(29 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ultrasound imaging modes and analysis packages, without mentioning any AI/ML capabilities.
No
The device is described as a "diagnostic ultrasound system" and its intended use is for "diagnostic ultrasound imaging and fluid analysis," indicating it's used for diagnosis rather than 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." Additionally, the "Device Description" calls it a "diagnostic ultrasound system" and notes it offers "analysis packages that provide information that is used to make a diagnosis."
No
The device description explicitly states it is a "diagnostic ultrasound system," which is a hardware device that uses software for control and image processing, but 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 a device that images the body directly using ultrasound waves, not a device that analyzes samples taken from the body (like blood, urine, or tissue) in a laboratory setting.
- Device Description: The description details how the device acquires and displays ultrasound data in various modes (B mode, M mode, Doppler, etc.) and provides measurement and analysis packages. This aligns with the function of an ultrasound imaging system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or performing tests on specimens outside of the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device is an imaging system that uses physical principles (ultrasound) to visualize internal structures.
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, 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 (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
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. (Specific notes further detail: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients, Renal, Pelvis, Prostate)
Indicated Patient Age Range
Adult, Pediatric, Neonatal (implied by "Neonatal Cephalic", "Pediatric", and "Cardiac Adult")
Intended User / Care Setting
Competent health care professionals (implied by diagnosis and clinical applications).
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. 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.
K133329, K141620, K132861, K122327, K130739
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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with a flowing design element extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 26, 2014
Samsung Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services 1394 25th Street, NW BUFFALO MN 55313
Re: K143089
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: October 27, 2014 Received: October 28, 2014
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.
This determination of substantial equivalence applies to the following transducers intended for use with the WS80A Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
SC1-6 | C2-6 | E3-12A |
---|---|---|
VR5-9 | L3-12A | L5-13 |
V4-8 | V5-9 | CA1-7A |
CA2-8A | CF4-9 | LA3-16A |
PE2-4 | CV1-8A | LV3-14A |
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
1
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.
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,
Robert A Ochs
for
Janine M. Morris 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
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, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, 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)
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)
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."
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
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 | Note 1 | Notes 2, 4, 5, 6, 7, 8, 9, 11 | ||
Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11, 12 | |
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& Other | Laparoscopic | |||||||
Pediatric | P | P | P | 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 | ||
Neonatal Cephalic | P | P | P | P | P | Note 1 | Notes 7, 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 | ||
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, 12 | ||
Cardiac | Cardiac Adult | P | P | P | P | P | Note 1 | Notes 4, 7 |
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 K133329; 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+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
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 | 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.) | ||||||||
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 K133329; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CV, B+C+PW, B+PD+PW, B+PPF+W, B+PPF+W, 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
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/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, 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 K133329; 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+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
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 7, 8, 9 | ||
Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Notes 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 7, 8, 9, 12 | ||
Trans-vaginal | P | P | P | P | P | Note 1 | Notes 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 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 K133329; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CV, B+C+PW, B+PD+PW, B+PPF+W, B+PPF+W, 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 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
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
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 | Specific | B | M | PWD | CWD | Color | Combined* | Other | |
(Track I only) | (Tracks I & III) | Doppler* | (Spec.) | (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 | b | P | b | 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 | Notes 2, 7, 8, 9, 12 | |||
Cardiac Adult | |||||||||
Cardiac | Cardiac Pediatric | ||||||||
Trans-esophageal (Cardiac) | |||||||||
Other (spec.) | |||||||||
Peripheral | Peripheral vessel | ||||||||
Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA K133329; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CV, B+C+PW, B+PD+PW, B+PPF+W, B+PPF+W, 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
Note 13: Includes Urology/Prostate
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 | Specific | B | M | PWD | CWD | Color | ||||
Doppler* | Combined* | |||||||||
(Spec.) | Other | |||||||||
(Spec.) | ||||||||||
(Track I only) | (Tracks I & III) | |||||||||
Ophthalmic | Ophthalmic | |||||||||
Fetal/Obstetrics (See Note 3) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | ||||
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 K133329; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CV, B+C+PW, B+PD+PW, B+PD+PW, B+PPF+W, 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
Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)
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 K133329; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CV, B+C+PW, B+PD+PW, B+PPF+W, B+PPF+W, 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
Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)
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/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, 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 K133329; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CV, B+C+PW, B+PD+PW, B+PPF+W, B+PPF+W, 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
Note 13: Includes Urology/Prostate
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 | 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 (spec.) (See Note 13) | P | P | P | P | P | Note 1 | Notes 2, 7, 8 | |
Cardiac Adult | ||||||||
Cardiac | Cardiac Pediatric | |||||||
Trans-esophageal (Cardiac) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | |||||||
Other (spec.) |
N= new indication; P= previously cleared by FDA K133329; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CV, B+C+PW, B+PD+PW, B+PPF+W, B+PPF+W, 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
Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)
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/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.) | ||||||||
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+PPF+W, B+PPH+W, B+ID+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
Note 13: Includes Urology/Prostate
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 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, 4, 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 K132861; 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+PPF+PW, B+PPH+PW, B+ID+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 13: Includes Urology/Prostate
Note 4: Color M-mode
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 | 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 | Notes 8, 9, 11 | ||
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& Other | 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 Adult | ||||||||
Cardiac | Cardiac Pediatric | |||||||
Trans-esophageal (Cardiac) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | P | P | P | P | Note 1 | Notes 8, 9, 11 | |
Other (spec.) |
N= new indication; P= previously cleared by FDA 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+ID, B+CW, B+C+PW, B+DD+PW, B+DPD+PW, B+PPI+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
Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)
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 | ||||||||
(Track I only) | Specific | |||||||
(Tracks I & III) | B | M | PWD | CWD | Color | |||
Doppler* | Combined* | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
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 | Note 1 | Note 2, 5, 6, 7, 9, 11, 12 | ||
Neonatal Cephalic | ||||||||
Adult Cephalic | ||||||||
Trans-rectal | ||||||||
Trans-vaginal | ||||||||
Trans-urethral | ||||||||
Trans-esoph. (non-Cardiac) | ||||||||
Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | ||
Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | ||
Intra-luminal | ||||||||
Other (See Note 13) | ||||||||
Cardiac | Cardiac Adult | |||||||
Cardiac Pediatric | ||||||||
Trans-esophageal (Cardiac) | ||||||||
Other (spec.) | ||||||||
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 K132861; 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
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
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 | |||||||||
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+ID, B+CW, B+C+PW, B+DD+PW, B+DPD+PW, B+PPI+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 Imaging | ||||||||
& | ||||||||
Other | Fetal/Obstetrics (See Note 3) | N | N | N | N | N | Note 1 | Note 2, 4, 7, 8, 9, 11 |
Abdominal (See Note 10) | N | N | N | N | N | Note 1 | Note 2, 7, 8, 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; 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+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 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients -
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
Note 6: Abdominal organs and peripheral vessel
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 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 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+DPD, B+PPI, B+CW, B+C+PW, B+PD+PW, B+PPF+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
19
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: September 24, 2014
2. Name of the device:
Common/Usual Name: Diagnostic Ultrasound System and Accessories Proprietary Name: WS80A Diagnostic Ultrasound System Classification Names: FR Number Product Code IYN Ultrasonic Pulsed Doppler Imaging System 892.1550 Ultrasound Pulsed Echo Imaging System 892.1560 IYO Diagnostic Ultrasound Transducer 892.1570 ITX
3. Identification of the predicate or legally marketed device:
- UGEO WS80A Diagnostic Ultrasound System (K133329) -
- RS80A Diagnostic Ultrasound System (K141620) -
- -UGEO H60 Diagnostic Ultrasound System (K132861)
- Voluson E8 Diagnostic Ultrasound System (K122327) -
- -ACUSON S2000 Diagnostic Ultrasound System (K130739)
20
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 Uses:
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, 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 WS80A is substantially equivalent with respect to safety, effectiveness, and functionality to the UGEO WS80A Diagnostic Ultrasound System (K133329), RS80A Diagnostic Ultrasound System (K141620) and UGEO H60 Diagnostic Ultrasound System (K132861).
It is substantially equivalent with respect to safety, effectiveness, and functionality to the [Syngo Auto OB Measurments®] of Siemens's ACUSON S2000 (K130739) in regards to the device with [5D CNS]. It is substantially equivalent with respect to safety, effectiveness, and functionality to the [SonoAVC follicle® and SonoVCAD heart®] of GE's Voluson E8 (K122327) in regards to the device with [5D Follicle and 5D Heart].
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.
21
WS80A (V2.00) | Comment | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Model Name | • Change of model name in the V2.00 | The model name in the V1.00 is UGEO WS80A. | ||||||||||||||||
Clinical application | • Addition of clinical applications : Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac Adult, Cardiac Pediatric | |||||||||||||||||
Operation of modes | • Addition of Continuous Wave (CW) Spectral Doppler | |||||||||||||||||
Applied transducers | • Addition of 7 transducers : CA1-7A, CA2-8A, CF4-9, LA3-16A, PE2-4, CV1-8A and LV3-14A. | Transducers The previously cleared transducers CA1-7A K141620 CA2-8A K132861 (CF2-8) CF4-9 K141620 LA3-16A K132861 (LF5-13) PE2-4 K141620 LV3-14A K141620 CV1-8A None | ||||||||||||||||
SW Features | • Addition of S/W Features : (new) 5D CNS, 5D Follicle and 5D Heart (previously cleared) RMS | |||||||||||||||||
• Change of S/W feature's name : SCI→MultiVision, SDMR→ClearVision, FRV→Realistic Vue | Description of S/W Features | |||||||||||||||||
• 5D CNS: This feature assists with diagnosis by taking measurements relating to fetal brain. | ||||||||||||||||||
• 5D Follicle: This feature assists with diagnosis by estimating the size and volume of a follicle in the ovary | ||||||||||||||||||
• 5D Heart: This feature assists with diagnosis of fetal heart conditions by using the STIC data of the fetus. | ||||||||||||||||||
• RMS: This feature is the collection of error data in the ultrasound imaging system, utilization logging, and the control of remote device. The collected data is transmitted to the RMS server over a network for customer service. | ||||||||||||||||||
HW Features | • Change of Monitor size and Physical Dimensions | |||||||||||||||||
• Addition of CW Probe Port |
22
| Feature / Characteristics | The subject
device
WS80A | UGEO WS80A
(K133329) | RS80A
(K141620) | The predicate devices
UGEO H60
(K132861) | Voluson E8
(K122327) | ACUSON
S2000
(K130739) |
|-----------------------------------------------|--------------------------------|-------------------------|--------------------|------------------------------------------------|-------------------------|------------------------------|
| 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 | √ | √ | √ | √ | √ | √ |
| - 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 | | | | | | |
| | The subject device | The predicate devices | | | | |
| Feature / Characteristics | WS80A | UGEO WS80A
(K133329) | RS80A
(K141620) | UGEO H60
(K132861) | Voluson E8
(K122327) | ACUSON
S2000
(K130739) |
| - 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) | √ | √ | √ | √ | | |
| - Spatial Compound
Imaging | √1) | √ | √ | √ | | |
| - SMDR (SMDR evo) | √2) | √ | √ | √ | | |
| - Auto IMT+
(Auto IMT) | √ | √ | √ | √ | | |
| - Elastoscan | √ | √ | √ | | | |
| - Panoramic | √ | √ | √ | | | |
| - 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 | √ | √ | √ | | | |
| - FRV | √3) | √ | | | | |
| - Volume NT/IT | √ | √ | √ | √ | | |
| - 5D NT | √ | √ | | | | |
| - 2D NT | √ | √ | | | | |
| | The subject
device | The predicate devices | | | | |
| Feature / Characteristics | WS80A | UGEO WS80A
(K133329) | RS80A
(K141620) | UGEO H60
(K132861) | Voluson E8
(K122327) | ACUSON
S2000
(K130739) |
| - 5D LB | √ | √ | | | | |
| - MPI | √ | √ | | | | |
| - 5D CNS | √ | | | | | √(4) |
| - 5D Follicle | √ | | | | √(5) | |
| - 5D Heart | √ | | | | √(6) | |
23
24
-
The name of the feature is changed to MultiVison.
-
The name of the feature is changed to Clear Vision
-
The name of the feature is changed to Realistic Vue.
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:
- 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. 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.