(41 days)
Not Found
No
The summary does not mention AI or ML, and the performance studies focus on traditional ultrasound measurements and image display features.
No.
The device is indicated for "visualization of structures, and dynamic processes with the human body using ultrasound" and to "provide image information for diagnosis," which are diagnostic purposes, not therapeutic.
Yes
The "Intended Use / Indications for Use" states that the device is used to "provide image information for diagnosis." Additionally, the "Device Description" explicitly refers to the systems as "mobile diagnostic ultrasound systems."
No
The device description explicitly states that the Aplio systems are "mobile diagnostic ultrasound systems" and employ "a wide array of probes," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device function: The description clearly states that the device is a "Diagnostic Ultrasound System" used for "visualization of structures, and dynamic processes within the human body using ultrasound and to provide image information for diagnosis". This involves imaging the inside of the body directly, not analyzing samples taken from the body.
- Intended Use/Indications for Use: The listed clinical applications are all based on direct imaging of various anatomical sites within the body.
- Device Description: It describes a mobile ultrasound system with probes, which are used for external or internal imaging, not for analyzing samples.
Therefore, the Aplio 500, 400, and 300 Diagnostic Ultrasound Systems are in vivo diagnostic devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The Diagnostic 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.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The Aplio 500 Model TUS-A500, Aplio 400 Model TUS-A400 and Aplio 300 Model TUS-A300 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 12 MHz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Intra-operative (abdominal), Pediatric, Small Organs (thyroid, breast and testicle), Trans-vaginal, Trans-rectal, Neonatal Cephalic, Adult Cephalic, Cardiac (Adult and Pediatric), Peripheral Vascular, Trans-esophageal, Musculo-skeletal (Conventional and Superficial), Laparoscopic.
Indicated Patient Age Range
Adult, Pediatric, Neonatal, Fetal.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Two studies were conducted to demonstrate that the new features and the improvements to existing features being implemented to the subject device performed as intended. One study demonstrated that the subject device accurately measured the shear wave speed and elasticity of known targets within an elasticity phantom and another study confirmed that the Smart 3D feature successfully displayed 3D images using existing 2D transducers.
Two clinical evaluations were conducted to demonstrate that the subject device performed as expected. In one study, representative clinical images of volunteers were obtained to confirm that the system provides acceptable images and numerical Shear wave results in vivo. Another study validated the performance of the Auto NT feature by demonstrating that the tool is able to equivalently measure Nuchal Translucency thickness when compared to manual measurement.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K141459, K072000, K131937, K142160
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a 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, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 9, 2015
Toshiba Medical Systems Corporation % Mr. Orlando Tadeo Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K151451
Trade/Device Name: Aplio 500/400/300 Diagnostic Ultrasound System, V6.0 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: May 26, 2015 Received: May 29, 2015
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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Aplio 500/400/300 Diagnostic Ultrasound System, V6.0
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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3
1
System: Aplio 500, Aplio 400, Aplio 300 V6.0
Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Oneration
| Clinical Application
Specific
(Tracks 3) | B | M | PW
D | CW
D | Color
Doppler | Combined
(Specify) * | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
|------------------------------------------------|---|---|---------|---------|------------------|-------------------------|-----|-----------------|-------|-----------|----|--------------------------------------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | 2 | P | P | P | | P | 5,7,8, 9,10,14,18,19 |
| Abdominal | P | P | P | P | P | 2,3 | P | P | P | | P | 5,7,8, 9,10,11,12,14,
15,16,18,19 |
| Intra-operative (Abdominal) | P | P | P | P | P | 2 | P | P | P | | | 4,5,7,11,19 |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | P | P | P | P | P | 2 | P | P | P | | | 5,7 |
| Pediatric | P | P | P | P | P | 2,3 | P | P | P | | P | 5,7,8,9,10,12,14,15,
18,19 |
| Small Organ (Note 1) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11,14,
15,16(N),17,18,19 |
| 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,
15,17,18,19 |
| Musculo-skeletal (Superficial) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11,14,
15,17,18,19 |
| 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,
15,17,18,19 |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Previous 510(k) of the transducers: K141459, K133761, K123992, K121422, 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; | ||
| 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 |
| Note 19 Smart 3D |
4
System:
Transducer: PST-25BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
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: K141459
Note 7 Precision Imaging Note 13 2D WMT Note 1 Small organ includes thyroid, breast and testicle Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; Note 8 STIC Note 14 Boost BDF/MDF; BDF/MDF/PWD Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; Note 9 3D Color (Volume Color) Note 15 SMI BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD Note 4 TDI Note 10 STIC Color Note 16 Shear wave Note 5 ApliPure Note 11 Elastography Note 17 BEAM Note 12 Fusion Note 18 Smart Navigation Note 6 MicroPure Note 19 Smart 3D
5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Color
Doppler | Combined
(Specify)
- | THI | Dynamic
Flow | Power | CHI
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: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
6
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
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: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
7
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify)* | THI | Dynamic | |||||||||||
| Flow | Power | CHI | |||||||||||
| 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: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
8
System: _Aplio 500, Aplio 400, Aplio 300 V6.0
Transducer:___PVT-375BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Other [Note] | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | | CHI
2D | 4D |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | 2 | P | P | P | | | 5,7,19 |
| Abdominal | P | P | P | P | P | 2 | P | P | P | | | 5,7,11,12,15,16,18,19 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 2 | P | P | P | | | 5, 7,12,15,18,19 |
| 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: K141459
| 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 | TDI |
|---|---|
| -------- | ----- |
| Note 5 | ApliPure |
|---|---|
| -------- | ---------- |
| Note 6 | MicroPure |
|---|---|
| -------- | ----------- |
| Note 7 | Precision Imaging |
|---|---|
| -------- | ------------------- |
| Note 8 | STIC |
|---|---|
| -------- | ------ |
| Note 9 | 3D Color (Volume Color) |
|---|---|
| -------- | ------------------------- |
| Note 10 | STIC Color |
|---|---|
| --------- | ------------ |
| Note 11 | Elastography |
|---|---|
| --------- | -------------- |
| Note 12 | Fusion |
|---|---|
| --------- | -------- |
| Note 13 | 2D WMT |
|---|---|
| --------- | -------- |
| Note 14 | Boost |
|---|---|
| --------- | ------- |
| Note 15 | SMI |
|---|---|
| --------- | ----- |
| Note 16 | Shear wave |
|---|---|
| --------- | ------------ |
| Note 17 | BEAM |
|---|---|
| --------- | ------ |
| Note 18 | Smart Navigation |
|---|---|
| --------- | ------------------ |
| Note 19 | Smart 3D |
|---|---|
| --------- | ---------- |
9
System: _Aplio 500, Aplio 400, Aplio 300 V6.0
Transducer: _ PVT-375SC
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
| (Tracks 3) | Mode of Operation | Other [Note] | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power
2D | CHI | 4D | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | | 5,7,19 |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 5,7,11,12,15,16,18,19 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | | 5,7,12,15,18,19 |
| 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: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
10
System:
Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Color
Doppler | Combined
(Specify)
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other [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: K141459
| 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 |
| Note 19 Smart 3D |
11
System: _Aplio 500, Aplio 400, Aplio 300 V6.0
Transducer:___PVT-382BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Other | [Note] | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | | | 5, 7,18,19 |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | | 5, 7,12,18,19 |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | | | 5, 7,12,18,19 |
| 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: K141459
| 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 |
| Note 19 Smart 3D |
12
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
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: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
13
System: Transducer:____PVT-661VT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
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 | | | | | | | | | | | | | |
| 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: K141459
| 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 |
| Note 19 Smart 3D |
14
System: Transducer:____PVT-781VT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Color
Doppler | Combined
(Specify)
- | THI | Dynamic
Flow | Power | CHI
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 | | | 4,5,7,11,12,15,18 | |
| Trans-vaginal | | P | P | P | P | P | 2 | P | P | P | | | 4,5,7,11,12,15,18 | |
| 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: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
15
System: Transducer: _ PVT-781VTE
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
| (Tracks 3) | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
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 | N | N | N | N | N | 2 | N | N | N | | | 4,5,7,11,12,15,18 | |
| Trans-vaginal | N | N | N | N | N | 2 | N | N | N | | | 4,5,7,11,12,15,18 | |
| 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 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
16
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | | 5,7,14,15,19 |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 5,7,14,15,19 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | | 5,7,14,15,19 |
| 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: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
17
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other | [Note] |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | 2 | P | P | P | | P | 5,7,8,9,10 | |
| Abdominal | P | 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 | 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: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
18
System: Aplio 500, Aplio 400, Aplio 300 V6.0
Transducer: PVT-675MVL
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
| (Tracks 3) | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other [Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | 2 | P | P | P | | P | 5,7,8,9,10 |
| Abdominal | P | 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 | 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: K141459
| 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 |
| Note 19 Smart 3D |
19
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
| (Tracks 3) | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
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 | P | P | P | 4,5,7,9,11 |
| Trans-vaginal | P | P | P | P | P | 2 | P | P | P | P | P | P | 4,5,7,9,11 |
| 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: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
20
System: _Aplio 500, Aplio 400, Aplio 300 V6.0 Transducer: _ PVT-681MVL
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
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 | N | N | N | N | N | 2 | N | N | N | N | N | 4,5,7,9,11,15 |
| Trans-vaginal | N | N | N | N | N | 2 | N | N | N | N | N | 4,5,7,9,11,15 |
| 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 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
21
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
| (Tracks 3) | Mode of Operation | Other | [Note] | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 5,7,19 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | | 5,7,19 | |
| Small Organ (Specify) (1) | | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | | P | 2 | P | P | P | | | 5,7,19 | |
| 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: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
22
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other | [Note] |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | | 5,7,19 |
| Intra-operative (Abdominal) | P | P | P | | P | 2 | P | P | P | | | | 5,7,19 |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| 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: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
23
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
| (Tracks 3) | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other | [Note] |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 5,7,19 | |
| Intra-operative (Abdominal) | P | P | P | | P | 2 | P | P | P | | | 5,7,19 | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| 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: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
24
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
| (Tracks 3) | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other | [Note] |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 5,7,19 | |
| Intra-operative (Abdominal) | P | P | P | | P | 2 | P | P | P | | | 5,7,19 | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| 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: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
25
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify)
- | THI | Dynamic
Flow | Power | CHI
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 | 2 | P | P | P | | | 4,5,7,11 | |
| Trans-vaginal | P | P | P | | P | 2 | P | P | P | | | 4,5,7,11 | |
| 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: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
26
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
| (Tracks 3) | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
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 | N | N | N | | N | 2 | N | N | N | | | | 5,7,12,15,18 |
| 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 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
27
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | | P | 2 | P | P | P | | | 5,7,17,19 |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | P | P | P | | P | 2 | P | P | P | | | 5,7,17,19 |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | | | 5,7,17,19 |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | 2 | P | P | P | | | 5,7,17,19 |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
Note 19 Smart 3D
28
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | | P | 2 | P | P | P | | | | 5,7,17,19 |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | P | P | P | | P | 2 | P | P | P | | | | 5,7,17,19 |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | | | | 5,7,19 |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | 2 | P | P | P | | | | 5,7,17,19 |
| Other (Specify) | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
Note 19 Smart 3D
29
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
(Tracks 3) | Mode of Operation | | | | | Combined
(Specify)
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other | [Note] | |
|------------------------------------------------|-------------------|---|---|--|---|----------------------------|-----|-----------------|-------|-----------|----|-------|-----------------|--|
| Ophthalmic | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | | P | 2 | P | P | P | | | | 5,7,14,15,17,19 | |
| Neonatal Cephalic | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | P | P | P | | P | 2 | P | P | P | | | | 5,7,14,15,17,19 | |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | | | | 5,7,14,15,17,19 | |
| Intravascular | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | 2 | P | P | P | | | | 5,7,14,15,17,19 | |
| Other (Specify) | | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
Note 19 Smart 3D
30
System: Aplio 500, Aplio 400, Aplio 300 V6.0
Transducer: PLT-705BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
| (Tracks 3) | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other [Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | P | P | 2 | P | P | P | | | 5,7,15,17,19 |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | P | P | P | P | P | 2 | P | P | P | | | 5,7,15,17,19 |
| Musculo-skeletal (Superficial) | P | P | P | P | P | 2 | P | P | P | | | 5,7,15,17,19 |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | 2 | P | P | P | | | 5,7,15,17,19 |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
31
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify)
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other | [Note] |
|------------------------------------------------|---|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|--------|--------|
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 5,7,19 | |
| Intra-operative (Abdominal) | P | P | P | | P | 2 | P | P | P | | | 5,7,19 | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| 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: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
32
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
| (Tracks 3) | Mode of Operation | Other | [Note] | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | | | 4D |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 5,7,19 | |
| Intra-operative (Abdominal) | P | P | P | | P | 2 | P | P | P | | | 5,7,19 | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| 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: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
33
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | | P | 2 | P | P | P | | | 5,6,7,11,17,19 |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | P | P | P | | P | 2 | P | P | P | | | 5,6,7,11,17,19 |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | | | 5,6,7,11,17,19 |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | 2 | P | P | P | | | 5,6,7,11,17,19 |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
Note 19 Smart 3D
34
1
System: _Aplio 500, Aplio 400, Aplio 300 V6.0
Transducer: _ PLT-1005BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
| Clinical Application
Specific
(Tracks 3) | B | M | PW
D | CW
D | Color
Doppler | Combine
d
(Specify)
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
|------------------------------------------------|---|---|---------|---------|------------------|--------------------------------|-----|-----------------|-------|-----------|----|---------------------------------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | | P | 2 | P | P | P | | | 5,6,7,11,12,14,15,
16(N), 17,18,19 |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | P | P | P | | P | 2 | P | P | P | | | 5,6,7,11,12,14,15,
17,18,19 |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | | | 5,6,7,11,12,14,15,
17,18,19 |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | 2 | P | P | P | | | 5,6,7,11,12,14,15,
17,18,19 |
| Other (Specify) | | | | | | | | | | | | |
Onlet \ Specify )
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459
| 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 |
| Note 19 Smart 3D |
35
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intra-operative (Abdominal) | P | P | P | | P | 2 | P | | P | | | | 4,5,11,19 |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | | P | 2 | P | | P | | | | 4,5,11,19 |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | P | P | P | | P | 2 | P | | P | | | | 4,5,11,19 |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | | P | | | | 4,5,11,19 |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | 2 | P | | P | | | | 4,5,11,19 |
| Other (Specify) | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
Note 19 Smart 3D
36
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other | [Note] |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | | P | 2 | P | P | P | | | | 4,5,6,7,11,15,17,19 |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | P | P | P | | P | 2 | P | P | P | | | | 4,5,6,7,11,15,17,19 |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | | | | 4,5,6,7,11,15,17,19 |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | 2 | P | P | P | | | | 4,5,6,7,11,15,17,19 |
| Other (Specify) | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
37
System: Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | | P | 2 | P | P | P | | | 5,7,15,17,19 |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | P | P | P | | P | 2 | P | P | P | | | 5,7,15,17,19 |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | | | 5,7,15,17,19 |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | 2 | P | P | P | | | 5,7,15,17,19 |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
Note 19 Smart 3D
38
System: _Aplio 500, Aplio 400, Aplio 300 V6.0 Transducer:___PLT-1204MV
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify)
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other
[Note] |
|------------------------------------------------|---|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|-----------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | | P | 2 | P | P | P | | P | 5,7,8,9,10 |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | P | P | P | | P | 2 | P | P | P | | P | 5,7,8,9,10 |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | | P | 5,7,8,9,10 |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | 2 | P | P | P | | P | 5,7,8,9,10 |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
Note 19 Smart 3D
39
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
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 | | | | | | | | | | | | | |
| 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) | P | P | P | P | P | 3 | P | | | | | | 4,13 |
| 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: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
40
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
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 | | | | | | | | | | | | | |
| 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) | P | P | P | P | P | 3 | P | | | | | 4,13 | |
| 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: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
41
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
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 | | | | | | | | | | | | | |
| 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) | P | P | P | P | P | 3 | P | | | | | 4,13 | |
| 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: K103629
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
42
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | |||||||||
| Doppler | Combined | |||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
2D | 4D | Other | [Note] | |
| Ophthalmic | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | |
| Laparoscopic | P | P | P | | P | 2 | P | P | P | | | 5,7 | | |
| Pediatric | | | | | | | | | | | | | | |
| 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: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
43
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks 3) | B | M | PWD | CWD | Color | ||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power | CHI
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 | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | | | P | | | | | | | | | |
| Cardiac Pediatric | | | | P | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | | | | P | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459
| 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 | TDI |
| Note 5 | ApliPure |
| Note 6 | MicroPure |
| Note 7 | Precision Imaging |
| Note 8 | STIC |
| Note 9 | 3D Color (Volume Color) |
| Note 10 | STIC Color |
| Note 11 | Elastography |
| Note 12 | Fusion |
| Note 13 | 2D WMT |
| Note 14 | Boost |
| Note 15 | SMI |
| Note 16 | Shear wave |
| Note 17 | BEAM |
| Note 18 | Smart Navigation |
| Note 19 | Smart 3D |
44
System: Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
| (Tracks 3) | Mode of Operation | [Note] | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | |||||||||
| Doppler | Combined | ||||||||||||
| (Specify) |
- | THI | Dynamic
Flow | Power
2D | CHI
2D | 4D | Other | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| 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 | | | P | | | | | | | | | | |
| Cardiac Pediatric | | | P | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | | | P | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K141459
| 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 |
| Note 19 | Smart 3D |
45
Image /page/45/Picture/0 description: The image shows the logo for Toshiba. The word "TOSHIBA" is written in large, bold, red letters. Below the company name is the slogan "Leading Innovation" in black font, followed by three right-pointing arrows that fade from black to gray.
TOSHIBA AMERICA MEDICAL SYSTEMS, INC
2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-5000
510(k) SUMMARY
SUBMITTER'S NAME: 1.
Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi-ken, Japan 324-8550
OFFICIAL CORRESPONDENT 2. Akinori Hatanaka
-
- ESTABLISHMENT REGISTRATION: 9614698
CONTACT PERSON: 4.
Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc 2441 Michelle Drive Tustin, CA 92780 (714) 669-7459
Date Prepared: 5.
May 26, 2015 (Updated July 8, 2015)
6. TRADE NAME(S):
Diagnostic Ultrasound System Aplio 500 Model TUS-A500 V6.0 Aplio 400 Model TUS-A400 V6.0 Aplio 300 Model TUS-A300 V6.0
7. COMMON NAME:
System, Diagnostic Ultrasound
DEVICE CLASSIFICATION: 8.
Class II
Ultrasonic Pulsed Doppler Imaging System – Product Code: 90-IYN [per 21 CFR 892.1550] Ultrasonic Pulsed Echo Imaging System – Product Code: 90-IYO [per 21 CFR 892.1560] Diagnostic Ultrasonic Transducer - Product Code: 90-ITX [per 21 CFR 892.1570]
46
9. PREDICATE DEVICE:
| Product | Marketed by | 510(k) Number | Clearance Date |
|---|---|---|---|
| Aplio 500/400/300 Diagnostic | |||
| Ultrasound System, V5.0 | Toshiba America | ||
| Medical Systems | K141459 | 10/3/2014 | |
| Aplio XG Diagnostic Ultrasound | |||
| System, Model SSA-790A | |||
| version 2.0 | Toshiba America | ||
| Medical Systems | K072000 | 07/30/2007 | |
| Voluson i/e | GE Healthcare | K131937 | 09/24/2013 |
| LOGIQ E9 Diagnostic | |||
| Ultrasound System | GE Healthcare | K142160 | 10/10/2014 |
10. REASON FOR SUBMISSION:
Modification of a cleared device
11. DEVICE DESCRIPTION:
The Aplio 500 Model TUS-A500, Aplio 400 Model TUS-A400 and Aplio 300 Model TUS-A300 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 12 MHz.
12. INDICATIONS FOR USE:
The Diagnostic 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 diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculoskeletal (both conventional and superficial) and laparoscopic.
13. SUBSTANTIAL EQUIVALENCE:
This device is substantially equivalent to the Aplio 500/400/300 V5.0 Diagnostic Ultrasound System, 510(k) cleared under K141459, marketed by Toshiba America Medical Systems. The Aplio 500 Model TUS-A500 Version 6.0, Aplio 400 Model TUS-A400 Version 6.0 and Aplio 300 Model TUS-A300 Version 6.0 functions in a manner similar to and is intended for the same use as the predicate devices referenced within this submission. The subject device includes modifications to the cleared device which expands the Shear Wave indication and implements improvements to the Smart Navigation and SMI tools. Additionally, new features determined to be substantially equivalent to features cleared under the predicate devices referenced within this submission are being added including Auto-NT, Smart 3D and three new transducers.
47
| Device | Aplio 500/400/300
V5.0 | Aplio 500/400/300
V6.0 | Comment |
|--------------------------|---------------------------------|---------------------------------------|-----------------------------|
| 510(K) Control Number | K141459 | This Submission | |
| Auto-NT | No | Yes | New Feature |
| Shear Wave (Small Organ) | No | Yes | New Indication |
| Smart 3D | No | Yes | New Feature |
| Shear Wave | Yes | Yes | Feature
Improvement(s) |
| SMI | Yes | Yes | Feature
Improvement(s) |
| Smart Navigation | Yes | Yes | Feature
Improvement(s) |
| Smart Fusion | Yes | Yes | Feature
Improvement(s) |
| OBR (On Board Report) | Yes | Yes | Feature
Improvement(s) |
| OB Work Flow | Yes | Yes | Feature
Improvement(s) |
| Elastography Kit | Aplio 500 and
Aplio 400 only | Aplio 500, Aplio
400 and Aplio 300 | Implemented on
Aplio 300 |
| PVT-781VTE | No | Yes | New Transducer |
| PVT-681MVL | No | Yes | New Transducer |
| PVL-715RST | No | Yes | New Transducer |
14. SAFETY:
The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC60601-1 (2005), IEC 60601-1-2:2007, IEC 60601-2-37 (2007), IEC 62304 (2006), AIUM RTD2-2004 Output Display and ISO 10993-1 standards.
15. TESTING
Risk Analysis, Verification/Validation testing conducted through bench testing and clinical evaluation.
Performance Testing - Bench
Two studies were conducted to demonstrate that the new features and the improvements to existing features being implemented to the subject device performed as intended. One study demonstrated that the subject device accurately measured the shear wave speed and elasticity of known targets within an elasticity phantom and another study confirmed that the Smart 3D feature successfully displayed 3D images using existing 2D transducers.
Performance Testing - Clinical
Two clinical evaluations were conducted to demonstrate that the subject device performed as expected. In one study, representative clinical images of volunteers were obtained to confirm that the system provides acceptable images and numerical Shear wave results in
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vivo. Another study validated the performance of the Auto NT feature by demonstrating that the tool is able to equivalently measure Nuchal Translucency thickness when compared to manual measurement.
Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.
Additionally, testing of the modified system was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices.
16. CONCLUSION
The modifications incorporated into the Aplio 500 Model TUS-A500 Version 6.0, Aplio 400 Model TUS-A400 Version 6.0 and Aplio 300 Model TUS-A300 Version 6.0 do not change the intended use of the device. Based upon bench testing, clinical evaluations, successful completion of software validation, application of risk management and design controls, it is concluded that this device is safe and effective for its intended use.