APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0
Device Facts
| Record ID | K141459 |
|---|---|
| Device Name | APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0 |
| Applicant | Toshibamedical Systems Corporation |
| Product Code | IYN · Radiology |
| Decision Date | Oct 28, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The Diaqnostic Ultrasound System Aplio 500 Model TUS-A500, Aplio 400 Model TUS-A400 And Aplio 300 Model TUS-A300 is indicated for the visualization of structures, and dynamic processes with the human body using 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, transesophaqeal, musculo-skeletal (conventional and superficial) and laparoscopic.
Device Story
Mobile diagnostic ultrasound system; uses flat linear, convex linear, and sector array probes (2-12 MHz). Transforms ultrasound echoes into real-time images for clinical diagnosis. Operated by clinicians in various settings. Features include needle enhancement for visualization, shear wave elastography for tissue elasticity measurement, and Smart Navigation for needle guidance. Output displayed on system monitor; assists clinicians in visualizing anatomy, guiding interventional procedures, and assessing tissue properties. Benefits include improved diagnostic accuracy and procedural guidance.
Clinical Evidence
Bench testing only. Three studies conducted: 1) Needle enhancement feature comparison; 2) Shear wave speed and elasticity measurement accuracy using an elasticity phantom; 3) Smart Navigation accuracy for needle path projection. Software validation and risk management documentation provided.
Technological Characteristics
Mobile ultrasound system; flat linear, convex linear, and sector array transducers (2-12 MHz). Modes: B, M, PWD, CWD, Color Doppler, THI, Dynamic Flow, Power, CHI 2D, 4D. Features: ApliPure, MicroPure, Precision Imaging, STIC, Elastography, Fusion, 2D WMT, Boost, SMI, Shear wave, BEAM, Smart Navigation. Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, AIUM RTD2-2004, and ISO 10993-1.
Indications for Use
Indicated for visualization of structures and dynamic processes in the human body for diagnostic imaging in fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (adult/pediatric), peripheral vascular, transesophageal, musculoskeletal (conventional/superficial), 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 500/400/300 Diagnostic Ultrasound System V4.0 (K133761)
- AIXPLORER Ultrasound System (K112255)
- GE Logiq E9 BT2010 Diagnostic Ultrasound System (K092271)
- Electromagnetic Tracking System (K092619)
- MicroMaxx High Resolution Ultrasound System (C3 Series) (K053069)
Related Devices
- K143027 — Xario 200, V3.0 · Toshibamedical Systems Corporation · Nov 20, 2014
- K172276 — Xario 200 Diagnostic Ultrasound System V6.0 · Toshibamedical Systems Corporation · Dec 12, 2017
- K151451 — Aplio 500/400/300 Diagnostic Ultrasound System V6.0 · Toshibamedical Systems Corporation · Jul 9, 2015
- K172059 — LinkQuest Diagnostic Ultrasound System model SQ860 · Linkquest, Inc. · Oct 5, 2017
- K191663 — Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 · Canon Medical Systems Corporation · Sep 18, 2019
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image contains the seal of the U.S. Department of Health & Human Services. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The emblem is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2014
Toshiba Medical Systems Corporation % Mr. Orlando Tadeo Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K141459
Trade/Device Name: Aplio 500/400/300 Diagnostic Ultrasound System, V5.0 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 2, 2014 Received: October 3, 2014
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.
This determination of substantial equivalence applies to the following transducers intended for use with the Aplio 500/400/300 Diagnostic Ultrasound System, V5.0. as described in your premarket notification:
Transducer Model Number
| PST-25BT | PST-30BT | PST-50BT |
|------------|------------|------------|
| PST-65AT | PVT-375BT | PVT-375SC |
| PVT-375MV | PVT-382BT | PVT-382MV |
| PVT-661VT | PVT-781VT | PVT-674BT |
| PVT-675MV | PVT-675MVL | PVT-681MV |
| PVT-712BT | PVT-745BTF | PVT-745BTH |
| PVT-745BTV | PVT-770RT | PLT-604AT |
| PLT-704AT | PLT-704SBT | PLT-705BT |
| PLT-705BTF | PVT-705BTH | PLT-805AT |
{1}------------------------------------------------
| PLT-1005BT☐ | PLT-1202S | PLT-1204BT |
|-------------|------------|------------|
| PLT-1204BX | PLT-1204MV | PET-508MA |
| PET-510MB | PET-512MC | PET-805LA |
| PC-20M | PC-50M | |
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.
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.
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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,
Sm. 7)
for
Janine M. Morris 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)
## K141459
## Device Name
Aplio 500/400/300 V5.0 Diagnostic Ultrasound System
### Indications for Use (Describe)
The Diaqnostic Ultrasound System Aplio 500 Model TUS-A500, Aplio 400 Model TUS-A400 And Aplio 300 Model TUS-A300 is indicated for the visualization of structures, and dynamic processes with the human body using 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, transesophaqeal, musculo-skeletal (both conventional and superficial) and laparoscopic.
Type of Use (Select one or both, as applicable)
ك 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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### System: _Aplio 500, Aplio 400, Aplio 300 V5.0
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<br>Doppler | Combined<br>(Specify) * | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other [Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | 2 | P | P | P | P | | 5,7,8,9,10,14,18 |
| Abdominal | P | P | P | P | P | 2,3 | P | P | P | P | | 5,7,8,9,10,11,12,14,<br>15,16,18 |
| Intra-operative (Abdominal) | P | P | P | P | P | 2 | P | P | P | | | 4,5,7,11 |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | N | N | N | N | N | 2 | N | N | N | | | 5,7 |
| Pediatric | P | P | P | P | P | 2,3 | P | P | P | P | | 5,7,8,9,10,12,14,15,<br>18 |
| Small Organ (Note 1) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11,14,<br>15,17,18 |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
| Adult Cephalic | P | P | P | P | P | 3 | P | P | P | | | |
| Trans-rectal | P | P | P | P | P | 2 | P | P | P | | P | 4,5,7,11,12,18 |
| Trans-vaginal | P | P | P | P | P | 2 | P | P | P | | P | 4,5,7,11,12,18 |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11,14,<br>15,17,18 |
| Musculo-skeletal (Superficial) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11,14,<br>15,17,18 |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | P | P | P | | 4,13 |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | P | | 4,13 |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | P | P | P | P | P | 3 | P | | | | | 4,13 |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11,14,<br>15,17,18 |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Previous 510(k) of the transducers: K133761, K123992, K121422 and K103629
| Note 1 Small organ includes thyroid, breast and testicle | Note 7 Precision Imaging | Note 13 2D WMT |
|----------------------------------------------------------------------------------------------|--------------------------------|--------------------------|
| Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;<br>BDF/MDF; BDF/MDF/PWD | Note 8 STIC | Note 14 Boost |
| Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;<br>BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD; | Note 9 3D Color (Volume Color) | Note 15 SMI |
| Note 4 TDI | Note 10 STIC Color | Note 16 Shear wave |
| Note 5 ApliPure | Note 11 Elastography | Note 17 BEAM |
| Note 6 MicroPure | Note 12 Fusion | Note 18 Smart Navigation |
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## System: _ Aplio 500, Aplio 400, Aplio 300 V5.0
Transducer: _ PST-25BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other | [Note] |
|------------------------------------------------|---|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|-------|--------|
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | P | P | | | 11 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | P | P | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | | |
| Adult Cephalic | P | P | P | P | P | 3 | P | P | 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 | P | | 4,13 | |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | P | | 4,13 | |
| 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 transducer: K133761
| Note 1 Small organ includes thyroid, breast and testicle | Note 7 Precision Imaging | Note 13 2D WMT |
|---------------------------------------------------------------------------------------------|--------------------------------|--------------------------|
| Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;<br>BDF/MDF; BDF/MDF/PWD | Note 8 STIC | Note 14 Boost |
| Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;<br>BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD | Note 9 3D Color (Volume Color) | Note 15 SMI |
| Note 4 TDI | Note 10 STIC Color | Note 16 Shear wave |
| Note 5 ApliPure | Note 11 Elastography | Note 17 BEAM |
| Note 6 MicroPure | Note 12 Fusion | Note 18 Smart Navigation |
{6}------------------------------------------------
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<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other | [Note] |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | P | P | | | 11 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | P | P | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | | |
| Adult Cephalic | P | P | P | P | P | 3 | P | P | 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 | P | | 4,13 | |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | P | | 4,13 | |
| 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 transducer: K133761
| Note 1 Small organ includes thyroid, breast and testicle | Note 7 Precision Imaging | Note 13 2D WMT |
|---------------------------------------------------------------------------------------------|--------------------------------|--------------------------|
| Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;<br>BDF/MDF; BDF/MDF/PWD | Note 8 STIC | Note 14 Boost |
| Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;<br>BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD | Note 9 3D Color (Volume Color) | Note 15 SMI |
| Note 4 TDI | Note 10 STIC Color | Note 16 Shear wave |
| Note 5 ApliPure | Note 11 Elastography | Note 17 BEAM |
| Note 6 MicroPure | Note 12 Fusion | Note 18 Smart Navigation |
{7}------------------------------------------------
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<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other | [Note] |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | P | P | | | 11 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | P | P | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | | |
| Adult Cephalic | P | P | P | P | P | 3 | P | P | 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 | P | | 4,13 | |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | P | | 4,13 | |
| 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 transducer: K133761
| Note 1 Small organ includes thyroid, breast and testicle | Note 7 Precision Imaging | Note 13 2D WMT |
|---------------------------------------------------------------------------------------------|--------------------------------|--------------------------|
| Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;<br>BDF/MDF; BDF/MDF/PWD | Note 8 STIC | Note 14 Boost |
| Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;<br>BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD | Note 9 3D Color (Volume Color) | Note 15 SMI |
| Note 4 TDI | Note 10 STIC Color | Note 16 Shear wave |
| Note 5 ApliPure | Note 11 Elastography | Note 17 BEAM |
| Note 6 MicroPure | Note 12 Fusion | Note 18 Smart Navigation |
{8}------------------------------------------------
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<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other | [Note] |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | P | P | | | 11 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | P | P | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | | |
| Adult Cephalic | P | P | P | P | P | 3 | P | P | 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 | P | | 4,13 | |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | P | | 4,13 | |
| 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 transducer: K133761
| Note 1 Small organ includes thyroid, breast and testicle | Note 7 Precision Imaging | Note 13 2D WMT |
|---------------------------------------------------------------------------------------------|--------------------------------|--------------------------|
| Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;<br>BDF/MDF; BDF/MDF/PWD | Note 8 STIC | Note 14 Boost |
| Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;<br>BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD | Note 9 3D Color (Volume Color) | Note 15 SMI |
| Note 4 TDI | Note 10 STIC Color | Note 16 Shear wave |
| Note 5 ApliPure | Note 11 Elastography | Note 17 BEAM |
| Note 6 MicroPure | Note 12 Fusion | Note 18 Smart Navigation |
{9}------------------------------------------------
### System: _Aplio 500, Aplio 400, Aplio 300 V5.0
Transducer:___PVT-375BT
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<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | | 5,7 |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 5,7,11,12,15,16,18 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | | 5, 7,12,15,18 |
| Small Organ (Specify) (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 transducer: K133761
| Note 1 Small organ includes thyroid, breast and testicle | Note 7 Precision Imaging | Note 13 2D WMT |
|------------------------------------------------------------------------------------------|--------------------------------|--------------------------|
| Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD | Note 8 STIC | Note 14 Boost |
| Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD | Note 9 3D Color (Volume Color) | Note 15 SMI |
| Note 4 TDI | Note 10 STIC Color | Note 16 Shear wave |
| Note 5 ApliPure | Note 11 Elastography | Note 17 BEAM |
| Note 6 MicroPure | Note 12 Fusion | Note 18 Smart Navigation |
{10}------------------------------------------------
## System: _Aplio 500, Aplio 400, Aplio 300 V 5.0
Transducer: _ PVT-375SC
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<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other | [Note] | |
| Ophthalmic | | | | | | | | | | | | | | |
| Fetal | N | N | N | N | N | 2 | N | N | N | | | 5,7 | | |
| Abdominal | N | N | N | N | N | 2 | N | N | N | | | 5,7,11,12,15,16,18 | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | |
| Pediatric | N | N | N | N | N | 2 | N | N | N | | | 5,7,12,15,18 | | |
| Small Organ (Specify) (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 transducer: N/A
| Note 1 Small organ includes thyroid, breast and testicle | Note 7 Precision Imaging | Note 13 2D WMT |
|---------------------------------------------------------------------------------------------|--------------------------------|--------------------------|
| Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;<br>BDF/MDF; BDF/MDF/PWD | Note 8 STIC | Note 14 Boost |
| Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;<br>BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD | Note 9 3D Color (Volume Color) | Note 15 SMI |
| Note 4 TDI | Note 10 STIC Color | Note 16 Shear wave |
| Note 5 ApliPure | Note 11 Elastography | Note 17 BEAM |
| Note 6 MicroPure | Note 12 Fusion | Note 18 Smart Navigation |
{11}------------------------------------------------
### System: _ Aplio 500, Aplio 400, Aplio 300 V5.0
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<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | P | 5,7,8,9,10 |
| Abdominal | P | P | P | | P | 2 | P | P | P | | P | 5,7,8,9,10 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | P | 5,7,8,9,10 |
| Small Organ (Specify) (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 transducer: K133761
| Note 1 Small organ includes thyroid, breast and testicle | Note 7 Precision Imaging | Note 13 2D WMT |
|---------------------------------------------------------------------------------------------|--------------------------------|--------------------------|
| Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;<br>BDF/MDF; BDF/MDF/PWD | Note 8 STIC | Note 14 Boost |
| Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;<br>BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD | Note 9 3D Color (Volume Color) | Note 15 SMI |
| Note 4 TDI | Note 10 STIC Color | Note 16 Shear wave |
| Note 5 ApliPure | Note 11 Elastography | Note 17 BEAM |
| Note 6 MicroPure | Note 12 Fusion | Note 18 Smart Navigation |
{12}------------------------------------------------
### System: _Aplio 500, Aplio 400, Aplio 300 V5.0
Transducer:___PVT-382BT
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<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other | [Note] |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | | | 5, 7,18 |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | | 5, 7,12,18 |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | | | 5, 7,12,18 |
| Small Organ (Specify) (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 transducer: K133761
| Note 1 Small organ includes thyroid, breast and testicle | Note 7 Precision Imaging | Note 13 2D WMT |
|---------------------------------------------------------------------------------------------|--------------------------------|--------------------------|
| Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;<br>BDF/MDF; BDF/MDF/PWD | Note 8 STIC | Note 14 Boost |
| Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;<br>BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD | Note 9 3D Color (Volume Color) | Note 15 SMI |
| Note 4 TDI | Note 10 STIC Color | Note 16 Shear wave |
| Note 5 ApliPure | Note 11 Elastography | Note 17 BEAM |
| Note 6 MicroPure | Note 12 Fusion | Note 18 Smart Navigation |
{13}------------------------------------------------
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Specific<br>(Tracks 3) | Mode of Operation | | B | M | PWD CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other | [Note] |
|------------------------------------------------|-------------------|--|---|---|---------|------------------|----------------------------|-----|-----------------|-------|-----------|----|-------|--------|
| Ophthalmic | | | | | | | | | | | | | | |
| Fetal | | | P | P | P | P | 2 | P | P | P | | P | 5,7,9 | |
| Abdominal | | | P | P | P | P | 2 | P | P | P | | P | 5,7,9 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | |
| Pediatric | | | P | P | P | P | 2 | P | P | P | | P | 5,7,9 | |
| Small Organ (Specify) (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 transducer: K133761
| Note 1 Small organ includes thyroid, breast and testicle | Note 7 Precision Imaging | Note 13 2D WMT |
|---------------------------------------------------------------------------------------------|--------------------------------|--------------------------|
| Note 2 Combined mode includes B/M; B/PWD; BDF/PWD;<br>BDF/MDF; BDF/MDF/PWD | Note 8 STIC | Note 14 Boost |
| Note 3 Combined mode includes B/M; B/PWD; BDF/PWD;<br>BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD | Note 9 3D Color (Volume Color) | Note 15 SMI |
| Note 4 TDI | Note 10 STIC Color | Note 16 Shear wave |
| Note 5 ApliPure | Note 11 Elastography | Note 17 BEAM |
| Note 6 MicroPure | Note 12 Fusion | Note 18 Smart Navigation |
{14}------------------------------------------------
System: _ Aplio 500, Aplio 400, Aplio 300 V5.0 Transducer:____PVT-661VT
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<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other | [Note] |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | P | P | P | P | P | 2 | P | P | P | | | 4,5,7,11 | |
| Trans-vaginal | P | P | P | P | P | 2 | P | P | P | | | 4,5,7,11 | |
| Trans-urethral | | | | | | | | |…
