← Product Code [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN) · K162155
# Xario 200 Diagnostic Ultrasound System V5.0 (K162155)
_Toshibamedical Systems Corporation · IYN · Nov 1, 2016 · Radiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K162155
## Device Facts
- **Applicant:** Toshibamedical Systems Corporation
- **Product Code:** [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN.md)
- **Decision Date:** Nov 1, 2016
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1550
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Pediatric
## Intended Use
The Diagnostic Ultrasound System Xario 200 Model TUS-X200 and Xario 200 Model TUS-X200S are 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), laparoscopic, pediatric, small organs, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.
## Device Story
The Xario 200 V5.0 is a mobile diagnostic ultrasound system used in clinical settings by healthcare professionals. It utilizes various ultrasound probes (linear, convex, sector) to acquire acoustic data from the human body. The system processes these signals to generate real-time B-mode, M-mode, Doppler (PWD/CWD/Color), and advanced imaging modes (e.g., SMI, Precision Plus Imaging, Elastography, Smart 3D). The device displays these images on a 19-inch LED monitor to assist clinicians in visualizing anatomical structures and dynamic processes. The output supports diagnostic decision-making across a wide range of clinical applications. The system benefits patients by providing non-invasive, real-time diagnostic information without ionizing radiation.
## Clinical Evidence
Bench testing and clinical image evaluation were performed. Representative clinical images were obtained to demonstrate that the implementation of SMI performed as expected, showing capability to image low-velocity flow with reduced clutter noise and high frame rates. No formal clinical trial with primary endpoints was required; safety and effectiveness were supported by design controls, risk management, and verification/validation testing.
## Technological Characteristics
Mobile diagnostic ultrasound system; 19-inch LED-backlit LCD monitor; wide array of probes (linear, convex, sector) with 2-12 MHz frequency range. Features include B-mode, M-mode, PWD, CWD, Color Doppler, THI, SMI, Precision Plus Imaging, Elastography, and Smart 3D. Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, and ISO 10993-1 standards.
## Regulatory Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
## Predicate Devices
- Xario200, V3.0 (Models: TUS-X200 and TUS-X200S) ([K143027](/device/K143027.md))
## Reference Devices
- Aplio 500/400/300 Diagnostic Ultrasound System, V6.0 ([K151451](/device/K151451.md))
- PET-512MC ([K103629](/device/K103629.md))
## Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 1, 2016
Toshiba Medical Systems Corporation % Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K162155
Trade/Device Name: Xario 200 Diagnostic Ultrasound System V5.0 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 13, 2016 Received: October 14, 2016
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. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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# Indications for Use
### 510(k) Number (if known) K162155
### Device Name
Xario 200 Diaqnostic Ultrasound System V5.0
### Indications for Use (Describe)
The Diaqnostic Ultrasound System Xario 200 Model TUS-X200 and Xario 200 Model TUS-X200S are 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), laparoscopic, pediatric, small orqans, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.
Type of Use (Select one or both, as applicable)
ال Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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# System: Xario 200 TUS-X200,TUS-X200S V5.0
Transducer:
| Clinical Application | | | Mode of Operation | | | | | | | | | | |
|---------------------------------|---|---|-------------------|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|----------------------------|--|
| Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) * | THI | Advanced
Dynamic
Flow | Power | CHI | 4D | Other
[Note] | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | P | 4,5,6,7,8,9,11(E),12(N) | |
| Abdominal | P | P | P | P | P | 2,3 | P | P | P | | P | 4,5,6,7,8,9,11(E),12(N) | |
| Intra-operative (Abdominal) | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11(E) | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | P | P | P | | P | 2 | P | P | P | | | 5,7 | |
| Pediatric | P | P | P | P | P | 2,3 | P | P | P | | P | 4,5,6,7,8,9,11(E),12(N) | |
| Small Organ (Note 1) | P | P | P | | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11(E),12(N) | |
| Neonatal Cephalic | P | P | P | P | P | 2,3 | P | P | P | | | 5,6,7,8,11(E) | |
| Adult Cephalic | P | P | P | P | P | 3 | P | P | P | | | 7 | |
| Trans-rectal | P | P | P | | P | 2 | P | P | P | | P | 4,5,6,7,8,9,12(N) | |
| Trans-vaginal | P | P | P | | P | 2 | P | P | P | | P | 4,5,6,7,8,9,12(N) | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | P | P | P | | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11(E),12(N) | |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11(E),12(N) | |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | P | P | P | | 4, 7 | |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | P | | 4,7 | |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | P | P | P | P | P | 3 | P | | | | | 4, 7 | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11(E),12(N) | |
| Other (Specify) | | | | | | | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027
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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
{4}------------------------------------------------
#### Xario 200 TUS-X200, TUS-X200S V5.0 System: _
Transducer:_ PSU-25BT
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-----------------|
| Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) * | THI | Advanced
Dynamic
Flow | Power | CHI | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Small Organ (Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Adult Cephalic | P | P | P | P | P | 3 | P | P | P | | | 7 |
| 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, 7 |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | P | | 4, 7 |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027
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 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
{5}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer:_ PSU-30BT
| Clinical Application
Mode of Operation | | | | | | | | | | | | |
|-------------------------------------------|---|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-----------------|
| Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) * | THI | Advanced
Dynamic
Flow | Power | CHI | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Small Organ (Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Adult Cephalic | P | P | P | P | P | 3 | P | P | P | | | 7 |
| 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, 7 |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | P | | 4, 7 |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027
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 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
{6}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer:_ PSU-50BT
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-----------------|
| Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) * | THI | Advanced
Dynamic
Flow | Power | CHI | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Small Organ (Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Adult Cephalic | P | P | P | P | P | 3 | P | P | P | | | 7 |
| 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, 7 |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | P | | 4,7 |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027
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 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
{7}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer:_ PSU-70BT
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-----------------|
| Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) * | THI | Advanced
Dynamic
Flow | Power | CHI | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | E | E | E | E | E | 3 | E | E | E | | | 7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | E | E | E | E | E | 3 | E | E | E | | | 7 |
| Small Organ (Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | E | E | E | E | E | 3 | E | E | E | | | 7 |
| Adult Cephalic | E | E | E | E | E | 3 | E | E | E | | | 7 |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | E | E | E | E | E | 3 | E | E | E | E | | 4, 7 |
| Cardiac Pediatric | E | E | E | E | E | 3 | E | E | E | E | | 4,7 |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027
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 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
{8}------------------------------------------------
#### System: _Xario 200 TUS-X200, TUS-X200S V5.0 Transducer:_ PVU-375BT
| Clinical Application | Mode of Operation | | | | | | | | | | | | |
|------------------------------------|-------------------|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-------|------------------------|
| Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) * | THI | Advanced
Dynamic
Flow | Power | CHI | 4D | Other | [Note] |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | 2 | P | P | P | | | | 4,5,6,7,8,9,11(E),12(N |
| Abdominal | P | P | P | P | P | 2 | P | P | P | | | | 4,5,6,7,8,9,11(E),12(N |
| Intra-operative
(Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 2 | P | P | P | | | | 4,5,6,7,8,9,11(E),12(N |
| Small Organ (Note 1) | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | | |
| Musculo-skeletal
(Superficial) | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027
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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
{9}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer:__ PVU-382BT
| Clinical Application
Specific
(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) * | THI | Advanced
Dynamic
Flow | Power | CHI | 4D | Other
[Note] |
|------------------------------------------------|-------------------|---|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-----------------|
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11(E |
| Abdominal | | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11(E |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11(E |
| Small Organ (Note 1) | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027
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 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
{10}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer:_ PVU-674BT
| Clinical Application
Specific
(Tracks 3) | Mode of Operation | | | | Combined
(Specify) * | THI | Advanced
Dynamic
Flow | Power | CHI | 4D | Other | [Note] | |
|------------------------------------------------|-------------------|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-------|--------|---------------------|
| B | M | PWD | CWD | Color
Doppler | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | | | 5,6,7,8,11(E),12(N) |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | | 5,6,7,8,11(E),12(N) |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | | | 5,6,7,8,11(E),12(N) |
| Small Organ (Note 1) | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal
(Conventional) | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027
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 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
{11}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer:_ PVU-674MV
| Clinical Application
Specific
(Tracks 3) | Mode of Operation | | | | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) * | THI | Advanced
Dynamic
Flow | Power | CHI | 4D | Other
[Note] |
|------------------------------------------------|-------------------|---|---|---|---|---|-----|-----|------------------|-------------------------|---------|-----------------------------|-------|-----|----|-----------------|
| Ophthalmic | | | | | | | | | | | | | | | | |
| Fetal | P | P | P | P | 2 | P | P | P | | P | 5,6,7,8 | | | | | |
| Abdominal | P | P | P | P | 2 | P | P | P | | P | 5,6,7,8 | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | 2 | P | P | P | | P | 5,6,7,8 | | | | | |
| Small Organ (Note 1) | | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027
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 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
Note 12 SMI
{12}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer: PVU-712BT
| Clinical Application | Mode of Operation | | | | | | | | CHI
2D | 4D | Other
[Note] | |
|---------------------------------|-------------------|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-----------|----|-----------------|--------------|
| Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) * | THI | Advanced
Dynamic
Flow | | | | Power |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11(E |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11(E |
| Small Organ (Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11(E |
| 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) | | | | | | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027
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 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
{13}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer:_ PVU-745BTF
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-----------------|
| Specific
(Tracks 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) * | THI | Advanced
Dynamic
Flow | Power | CHI | 4D | Other
[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11(E) |
| Intra-operative (Abdominal) | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11(E) |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Note 1) | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11(E) |
| 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) | | | | | | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K143027
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 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
{14}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V5.0 Transducer:_ PVU-745BTH
| Clinical Application
Specific
(Tracks 3) | | Mode of Operation | | | | | | | | | | | |
|------------------------------------------------|---|-------------------|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-----------------|--|
| | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) * | THI | Advanced
Dynamic
Flow | Power | CHI | 4D | Other
[Note] | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11(E) | |
| Intra-operative (Abdominal) | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11(E) | |
| Intra-operative (Neuro)…
---
**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K162155](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K162155)
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