(121 days)
Not Found
Unknown
The summary mentions "BiometryAssist" and "IOTA-ADNEX" as features tested for performance. While these features could potentially utilize AI/ML for automated measurements or analysis, the summary does not explicitly state that AI/ML is used in their implementation. Without further information, it's impossible to confirm the presence of AI/ML.
No
The device is described as a "diagnostic ultrasound system" intended 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 indication that it is used for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The WS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body." The "Device Description" also refers to it as a "diagnostic ultrasound system".
No
The device description explicitly states it is a "diagnostic ultrasound system," which inherently includes hardware components (transducers, processing unit, display) to acquire and display ultrasound data. While it is "software controlled," it is not solely software.
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 in-vivo (within the living body) diagnostic process, not an in-vitro (outside the living body) diagnostic process.
- Device Description: The description details how the system acquires and processes ultrasound data to display images of anatomical structures and fluid flow within the body. This is characteristic of an ultrasound system used for in-vivo imaging.
- Mechanism of Action: The device transmits ultrasonic energy into patients and processes the received echoes. This is the fundamental principle of ultrasound imaging, which is an in-vivo modality.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) outside the body, which is the defining characteristic of an IVD.
While the device is used for diagnosis, the method of diagnosis is through imaging the body directly, not by analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The WS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel. (from page 2)
The WS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel. (from page 31)
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The WS80A 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, M 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 WS80A 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 WS80A 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
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel. Specific organs mentioned include thyroid, breast, scrotum, penis, renal, and pelvis.
Indicated Patient Age Range
Adult, Pediatric, Neonatal (implied by "Neonatal Cephalic", "Adult Cephalic", and "Cardiac Pediatric" applications, and also by "adult, pediatric and neonatal patients" in Note 5)
Intended User / Care Setting
Competent health care professionals (implied by "analysis packages that provide information that is used to make a diagnosis by competent health care professionals.")
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Performance tests were conducted to test the functionality of the "IOTA-ADNEX" and "BiometryAssist". Image performance assessments were conducted to the "CrystalVue Flow" and Needle Mate". These tests have been performed to assess the functionality of the subject device. Results of all conducted testing and assessments were found acceptable and did not raise any new issues of safety or effective.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance tests were conducted to test the functionality of the "IOTA-ADNEX" and "BiometryAssist". Image performance assessments were conducted to the "CrystalVue Flow" and Needle Mate". These tests have been performed to assess the functionality of the subject device. Results of all conducted testing and assessments were found acceptable and did not raise any new issues of safety or effective.
Summary of Clinical Tests: Not applicable. The subject of this submission, WS80A, 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.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 seal of the Department of Health and Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus with three human profiles facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the logo.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 9, 2017
SAMSUNG MEDISON CO., LTD. % Emily Woo Regulatory Affairs Manager 42. Teheran-ro 108-gil Gangnam-gu. Seoul 06176 KOREA
Re: K171070
Trade/Device Name: WS80A Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: July 12, 2017 Received: July 25, 2017
Dear Emily Woo:
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
1
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.
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/ResourcesforYou/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,
Michael D. O'HaraFor
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)
K171070
Device Name WS80A Diagnostic Ultrasound System
Indications for Use (Describe)
The WS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) No.:
Device Name: WS80A 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, 5, 6, 7, 8, 9, 11, 12 | |
| Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Notes 2, 4, 5, 6, 7, 8, 9,10, 11, 12 | |
| 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, 4, 6, 7, 8, 9, 11 | |
| Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 12 | ||
| Neonatal Cephalic | P | P | P | P | P | Note 1 | Notes 7 | |
| 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 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | ||
| Intra-luminal | ||||||||
| Other (spec.) (See Note 13) | P | P | P | P | Note 1 | Notes 2, 7,8, 9, 11, 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 | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA K153529; 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+DD+PW, B+PPI+PW, B+PPI+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
- 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
4
510(k) No.:
Device Name: SC1-6 for use with WS80A
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, 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 (spec.) (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 K153529; 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+DD+PW, B+PD+PW, B+PPI+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
-
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
5
510(k) No.:
Device Name: C2-6 for use with WS80A
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 | P | Note 1 | Notes 2, 4, 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.) | ||||||||
| 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) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K153529; 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+DD+PW, B+PD+PW, B+PPI+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
-
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
6
510(k) No.:
Device Name: E3-12A for use with WS80A
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, 8, 7, 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 (spec.) (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 K153529; 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+PPH+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
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
7
510(k) No.:
Device Name: VR5-9 for use with WS80A
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 | Note 1 | Note 2, 7, 8, 9, 12 | ||
| Trans-vaginal | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) (See Note 13) | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | ||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K153529; 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+PPH+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
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
8
510(k) No.:
Device Name: L3-12A for use with WS80A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetrics (See Note 3) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | ||
| Abdominal (See Note 10) | P | P | P | P | Note 1 | Notes 2, 4, 6, 7, 9, 11 | ||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | Laparoscopic | |||||||
| & | ||||||||
| Other | Pediatric | P | P | P | P | Note 1 | Notes 2, 4, 6, 7, 9, 11 | |
| 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 (spec.) (See Note 13) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | |
| Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA153529; 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+PPH+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
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
9
510(k) No.:
Device Name: L5-13 for use with WS80A
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, 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 (spec.) (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 K153529; 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+PPH+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
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
10
510(k) No.:
Device Name: V4-8 for use with WS80A
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 | P | Note 1 | Note 2, 4, 7, 8, 9, 11 |
| Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Note 2, 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 (spec.) (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 K153529; 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+PPH+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
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
11
510(k) No.:
Device Name: V5-9 for use with WS80A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetrics (See Note 3) | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 11 | ||
| Abdominal (See Note 10) | P | P | P | P | Note 1 | Note 2, 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 | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 11 | ||
| Trans-vaginal | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 11 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) (See Note 13) | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11 | ||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA K153529; 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+PPH+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
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
12
510(k) No.:
Device Name: CA1-7A for use with WS80A
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 | P | Note 1 | Notes 2, 4, 7, 8, 9, 11 |
| Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11, 13 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| 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 | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K153529; 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+PPH+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
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
13
510(k) No.:
Device Name: CA2-8A for use with WS80A
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 | ||
| Abdominal (See Note 10) | P | 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 | Peripheral vessel | ||||||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA K153529; 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+PPH+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
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
14
510(k) No.:
Device Name: CF4-9 for use with WS80A
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 | |||||||||
| 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 K153529; 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+PPF+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
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
15
510(k) No.:
Device Name: LA3-16A for use with WS80A
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 Imaging | ||||||||||
| & Other | Fetal (See Note 3) | |||||||||
| Abdominal (See Note 10) | ||||||||||
| Intra-operative (See Note 6) | ||||||||||
| Intra-operative (Neuro.) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (See Note 5) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11, 12 | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Cardiac) | ||||||||||
| Musculo-skel. (Convent.) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | |||
| Musculo-skel. (Superfic.) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | |||
| Intra-luminal | ||||||||||
| Other (See Note 13) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Trans-esophageal (Cardiac) | ||||||||||
| Other (spec.) | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | ||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K153529; 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+PPF+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
Note 2: Includes imaging for guidance of biopsy
- Note 3: Includes infertility monitoring of follicle development
- 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 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
16
510(k) No.:
Device Name: PE2-4 for use with WS80A
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 | 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 | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA K153529; 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+DD+PW, B+DPD+PW, B+PPF+PW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
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
17
510(k) No.:
Device Name: CV1-8A for use with WS80A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetrics (See Note 3) | P | P | P | P | Note 1 | Note 2, 4, 7, 8, 9, 11 | ||
| Abdominal (See Note 10) | P | P | P | P | Note 1 | Note 2, 7, 8, 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 (spec.) (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 K153529; 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+PPF+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
Note 2: Includes imaging for guidance of biopsy
- Note 3: Includes infertility monitoring of follicle development
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 4: Color M-mode
18
510(k) No.:
Device Name: LV3-14A for use with WS80A
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 K153529; 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+PPF+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
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
19
510(k) No.:
Device Name: CA2-9A for use with WS80A
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 | |
| Abdominal (See Note 10) | P | 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 K153529; 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+PPH+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
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
20
510(k) No.:
Device Name: CA3-10A for use with WS80A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler* | Combined* | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal/Obstetrics (See Note 3) | P | P | P | P | Note 1 | Notes 2, 3, 7, 8, 9, 11 | |||
| Abdominal (See Note 10) | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11 | |||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging | |||||||||
| & Other | Laparoscopic | ||||||||
| Pediatric | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11 | |||
| Small Organ (See Note 5) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| 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 2, 7, 8, 9, 11 | ||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K153529; 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+PPF+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
Note 2: Includes imaging for guidance of biopsy
- Note 3: Includes infertility monitoring of follicle development
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 4: Color M-mode
21
510(k) No.:
Device Name: EA2-11B for use with WS80A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler* | Combined* | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal/Obstetrics (See Note 3) | P | P | P | P | Note 1 | Note 2, 7, 8, 9 | |||
| Abdominal (See Note 10) | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | |||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging | Laparoscopic | ||||||||
| & | |||||||||
| Other | Pediatric | ||||||||
| Small Organ (See Note 5) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | |||
| Trans-vaginal | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | |||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (See Note 13) | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | |||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA K153529; 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+PPH+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
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
22
510(k) No.:
Device Name: LA2-9A for use with WS80A
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 | 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 K153529; 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+PPF+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
Note 2: Includes imaging for guidance of biopsy
- Note 3: Includes infertility monitoring of follicle development
- 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 4: Color M-mode
23
510(k) No.:
Device Name: LA3-16AI for use with WS80A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetrics (See Note 3) | ||||||||
| Abdominal (See Note 10) | ||||||||
| Intra-operative (See Note 6) | P | P | P | P | Note 1 | Note 7, 9, 11 | ||
| Intra-operative (Neuro.) | P | P | P | P | Note 1 | Note 7, 9, 11 | ||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Note 7, 9, 11 | ||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 7, 9, 11 | ||
| Intra-luminal | ||||||||
| Other (See Note 13) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | Note 1 | Note 7, 9, 11 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA K153529; 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+PPF+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
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
24
510(k) No.:
Device Name: LA4-18B for use with WS80A
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 | |||
| 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 K153529; 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+PPF+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
- 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 4: Color M-mode
25
510(k) No.:
Device Name: PA3-8B for use with WS80A
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 K153529; 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+PPF+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
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
26
510(k) No.:
Device Name: PM1-6A for use with WS80A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetrics (See Note 3) | ||||||||
| Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Note 7 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | P | P | P | P | Note 1 | Note 7 | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (See Note 13) | ||||||||
| Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K153529; 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+PPF+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
Note 2: Includes imaging for guidance of biopsy
- Note 3: Includes infertility monitoring of follicle development
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 4: Color M-mode
27
510(k) No.:
Device Name: EV3-10B for use with WS80A
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, 12 | |
| Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 11, 12 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | Laparoscopic | |||||||
| & | ||||||||
| Other | Pediatric | |||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 11, 12 | |
| Trans-vaginal | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 11, 12 | |
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (See Note 13) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 11, 12 | |
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA; 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+PPF+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
Note 2: Includes imaging for guidance of biopsy
- Note 3: Includes infertility monitoring of follicle development
- 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 4: Color M-mode
28
510(k) No.:
Device Name: LM4-15B for use with WS80A
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 | ||
| 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 K162094; 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+PPF+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
- 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
29
510(k) No.:
Device Name: PA4-12B for use with WS80A
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 | Note 1 | |||
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | P | P | P | P | Note 1 | |||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | P | P | P | P | Note 1 | |||
| 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 | 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 K162094; 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+PPF+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
Note 2: Includes imaging for guidance of biopsy
-
Note 3: Includes infertility monitoring of follicle development
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 4: Color M-mode
30
510(k) Premarket Notification - Traditional
Image /page/30/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue, oval-shaped background. The oval is tilted slightly, giving the logo a dynamic appearance.
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:
Emily Woo Regulatory Affairs Manager
| Telephone: | 82.2.2194.7120 |
|---|---|
| Facsimile: | 82.2.556.3974 |
Data Prepared: July 12, 2017
2. Device Name and Classification:
| Common/Usual Name: | Diagnostic Ultrasound System and Accessories | ||
|---|---|---|---|
| Proprietary Name: | WS80A Diagnostic Ultrasound System | ||
| Device Class: | Class II | ||
| Classification Names | |||
| /FR Number/ | |||
| Product Code: | Ultrasonic Pulsed Doppler Imaging System | ||
| Ultrasound Pulsed Echo Imaging System | |||
| Diagnostic Ultrasound Transducer | 892.1550 | ||
| 892.1560 | |||
| 892.1570 | IYN | ||
| IYO | |||
| ITX |
3. Identification of the predicate or legally marketed device:
- WS80A Diagnostic Ultrasound System (K153529) -
- -RS80A Diagnostic Ultrasound System (K162094)
- -Voluson E8 Diagnostic Ultrasound System (K142472)
31
510(k) Premarket Notification - Traditional
Image /page/31/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The oval is tilted slightly, giving the logo a dynamic appearance.
4. Device Description:
The WS80A 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, M 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 WS80A 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 WS80A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
5. Intended Use:
The WS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
6. Substantial Equivalence:
The WS80A is substantially equivalent with respect to safety, effectiveness, and functionality to the WS80A Diagnostic Ultrasound System (K153529), RS80A Diagnostic Ultrasound System (K162094), and Voluson E8 Diagnostic Ultrasound System (K142472).
It is substantially equivalent with respect to safety, effectiveness, and functionality to the [LR21] of Voluson E8 (K142472) in regards to the device with [IOTA-ADNEX]. It is substantially equivalent with respect to safety, effectiveness, and functionality to the [Sono Biometry2] of Voluson E8 (K142472) in regards to the device with [Biometry Assist]. It is substantially equivalent with respect to safety, effectiveness, and functionality to the [Crystal Vue2] of WS80A (K1535529) in regards to the device with [CrystalVue Flow].
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.
32
510(k) Premarket Notification – Traditional
Image /page/32/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The font is sans-serif and bold, and the oval is tilted slightly.
| WS80A | V4.00 | Comment | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | ||||||||||
| application | • No addition | |||||||||
| Operation of | ||||||||||
| modes | • No addition | |||||||||
| Applied | ||||||||||
| transducers | • Addition of 3 transducers | |||||||||
| : EV3-10B, LM4-15B and PA4-12B | Transducers The previously cleared transducers EV3-10B None (but upgraded from V5-9 in K153529) LM4-15B K162094 PA4-12B K162094 | |||||||||
| SW Features | • Adding the new S/W features | |||||||||
| : IOTA-ADNEX, BiometryAssist. | ||||||||||
| • Improved S/W feature which was | ||||||||||
| previously cleared in WS80A (K153529) | ||||||||||
| : CrystalVue Flow (from Crystal Vue) | ||||||||||
| • Improved the image quality of the S/W | ||||||||||
| which was cleared previously (K153529). | ||||||||||
| : Needle Mate | Description of S/W Features | |||||||||
| • IOTA-ADNEX: This feature provides statistical | ||||||||||
| information according to the ADNEX Risk Model for | ||||||||||
| ovary ultrasound exams. | ||||||||||
| • BiometryAssist: This function helps the user measure | ||||||||||
| fetal growth indices. | ||||||||||
| • CrystalVue Flow: This feature is to display rendered | ||||||||||
| images in Crystal Vue(K153529) with Color Doppler. | ||||||||||
| HW Features | • No addition |
33
Image /page/33/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is set against a blue, oval-shaped background.
510(k) Premarket Notification – Traditional
| Feature / Characteristics | The subject device
WS80A | WS80A
(K153529) | RS80A
(K162094) | Voluson E8
(K142472) |
|------------------------------------------------------|-----------------------------|--------------------|--------------------|-------------------------|
| 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 | √ | √ | √ | √ |
| - Intra-operative | √ | √ | √ | √ |
| 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 | | | | |
| Feature / Characteristics | The subject device
WS80A | Predicate devices | | |
| | | WS80A
(K153529) | RS80A
(K162094) | Voluson E8
(K142472) |
| - 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 | | | | |
| - Quick Scan (Q Scan) | √ | √ | √ | |
| - ClearVision
(SMDR/SMDR evo) | √ | √ | √ | |
| - MultiVision
(Spatial Compound
Imaging) | √ | √ | √ | |
| - Panoramic | √ | √ | √ | |
| - Needle Mate | √ | √ | √ | |
| - Elastoscan | √ | √ | √ | |
| - E-Thyroid | √ | √ | √ | |
| - E-Breast | √ | √ | √ | |
| - 3D Imaging
(Volume Data
Acquisition) | √ | √ | √ | |
| - 3D Imaging
presentation | | | | |
| 3D Cine/4D Cine | √ | √ | √ | |
| 5D Cine | √ | √ | | |
| - 3D Rendering
MPR
(Multi Planer Render) | √ | √ | √ | |
| - 3D XI
MSV
(Multi Slice View)
Oblique View | √ | √ | √ | |
| - 3D MXI
Volume Slice,
Mirror View | √ | √ | √ | |
| - XI Volume CT
(Volume CT) | √ | √ | √ | |
| - 3D MagiCut | √ | √ | √ | |
| - Volume Calculation
(VOCAL, XI
VOCAL) | √ | √ | √ | |
| - XI STIC | √ | √ | √ | |
| - HDVI | √ | √ | √ | |
| - 5D LB | √ | √ | | |
| - 5D CNS / 5D CNS+ | √ | √ | | |
| | The subject device | Predicate devices | | |
| Feature / Characteristics | WS80A | WS80A | RS80A | Voluson E8 |
| | | (K153529) | (K162094) | (K142472) |
| - 5D Follicle | √ | √ | | |
| - 5D Heart / 5D Heart | √ | √ | | |
| Color | | | | |
| - 5D Limb Vol | √ | √ | | √ |
| - Realistic Vue (FRV) | √ | √ | √ | |
| - Crystal Vue / | √ | √(3) | | |
| CrystalVue Flow | | | | |
| - Volume NT/IT | √ | √ | | |
| - 5D NT | √ | √ | | |
| - 2D NT | √ | √ | | |
| - Auto IMT+ | √ | √ | √ | |
| (Auto IMT) | | | | |
| - MPI | √ | √ | | |
| - ADVR | √ | √ | √ | |
| - IOTA-ADNEX | √ | | | √(1) |
| - BiometryAssist | | | | √(2) |
34
Image /page/34/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is placed inside of a blue, oval-shaped background.
510(k) Premarket Notification – Traditional
35
Image /page/35/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is placed inside a blue, oval-shaped background.
510(k) Premarket Notification – Traditional
-
LR2
-
Sono Biometry
-
Crystal Vue
36
510(k) Premarket Notification - Traditional
Image /page/36/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is placed inside of a blue, oval shape.
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 WS80A and its application comply with voluntary standards as below: | |
|---|---|
| Reference No. | Title |
| IEC 60601-1 | AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and |
| A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General | |
| requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) | |
| IEC 60601-1-2 | AAMI / ANSI / IEC 60601-1-2:2007(R)2012, Medical electrical equipment - Part 1-2: |
| General requirements for basic safety and essential performance – Collateral standard: | |
| Electromagnetic compatibility - Requirements and tests (Edition 3) | |
| IEC 60601-2-37 | IEC 60601-2-37:2007 Edition 2.0 2007-08, Medical electrical equipment - Part 2-37: |
| Particular requirements for the basic safety and essential performance of ultrasonic | |
| medical diagnostic and monitoring equipment | |
| ISO10993-1 | AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices |
| – Part 1: Evaluation and testing within a risk management process | |
| ISO14971 | ISO 14971:2007, Medical devices - Application of risk management to medical devices |
| NEMA UD 2-2004 | NEMA UD 2-2004 (R2009) |
| Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment | |
| Revision 3 | |
| NEMA UD 3-2004 | NEMA UD 3-2004 (R2009) |
| Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices | |
| on Diagnostic Ultrasound Equipment, Revision 2 |
The WS80A and its application comply with voluntary standards as below:
Summary of the performance testing data:
Performance tests were conducted to test the functionality of the "IOTA-ADNEX" and "BiometryAssist". Image performance assessments were conducted to the "CrystalVue Flow" and Needle Mate". These tests have been performed to assess the functionality of the subject device. Results of all conducted testing and assessments were found acceptable and did not raise any new issues of safety or effective.
Summary of Clinical Tests:
Not applicable. The subject of this submission, WS80A, 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 WS80A to be as safe, as effective, and performance is substantially equivalent to the predicate devices.