← Product Code [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN) · K150478
# A35 Diagnostic Ultrasound System (K150478)
_Samsung Medison Co., Ltd. · IYN · Mar 26, 2015 · Radiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K150478
## Device Facts
- **Applicant:** Samsung Medison Co., Ltd.
- **Product Code:** [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN.md)
- **Decision Date:** Mar 26, 2015
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1550
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Pediatric, 3rd-Party Reviewed
## Intended Use
The A35 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
## Device Story
A35 is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via various transducers (linear, curved, endocavity, phased array) and displays it in B-mode, M-mode, Color/Power Doppler, PW/CW Spectral Doppler, Harmonic imaging, Tissue Doppler, 3D/4D imaging, and Elastoscan. Operated by healthcare professionals in clinical settings, the device provides real-time acoustic output displays (mechanical/thermal indices). It includes analysis packages for anatomical measurements and fluid flow assessment. The system supports advanced features like Volume IT (intracranial translucency calculation for spina bifida testing), FVR (global illumination rendering for fetal morphology), Stereo Cine (5D Cine), Stress Echo, and Strain imaging. Output is displayed on a 23-inch monitor, aiding clinicians in diagnosis and clinical decision-making. Benefits include non-invasive visualization of internal structures and guidance for biopsy procedures.
## Clinical Evidence
No clinical data was required to support substantial equivalence. The device evaluation relied on bench testing, including acoustic output measurements, biocompatibility testing (ISO 10993-1), and electrical/electromagnetic safety testing (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37).
## Technological Characteristics
Mobile ultrasound system with 23-inch monitor. Supports linear, curved, endocavity, and phased array transducers (1.0–20.0 MHz). Modes: B, M, PW/CW Doppler, Color/Power Doppler, Tissue Harmonic, 3D/4D, Elastoscan. Connectivity includes USB for data export. Software features include Volume IT, FVR, Stereo Cine, Stress Echo, and Strain imaging. Complies with IEC 60601-1, IEC 60601-2-37, and ISO 10993-1.
## Regulatory 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.
## Predicate Devices
- ACCUVIX A30 Diagnostic Ultrasound System ([K112339](/device/K112339.md))
- WS80A Diagnostic Ultrasound System ([K143089](/device/K143089.md))
- H60 Diagnostic Ultrasound System ([K143264](/device/K143264.md))
- UGEO PT60A Diagnostic Ultrasound System ([K142466](/device/K142466.md))
- SONOACE R7 Diagnostic Ultrasound System ([K133505](/device/K133505.md))
## Submission Summary (Full Text)
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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.
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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
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# 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)
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### 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) | | | | |…
---
**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K150478](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K150478)
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