 Diagnostic Ultrasound System (K142160)
- Aixplorer Diagnostic Ultrasound System (K132274) -
- -S2000/S3000 Diagnostic Ultrasound System (K131164/K130881)
- -QLAB (K021966)
27
4. Device Description:
The RS80A is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The RS80A also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The RS80A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
5. Intended Uses:
The RS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
6. Technological Characteristics:
The RS80A is substantially equivalent with respect to safety, effectiveness, and functionality to the RS80A Diagnostic Ultrasound System (K141620), A35 Diagnostic Ultrasound System (K150478), WS80A Diagnostic Ultrasound System (K143089), HM70A Diagnostic Ultrasound System (K130803) and PT60A Diagnostic Ultrasound System (K142466).
- It is substantially equivalent with respect to safety, effectiveness, and functionality to the Realistic Vue of RS80A (K141620) in regards to the device with Natural Vue.
- It is substantially equivalent with respect to safety, effectiveness, and functionality to the Clear Track of RS80A (K141620) in regards to the device with Virtual Track.
- It is substantially equivalent with respect to safety, effectiveness, and functionality to the Breast Productivity package® of GE's LOGIO E9 (K142160) in regards to the device with S-Detect.
- It is substantially equivalent with respect to safety, effectiveness, and functionality to the Volume Navigation® of GE's LOGIQ E9 (K142160) in regards to the device with S-Fusion.
- It is substantially equivalent with respect to safety, effectiveness, and functionality to the VTQ2 of Siemens's S2000/S3000 (K131164) and Shearwave elastography® of SSI's AIXPLORER (K132274) in regards to the device with S-Shearwave.
- It is substantially equivalent with respect to safety, effectiveness, and functionality to the Elastoscan of RS80A (K141620) and Philips's QLAB ROI® (K021966) in regards to the device with E-Thyroid.
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- It is substantially equivalent with respect to safety, effectiveness, and functionality to the Elastoscan of RS80A (K141620) and Shearwave elastography® of SSI's AIXPLORER (K132274) in regards to the device with E-Breast.
All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All system allow for specialized measurements of structures and flow and calculations.
These are described in detail in the technological characteristics comparison table as below.
| RS80A | V2.00 | Remarks | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | ||||||||||||||||||||||
| application | • No addition | |||||||||||||||||||||
| Operation of | ||||||||||||||||||||||
| modes | • No addition | |||||||||||||||||||||
| Applied | ||||||||||||||||||||||
| transducers | • Addition of 9 transducers | |||||||||||||||||||||
| : CA2-8A, LA3-16A, LA3-16AI, LA4- | ||||||||||||||||||||||
| 18B, PA3-8B, PA4-12B, CV1-8A, V4- | ||||||||||||||||||||||
| 8 and DP2B. | Transducers The previously | |||||||||||||||||||||
| cleared transducers CA2-8A K143089 LA3-16A K150478 LA3-16AI K150478 (LS6-15) LA4-18B None PA3-8B K130803 PA4-12B K142466 (P4-12) CV1-8A K150478 V4-8 K150478 DP2B K150478 | ||||||||||||||||||||||
| SW Features | • Adding the new S/W features | |||||||||||||||||||||
| : Natural Vue, S-Shearwave, S-Fusion, | ||||||||||||||||||||||
| Virtual Track, S-Detect, E-Thyroid, E- | ||||||||||||||||||||||
| Breast | ||||||||||||||||||||||
| • Adding the predicate S/W feature | ||||||||||||||||||||||
| : Needle Mate, Strain+, StressEcho | ||||||||||||||||||||||
| • Improving the S/W feature that was | ||||||||||||||||||||||
| previously cleared in RS80A(K141620) | ||||||||||||||||||||||
| : DICOM, EZ Exam+ | ||||||||||||||||||||||
| • Changing the S/W feature's name |
- SCI (Spatial Compound Imaging) →
MultiVision - Low MI → CUES+
- EZexam → EZexam+
Software improvements migrated from
predicate device as below. | Description of S/W Features
• Natural Vue: This function allows realistic
visualization of 3D Volume Data by specular
shading technique. It is a rendering method
that uses global illumination and used to
create a realistic volume rendering image.
• S-Shearwave: It provides the user with tissue
stiffness information. This is mainly used to
help diagnose hepatic tissues.
• S-Fusion: Based on the 3 dimensional CT,
MR, ultrasound (US) images acquired
previously, the sensors installed in the probe
will be used to adjust with the real-time
ultrasound wave. The position of the probe
will be tracked to display the real-time
ultrasound image of the same plane and the
registered 3-dimensional image
• Virtual Track: This module tracks the
direction of needle by using the sensing
device.
• S-Detect: This module analyzes the selected
lesion from the ultrasound image and shows | | | | | | | | | | | | | | | | | | | | |
| | SW Features The previously
cleared SW
Features Needle Mate K142466 Strain+ K150478 | | | | | | | | | | | | | | | | | | | | | |
29
| RS80A | V2.00 | Remarks | ||||
|---|---|---|---|---|---|---|
| StressEcho | ||||||
| K150478 | the analyzed data. | |||||
| • E-Thyroid: This function assists with the | ||||||
| diagnosis of thyroid lesions. ROI is used to | ||||||
| show the contrast of an elastogram. | ||||||
| • E-Breast: This is the function for breast | ||||||
| lesion exam. Calculates the strain between | ||||||
| the area of the suspected lesion (ROI) and | ||||||
| normal breast fat and displays the results. | ||||||
| • Stress Echo: It provides functions to support | ||||||
| cardio-vascular application. It's for diagnosis | ||||||
| of heart moving, using by agents or | ||||||
| exercises. | ||||||
| • Strain: It provides functions to support | ||||||
| cardio-vascular application. It's for diagnosis | ||||||
| of heart moving, using by motion vector. | ||||||
| HW Features | • Applying the previously cleared | |||||
| Wireless LAN Card with system. HW Features The previously | ||||||
| cleared HW | ||||||
| Features Wireless LAN Card K142466 | • Wireless LAN Card: It is intended use a USB | |||||
| adapter to connect the system to a wireless | ||||||
| network. |
| Feature /
Characteristics | The subject
device
RS80A
V2.00 | The predicate devices | | | | | |
|--------------------------------------------------------|-----------------------------------------|-----------------------|------------------|--------------------|--------------------|--------------------|-----------------------|
| | | RS80A
(K141620) | A35
(K150478) | WS80A
(K143089) | HM70A
(K130803) | PT60A
(K142466) | LOGIQ E9
(K123564) |
| Indication for Use | | | | | | | |
| - Fetal/Obstetrics | √ | √ | √ | √ | √ | √ | √ |
| - Abdominal | √ | √ | √ | √ | √ | √ | √ |
| - Gynecology | √ | √ | √ | √ | √ | √ | √ |
| - Pediatric | √ | √ | √ | √ | √ | √ | √ |
| - Small Organ | √ | √ | √ | √ | √ | √ | √ |
| - Neonatal Cephalic | √ | √ | √ | √ | √ | √ | √ |
| - Adult Cephalic | √ | √ | √ | √ | √ | √ | √ |
| - Trans-rectal | √ | √ | √ | √ | √ | √ | √ |
| - Trans-vaginal | √ | √ | √ | √ | √ | √ | √ |
| - Musculo-skeletal
(Conventional) | √ | √ | √ | √ | √ | √ | √ |
| - Musculo-skeletal
(Superficial) | √ | √ | √ | √ | √ | √ | √ |
| - Urology | √ | √ | √ | √ | √ | √ | √ |
| - Cardiac Adult | √ | √ | √ | √ | √ | √ | √ |
| - Cardiac Pediatric | √ | √ | √ | √ | √ | √ | √ |
| - Peripheral vessel | √ | √ | √ | √ | √ | √ | √ |
| Scanhead Types | | | | | | | |
| - Linear Array | √ | √ | √ | √ | √ | √ | √ |
| - Curved Linear Array | √ | √ | √ | √ | √ | √ | √ |
| Feature /
Characteristics | The subject
device
RS80A
V2.00 | RS80A
(K141620) | A35
(K150478) | WS80A
(K143089) | HM70A
(K130803) | PT60A
(K142466) | LOGIQ E9
(K123564) |
| - Endocavity | √ | √ | √ | √ | √ | √ | √ |
| - Phased Array | √ | √ | √ | √ | √ | √ | √ |
| - Static Probes | √ | √ | √ | √ | √ | √ | √ |
| Scanhead Frequency | | | | | | | |
| 1.0 ~ 20.0 MHz | √ | √ | √ | √ | √ | √ | √ |
| Modes of Operation | | | | | | | |
| - B-mode | √ | √ | √ | √ | √ | √ | √ |
| - M-mode | √ | √ | √ | √ | √ | √ | √ |
| - Pulsed wave (PW)
Doppler | √ | √ | √ | √ | √ | √ | √ |
| - Continuous wave
(CW) Doppler | √ | √ | √ | √ | √ | √ | √ |
| - Color Doppler | √ | √ | √ | √ | √ | √ | √ |
| - Power Amplitude
Doppler | √ | √ | √ | √ | √ | √ | √ |
| - Tissue Harmonic
Imaging | √ | √ | √ | √ | √ | √ | √ |
| - 3D/4D imaging
mode | √ | √ | √ | √ | √ | √ | √ |
| - Combined modes | √ | √ | √ | √ | √ | √ | √ |
| Safety & EMC
Compliance | | | | | | | |
| - IEC 60601-1 | | | | | | | |
| - UL 60601-1 | √ | √ | √ | √ | √ | √ | √ |
| - CSA C22.2 No.601.1 | | | | | | | |
| - IEC 60601-2-37 | √ | √ | √ | √ | √ | √ | √ |
| - IEC 60601-1-2
Acoustic Output Display
Standard | √ | √ | √ | √ | √ | √ | √ |
| Track 3 | √ | √ | √ | √ | √ | √ | √ |
| Patient Contact
Materials | | | | | | | |
| Tested to ISO 10993-1 | √ | √ | √ | √ | √ | √ | √ |
| Functionality | | | | | | | |
| - Q Scan | √ | √ | √ | √ | √ | √ | - |
| - ClearVision | √ | √ | √ | √ | √ | √ | - |
| - Spatial Compound
Imaging | √1) | √ | √ | √1) | √ | √1) | - |
| - Panoramic | √ | √ | √ | √ | √ | √ | - |
| - Needle Mate | √ | √ | | | | √ | - |
| - Auto IMT+
(Auto IMT) | √ | √ | √ | √ | √ | √ | - |
| - Strain+ | √ | | | | | | |
| - Stress Echo | √ | | | | | | |
| - Elastoscan | √ | √ | √ | √ | √ | √ | √ |
| - E-Thyroid | √
(Table 2) | | | | | | |
| - E-Breast | √
(Table 2) | | | | | | |
| Feature /
Characteristics | The subject
device | The predicate devices | | | | | |
| | RS80A
V2.00
(Table 2) | RS80A
(K141620) | A35
(K150478) | WS80A
(K143089) | HM70A
(K130803) | PT60A
(K142466) | LOGIQ E9
(K123564) |
| - S-Detect | √ | √ | | | | | √3) |
| - S-Fusion | √ | | | | | | √4) |
| - Clear Track | √ | √ | | | | | √ |
| - Virtual Track | √ | | | | | | √ |
| - ADVR | √ | √ | √ | √ | √ | | - |
| - 3D Imaging
(Volume Data
Acquisition) | √ | √ | √ | √ | √ | | √ |
| - 3D Imaging
presentation | | | | | | | - |
| 3D Cine/4D Cine | √ | √ | √ | √ | √ | | - |
| - 3D Rendering
MPR | √ | √ | √ | √ | √ | | - |
| - 3D XI
MSV/Oblique View | √ | √ | √ | √ | √ | | - |
| - 3D MXI
Volume Slice/Mirror View | √ | √ | √ | √ | | | - |
| - Volume CT | √ | √ | √ | √ | √ | | - |
| - 3D MagiCut | √ | √ | √ | √ | √ | | - |
| - Volume Calculation
(VOCAL, XI VOCAL) | √ | √ | √ | √ | √ | | - |
| - XI STIC | √ | √ | √ | √ | √ | | - |
| - HDVI | √ | √ | √ | √ | √ | | - |
| - Realistic Vue | √ | √ | √2) | √2) | | | - |
| - Natural Vue | √ | | | | | | - |
30
31
| The subject device | The predicate devices | |||
|---|---|---|---|---|
| Feature / Characteristics | RS80A | |||
| V2.00 | Aixplorer | |||
| (K132274) | S2000/S3000 | |||
| (K131164/ | ||||
| K130881) | QLAB | |||
| (K021966) | ||||
| Indication for Use | ||||
| - Fetal/Obstetrics | √ | √ | - | |
| - Abdominal | √ | √ | √ | - |
| - Gynecology | √ | √ | √ | - |
| - Pediatric | √ | √ | √ | - |
| - Small Organ | √ | √ | √ | - |
| - Neonatal Cephalic | √ | √ | √ | - |
| - Adult Cephalic | √ | √ | - | |
| - Trans-rectal | √ | √ | √ | - |
| - Trans-vaginal | √ | √ | √ | - |
| - Musculo-skeletal | ||||
| (Conventional) | √ | √ | √ | - |
| - Musculo-skeletal | ||||
| (Superficial) | √ | √ | √ | - |
| - Urology | √ | √ | - | |
| - Cardiac Adult | √ | √ | - | |
| Feature / Characteristics | The subject device | |||
| RS80A | ||||
| V2.00 | Aixplorer | |||
| (K132274) | The predicate devices | |||
| S2000/S3000 | ||||
| (K131164/ | ||||
| K130881) | QLAB | |||
| (K021966) | ||||
| - Cardiac Pediatric | √ | √ | - | |
| - Peripheral vessel | √ | √ | √ | - |
| Scanhead Types | ||||
| - Linear Array | √ | √ | √ | - |
| - Curved Linear Array | √ | √ | √ | - |
| - Endocavity | √ | √ | √ | - |
| - Phased Array | √ | √ | - | |
| - Static Probes | √ | √ | - | |
| Scanhead Frequency | ||||
| 1.0 ~ 20.0 MHz | √ | √ | √ | - |
| Modes of Operation | ||||
| - B-mode | √ | √ | √ | - |
| - M-mode | √ | √ | √ | - |
| - Pulsed wave (PW) | ||||
| Doppler | √ | √ | √ | - |
| - Continuous wave | ||||
| (CW) Doppler | √ | √ | √ | - |
| - Color Doppler | √ | √ | √ | - |
| - Power Amplitude | ||||
| Doppler | √ | √ | √ | - |
| - Tissue Harmonic | ||||
| Imaging | √ | √ | √ | - |
| - 3D/4D imaging mode | √ | √ | √ | - |
| - Combined modes | √ | √ | √ | - |
| Safety & EMC Compliance | ||||
| - IEC 60601-1 |
- UL 60601-1
- CSA C22.2No.601.1 | √ | √ | √ | - |
| - IEC 60601-2-37 | √ | √ | √ | - |
| - IEC 60601-1-2 | √ | √ | √ | - |
| Acoustic Output Display
Standard | √ | √ | √ | - |
| Track 3
Patient Contact
Materials | √ | √ | √ | - |
| Tested to ISO 10993-1 | √ | √ | √ | - |
| Functionality | | | | |
| - Q Scan | √ | | | - |
| - ClearVision | √ | | | - |
| - Spatial Compound
Imaging | √1) | √ | √ | - |
| - Panoramic | √ | √ | √ | - |
| - Needle Mate | √ | | | - |
| - Auto IMT+
(Auto IMT) | √ | | | - |
| - Strain+ | √ | | | - |
| - Stress Echo | √ | | | - |
| | The subject device | The predicate devices | | |
| Feature / Characteristics | RS80A
V2.00 | Aixplorer
(K132274) | S2000/S3000
(K131164/
K130881) | QLAB
(K021966) |
| - E-Thyroid | √ | | | √ 5) |
| - E-Breast | √ | √ 6) | | - |
| - S-Shearwave | √ | √ 6) | √ 7) | - |
| - S-Detect | √ | | | - |
| - S-Fusion | √ | | | - |
| - Clear Track | √ | | | - |
| - Virtual Track | √ | | | - |
| - 3D Imaging | √ | √ | √ | - |
32
33
| 1) The name of the feature is changed to MultiVision.
2) The old name of this feature is FRV.
3) Breast Productivity Package | 4) Volume Navigation
5) QLAB ROI
6) Shearwave Elastography
7) VTQ |
| ------------------------------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------------------------- |
|---|
34
7. A brief discussion of the bench and non-clinical tests conducted on the subject device
The device has been evaluated for acoustic output, biocompatibility effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform to applicable medical device safety standards.
The RS80A and its application comply with voluntary standards as below:
- UL 60601-1, Safety requirements for Medical Equipment
- CSA C22.2 No. 601.1, Safety requirements for Medical Equipment
- IEC60601-2-37, Diagnostic Ultrasound Safety Standards
- EN/IEC60601-1, Safety requirements for Medical Equipment
- EN/IEC60601-1-2, EMC requirements for Medical Equipment
- NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- ISO10993-1, Biocompatibility
- ISO14971, Application of risk management to medical devices
Summary of Clinical Tests:
Not applicable. The subject of this submission, RS80A, did not require clinical studies to support substantial equivalence.
8. Conclusion
Intended uses and other key features are consistent with traditional clinical practices and FDA guidelines. The design, development and quality process of the manufacturer confirms with 21 CFR 820 and ISO 13485. The device is designed to conform to applicable medical device safety standards and compliance. Therefore, SAMSUNG MEDISON CO., LTD. considers the RS80A to be as safe, as effective, and performance is substantially equivalent to the predicate devices.