(30 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 capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is explicitly stated to be for "diagnostic ultrasound imaging and fluid analysis of the human body" and its function is to "acquire ultrasound data and to display the data" for the purpose of making a diagnosis, rather than for treatment.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "The A35 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body." Additionally, the 'Device Description' refers to it as a "diagnostic ultrasound system" and mentions that it "offers analysis packages that provide information that is used to make a diagnosis."
No
The device description explicitly states it is a "diagnostic ultrasound system," which inherently includes hardware components (transducers, system unit) to acquire ultrasound data, in addition to the software control and processing. The performance studies also mention evaluation of acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety, all of which relate to hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The A35 Diagnostic Ultrasound System uses ultrasound waves to create images of internal structures of the human body. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging and fluid analysis of the human body," which refers to imaging fluids within the body, not analyzing fluids taken from the body.
- Clinical Applications: All listed clinical applications involve imaging internal anatomical sites.
Therefore, based on the provided information, the A35 Diagnostic Ultrasound System is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The A35 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
Product codes
IYN, IYO, ITX
Device Description
The A35 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, PW/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 A35 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 A35 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Peripheral vessel
Indicated Patient Age Range
Adult, Pediatric, Neonatal (referring to specific small organ imaging)
Intended User / Care Setting
Competent health care professionals / Not explicitly stated, but implied to be a clinical setting for diagnostic imaging.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not applicable. The subject of this submission. A35, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K112339, K143089, K143264, K142466, K133505
Reference Device(s)
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 U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human profiles in a row, with a triple-strand helix wrapping around them. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 26, 2015
SAMSUNG MEDISON CO., LTD. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K150478
Trade/Device Name: A35 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: February 23, 2015 Received: February 24, 2015
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K150478
Device Name A35 Diagnostic Ultrasound System
Indications for Use (Describe)
The A35 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, 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: A35 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 | Specific | B | M | PWD | CWD | Color | Combined* | Other | ||
(Track I only) | (Tracks I & III) | Doppler* | (Spec.) | (Spec.) | ||||||
Ophthalmic | Ophthalmic | |||||||||
Fetal/Obstetrics (See Note 3) | P | P | P | P | Note 1 | Notes 2, 4, 5, 6, 7, 8, 9, 10, 11 | ||||
Abdominal (See Note 12) | b | P | P | P | P | Note 1 | Notes 2, 4, 7, 8, 9, 10, 11 | |||
Intra-operative (See Note 6) | ||||||||||
Intra-operative (Neuro.) | ||||||||||
Fetal Imaging | Laparoscopic | |||||||||
& | ||||||||||
Other | Pediatric | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9 | ||
Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 10, 11 | ||||
Neonatal Cephalic | P | P | P | P | Note 1 | Note 2, 7, 8, 9 | ||||
Adult Cephalic | P | P | P | P | P | Note 1 | Note 4, 7 | |||
Trans-rectal | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 10 | ||||
Trans-vaginal | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 10 | ||||
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.) | b | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | ||||
Intra-luminal | ||||||||||
Other (spec.) (See Note 13) | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 10 | ||||
Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7 | |||
Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 | ||
Trans-esophageal (Cardiac) | ||||||||||
Other (spec.) | ||||||||||
Peripheral | Peripheral vessel | 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 K112339; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note10: ElastoScan
Note11: Spatial Compound Imaging
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
4
510(k) No.: Device Name: C2-6IC for use with A35 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 12) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 | |
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | Laparoscopic | |||||||
& | ||||||||
Other | Pediatric | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 |
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 | Peripheral vessel | |||||||
Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA K112339; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual /Quad, B+C+CW, B+PD+CW, B+E
-
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: Panoramic imaging
Note10: ElastoScan
Note11: Spatial Compound Imaging
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
5
510(k) No.: Device Name: CF4-9 for use with A35 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
---|---|---|---|---|---|---|---|---|---|
General | |||||||||
(Track I only) | Specific | ||||||||
(Tracks I & III) | B | M | PWD | CWD | Color | ||||
Doppler* | Combined* | ||||||||
(Spec.) | Other | ||||||||
(Spec.) | |||||||||
Ophthalmic | Ophthalmic | ||||||||
Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 | ||
Abdominal (See Note 12) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 | ||
Intra-operative (See Note 6) | |||||||||
Intra-operative (Neuro.) | |||||||||
Fetal Imaging | Laparoscopic | ||||||||
& | |||||||||
Other | Pediatric | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 | |
Small Organ (See Note 5) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 | ||
Neonatal Cephalic | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 | ||
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 | Peripheral vessel | P | P | P | P | Note 1 | Notes 2, 7, 8 | ||
Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA K112339 (C5-8); E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual /Quad, B+C+CW, B+PD+CW, B+E
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, 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: Panoramic imaging
Note10: ElastoScan
Note11: Spatial Compound Imaging
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
6
510(k) No.: Device Name: EC4-9IS for use with A35 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
---|---|---|---|---|---|---|---|---|
General | ||||||||
(Track I only) | Specific | |||||||
(Tracks I & III) | B | M | PWD | CWD | Color | |||
Doppler* | Combined* | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
Ophthalmic | Ophthalmic | |||||||
Fetal/Obstetrics (See Note 3) | P | P | P | P | Note 1 | Note 2, 7 | ||
Abdominal (See Note 12) | P | P | P | P | Note 1 | Note 2, 7, 10 | ||
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& Other | Laparoscopic | |||||||
Pediatric | ||||||||
Small Organ (See Note 5) | ||||||||
Neonatal Cephalic | ||||||||
Adult Cephalic | ||||||||
Trans-rectal | P | P | P | P | Note 1 | Note 2, 7, 8, 10 | ||
Trans-vaginal | P | P | P | P | Note 1 | Note 2, 7, 8, 10 | ||
Trans-urethral | ||||||||
Trans-esoph. (non-Cardiac) | ||||||||
Musculo-skel. (Convent.) | ||||||||
Musculo-skel. (Superfic.) | ||||||||
Intra-luminal | ||||||||
Other (spec.) (See Note 13) | P | P | P | P | Note 1 | Note 2, 7, 10 | ||
Cardiac Adult | ||||||||
Cardiac | Cardiac Pediatric | |||||||
Trans-esophageal (Cardiac) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | |||||||
Other (spec.) |
N= new indication; P= previously cleared by FDA K112339; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual /Quad, B+C+CW, B+PD+CW, B+E
-
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: Panoramic imaging
Note10: ElastoScan
Note11: Spatial Compound Imaging
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
7
510(k) No.:
Device Name: L4-7 for use with A35 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 12) | P | P | P | P | Note 1 | Note 2, 7, 9, 11 | ||
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& Other | Laparoscopic | |||||||
Pediatric | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9 | ||
Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 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, 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 K112339; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CW, B+C+PW, B+PD+PW, B+PPI+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual /Quad, B+C+CW, B+PD+CW, B+E
- Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note10: ElastoScan
Note11: Spatial Compound Imaging
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
8
510(k) No.: Device Name: L5-13IS for use with A35 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 12) | ||||||||
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& Other | Laparoscopic | |||||||
Pediatric | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9 | |
Small Organ (See Note 5) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 10, 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, 9, 11 | |
Musculo-skel. (Superfic.) | P | 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 | P | Note 1 | Note 2, 5, 6, 7, 9, 11 |
Other (spec.) |
N= new indication; P= previously cleared by FDA K112339; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual /Quad, B+C+CW, B+PD+CW, B+E
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
Note 9: Panoramic imaging
Note10: ElastoScan
Note11: Spatial Compound Imaging
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
9
510(k) No.: Device Name: L7-16IS for use with A35 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 12) | ||||||||||
Intra-operative (See Note 6) | ||||||||||
Intra-operative (Neuro.) | ||||||||||
Fetal Imaging | Laparoscopic | |||||||||
& | ||||||||||
Other | Pediatric | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9 | |||
Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 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, 9, 11 | ||||
Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | ||||
Intra-luminal | ||||||||||
Other (spec.) (See Note 13) | ||||||||||
Cardiac Adult | ||||||||||
Cardiac | Cardiac Pediatric | |||||||||
Trans-esophageal (Cardiac) | ||||||||||
Other (spec.) | ||||||||||
Peripheral | Peripheral vessel | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | |||
Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA K112339; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual /Quad, B+C+CW, B+PD+CW, B+E
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note10: ElastoScan
Note11: Spatial Compound Imaging
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
10
510(k) No.: Device Name: P2-4BA for use with A35 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 12) | P | P | P | P | P | Note 1 | Note 4, 7 | ||
Intra-operative (See Note 6) | |||||||||
Intra-operative (Neuro.) | |||||||||
Fetal Imaging | Laparoscopic | ||||||||
& | |||||||||
Other | Pediatric | ||||||||
Small Organ (See Note 5) | |||||||||
Neonatal Cephalic | |||||||||
Adult Cephalic | P | P | P | P | P | Note 1 | Note 4, 7 | ||
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 | P | P | P | P | P | Note 1 | Note 4, 7 | ||
Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 | |
Trans-esophageal (Cardiac) | |||||||||
Other (spec.) | |||||||||
Peripheral | Peripheral vessel | ||||||||
Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA K112339; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual /Quad, B+C+CW, B+PD+CW, B+E
-
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: Panoramic imaging
Note10: ElastoScan
Note11: Spatial Compound Imaging
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
11
510(k) No.:
Device Name: V2-6 for use with A35 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation (includes simultaneous B-mode) | | | | | | Other
(Spec.) |
|---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined*
(Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Note 2, 4, 7, 8 |
| | Abdominal (See Note 12) | P | P | P | | P | Note 1 | Note 2, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging
& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Note 2, 7, 8 |
| | 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 K112339; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual /Quad, B+C+CW, B+PD+CW, B+E
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note10: ElastoScan
Note11: Spatial Compound Imaging
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
12
510(k) No.:
Device Name: V5-9 for use with A35 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
---|---|---|---|---|---|---|---|---|---|
General | |||||||||
(Track I only) | Specific | ||||||||
(Tracks I & III) | B | M | PWD | CWD | Color | ||||
Doppler* | Combined* | ||||||||
(Spec.) | Other | ||||||||
(Spec.) | |||||||||
Ophthalmic | Ophthalmic | ||||||||
Fetal Imaging | |||||||||
& Other | Fetal/Obstetrics (See Note 3) | P | P | P | P | Note 1 | Note 2, 7, 8 | ||
Abdominal (See Note 12) | P | P | P | P | Note 1 | Note 2, 7, 8 | |||
Intra-operative (See Note 6) | |||||||||
Intra-operative (Neuro.) | |||||||||
Laparoscopic | |||||||||
Pediatric | |||||||||
Small Organ (See Note 5) | |||||||||
Neonatal Cephalic | |||||||||
Adult Cephalic | |||||||||
Trans-rectal | P | P | P | P | Note 1 | Note 2, 7, 8 | |||
Trans-vaginal | P | P | P | P | Note 1 | Note 2, 7, 8 | |||
Trans-urethral | |||||||||
Trans-esoph. (non-Cardiac) | |||||||||
Musculo-skel. (Convent.) | |||||||||
Musculo-skel. (Superfic.) | |||||||||
Intra-luminal | |||||||||
Other (spec.) (See Note 13) | P | P | P | P | Note 1 | Note 2, 7, 8 | |||
Cardiac | Cardiac Adult | ||||||||
Cardiac Pediatric | |||||||||
Trans-esophageal (Cardiac) | |||||||||
Other (spec.) | |||||||||
Peripheral | |||||||||
Vessel | Peripheral vessel | ||||||||
Other (spec.) |
N= new indication; P= previously cleared by FDA K112339; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual /Quad, B+C+CW, B+PD+CW, B+E
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
Note 9: Panoramic imaging
Note10: ElastoScan
Note11: Spatial Compound Imaging
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
13
510(k) No.: Device Name: CW2.0 for use with A35 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 | B | M | PWD | CWD | Color | |||
Doppler* | Combined* | Other | |||||||
(Spec.) | |||||||||
(Tracks I & III) | |||||||||
Ophthalmic | (Spec.) | ||||||||
Ophthalmic | |||||||||
Fetal/Obstetrics (See Note 3) | |||||||||
Abdominal (See Note 12) | |||||||||
Intra-operative (See Note 6) | |||||||||
Intra-operative (Neuro.) | |||||||||
Fetal Imaging | Laparoscopic | ||||||||
& | |||||||||
Other | Pediatric | ||||||||
Small Organ (See Note 5) | |||||||||
Neonatal Cephalic | |||||||||
Adult Cephalic | P | ||||||||
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 | P | ||||||||
Cardiac | Cardiac Pediatric | P | |||||||
Trans-esophageal (Cardiac) | |||||||||
Other (spec.) | |||||||||
Peripheral | Peripheral vessel | P | |||||||
Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA K112339; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual /Quad, B+C+CW, B+PD+CW, B+E
-
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: Panoramic imaging
Note10: ElastoScan
Note11: Spatial Compound Imaging
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
14
510(k) No.: Device Name: CW4.0 for use with A35 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 12) | ||||||||||
Intra-operative (See Note 6) | ||||||||||
Intra-operative (Neuro.) | ||||||||||
Fetal Imaging | Laparoscopic | |||||||||
& | ||||||||||
Other | Pediatric | P | ||||||||
Small Organ (See Note 5) | ||||||||||
Neonatal Cephalic | ||||||||||
Adult Cephalic | P | |||||||||
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 | P | |||||||||
Cardiac | Cardiac Pediatric | P | ||||||||
Trans-esophageal (Cardiac) | ||||||||||
Other (spec.) | ||||||||||
Peripheral | Peripheral vessel | P | ||||||||
Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA K112339; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual /Quad, B+C+CW, B+PD+CW, B+E
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, 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: Panoramic imaging
Note10: ElastoScan
Note11: Spatial Compound Imaging
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
15
510(k) No.: Device Name: CW6.0 for use with A35 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 12) | ||||||||
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& Other | Laparoscopic | |||||||
Pediatric | P | |||||||
Small Organ (See Note 5) | ||||||||
Neonatal Cephalic | ||||||||
Adult Cephalic | P | |||||||
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 | P | |||||||
Cardiac | Cardiac Pediatric | P | ||||||
Trans-esophageal (Cardiac) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | P | ||||||
Other (spec.) |
N= new indication; P= previously cleared by FDA K112339; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual /Quad, B+C+CW, B+PD+CW, B+E
-
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: Panoramic imaging
Note10: ElastoScan
Note11: Spatial Compound Imaging
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
16
510(k) No.: Device Name: CA1-7A for use with A35 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
---|---|---|---|---|---|---|---|---|---|
General | |||||||||
(Track I only) | Specific | ||||||||
(Tracks I & III) | B | M | PWD | CWD | Color | ||||
Doppler* | Combined* | ||||||||
(Spec.) | Other | ||||||||
(Spec.) | |||||||||
Ophthalmic | Ophthalmic | ||||||||
Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Note 2, 4, 7, 8, 9, 11 | ||
Abdominal (See Note 12) | P | P | P | P | P | Note 1 | Note 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 (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+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual /Quad, B+C+CW, B+PD+CW, B+E
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging
Note 9: Panoramic imaging
Note10: ElastoScan
Note11: Spatial Compound Imaging
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
17
510(k) No.: Device Name: SC1-6 for use with A35 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
---|---|---|---|---|---|---|---|---|
General | ||||||||
(Track I only) | Specific | |||||||
(Tracks I & III) | B | M | PWD | CWD | Color | |||
Doppler* | Combined* | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
Ophthalmic | Ophthalmic | |||||||
Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Note 2, 4, 7, 8, 9, 11 | |
Abdominal (See Note 12) | P | P | P | P | P | Note 1 | Note 2, 4, 7, 8, 9, 11 | |
Fetal Imaging | ||||||||
& Other | Intra-operative (See Note 6) | |||||||
Intra-operative (Neuro.) | ||||||||
Laparoscopic | ||||||||
Pediatric | ||||||||
Small Organ (See Note 5) | ||||||||
Neonatal Cephalic | ||||||||
Adult Cephalic | ||||||||
Trans-rectal | ||||||||
Trans-vaginal | ||||||||
Trans-urethral | ||||||||
Trans-esoph. (non-Cardiac) | ||||||||
Musculo-skel. (Convent.) | ||||||||
Musculo-skel. (Superfic.) | ||||||||
Intra-luminal | ||||||||
Other (spec.) (See Note 13) | ||||||||
Cardiac | Cardiac Adult | |||||||
Cardiac Pediatric | ||||||||
Trans-esophageal (Cardiac) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | |||||||
Other (spec.) |
N= new indication; P= previously cleared by FDA 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+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual /Quad, B+C+CW, B+PD+CW, B+E
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note10: ElastoScan
Note11: Spatial Compound Imaging
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
18
510(k) No.: Device Name: EA2-11B for use with A35 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 | Note 2, 7, 10 | |
Abdominal (See Note 12) | N | N | N | N | N | Note 1 | Note 2, 7, 10 | |
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& Other | Laparoscopic | |||||||
Pediatric | ||||||||
Small Organ (See Note 5) | ||||||||
Neonatal Cephalic | ||||||||
Adult Cephalic | ||||||||
Trans-rectal | N | N | N | N | N | Note 1 | Note 2, 7, 10 | |
Trans-vaginal | N | N | N | N | N | Note 1 | Note 2, 7, 10 | |
Trans-urethral | ||||||||
Trans-esoph. (non-Cardiac) | ||||||||
Musculo-skel. (Convent.) | ||||||||
Musculo-skel. (Superfic.) | ||||||||
Intra-luminal | ||||||||
Other (spec.) (See Note 13) | N | N | N | N | N | Note 1 | Note 2, 7, 10 | |
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+CW, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual /Quad, B+C+CW, B+PD+CW, B+E
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note10: ElastoScan
Note11: Spatial Compound Imaging
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
19
510(k) No.: Device Name: VR5-9 for use with A35 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
---|---|---|---|---|---|---|---|---|
General | ||||||||
(Track I only) | Specific | |||||||
(Tracks I & III) | B | M | PWD | CWD | Color | |||
Doppler* | Combined* | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
Ophthalmic | Ophthalmic | |||||||
Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9 | |
Abdominal (See Note 12) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 10 | |
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& Other | Laparoscopic | |||||||
Pediatric | ||||||||
Small Organ (See Note 5) | ||||||||
Neonatal Cephalic | ||||||||
Adult Cephalic | ||||||||
Trans-rectal | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 10 | |
Trans-vaginal | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 10 | |
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, 10 | |
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+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual /Quad, B+C+CW, B+PD+CW, B+E
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note10: ElastoScan
Note11: Spatial Compound Imaging
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
20
510(k) No.: Device Name: L5-13/50 for use with A35 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 12) | ||||||||
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& | ||||||||
Other | Laparoscopic | |||||||
Pediatric | ||||||||
Small Organ (See Note 5) | N | N | N | N | N | Note 1 | Note 2, 7, 9, 10, 11 | |
Neonatal Cephalic | ||||||||
Adult Cephalic | ||||||||
Trans-rectal | ||||||||
Trans-vaginal | ||||||||
Trans-urethral | ||||||||
Trans-esoph. (non-Cardiac) | ||||||||
Musculo-skel. (Convent.) | N | N | N | N | N | Note 1 | Note 2, 7, 9, 11 | |
Musculo-skel. (Superfic.) | N | N | N | N | N | Note 1 | Note 2, 7, 9, 11 | |
Intra-luminal | ||||||||
Other (spec.) (See Note 13) | ||||||||
Cardiac Adult | ||||||||
Cardiac | Cardiac Pediatric | |||||||
Trans-esophageal (Cardiac) | ||||||||
Other (spec.) | ||||||||
Peripheral | ||||||||
Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | Note 2, 7, 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+CW, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual /Quad, B+C+CW, B+PD+CW, B+E
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note10: ElastoScan
Note11: Spatial Compound Imaging
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
21
510(k) No.: Device Name: LA3-14A for use with A35 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 12) | ||||||||||
Intra-operative (See Note 6) | ||||||||||
Intra-operative (Neuro.) | ||||||||||
Fetal Imaging | Laparoscopic | |||||||||
Other | ||||||||||
& | Pediatric | |||||||||
Small Organ (See Note 5) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 10, 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, 9, 11 | |||
Musculo-skel. (Superfic.) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | |||
Intra-luminal | ||||||||||
Other (spec.) (See Note 13) | ||||||||||
Cardiac Adult | ||||||||||
Cardiac | Cardiac Pediatric | |||||||||
Trans-esophageal (Cardiac) | ||||||||||
Other (spec.) | ||||||||||
Peripheral | Peripheral vessel | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | ||
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+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual /Quad, B+C+CW, B+PD+CW, B+E
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note10: ElastoScan
Note11: Spatial Compound Imaging
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
22
510(k) No.: Device Name: LA3-16A for use with A35 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 12) | ||||||||
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, 10, 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, 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+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual /Quad, B+C+CW, B+PD+CW, B+E
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients -
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI) -
Note 8: 3D imaging
Note 9: Panoramic imaging -
Note10: ElastoScan
Note11: Spatial Compound Imaging
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
23
510(k) No.: Device Name: LS6-15 for use with A35 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 12) | |||||||||
Intra-operative (See Note 6) | |||||||||
Intra-operative (Neuro.) | |||||||||
Fetal Imaging | Laparoscopic | ||||||||
& | |||||||||
Other | Pediatric | ||||||||
Small Organ (See Note 5) | |||||||||
Neonatal Cephalic | |||||||||
Adult Cephalic | |||||||||
Trans-rectal | |||||||||
Trans-vaginal | |||||||||
Trans-urethral | |||||||||
Trans-esoph. (non-Cardiac) | |||||||||
Musculo-skel. (Convent.) | P | P | P | P | P | Note 1 | Note 7, 9, 11 | ||
Musculo-skel. (Superfic.) | P | P | P | P | P | Note 1 | Note 7, 9, 11 | ||
Intra-luminal | |||||||||
Other (spec.) (See Note 13) | |||||||||
Cardiac Adult | |||||||||
Cardiac | Cardiac Pediatric | ||||||||
Trans-esophageal (Cardiac) | |||||||||
Other (spec.) | |||||||||
Peripheral | Peripheral vessel | P | P | P | P | P | Note 1 | Note 7, 9, 11 | |
Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA K142466; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual /Quad, B+C+CW, B+PD+CW, B+E
-
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: Panoramic imaging
Note10: ElastoScan
Note11: Spatial Compound Imaging
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
24
510(k) No.: Device Name: CV1-8A for use with A35 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
---|---|---|---|---|---|---|---|---|
General | ||||||||
(Track I only) | Specific | |||||||
(Tracks I & III) | B | M | PWD | CWD | Color | |||
Doppler* | Combined* | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
Ophthalmic | Ophthalmic | |||||||
Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Note 2, 4, 7, 8, 9, 11 | |
Abdominal (See Note 12) | P | P | P | P | P | Note 1 | Note 2, 4, 7, 8, 9 | |
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& Other | Laparoscopic | |||||||
Pediatric | ||||||||
Small Organ (See Note 5) | ||||||||
Neonatal Cephalic | ||||||||
Adult Cephalic | ||||||||
Trans-rectal | ||||||||
Trans-vaginal | ||||||||
Trans-urethral | ||||||||
Trans-esoph. (non-Cardiac) | ||||||||
Musculo-skel. (Convent.) | ||||||||
Musculo-skel. (Superfic.) | ||||||||
Intra-luminal | ||||||||
Other (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+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual /Quad, B+C+CW, B+PD+CW, B+E
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients
Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)
Note 8: 3D imaging
Note 9: Panoramic imaging
Note10: ElastoScan
Note11: Spatial Compound Imaging
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
25
510(k) No.:
Device Name: V4-8 for use with A35 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
---|---|---|---|---|---|---|---|---|
General | ||||||||
(Track I only) | Specific | |||||||
(Tracks I & III) | B | M | PWD | CWD | Color | |||
Doppler* | Combined* | |||||||
(Spec.) | Other | |||||||
(Spec.) | ||||||||
Ophthalmic | Ophthalmic | |||||||
Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Note 2, 4, 7, 8, 9, 11 | |
Abdominal (See Note 12) | P | P | P | P | P | Note 1 | Note 2, 4, 7, 8, 9 | |
Intra-operative (See Note 6) | ||||||||
Intra-operative (Neuro.) | ||||||||
Fetal Imaging | ||||||||
& Other | Laparoscopic | |||||||
Pediatric | ||||||||
Small Organ (See Note 5) | ||||||||
Neonatal Cephalic | ||||||||
Adult Cephalic | ||||||||
Trans-rectal | ||||||||
Trans-vaginal | ||||||||
Trans-urethral | ||||||||
Trans-esoph. (non-Cardiac) | ||||||||
Musculo-skel. (Convent.) | ||||||||
Musculo-skel. (Superfic.) | ||||||||
Intra-luminal | ||||||||
Other (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+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual /Quad, B+C+CW, B+PD+CW, B+E
-
Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development -
Note 4: Color M-mode
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients -
Note 6: Abdominal organs and peripheral vessel
-
Note 7: Tissue Harmonic Imaging (THI)
-
Note 8: 3D imaging
Note 9: Panoramic imaging
Note10: ElastoScan
- Note11: Spatial Compound Imaging
- Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
26
510(k) No.: Device Name: DP2B for use with A35 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
---|---|---|---|---|---|---|---|---|---|
General | |||||||||
(Track I only) | Specific | ||||||||
(Tracks I & III) | B | M | PWD | CWD | Color | ||||
Doppler* | Combined* | ||||||||
(Spec.) | Other | ||||||||
(Spec.) | |||||||||
Ophthalmic | Ophthalmic | ||||||||
Fetal Imaging | |||||||||
& | |||||||||
Other | Fetal/Obstetrics (See Note 3) | ||||||||
Abdominal (See Note 12) | |||||||||
Intra-operative (See Note 6) | |||||||||
Intra-operative (Neuro.) | |||||||||
Laparoscopic | |||||||||
Pediatric | |||||||||
Small Organ (See Note 5) | |||||||||
Neonatal Cephalic | |||||||||
Adult Cephalic | P | ||||||||
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 | P | |||||||
Cardiac Pediatric | P | ||||||||
Trans-esophageal (Cardiac) | |||||||||
Other (spec.) | |||||||||
Peripheral | |||||||||
Vessel | Peripheral vessel | P | |||||||
Other (spec.) |
N= new indication; P= previously cleared by FDA K143264; E= added under Appendix E
Additional Comments:
Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+PW, B+TD+PW, B+C+M, Dual /Quad, B+C+CW, B+PD+CW, B+E
-
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: Panoramic imaging
Note10: ElastoScan
Note11: Spatial Compound Imaging
Note12: Includes Renal, Gynecology/Pelvis
Note13: Includes Urology/Prostate
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:
Jiyoung, Kim Regulatory Affairs Manager
Telephone: | 82.2.2194.1299 |
---|---|
Facsimile: | 82.2.556.3974 |
Data Prepared: January 23, 2015
2. Name of the device:
Common/Usual Name: | ||
---|---|---|
Diagnostic Ultrasound System and Accessories | ||
Proprietary Name: | ||
A35 Diagnostic Ultrasound System | ||
Classification Names: | FR Number | Product Code |
Ultrasonic Pulsed Doppler Imaging System | 892.1550 | IYN |
Ultrasound Pulsed Echo Imaging System | 892.1560 | IYO |
3. Identification of the predicate or legally marketed device:
- ACCUVIX A30 Diagnostic Ultrasound System (K112339) -
- WS80A Diagnostic Ultrasound System (K143089) -
- -H60 Diagnostic Ultrasound System (K143264)
- UGEO PT60A Diagnostic Ultrasound System (K142466) -
- -SONOACE R7 Diagnostic Ultrasound System (K133505)
28
4. Device Description:
The A35 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, PW/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 A35 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 A35 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 A35 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Peripheral vessel
6. Technological Characteristics:
The A35 is substantially equivalent with respect to safety, effectiveness, and functionality to the ACCUVIX A30 Diagnostic Ultrasound System (K112339), WS80A Diagnostic Ultrasound System (K143089), H60 Diagnostic Ultrasound System (K143264), UGEO PT60A Diagnostic Ultrasound System (K142466) and SONOACE R7 Diagnostic Ultrasound System (K133505).
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.
29
A35 | V3.01 | Remarks | ||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Model Name | • Change of model name in the V3.01 | |||||||||||||||||||||||||
Clinical application | • No addition | The clinical application was described in more detail. | ||||||||||||||||||||||||
Operation of modes | • No addition | |||||||||||||||||||||||||
Applied transducers | • Addition of 12 transducers: | |||||||||||||||||||||||||
CA1-7A, SC1-6, EA2-11B, VR5-9, L5-13/50, | ||||||||||||||||||||||||||
LA3-14A, LA3-16A, LS6-15, CV1-8A, V4-8, DP2B | Transducers The previously cleared transducers CA1-7A K143089 SC1-6 K143089 EA2-11B None VR5-9 K143089 L5-13/50 None LA3-14A K143089 (L3-12A) LA3-16A K143089 LS6-15 K142466 CV1-8A K143089 V4-8 K143089 DP2B K143264 | |||||||||||||||||||||||||
SW Features | Additional software features cleared on the predicate devices have been added. | |||||||||||||||||||||||||
• SW Features | ||||||||||||||||||||||||||
Software improvements migrated from predicate device as below. | ||||||||||||||||||||||||||
SW Features The previously cleared SW Features Volume IT K143089 FRV K143089 Stereo cine (5D Cine) K143089 Stress Echo, Strain K133505 | Description of S/W Features | |||||||||||||||||||||||||
• Volume IT: Volume IT provides to calculate the Thickness of IT (Intracranial Translucency) at the sagittal view by acquiring the 3D ultrasound data of a fetus. This feature locates mid-sagittal view and tests the fetus for spina bifida. In normal fetuses the fourth cerebral ventricle presents as an intracranial translucency (IT) parallel to the NT, while in fetuses with open spina bifida there may be absence of the IT. | ||||||||||||||||||||||||||
• FVR: This function allows realistic visualization of 3D Volume Data by global illumination technique. This semitransparent rendering technique is useful for detecting morphological abnormalities or malformations of fetuses. | ||||||||||||||||||||||||||
• Stereo cine (5D Cine): Generate a 3D Cine image, and save it to portable media such as a USB device. | ||||||||||||||||||||||||||
• Stress Echo: It provides functions to support cardio-vascular application. It's for diagnosis of heart moving, using by agents or exercises. | ||||||||||||||||||||||||||
• Strain (including TMAD): It provides |
30
A35 | V3.01 | Remarks |
---|---|---|
application. It's for diagnosis of heart | ||
moving, using by motion vector. | ||
HW Features | • Change of Monitor size | |
(21.5 inch → 23 inch) |
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| | The subject
device | The predicate devices | | | | |
|------------------------------------------------|---------------------------|-----------------------------|--------------------|------------------|-------------------------|-------------------------|
| Feature / Characteristics | A35 | ACCUVIX
A30
(K112339) | WS80A
(K143089) | H60
(K143264) | UGEO PT60A
(K142466) | SONOACE R7
(K133505) |
| Indication for Use | | | | | | |
| - Fetal/Obstetrics | √ | √ | √ | √ | √ | √ |
| - Abdominal | √ | √ | √ | √ | √ | √ |
| - Gynecology | √ | √ | √ | √ | √ | √ |
| - Pediatric | √ | √ | √ | √ | √ | √ |
| - Small Organ | √ | √ | √ | √ | √ | √ |
| - Neonatal Cephalic | √ | √ | √ | √ | √ | √ |
| - Adult Cephalic | √ | √ | √ | √ | √ | √ |
| - Trans-rectal | √ | √ | √ | √ | √ | √ |
| - Trans-vaginal | √ | √ | √ | √ | √ | √ |
| - Musculo-skeletal
(Conventional) | √ | √ | √ | √ | √ | √ |
| - Musculo-skeletal
(Superficial) | √ | √ | √ | √ | √ | √ |
| - Urology | √ | √ | √ | √ | √ | √ |
| - Cardiac Adult | √ | √ | √ | √ | √ | √ |
| - Cardiac Pediatric | √ | √ | √ | √ | √ | √ |
| - Peripheral vessel | √ | √ | √ | √ | √ | √ |
| Scanhead Types | | | | | | |
| - Linear Array | √ | √ | √ | √ | √ | √ |
| - Curved Linear Array | √ | √ | √ | √ | √ | √ |
| - Endocavity | √ | √ | √ | √ | √ | √ |
| - Phased Array | √ | √ | √ | √ | √ | √ |
| - Static Probes | √ | √ | √ | √ | √ | √ |
| Scanhead Frequency | | | | | | |
| 1.0 ~ 20.0 MHz | √ | √ | √ | √ | √ | √ |
| Modes of Operation | | | | | | |
| - B-mode | √ | √ | √ | √ | √ | √ |
| - M-mode | √ | √ | √ | √ | √ | √ |
| - Pulsed wave (PW)
Doppler | √ | √ | √ | √ | √ | √ |
| - Continuous wave
(CW) Doppler | √ | √ | √ | √ | √ | √ |
| - Color Doppler | √ | √ | √ | √ | √ | √ |
| - Power Amplitude
Doppler | √ | √ | √ | √ | √ | √ |
| - Tissue Harmonic
Imaging | √ | √ | √ | √ | √ | √ |
| - 3D/4D imaging mode | √ | √ | √ | √ | √ | √ |
| - Combined modes | √ | √ | √ | √ | √ | √ |
| Safety & EMC
Compliance | | | | | | |
| - IEC 60601-1 | | | | | | |
| - UL 60601-1 | √ | √ | √ | √ | √ | √ |
| - CSA C22.2 No 601.1 | | | | | | |
| Feature / Characteristics | The subject device
A35 | The predicate devices | | | | |
| | | ACCUVIX A30
(K112339) | WS80A
(K143089) | H60
(K143264) | UGEO PT60A
(K142466) | SONOACE R7
(K133505) |
| - 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) | √ | √ | √ | √ | √ | √ |
| - DMR+(Dynamic MR Plus) | √ | √ | √ | √ | √ | √ |
| - Spatial Compound Imaging | √ | √ | √ | √ | √ | √ |
| - Auto IMT(Auto IMT+) | √ | √ | √ | √ | √ | √ |
| - Elastoscan | √ | √ | √ | √ | | √ |
| - Panoramic | √ | √ | √ | √ | | √ |
| - 3D Imaging
(Volume Data Acquisition) | √ | √ | √ | √ | | √ |
| - 3D Imaging presentation | | | | | | |
| 3D Cine/4D Cine
/Stereo Cine(5D Cine) | √ | √ | √ | √ | | √ |
| - 3D Rendering
MPR(Multi Planer Render) | √ | √ | √ | √ | | √ |
| - 3D XI
MSV(Multi Slice View), Oblique View | √ | √ | √ | √ | | √ |
| - 3D MXI
Volume Slice, Mirror View | √ | √ | √ | | | |
| Volume CT | √ | √ | √ | | | |
| - 3D MagiCut | √ | √ | √ | √ | | √ |
| - Volume Calculation
(VOCAL, XI VOCAL) | √ | √ | √ | √ | | |
| - XI STIC | √ | √ | √ | √ | | |
| - HDVI | √ | √ | √ | | | |
| - FRV | √ | | √ | | | |
| - Volume NT | √ | √ | √ | √ | | |
| Volume IT | √ | | √ | √ | | |
| - ADVR (Screen DVR) | √ | √ | √ | | | |
| - Strain | √ | | | | | √ |
32
33
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 A35 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. A35, 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 A35 to be as safe, as effective, and performance is substantially equivalent to the predicate devices.