Xario 200 Diagnostic Ultrasound System V6.0
Device Facts
| Record ID | K172276 |
|---|---|
| Device Name | Xario 200 Diagnostic Ultrasound System V6.0 |
| Applicant | Toshibamedical Systems Corporation |
| Product Code | IYN · Radiology |
| Decision Date | Dec 12, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| 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 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.
Device Story
Mobile diagnostic ultrasound system; uses wide array of probes (linear, convex, sector) with 2-12 MHz frequency range; inputs ultrasound signals to generate real-time images; provides diagnostic information for various clinical applications; operated by clinicians in clinical settings; includes features like 2D Wall Motion Tracking, Shear Wave, and SMI; output displayed on system monitor for diagnostic decision-making; benefits include non-invasive visualization of internal structures and dynamic processes.
Clinical Evidence
Bench testing and clinical image evaluation performed. Bench testing used elasticity phantoms to validate Shear Wave measurement accuracy and precision. Clinical image evaluation of volunteers confirmed 2D Wall Motion Tracking (WMT) performance for cardiac wall tracing, motion tracking, and function analysis compared to the predicate. No clinical trials on patients were required.
Technological Characteristics
Mobile ultrasound system; probes include flat linear, convex, and sector arrays (2-12 MHz). Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, and ISO 10993-1. Features include UPS, 2D Wall Motion Tracking, Shear Wave, and SMI. Software is Moderate Level of Concern.
Indications for Use
Indicated for ultrasound visualization and diagnosis of fetal, abdominal, intra-operative, laparoscopic, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, and peripheral vessel structures and dynamic processes.
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
- Xario200, V5.0 (Models: TUS-X200 and TUS-X200S) (K162155)
Related Devices
- K133277 — XARIO 100 · Toshibamedical Systems Corporation · Jan 17, 2014
- K151451 — Aplio 500/400/300 Diagnostic Ultrasound System V6.0 · Toshibamedical Systems Corporation · Jul 9, 2015
- K093171 — VIAMO SSA-640A VERSION 1.2 · Toshiba America Medical Systems, In.C · Dec 4, 2009
- K191663 — Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 · Canon Medical Systems Corporation · Sep 18, 2019
- K013633 — SSA-770A, APLIO ULTRASOUND SYSTEM · Toshiba America Medical Systems, In.C · Nov 13, 2001
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. The word "Administration" is on the second line.
December 12, 2017
Toshiba Medical Systems Corporation % Orlando Tadeo Manager, Regulatory Affairs Toshiba America Medical Systems, Inc 2441 Michelle Drive TUSTIN, CA 92780
Re: K172276
Trade/Device Name: Xario 200 Diagnostic Ultrasound System V6.0 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: July 26, 2017 Received: July 28, 2017
Dear Orlando 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 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);
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# Page 2 - Orlando Tadeo
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert A. 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)
K172276
### Device Name
Xario 200 Diaqnostic Ultrasound System V6.0
### 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)
ك Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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### FOR FDA USE ONLY
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# System: Xario 200 TUS-X200,TUS-X200S V6.0
Transducer:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|------|----|----------------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) * | THI | Advanced<br>Dynamic<br>Flow | Power | CHI> | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | P | 4,5,6,7,8,9,11,12 |
| Abdominal | P | P | P | P | P | 2,3 | P | P | P | | P | 4,5,6,7,8,9,11,12,14 |
| Intra-operative (Abdominal) | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11 |
| 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 | 4,5,6,7,8,9,11,12 |
| Small Organ (Note 1) | P | P | P | | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11,12 |
| Neonatal Cephalic | P | P | P | P | P | 2,3 | P | P | P | | | 5,6,7,8,11 |
| 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 |
| Trans-vaginal | P | P | P | | P | 2 | P | P | P | | P | 4,5,6,7,8,9,12 |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | P | P | P | | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11,12 |
| Musculo-skeletal (Superficial) | P | P | P | | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11,12 |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | P | P | | | 4, 7, 13(N) |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | | | 4, 7, 13(N) |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | P | P | P | P | P | 3 | P | | | | | 4, 7, 13(N) |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,10,11,12 |
| 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
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
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#### Xario 200 TUS-X200, TUS-X200S V6.0 System: _ Transducer: PSU-25BT
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) * | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | 4D | Other<br>[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 | | | 4, 7, 13(N) |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | | | 4, 7, 13(N) |
| 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
- Note 13 2D Wall Motion Tracking
Note 14 Shear Wave
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#### System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer:_ PSU-30BT
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) * | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | 4D | Other<br>[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 | | | 4, 7, 13(N |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | | | 4, 7, 13(N |
| 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
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
{6}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer:_ PSU-50BT
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) * | THI | Advanced<br>Dynamic<br>Flow | Power | CHI> | 4D | Other<br>[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 | | | 4, 7, 13(N) |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | | | 4, 7, 13(N) |
| 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
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
{7}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer:_ PSU-70BT
| Clinical Application | Mode of Operation | | | | | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-----------------|--|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) * | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | 4D | Other<br>[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 | | | 4, 7, 13(N) | |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | | | 4, 7, 13(N) | |
| 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
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
{8}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer: __ PVU-375BT
| Clinical Application<br>Specific<br>(Tracks 3) | Mode of Operation | | | | | | | | | | | |
|------------------------------------------------|-------------------|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|---------------------|
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) * | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,11,12 |
| Abdominal | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,11,12,1 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,11,12 |
| Small Organ (Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal<br>(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 9 Elastography
No. 10 BEAM
Note 10 BEAM
Note 11 Smart 3D Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave
{9}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer: __ PVU-382BT
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) * | THI | Advanced<br>Dynamic<br>Flow | Power | CHI> | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8,11 |
| Abdominal | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8,11 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8,11 |
| 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
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
{10}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer: PVU-674BT
| Clinical Application<br>Specific<br>(Tracks 3) | Mode of Operation | | | | | | | | | | | | |
|------------------------------------------------|-------------------|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-----------------|--|
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) * | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | 4D | Other<br>[Note] | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11,1 | |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11,1 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11,1 | |
| 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
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
{11}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer:_ PVU-674MV
| Clinical Application<br>Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) * | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | 4D | Other<br>[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
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
{12}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer: PVU-712BT
| Clinical Application | Mode of Operation | | | | | | | | | Other<br>[Note] |
|---------------------------------|-------------------|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) * | THI | Advanced<br>Dynamic<br>Flow | Power | |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 2 | P | P | P | 5,6,7,8,1 |
| Intra-operative (Abdominal) | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 2 | P | P | P | 5,6,7,8,1 |
| Small Organ (Note 1) | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 2 | P | P | P | 5,6,7,8,1 |
| 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
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
{13}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer: PVU-745BTF
| Clinical Application | Mode of Operation | | | | | | | | | | | | |
|---------------------------------|-------------------|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-----------------|--|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) * | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | 4D | Other<br>[Note] | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,1 | |
| Intra-operative (Abdominal) | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,1 | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Note 1) | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,1 | |
| 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
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
{14}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V6.0 Transducer: PVU-745BTH
| Clinical Application<br>Specific<br>(Tracks 3) | Mode of Operation | | | | | | | | | | | | |
|------------------------------------------------|-------------------|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-----------------|--|
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) * | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | 4D | Other<br>[Note] | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8,11 | |
| Intra-operative (Abdominal) | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8,11 | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Note 1) | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8,11 | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | |…
