APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0
Device Facts
| Record ID | K133761 |
|---|---|
| Device Name | APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0 |
| Applicant | Toshibamedical Systems Corporation |
| Product Code | IYN · Radiology |
| Decision Date | Apr 22, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended 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, and musculo-skeletal (both conventional and superficial).
Device Story
Mobile diagnostic ultrasound systems (Aplio 500/400/300 V4.0) for clinical imaging; utilizes various probes (linear, convex, sector) with 2-12 MHz frequency range. Systems acquire ultrasound signals to generate B-mode, M-mode, Pulsed/Continuous Wave Doppler, Color Doppler, and other advanced modes (e.g., ApliPure, Elastography, Fusion, 2D WMT). Operated by clinicians in various settings (e.g., clinic, OR) to visualize internal structures and blood flow. Output displayed on system monitor for real-time diagnostic assessment. Modifications in V4.0 improve blood flow visualization. Benefits include enhanced diagnostic information for patient management.
Clinical Evidence
No clinical trials were conducted. Evidence consists of bench testing and the acquisition of representative clinical images to verify the performance of improved/added features. Conformance to IEC 60601-1, 60601-1-1, 60601-1-2, 60601-1-4, 60601-2-37, 62304, NEMA UD3, and ISO 10993-1 standards was demonstrated.
Technological Characteristics
Mobile diagnostic ultrasound systems; wide array of probes (linear, convex, sector); frequency range 2-12 MHz. Conforms to IEC 60601-1, IEC 60601-2-37, ISO 10993-1, and NEMA UD3. Software validation per IEC 62304. Features include B-mode, M-mode, Doppler, THI, ApliPure, Elastography, Fusion, and 2D WMT.
Indications for Use
Indicated for visualization of structures and dynamic processes in the human body for diagnostic imaging in fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal/adult cephalic, cardiac (adult/pediatric), peripheral vascular, transesophageal, and musculo-skeletal applications.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- Aplio 500/400/300 Diagnostic Ultrasound System (K123992)
Reference Devices
Related Devices
- K110870 — APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM · Toshiba America Medical Systems, In.C · Oct 4, 2011
- K123992 — APLIO 500/400/300 V3.0 · Toshibamedical Systems Corporation · Feb 6, 2013
- K091295 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0 · Toshiba America Medical Systems, In.C · May 15, 2009
- K121422 — APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM · Toshiba Medical Systems Coporation, Japan · Aug 16, 2012
- K140729 — APLIO ARTIDA, V3.2 · Toshiba America Medical Systems, In.C · May 23, 2014
Submission Summary (Full Text)
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K133761
# TOSHIBA Leading Innovation 787
# APR 2 2 2014
TOSHIBA AMERICA MEDICAL BYSTEMS, INC. 2441 Michelle Drive. Tustin. CA 92780
Phone: (714) 730-5000
## 510(k) SUMMARY
- 1. SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
- 2. ADDRESS: 2441 Michelle Drive Tustin, CA. 92780-2068
- 3. ESTABLISHMENT REGISTRATION: 2020563
- CONTACT PERSON: 4. Mr. Charlemagne Chua Manager, Regulatory Affairs (714) 669-7896
5. Date Prepared: December 6, 2013
#### TRADE NAME(S): 6.
.
Diagnostic Ultrasound System Aplio 500 Model TUS-A500 V4.0 Aplio 400 Model TUS-A400 V4.0 Aplio 300 Model TUS-A300 V4.0
#### 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]
### 9. PREDICATE DEVICE:
| Product | Marketed by | 510(k) Number | Clearance Date |
|---------------------------------------------------|------------------------------------|---------------|-----------------|
| Aplio 500/400/300 Diagnostic<br>Ultrasound System | Toshiba America<br>Medical Systems | K123992 | February 6,2013 |
{1}------------------------------------------------
#### 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, and musculo-skeletal (both conventional and superficial).
#### 13. SUBSTANTIAL EQUIVALENCE:
This device is substantially equivalent to the Aplio 500/400/300 V3.0 Diagnostic Ultrasound System, 510(k) cleared under K123992, marketed by Toshiba America Medical Systems. The Aplio 500 Model TUS-A500 Version 4.0, Aplio 400 Model TUS-A400 Version 4.0 and Aplio 300 Model TUS-A300 Version 4.0, functions in a manner similar to and is intended for the same use as the predicate device. The subject device includes modifications to the cleared device which improves upon existing features including the image visualization of blood flow. A comparison table is included in this submission detailing the similarities and differences between the predicate device and the subject device.
#### 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, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37, IEC 62304, NEMA UD3 Output Display and ISO 10993-1 standards.
#### 15. TESTING
Risk Analysis, Verification/Validation testing conducted through bench testing and the acquisition of representative clinical images included in this submission demonstrate that the requirements for the improved/added features have been met.
Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.
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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 4.0, Aplio 400 Model TUS-A400 Version 4.0 and Aplio 300 Model TUS-A300 Version 4.0 do not change the indications for use or the intended use of the device. Based upon bench testing, acquisition of representative clinical images, 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.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized symbol that resembles a person embracing another person.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
## April 22, 2014
Toshiba Medical Systems Corporation Paul Biggins 2441 Michelle Drive TUSTIN CA 92780
Re: K133761
Trade/Device Name: Aplio 500/400/300 Diagnostic Ultrasound System V4.0 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 20, 2014 Received: March 21, 2014
#### Dear Mr. Biggins:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
This determination of substantial equivalence applies to the following transducers intended for use with the Aplio 55/400/300 Diagnostic Ultrasound System V4.0. as described in your premarket notification:
Transducer Model Number
| PST-25BT | PST-30BT | PST-50BT | PST-65AT |
|------------|------------|------------|------------|
| PVT-375BT | PVT-375MV | PVT-382BT | PVT-382MV |
| PVT-661VT | PVT-781VT | PVT-674BT | PVT-675MV |
| PVT-681MV | PVT-712BT | PVT-745BTF | PVT-745BTH |
| PVT-745BTV | PVT-770RT | PLT-604AT | PLT-704AT |
| PLT-704SBT | PLT-705BTF | PVT-705BTH | PLT-805AT |
| PLT-1005BT | PLT-1202S | PLT-1204BT | PLT-1204BX |
| PLT-1204MV | PET-508MA | PET-510MB | PET-512MC |
| | PC-20M | PC-50M | |
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## Page 2-Mr. Biggins
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 -CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
FDA
for
Janine Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
#### 510(k) Number (if known)
K133761
#### Device Name
Aplio 500/400/300 V4.0 Diagnostic Ultrasound System
#### Indications for Use (Describe)
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, and musculo-skeletal (both conventional and superficial).
Type of Use (Select one or both, as applicable)
كا 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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This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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#### System: _ Aplio 500, Aplio 400. Aplio 300 V4.0
Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical<br>Application | Mode of Operation | | | | | | | | | | | |
|------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|-------------------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other [Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | 2 | P | P | P | | P | 5,7,8,9,10,14 |
| Abdominal | P | P | P | P | P | 2,3 | P | P | P | | P | 5,7,8,9,10,11,12,14,15 |
| Intra-operative<br>(Abdominal) | P | P | P | P | P | 2 | P | P | P | | | 4,5,7,11 |
| Intra-operative<br>(Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 2,3 | P | P | P | | P | 5,7,8,9,10,12,14,15 |
| Small Organ (Note<br>1) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11,14,15 |
| 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 |
| Trans-vaginal | P | P | P | P | P | 2 | P | P | P | | P | 4,5,7,11,12 |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph.<br>(non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11,14,15 |
| Musculo-skeletal<br>(Superficial) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11,14,15 |
| 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<br>(Cardiac) | | | | | | | | | | | | |
| Trans-esoph.<br>(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 |
| Other (Specify) | | | | | | | | | | | | |
N = new indication: P = previously cleared by FDA: E = added under this appendix Previous 510(k) of the transducers: K123992, K121422 and 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 BIM: 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
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#### 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<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[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: K123992
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/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
{8}------------------------------------------------
#### System: __ Aplio 500, Aplio 400, Aplio 300 V4.0 Transducer: PST-30BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| 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: K123992
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/PWD; 2D/CWD; BDF/CWD
Notc 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
{9}------------------------------------------------
System: Aplio 500. Aplio 400. Aplio 300 V4.0 Transducer:_ PST-50BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| 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: K123992
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
{10}------------------------------------------------
System: Transducer: PST-65AT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Specific<br>(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[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: K123992
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
{11}------------------------------------------------
### Toshiba America Medical Systems, Inc.
#### System: __ Aplio_500, Aplio 400, Aplio 300 V4.0 Transducer:____ PVT-375BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|-------------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | | 5, 7 |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 5, 7,11,12<br>,15 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | | 5, 7,12,15 |
| 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: K123992
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
Notel 5 SMI
{12}------------------------------------------------
#### System: _ Aplio 500. Aplio 400. Aplio 300 V4.0 Transducer:____PVT-375MV
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | | | | |
|------------------------------------|----|---|-------------------|---------|------------------|----------------------------|-----|-----------------|-------|-----------|----|----------------|
| Specific<br>(Tracks 3) | B | M | | PWD CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | b | | N | 15,7,8,9,10 |
| Abdominal | ర్ | P | P | | P | 2 | P | P | P . | | N | 5,7,8,9,10 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P · | P | P | | N | 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<br>(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: K123992
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/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
{13}------------------------------------------------
#### System: __ Aplio 500, Aplio 400, Aplio 300 V4.0 Transducer:___ PVT-382BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | | 5, 7 |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 5, 7,12 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | | 5,7,12 |
| 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: K123992
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/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
{14}------------------------------------------------
#### System: Aplio 500. Aplio 400, Aplio 300 V4.0 Transducer: PVT-382MV
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | 2 | P | P | P | | P | 5,7,9 |
| Abdominal | P | P | P | P | P | 2 | P | P | P | | P | 5,7,9 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | 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: K123992
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/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
{15}------------------------------------------------
#### System: _ Aplio 500. Aplio 400. Aplio 300 V4.0 Transducer: PVT-66IVT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| 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: K123992
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
{16}------------------------------------------------
System: __ Aplio 500, Aplio 400, Aplio 300 V4.0 Transducer: PVT-781VT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Specific<br>(Tracks 3) | Mode of Operation | B | M | PWD CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[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 | | | 4,5,7,11,1 | |
| Trans-vaginal | P | P | P | P | 2 | P | P | P | | | 4,5,7,11,1 | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric…
