(55 days)
Not Found
No
The summary describes a standard diagnostic ultrasound system with various imaging modes and analysis packages, but there is no mention of AI or ML technology being incorporated.
No.
The "Intended Use / Indications for Use" states that the device is intended for "diagnostic ultrasound imaging and fluid analysis of the human body," not 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." Additionally, the "Device Description" mentions that it provides "analysis packages that provide information that is used to make a diagnosis by competent health care professionals."
No
The device description clearly states it is a "diagnostic ultrasound system" and mentions acquiring ultrasound data, which inherently requires hardware components (transducers, processing unit, etc.) to generate and receive ultrasound waves. While it is software-controlled, it is not solely software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body. The WS80A Diagnostic Ultrasound System is used for in vivo imaging of the human body.
- The intended use and device description clearly state that it is a diagnostic ultrasound system for imaging the human body. It acquires ultrasound data and displays it as images and measurements of anatomical structures and fluid flow within the body.
- The clinical applications listed are all related to imaging internal structures and systems of the body.
Therefore, the WS80A Diagnostic Ultrasound System falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
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.
WS80A Diagnostic Ultrasound System:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal/Obstetrics, Abdominal, Intra-operative, Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ, 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 Pediatric, Trans-esophageal (Cardiac), Other (spec.), Peripheral vessel, Other (spec.).
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+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
SC1-6 for use with WS80A:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal/Obstetrics, Abdominal.
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PPF+W, B+PPI+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 4: Color M-mode
C2-6 for use with WS80A:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal/Obstetrics, Abdominal.
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+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 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 4: Color M-mode
Note 8: 3D imaging
E3-12A for use with WS80A:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal/Obstetrics, Abdominal, Trans-rectal, Trans-vaginal, Other (spec.) (See Note 13).
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, 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 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
VR5-9 for use with WS80A:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal/Obstetrics, Abdominal, Trans-rectal, Trans-vaginal, Other (spec.) (See Note 13).
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PPF+W, B+PPH+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
L3-12A for use with WS80A:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal/Obstetrics, Abdominal, Pediatric, Small Organ, Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Peripheral vessel.
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PPF+W, B+PPH+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
L5-13 for use with WS80A:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Small Organ, Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Peripheral vessel.
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+PPI+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 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
V4-8 for use with WS80A:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal/Obstetrics, Abdominal.
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PPF+W, B+PPH+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
V5-9 for use with WS80A:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal/Obstetrics, Abdominal, Trans-rectal, Trans-vaginal, Other (spec.) (See Note 13).
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+PPI+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 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
CA1-7A for use with WS80A:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal/Obstetrics, Abdominal, Pediatric, Musculo-skel. (Convent.), Musculo-skel. (Superfic.).
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PPF+W, B+PPH+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
CA2-8A for use with WS80A:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal/Obstetrics, Abdominal.
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+PPI+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 4: Color M-mode
Note 13: Includes Urology/Prostate
CF4-9 for use with WS80A:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Pediatric, Neonatal Cephalic, Peripheral vessel.
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+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 7: Tissue Harmonic Imaging (THI)
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 8: 3D imaging
LA3-16A for use with WS80A:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Small Organ, Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Peripheral vessel.
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+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
PE2-4 for use with WS80A:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Neonatal Cephalic, Adult Cephalic, Cardiac Adult, Cardiac Pediatric.
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+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
CV1-8A for use with WS80A:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal/Obstetrics, Abdominal, Trans-rectal, Trans-vaginal, Other (spec.) (See Note 13).
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+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
LV3-14A for use with WS80A:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Small Organ, Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Peripheral vessel.
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+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 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 4: Color M-mode
Note 8: 3D imaging
CA2-9A for use with WS80A:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal/Obstetrics, Abdominal.
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PPF+W, B+PPH+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
CA3-10A for use with WS80A:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal/Obstetrics, Abdominal, Pediatric, Peripheral vessel.
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+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 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 6: Abdominal organs and peripheral vessel
EA2-11B for use with WS80A:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal/Obstetrics, Abdominal, Trans-rectal, Trans-vaginal, Other (See Note 13).
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PP1+PW, B+PPI+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 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
LA2-9A for use with WS80A:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Small Organ, Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Peripheral vessel.
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+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
LA3-16AI for use with WS80A:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intra-operative, Intra-operative (Neuro.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Peripheral vessel.
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+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 4: Color M-mode
LA4-18B for use with WS80A:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Small Organ, Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Peripheral Vessel.
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+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 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 4: Color M-mode
Note 8: 3D imaging
PA3-8B for use with WS80A:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac Adult, Cardiac Pediatric.
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+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 4: Color M-mode
PM1-6A for use with WS80A:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Adult Cephalic, Cardiac Adult, Cardiac Pediatric.
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+DPI, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
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 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 4: Color M-mode
Note 6: Abdominal organs and peripheral vessel
Note 8: 3D imaging
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, Intra-operative, Pediatric, Small Organ (e.g., thyroid, parathyroid, breast, scrotum and penis), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Peripheral vessel, Renal, Pelvis, Prostate.
Indicated Patient Age Range
Adult, Pediatric, Neonatal (for small organ examinations).
Intended User / Care Setting
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
WS80A Diagnostic Ultrasound System (K143089), HS70A Diagnostic Ultrasound System (K152962), RS80A Diagnostic Ultrasound System (K151663), A35 Diagnostic Ultrasound System (K150478), Voluson E8 Diagnostic Ultrasound System (K122327), LOGIQ E9 Diagnostic Ultrasound System (K142160)
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
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 Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized image of three overlapping human profiles, which are connected to three wavy lines below.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 2, 2016
Samsung Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K153529
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: January 18, 2016 Received: January 19, 2016
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Ocks
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
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, 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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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 Imaging | ||||||||
| & Other | Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Notes 2, 3,4, 5, 6, 7, 8, 9, 11 |
| 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) | N | N | N | N | N | Note 1 | Note 7, 9, 11 | |
| Intra-operative (Neuro.) | N | N | N | N | N | Note 1 | Note 7, 9, 11 | |
| Laparoscopic | ||||||||
| & Other | 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 | 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 | P | Note 1 | Notes 2, 7, 8, 9, 11, 12 | |
| Trans-vaginal | P | 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 | 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 (spec.) (See Note 13) | P | P | P | P | P | Note 1 | Notes 2, 7,8, 9, 11, 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 | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 |
| Other (spec.) |
N= new indication; P= previously cleared by FDA K143089; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+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 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)
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 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.) | |||||||||
| 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 K143089; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PPF+W, B+PPI+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 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 | 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 K143089; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+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 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 4: Color M-mode
Note 8: 3D imaging
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 K143089; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, 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 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
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 | P | Note 1 | Note 2, 7, 8, 9, 12 | ||
| Trans-vaginal | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) (See Note 13) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | ||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K143089; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PPF+W, B+PPH+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 | |||||||||
| (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, 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 | |||||||||
| & Other | Laparoscopic | ||||||||
| 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 | |||||||||
| 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 K152962; 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+W, B+PPH+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
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 K143089; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PPF+PW, B+PPI+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 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
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.) | ||||||||
| 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 K143089; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PPF+W, B+PPH+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
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, 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.) | |||||||||
| 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, 11 | ||
| Trans-vaginal | P | 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 | P | Note 1 | Notes 2, 7, 8, 9, 11 | ||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K143089; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PPF+PW, B+PPI+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 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
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 | | B | M | PWD | CWD | Color
Doppler* | Combined*
(Spec.) | Other
(Spec.) |
|---------------------------|-------------------------------|---|---|-----|-----|-------------------|----------------------|--------------------------|
| General
(Track I only) | Specific
(Tracks I & III) | | | | | | | |
| 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, 13 |
| | 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.) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 11 |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 11 |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA K152962; 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+W, B+PPH+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
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 | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K143089; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PPF+PW, B+PPI+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 4: Color M-mode
Note 13: Includes Urology/Prostate
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 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 K143089; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+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 7: Tissue Harmonic Imaging (THI)
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 8: 3D imaging
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 (See Note 3) | |||||||||
| Abdominal (See Note 10) | |||||||||
| Intra-operative (See Note 6) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging | |||||||||
| & Other | Laparoscopic | ||||||||
| Pediatric | |||||||||
| Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11, 12 | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | |||
| Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | |||
| Intra-luminal | |||||||||
| Other (See Note 13) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | ||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K143089; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+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 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
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 K143089; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+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 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 Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K143089; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+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
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 K143089; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+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 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 4: Color M-mode
Note 8: 3D imaging
Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)
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) | N | N | N | N | N | Note 1 | Notes 2, 4, 7, 8, 9, 11 | ||
| Abdominal (See Note 10) | N | N | N | N | N | 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; 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+W, B+PPH+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
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 Imaging | ||||||||
| & Other | Fetal/Obstetrics (See Note 3) | N | N | N | N | N | Note 1 | Notes 2, 3, 7, 8, 9, 11 |
| Abdominal (See Note 10) | N | N | N | N | N | Note 1 | Notes 2, 7, 8, 9, 11 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | 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 | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | Notes 2, 7, 8, 9, 11 |
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+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 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 6: Abdominal organs and peripheral vessel
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 | P | Note 1 | Note 2, 7, 8, 9 | |||
| Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | |||
| Intra-operative (See Note 6) | ||||||||||
| Intra-operative (Neuro.) | ||||||||||
| Fetal Imaging | ||||||||||
| & Other | Laparoscopic | |||||||||
| Pediatric | ||||||||||
| Small Organ (See Note 5) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | |||
| Trans-vaginal | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | |||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Cardiac) | ||||||||||
| Musculo-skel. (Convent.) | ||||||||||
| Musculo-skel. (Superfic.) | ||||||||||
| Intra-luminal | ||||||||||
| Other (See Note 13) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | |||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Trans-esophageal (Cardiac) | ||||||||||
| Other (spec.) | ||||||||||
| Peripheral | Peripheral vessel | |||||||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA K150478; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PP1+PW, B+PPI+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 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
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 Imaging | |||||||||
| & Other | 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.) | |||||||||
| Laparoscopic | |||||||||
| & Other | 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 K151663; 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+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
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 | Specific | B | M | PWD | CWD | Color | ||||
| Doppler* | Combined* | |||||||||
| (Spec.) | Other | |||||||||
| (Spec.) | ||||||||||
| (Track I only) | (Tracks I & III) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal/Obstetrics (See Note 3) | ||||||||||
| Abdominal (See Note 10) | ||||||||||
| Intra-operative (See Note 6) | 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 K152962; 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+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 4: Color M-mode
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 | Specific | B | M | PWD | CWD | Color | ||||
| Doppler* | Combined* | |||||||||
| (Spec.) | Other | |||||||||
| (Spec.) | ||||||||||
| (Track I only) | (Tracks I & III) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal/Obstetrics (See Note 3) | ||||||||||
| Abdominal (See Note 10) | ||||||||||
| Intra-operative (See Note 6) | ||||||||||
| Intra-operative (Neuro.) | ||||||||||
| Fetal Imaging | Laparoscopic | |||||||||
| & | ||||||||||
| Other | Pediatric | |||||||||
| Small Organ (See Note 5) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Cardiac) | ||||||||||
| Musculo-skel. (Convent.) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | |||
| Musculo-skel. (Superfic.) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | |||
| Intra-luminal | ||||||||||
| Other (See Note 13) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Trans-esophageal (Cardiac) | ||||||||||
| Other (spec.) | ||||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | ||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA K151663; 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+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 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 4: Color M-mode
Note 8: 3D imaging
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 Imaging | ||||||||
| & Other | Fetal/Obstetrics (See Note 3) | |||||||
| Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Note 7 | |
| Intra-operative (See Note 6) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | 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 | Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7 |
| Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA K152962; 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+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 4: Color M-mode
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 K151663; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+DPI, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E
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 9: MultiVision (Spatial Compound Imaging)
Note 10: Includes Renal, Gynecology/Pelvis
Note 11: Panoramic imaging
Note 12: ElastoScan
Note 4: Color M-mode
Note 6: Abdominal organs and peripheral vessel
Note 8: 3D imaging
27
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: November 5, 2015
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 |
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | IYN |
| Ultrasound Pulsed Echo Imaging System | 892.1560 | IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | ITX |
3. Identification of the predicate or legally marketed device:
- WS80A Diagnostic Ultrasound System (K143089) -
- -HS70A Diagnostic Ultrasound System (K152962)
- -RS80A Diagnostic Ultrasound System (K151663)
- A35 Diagnostic Ultrasound System (K150478) -
- -Voluson E8 Diagnostic Ultrasound System (K122327)
- -LOGIQ E9 Diagnostic Ultrasound System (K142160)
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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, Intra-operative, 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 WS80A Diagnostic Ultrasound System (K143089), HS70A Diagnostic Ultrasound System (K152962), RS80A Diagnostic Ultrasound System (K151663), A35 Diagnostic Ultrasound System (K150478), Voluson E8 Diagnostic Ultrasound System (K122327) and LOGIQ E9 Diagnostic Ultrasound System (K142160).
It is substantially equivalent with respect to safety, effectiveness, and functionality to the [5D LB]] of WS80A (K143089) and [Fractional Limb2] of Voluson E8 (K113758) in regards to the device with [5D Limb Vol].
It is substantially equivalent with respect to safety, effectiveness, and functionality to the [Realistic Vue] and [Natural Vue3] and of RS80A (K151663) in regards to the device with [Crystal Vue]. It is substantially equivalent with respect to safety, effectiveness, and functionality to the [5D CNS] of
WS80A (K143089) in regards to the device with [5D CNS+]. It is substantially equivalent with respect to safety, effectiveness, and functionality to the [5D Heart] of
WS80A (K143089) in regards to the device with [5D Heart Color].
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.
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| WS80A | V3.00 | Comment | ||||||||||||||||||
| Clinical | ||||||||||||||||||||
| application | • Addition of clinical applications | |||||||||||||||||||
| : Intra-operative | ||||||||||||||||||||
| Operation of | ||||||||||||||||||||
| modes | • No addition | |||||||||||||||||||
| Applied | ||||||||||||||||||||
| transducers | • Addition of 8 transducers | |||||||||||||||||||
| : CA2-9A, CA3-10A, EA2-11B, | ||||||||||||||||||||
| LA2-9A, LA3-16AI, LA4-18B, | ||||||||||||||||||||
| PA3-8B and PM1-6A. | Transducers The previously | |||||||||||||||||||
| cleared transducers CA2-9A None CA3-10A None EA2-11B K150478 LA2-9A K151663 LA3-16AI K152962 LA4-18B K151663 PA3-8B K151663 PM1-6A K152962 | ||||||||||||||||||||
| SW Features | • Adding the new S/W features | |||||||||||||||||||
| : 5D Limb Vol and Crystal Vue. | ||||||||||||||||||||
| • Adding the predicate S/W features | ||||||||||||||||||||
| : S-Detect, E-Thyroid, E-Breast and | ||||||||||||||||||||
| Needle Mate. | ||||||||||||||||||||
| • Improving the S/W feature that was | ||||||||||||||||||||
| previously cleared in WS80A | ||||||||||||||||||||
| (K143089) | ||||||||||||||||||||
| : 5D CNS+, 5D Heart Color, DICOM, | ||||||||||||||||||||
| EZ Exam+, Setup&Preference. | ||||||||||||||||||||
| • Changing the S/W feature's name |
- EZ Exam → EZ Exam+
Software improvements migrated from
predicate device as below. |
• 5D Limb Vol: This feature allows you to detect
fractional limb contour and to measure semi-
automatically the volume of fractional limb.
• Crystal Vue: This feature is the volume
rendering technology that visualizing interior
and exterior structures of 3D volume data.
• 5D CNS+: This feature is an expanded version of
5D CNS, providing the additional six reference
views for fetal brain diagnostics.
• 5D Heart (including 5D Heart Color): This
feature assists with diagnosis of fetal heart
conditions by using the STIC data of the fetus.
5D Heart Color is an expanded version of 5D
Heart, providing the color data for the diagnosis
of fetal heart blood flow.
• S-Detect: This module analyzes the selected
lesion from the ultrasound image and shows the
analyzed data.
• E-Thyroid: This function assists with the
diagnosis of thyroid lesions. ROI is used to show
the contrast of an elastogram.
• E-Breast: This is the function for breast lesion
exam. Calculates the strain between the area of
the suspected lesion (ROI) and normal breast fat
and displays the results.
• Needle Mate: It provides the Needle Mate
function to display the Needle position more
clearly in B Image by emphasizing the Needle
image | | | | | | | | | | | | | | | | | | |
| | SW Features The previously
cleared SW
Features S-Detect K151663 E-Thyroid K151663 E-Breast K151663 Needle Mate K151663 | | | | | | | | | | | | | | | | | | | |
| HW Features | • No addition | | | | | | | | | | | | | | | | | | | |
30
| Feature / Characteristics | The subject device
WS80A | WS80A
(K143089) | HS70A
(K152962) | RS80A
(K151663) | A35
(K150478) | Voluson E8
(K122327) | LOGIQ E9
(K142160) | |
|------------------------------------------------------|--------------------------------|--------------------|--------------------|--------------------|--------------------|-------------------------|-------------------------|-----------------------|
| 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 | WS80A
(K143089) | HS70A
(K152962) | RS80A
(K151663) | A35
(K150478) | Voluson E8
(K122327) | LOGIQ E9
(K142160) | |
| - 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+ | √ | √ | | | | | | |
| Feature / Characteristics | The subject
device | WS80A | WS80A
(K143089) | HS70A
(K152962) | RS80A
(K151663) | A35
(K150478) | Voluson E8
(K122327) | LOGIQ E9
(K142160) |
| | - 5D Heart / 5D Heart
Color | √ | √ | √ | | | | |
| - 5D Limb Vol | √ | √ | √ 1) | | | | √ 2) | |
| - Realistic Vue (FRV) | √ | √ | √ | √ | √ | √ | | |
| - Crystal Vue | √ | √ | | | √ 3) | | | |
| - Volume NT/IT | √ | √ | √ | | | | | |
| - 5D NT | √ | √ | √ | | | | | |
| - 2D NT | √ | √ | √ | √ | | | | |
| - Auto IMT+
(Auto IMT) | √ | √ | √ | √ | √ | √ | | |
| - MPI | √ | √ | √ | | | | | |
| - S-Detect | √ | √ | | √ | √ | | | |
| - ADVR | √ | √ | √ | √ | √ | √ | | |
510(k) Summary / Statement Certification
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510(k) Summary / Statement Certification
32
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.