Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1
Device Facts
| Record ID | K163702 |
|---|---|
| Device Name | Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 |
| Applicant | Toshibamedical Systems Corporation |
| Product Code | IYN · Radiology |
| Decision Date | May 30, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The Diagnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-AI700 are indicated for the visualization of structures, and dynamic processes with the human body usinq ultrasound and to provide image information for diaqnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small orqans, trans-vaqinal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic.
Device Story
Mobile diagnostic ultrasound system; uses wide array of probes (linear, convex, sector) with 2-20 MHz frequency range. Inputs: ultrasound signals from human body. Transforms inputs into diagnostic images and measurements via signal processing and software analysis. Outputs: real-time ultrasound images, wall motion tracking (2D WMT) data, cardiac function analysis (GLS, GCS, GRS, EDV, ESV, EF). Used in clinical settings by physicians/sonographers. 2D WMT feature provides auto-initial contour setting for cardiac wall tracing, local wall motion tracking, and polar map displays. Benefits: improved workflow efficiency, reduced operation time, and automated cardiac function quantification. Healthcare providers use output for diagnosis and clinical decision-making.
Clinical Evidence
Bench testing and clinical image assessment. 10-patient study with 3 clinicians evaluated 2D WMT parameters (EDV, ESV, strain metrics). Results showed <11% coefficient of variation for major parameters. Study concluded 2D WMT function is substantially equivalent to predicate and reduces operation time.
Technological Characteristics
Mobile ultrasound system; flat linear, convex linear, and sector array probes (2-20 MHz). Connectivity: standard ultrasound interfaces. Software: Moderate level of concern. Conformance: IEC 60601-1, IEC 60601-2-37, IEC 62304, AIUM RTD2-2004, ISO 10993-1.
Indications for Use
Indicated for visualization of structures and dynamic processes in the human body using ultrasound for diagnosis in fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (adult/pediatric), peripheral vascular, transesophageal, musculoskeletal, and laparoscopic applications.
Regulatory Classification
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
- Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 (K161843)
- Aplio 500/400/300 Diagnostic Ultrasound System, V6.0 (K151451)
Related Devices
- K173090 — Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 · Toshibamedical Systems Corporation · Jan 11, 2018
- K220242 — TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 25, 2022
- K191467 — Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 · Canon Medical Systems Corporation · Jul 19, 2019
- K200497 — Vivid S60N, Vivid S70N · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jul 16, 2020
- K212960 — Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 · Canon Medical Systems Corporation · Mar 22, 2022
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a triple-lined design above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 30, 2017
Toshiba Medical Systems Corporation % Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc 2441 Michelle Drive TUSTIN CA 92780
Re: K163702
Trade/Device Name: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: April 21, 2017 Received: April 25, 2017
Dear Mr. Tadeo:
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,
Michael D'Hara For
Robert Ochs, Ph.D 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)
K163702
#### Device Name
Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1
#### Indications for Use (Describe)
The Diaqnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-AI700 are indicated for the visualization of structures, and dynamic processes with the human body usinq ultrasound and to provide image information for diaqnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small orqans, trans-vaqinal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic.
Type of Use (Select one or both, as applicable)
اك Prescription Use (Part 21 CFR 801 Subpart D)
- Over-The-Counter Use (21 CFR 801 Subpart C)
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### FOR FDA USE ONLY
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Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical |
|----------|
|----------|
| Clinical Application | Mode of Operation | | | | | | | | | | | | | | | | | | | | | | | |
|--------------------------------|-------------------|---|-----|-----|---------------|-----------------------------------------|------------|-----------|-------|------|-----|--------------|----------|------------|----------------------|----------|------|------------|----------|--------|------------------|--------|-----------------|--|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color Doppler | Precision Imaging<br>Combined (Specify) | Micro Pure | Apli Pure | Power | BEAM | TDI | Elastography | SMI(ADF) | Shear wave | 4D<br>(Volume color) | 3D Color | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other<br>[Note] | |
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | | | P | | | P | | P | P | P | P | P | | | 6,8 | |
| Abdominal | P | P | P | P | P | 2,3 | P | P | | | P | | P | P | P | P | P | P | P | P | P | | 4,5,6,7,8 | |
| Intra-operative (Abdominal) | P | P | P | | P | 2 | P | P | | | P | | | | | | | | P | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | P | P | P | | P | 2 | P | P | | | P | | P | P | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 2,3 | P | P | | | P | | | P | | P | P | P | P | P | P | | 6,8 | |
| Small Organ (Note 1) | P | P | P | | P | 2 | P | P | P | P | P | | P | P | P | | | | | P | P | P | 6 | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | | | | P | | | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | 3 | | | | | P | | | | | | | | | | | | | |
| Trans-rectal | P | P | P | | P | 2 | P | P | | | P | | P | P | | P | P | | | | P | | 8 | |
| Trans-vaginal | P | P | P | | P | 2 | P | P | | | P | | P | P | | P | P | | | | P | | 8 | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal(Conventional) | P | P | P | | P | 2 | P | P | P | P | P | | P | P | | | | | | P | P | P | 6 | |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | P | P | | P | P | | | | | | P | P | P | 6 | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | | | | P | P | | | | | | | | | | | N 7,8 | |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | | | | P | P | | | | | | | | | | | N 7,8 | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | P | P | P | P | P | 3 | P | | | | | P | | | | | | | | | | | N 8 | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | 2 | P | P | P | P | P | | P | P | | | | | | P | P | P | 6 | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K161843 Prescription Use Only (Per 21 CFR 801.109)
Note 1 Small organ includes thyroid, breast and testicle
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
{4}------------------------------------------------
Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | | | | | | Other | | [Note] | | | | | | |
|---------------------------------|-------------------|---|-----|-----|---------------|-------------------------------------------|-----------|------------|------|-------|-----|--------------|----------|------------|----------------------|----------------------------|-------|------------|----------|--------|------------------|--------|-------|--------|--|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color Doppler | Precision Imaging<br>Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D<br>(Volume color) | 3D Color<br>(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] | |
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | | | P | | | P | | | | | | | P | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | | | P | | | P | | | | | | | P | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | | | P | | | | | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | 3 | | | P | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | | | P | P | | | | | | | | | | | | N 7 | | |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | | | P | P | | | | | | | | | | | | N 7 | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K161843 Prescription Use Only (Per 21 CFR 801.109)
Note 1 Small organ includes thyroid, breast and testicle
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI Note 5 Tissue Intensity Analysis Note 6 Sensor3D Note 7 CHI (Per FDA approved contrast agent prescribing information)
{5}------------------------------------------------
Transducer: PSI-70BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | | | | | | | | Other | [Note] | | | | |
|--------------------------------|-------------------|---|-----|-----|---------------|-------------------------------------------|-----------|------------|------|-------|-----|--------------|------------|----------|----------------------|----------|------|------------|----------|--------|------------------|--------|-------|--------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color Doppler | Precision Imaging<br>Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | Shear wave | SMI(ADF) | 4D<br>(Volume color) | 3D Color | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | | | P | | | P | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | | | P | | | P | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | | | P | | | | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | 3 | | | | P | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal(Conventional) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | | | P | P | | | | | | | | | | | N 7 | | |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | | | P | P | | | | | | | | | | | N 7 | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K161843 Prescription Use Only (Per 21 CFR 801.109)
Note 1 Small organ includes thyroid, breast and testicle
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
{6}------------------------------------------------
Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | | | Other | | [Note] | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|---------------|-------------------|----------------------|------------|------|-------|-----|--------------|------------|----------|----------------------|----------|------|------------|----------|--------|------------------|--------|-------|--------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color Doppler | Precision Imaging | Combined (Specify) * | Micro Pure | BEAM | Power | TDI | Elastography | Shear wave | SMI(ADF) | 4D<br>(Volume color) | 3D Color | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | | P | | | | P | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | | P | | | | P | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | | P | | | | | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | 3 | | | P | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | | P | P | | | | | | | | | | | | N | | |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | | P | P | | | | | | | | | | | | N | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K161843 Prescription Use Only (Per 21 CFR 801.109)
Note 1 Small organ includes thyroid, breast and testicle
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
{7}------------------------------------------------
PST-30BT Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color Doppler | Precision Imaging<br>Combined (Specify) * | Micro Pure<br>Apli Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D | 3D Color<br>(Volume color) | STIC | STIC Color | Smart 3D | Fusion<br>Smart Navigation | 2D WMT | Other | [Note] |
|---------------------------------|---|---|-----|-----|---------------|-------------------------------------------|-------------------------|------|-------|-----|--------------|----------|------------|----|----------------------------|------|------------|----------|----------------------------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | | P | | | | P | | | | | | | 7 | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | | P | | | | P | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | | | P | | | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | 3 | | | P | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | | | P | P | | | | | | | | | | N 7 | | |
| Cardiac Pediatric | P | P | P | P | P | 3 | | | P | P | | | | | | | | | | N 7 | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K161843 Prescription Use Only (Per 21 CFR 801.109)
Note 1 Small organ includes thyroid, breast and testicle
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
{8}------------------------------------------------
PST-50BT Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Precision Imaging<br>Combined (Specify) * | Color Doppler | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D<br>(Volume color) | 3D Color | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
|---------------------------------|---|---|-----|-----|-------------------------------------------|---------------|-----------|------------|------|-------|-----|--------------|----------|------------|----------------------|----------|------|------------|----------|--------|------------------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | | P | | P | | E | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | | P | | P | | E | | | | | | | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | | | | | P | | | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | 3 | | | | | P | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | | | | | P | P | | | | | | | | | | | N | |
| Cardiac Pediatric | P | P | P | P | P | 3 | | | | | P | P | | | | | | | | | | | N | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K161843 Prescription Use Only (Per 21 CFR 801.109)
Note 1 Small organ includes thyroid, breast and testicle
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
{9}------------------------------------------------
Transducer: PVI-475BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
| Clinical Application<br>Specific<br>(Tracks 3) | B | M | PWD | CWD | Precision Imaging<br>Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D | 3D Color<br>(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
|------------------------------------------------|---|---|-----|-----|-------------------------------------------|-----------|------------|------|-------|-----|--------------|----------|------------|----|----------------------------|------|------------|----------|--------|------------------|--------|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | P | P | P | P | 2 | P | P | | P | | | | P | | | | | P | | | | | |
| Abdominal | P | P | P | P | 2 | P | P | | P | P | P | P | E | | | | | P | P | P | | 6,7 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | 2 | P | P | | P | | | | P | | | | | P | P | P | | 6 | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K161843 Prescription Use Only (Per 21 CFR 801.109)
Note 1 Small organ includes thyroid, breast and testicle
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
{10}------------------------------------------------
Transducer: PVI-475BX
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application
| Clinical Application<br>Specific<br>(Tracks 3) | B | M | PWD | CWD | Color Doppler | Precision Imaging<br>Combined (Specify) * | Apli Pure | Micro Pure | BEAM | Power | TDI | Elastography | SMI(ADF) | Shear wave | 4D | 3D Color<br>(Volume color) | STIC | STIC Color | Smart 3D | Fusion | Smart Navigation | 2D WMT | Other | [Note] |
|------------------------------------------------|---|---|-----|-----|---------------|-------------------------------------------|-----------|------------|------|-------|-----|--------------|----------|------------|----|----------------------------|------|------------|----------|--------|------------------|--------|---------|--------|
| Ophthalmic | | | | | | | | | | | | | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | | P | | | P | | | | | | P | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | | P | P | P | P | | | | | | P | P | P | | 4,5,6,7 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | |…
