Xario 200, V3.0
Device Facts
| Record ID | K143027 |
|---|---|
| Device Name | Xario 200, V3.0 |
| Applicant | Toshibamedical Systems Corporation |
| Product Code | IYN · Radiology |
| Decision Date | Nov 20, 2014 |
| 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 (flat linear, convex linear, sector) with 2-12 MHz frequency range. Inputs: ultrasound signals from transducers. Transforms signals into diagnostic images/fluid flow analysis. Used in clinical settings by healthcare professionals. Features BEAM for improved needle visualization during biopsy. Output: real-time ultrasound images/data for clinical diagnosis. Benefits: aids visualization of structures/dynamic processes, improves needle guidance during procedures.
Clinical Evidence
Bench testing only. Study compared existing imaging mode with the BEAM needle enhancement feature, confirming improved needle visualization. Software validation and acoustic output testing (UD3, 2004) were performed. No clinical data presented.
Technological Characteristics
Mobile diagnostic ultrasound system. Transducers: flat linear, convex linear, sector arrays (2-12 MHz). Connectivity: standard ultrasound system interfaces. Software: Moderate Level of Concern. Standards: IEC 60601-1 (2005), IEC 60601-1-2:2007, IEC 60601-2-37 (2007), IEC 62304 (2006), AIUM RTD2-2004, ISO 10993-1, ISO 14971, ISO 13485.
Indications for Use
Indicated for visualization of structures and dynamic processes in the human body using ultrasound for diagnosis. Clinical applications include fetal, abdominal, intra-operative (abdominal), laparoscopic, pediatric, small organs (thyroid, breast, testicle), neonatal/adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional/superficial), cardiac (adult/pediatric/trans-esophageal), and peripheral vessel.
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 Model TUS-X200, TUS-X200S, v1.0 (K131507)
- MicroMaxx High Resolution Ultrasound System (C3 Series) (K053069)
Related Devices
- K143046 — Xario 100, V3.0 · Toshibamedical Systems Corporation · Nov 19, 2014
- K133277 — XARIO 100 · Toshibamedical Systems Corporation · Jan 17, 2014
- K131507 — XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM · Toshibamedical Systems Corporation · Aug 28, 2013
- K093171 — VIAMO SSA-640A VERSION 1.2 · Toshiba America Medical Systems, In.C · Dec 4, 2009
- K172276 — Xario 200 Diagnostic Ultrasound System V6.0 · Toshibamedical Systems Corporation · Dec 12, 2017
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The caduceus is depicted with a modern, abstract design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2014
Toshiba Medical Systems Corporation % Mr. Orlando Tadeo. Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K143027
Trade/Device Name: Xario 200. V3.0 (Models: TUS-X200 and TUS-X200S) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN Dated: October 20, 2014 Received: October 21, 2014
Dear Mr. Tadeo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
This determination of substantial equivalence applies to the following transducers intended for use with the Xario 200 TUS-X200, TUS-X200S V3.0 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| PSU-25BT | PSU-30BT | PSU-50BT |
|------------|------------|------------|
| PVU-375BT | PVU-382BT | PVU-674BT |
| PVU-674MV | PVU-712BT | PVU-745BTF |
| PVU-745BTH | PVU-745BTV | PVU-681MVL |
| PVU-770ST | PVU-781VT | PVL-715RS |
| PLU-704BT | PLU-1005BT | PLU-1204BT |
| PET-512MC | PET-805LA | PC-20M |
| PC-50M | | |
{1}------------------------------------------------
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Robert A Ochs
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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# Indications for Use
### 510(k) Number (if known)
K143027
### Device Name
Xario 200 TUS-X200 and TUS-X200S, V3.0
### 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 V3.0
Transducer: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | 2 | P | P | P | | P | 4,5,6,7,8,9 |
| Abdominal | P | P | P | P | P | 2,3 | P | P | P | | P | 4,5,67,8,9 |
| Intra-operative (Abdominal) | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8 |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | N | N | N | N | N | 2 | N | N | N | | | 5,7 |
| Pediatric | P | P | P | P | P | 2,3 | P | P | P | | P | 4,5,6,7,8,9 |
| Small Organ (Note 1) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,10 |
| Neonatal Cephalic | P | P | P | P | P | 2,3 | P | P | P | | | 5,6,7,8 |
| Adult Cephalic | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Trans-rectal | P | P | P | P | P | 2 | P | P | P | | N | 5,6,7,8,9 |
| Trans-vaginal | P | P | P | P | P | 2 | P | P | P | | N | 5,6,7,8,9 |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,10 |
| Musculo-skeletal<br>(Superficial) | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,10 |
| 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 |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers:K131507
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
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#### Xario 200 TUS-X200, TUS-X200S V3.0 System: _ Transducer:_ PSU-25BT
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | 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 (Specify) (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<br>(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:K131507
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
{5}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V3.0 Transducer: PSU-30BT
| Clinical Application | Mode of Operation | | | | | | | | | | | | |
|------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----|----|-----------------|--|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | 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 (Specify) (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<br>(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:K131507
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
{6}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V3.0 Transducer: PSU-50BT
| Clinical Application | Mode of Operation | | | | | | | | | | Other<br>[Note] | |
|------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----|-----------------|------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | | 4D |
| 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 (Specify) (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<br>(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:K131507
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
{7}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V3.0 Transducer: PVU-375BT
| 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 | | | 4,5,6,7,8, |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 4,5,6,7,8, |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | | 4,5,6,7,8, |
| 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) | | | | | | | | | | | | |
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:K131507
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
{8}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V3.0 Transducer: PVU-382BT
| Clinical Application | Mode of Operation | | | | | | | | | | | | |
|------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----|----|-----------------|--|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | 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 | |
| Abdominal | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8 | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8 | |
| 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) | | | | | | | | | | | | | |
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:K131507
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
{9}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V3.0 Transducer: PVU-674BT
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | E | E | E | E | E | 2 | E | E | E | | | 5,6,7,8 |
| Abdominal | E | E | E | E | E | 2 | E | E | E | | | 5,6,7,8 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | E | E | E | E | E | 2 | E | E | E | | | 5,6,7,8 |
| 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) | | | | | | | | | | | | |
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:K131507
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
{10}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V3.0 Transducer: PVU-674MV
| Clinical Application | | | | Mode of Operation | | | | | | | | | |
|------------------------------------|---|---|---------|-------------------|----------------------------|-----|-----------------------------|-------|-----|----|-----------------|--|--|
| Specific<br>(Tracks 3) | B | M | PWD CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | 4D | Other<br>[Note] | | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | P | P | P P | P | 2 | P | P | P | | P | 5,6,7,8 | | |
| Abdominal | P | 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 | P | 2 | P | P | P | | P | 5,6,7,8 | | |
| 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) | | | | | | | | | | | | | |
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:K131507
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
{11}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V3.0 Transducer: PVU-712BT
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----------|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Advanced<br>Dynamic<br>Flow | Power | CHI<br>2D | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8 |
| Small Organ (Specify) (1) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8 |
| 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) | | | | | | | | | | | | |
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:K131507
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
{12}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V3.0 Transducer: PVU-745BTF
| Clinical Application | Mode of Operation | | | | | | | | | Other<br>[Note] | | |
|------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----------------|-----|---------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Advanced<br>Dynamic<br>Flow | Power | | CHI | 4D |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | N | N | N | N | N | 2 | N | N | N | | | 5,6,7,8 |
| Intra-operative (Abdominal) | N | N | N | N | N | 2 | N | N | N | | | 5,6,7,8 |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | N | N | N | N | N | 2 | N | N | N | | | 5,6,7,8 |
| 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) | | | | | | | | | | | | |
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
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 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
{13}------------------------------------------------
#### System: _Xario 200 TUS-X200, TUS-X200S V3.0 Transducer: PVU-745BTH
| Clinical Application<br>Specific<br>(Tracks 3) | Mode of Operation | | | | | | | | | | | |
|------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----|----|-----------------|
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | N | N | N | N | N | 2 | N | N | N | | | 5,6,7,8 |
| Intra-operative (Abdominal) | N | N | N | N | N | 2 | N | N | N | | | 5,6,7,8 |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | N | N | N | N | N | 2 | N | N | N | | | 5,6,7,8 |
| 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) | | | | | | | | | | | | |
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
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
{14}------------------------------------------------
#### System: Xario 200 TUS-X200, TUS-X200S V3.0 Transducer: PVU-745BTV
| Clinical Application | Mode of Operation | | | | | | | | | | | |
|------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----|----|-----------------|
| Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify)<br>* | 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 |
| Intra-operative (Abdominal) | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8 |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) (1) | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8 |
| Neonatal Cephalic…
