Who is the manufacturer of XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM?

Toshibamedical Systems Corporation filed the 510(k) submission for XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM (K131507).

What is the FDA product code for XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM?

Aplio 500/400/300 Diagnostic Ultrasound System V3.0 (K123992).

Who can help prepare an FDA 510(k) submission like XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM

K131507 · Toshibamedical Systems Corporation · IYN · Aug 28, 2013 · Radiology

Device Facts

Record ID	K131507
Device Name	XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant	Toshibamedical Systems Corporation
Product Code	IYN · Radiology
Decision Date	Aug 28, 2013
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 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, intraoperative (abdominal), pediatric, small organs, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, and musculoskeletal (both conventional and superficial).

Device Story

Mobile diagnostic ultrasound system; utilizes wide array of probes (flat linear, convex linear, sector) with frequency range 2-7.5 MHz. Inputs: ultrasound signals from human body. Processing: system transforms acoustic signals into visual images/flow data for diagnostic use. Output: real-time ultrasound images/measurements displayed on system monitor. Used in clinical settings by physicians/sonographers. Healthcare providers use output for diagnostic visualization of anatomical structures and dynamic processes. Benefits: non-invasive diagnostic imaging for various clinical applications.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation testing conducted to confirm requirements met, including compliance with IEC 60601-1, IEC 60601-2-37, IEC 62304, AIUM RTD2-2004, and ISO 10993-1 standards.

Technological Characteristics

Mobile diagnostic ultrasound system; flat linear, convex linear, and sector array transducers; frequency range 2-7.5 MHz. Modes: B, M, PWD, CWD, Color Doppler, THI, Advanced Dynamic Flow, Power, CHI, 4D. Connectivity: standard ultrasound system interfaces. Software: Moderate Level of Concern. Standards: IEC 60601-1, IEC 60601-2-37, IEC 62304, ISO 10993-1.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis of fetal, abdominal, intraoperative (abdominal), pediatric, small organ (thyroid, breast, testicle), trans-rectal, trans-vaginal, neonatal/adult cephalic, cardiac (adult/pediatric), peripheral vascular, transesophageal, and musculoskeletal structures/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

Aplio 500/400/300 Diagnostic Ultrasound System V3.0 (K123992)

Related Devices

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K133277 — XARIO 100 · Toshibamedical Systems Corporation · Jan 17, 2014
K093171 — VIAMO SSA-640A VERSION 1.2 · Toshiba America Medical Systems, In.C · Dec 4, 2009
K092948 — APLIO MX SSA-780A, VERSION 1.0 · Toshiba America Medical Systems, In.C · Oct 9, 2009
K991858 — SSA-390A/POWER VISION 8000 · Toshiba America Medical Systems, In.C · Jun 16, 1999

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central graphic. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Toshiba Medical Systems Corporation Mr. Charlemagne Chua Manager, Regulatory Affairs 2441 Michelle Drive TUSTIN CA 92780 August 28, 2015 Re: K131507 Trade/Device Name: Xario 200 TUS-X200 and TUS-X200S, v1.0 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: May 22, 2013 Received: May 30, 2013 Dear Mr. Chua: This letter corrects our substantially equivalent letter of August 28, 2013. 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 and TUS-X200S, v1.0, as described in your premarket notification: ### Transducer Model Number | PSU-25BT | PSU-30BT | PSU-50BT | |-----------|------------|-----------| | PVU-375BT | PVU-382BT | PVU-674MV | | PVU-712BT | PVU-745BTV | PVU-770ST | | PLU-704BT | PET-512MC | PC-20M | 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 {1}------------------------------------------------ found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. of Surveillance and Biometrics/Division of Postmarket Surveillance. Sincerely yours, Robert A Ochs Robert Ochs, Ph.D. Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known): K131507 Device Name: Xario 200 TUS-X200 and TUS-X200S, v1.0 Indications For Use: The Diagnostic Ultrasound System Xario 200 Model TUS-X200 and 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, intraoperative (abdominal), pediatric, small organs, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, and musculoskeletal (both conventional and superficial). Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Smh.7) (Division Sian-Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k): K131507 {3}------------------------------------------------ ### System: Xario 200 TUS-X200,TUS-X200S V1.0 Transducer: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | | | | | |------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|-----|-----------------------------|-------|-----|----|-----------------| | Specific (Tracks 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) | THI | Advanced Dynamic Flow | Power | CHI | 4D | Other [Note] | | Ophthalmic | | | | | | | | | | | | | | Fetal | N | N | N | N | N | 2 | N | N | N | N | N | 5,6,7,8 | | Abdominal | N | N | N | N | N | 2,3 | N | 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 | N | N | N | N | N | 2,3 | N | N | N | | N | 5,6,7,8 | | Small Organ (Note 1) | N | N | N | N | N | 2 | N | N | N | | | 5,6,7,8 | | Neonatal Cephalic | N | N | N | N | N | 2,3 | N | N | N | | | 5,6,7,8 | | Adult Cephalic | N | N | N | N | N | 3 | N | N | N | | | 7 | | Trans-rectal | N | N | N | N | N | 2 | N | N | N | | | 5,6,7,8 | | Trans-vaginal | N | N | N | N | N | 2 | N | N | N | | | 5,6,7,8 | | Trans-urethral | | | | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | Musculo-skeletal (Conventional) | N | N | N | N | N | 2 | N | N | N | | | 5,6,7,8 | | Musculo-skeletal (Superficial) | N | N | N | N | N | 2 | N | N | N | | | 5,6,7,8 | | Intravascular | | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | | | Cardiac Adult | N | N | N | N | N | 3 | N | N | N | N | | 4,7 | | Cardiac Pediatric | N | N | N | N | N | 3 | N | N | N | N | | 4,7 | | Intravascular (Cardiac) | | | | | | | | | | | | | | Trans-esoph. (Cardiac) | N | N | N | N | N | 3 | N | | | | | 4,7 | | Intra-cardiac | | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | | | Peripheral vascular | N | N | N | N | N | 2 | N | N | N | | | 5,6,7,8 | | Other (Specify) | | | | | | | | | | | | | 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 {4}------------------------------------------------ #### Xario 200 TUS-X200, TUS-X200S V1.0 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 | N | N | N | N | N | 3 | N | N | N | | | 7 | | Intra-operative (Abdominal) | | | | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | | Pediatric | N | N | N | N | N | 3 | N | N | N | | | 7 | | Small Organ (Specify) (1) | | | | | | | | | | | | | | Neonatal Cephalic | N | N | N | N | N | 3 | N | N | N | | | 7 | | Adult Cephalic | N | N | N | N | N | 3 | N | N | N | | | 7 | | Trans-rectal | | | | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | | | | Trans-urethral | | | | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | | | Cardiac Adult | N | N | N | N | N | 3 | N | N | N | N | | 4, 7 | | Cardiac Pediatric | N | N | N | N | N | 3 | N | N | N | N | | 4, 7 | | Intravascular (Cardiac) | | | | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | | | Peripheral vascular | | | | | | | | | | | | | | 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 {5}------------------------------------------------ #### System: _Xario 200 TUS-X200, TUS-X200S V1.0 Transducer:_ PSU-30BT | 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 | N | N | N | N | N | 3 | N | N | N | | | 7 | | Intra-operative (Abdominal) | | | | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | | Pediatric | N | N | N | N | N | 3 | N | N | N | | | 7 | | Small Organ (Specify) (1) | | | | | | | | | | | | | | Neonatal Cephalic | N | N | N | N | N | 3 | N | N | N | | | 7 | | Adult Cephalic | N | N | N | N | N | 3 | N | N | N | | | 7 | | Trans-rectal | | | | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | | | | Trans-urethral | | | | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | | | Cardiac Adult | N | N | N | N | N | 3 | N | N | N | N | | 4,7 | | Cardiac Pediatric | N | N | N | N | N | 3 | N | N | N | N | | 4, 7 | | Intravascular (Cardiac) | | | | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | | | Peripheral vascular | | | | | | | | | | | | | | 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 {6}------------------------------------------------ #### System: _Xario 200 TUS-X200, TUS-X200S V1.0 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 | N | N | N | N | N | 3 | N | N | N | | | 7 | | Intra-operative (Abdominal) | | | | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | | Pediatric | N | N | N | N | N | 3 | N | N | N | | | 7 | | Small Organ (Specify) (1) | | | | | | | | | | | | | | Neonatal Cephalic | N | N | N | N | N | 3 | N | N | N | | | 7 | | Adult Cephalic | N | N | N | N | N | 3 | N | N | N | | | 7 | | Trans-rectal | | | | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | | | | Trans-urethral | | | | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | | | Cardiac Adult | N | N | N | N | N | 3 | N | N | N | N | | 4, 7 | | Cardiac Pediatric | N | N | N | N | N | 3 | N | N | N | N | | 4, 7 | | Intravascular (Cardiac) | | | | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | | | Peripheral vascular | | | | | | | | | | | | | | 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 {7}------------------------------------------------ ### System: _Xario 200 TUS-X200, TUS-X200S V1.0 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 | N | N | N | N | 2 | N | N | N | | | 5,6,7,8 | | | | Abdominal | N | N | N | N | 2 | N | N | N | | | 5,6,7,8 | | | | Intra-operative (Abdominal) | | | | | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | | | Pediatric | N | N | N | N | 2 | N | N | N | | | 5,6,7,8 | | | | Small Organ (Specify) (1) | | | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | | | Trans-rectal | | | | | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | | | | | Trans-urethral | | | | | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | | | | Cardiac Adult | | | | | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | | | | Peripheral vascular | | | | | | | | | | | | | | | 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 {8}------------------------------------------------ ### System: _Xario 200 TUS-X200, TUS-X200S V1.0 Transducer: PVU-382BT | 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 | N | N | N | N | N | 2 | N | N | N | | | 5,6,7,8 | | Abdominal | N | N | N | N | N | 2 | N | N | N | | | 5,6,7,8 | | Intra-operative (Abdominal) | | | | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | | Pediatric | N | N | N | N | N | 2 | N | N | N | | | 5,6,7,8 | | Small Organ (Specify) (1) | | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | | Trans-rectal | | | | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | | | | Trans-urethral | | | | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | | | Cardiac Adult | | | | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | | | Peripheral vascular | | | | | | | | | | | | | | 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 {9}------------------------------------------------ ### System: _Xario 200 TUS-X200, TUS-X200S V1.0 Transducer:_ PVU-674MV | 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 | N | N | N | | N | 2 | N | N | N | | N | 5,6,7,8 | | Abdominal | N | N | N | | N | 2 | N | N | N | | N | 5,6,7,8 | | Intra-operative (Abdominal) | | | | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | | Pediatric | N | N | N | | N | 2 | N | N | N | | N | 5,6,7,8 | | Small Organ (Specify) (1) | | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | | Trans-rectal | | | | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | | | | Trans-urethral | | | | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | | | Cardiac Adult | | | | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | | | Peripheral vascular | | | | | | | | | | | | | | 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 {10}------------------------------------------------ ### System: Xario 200 TUS-X200, TUS-X200S V1.0 Transducer:_ PVU-712BT | Clinical Application | Mode of Operation | | | | | | | | | | | | |------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----------|----|-----------------| | Specific (Tracks 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) * | THI | Advanced Dynamic Flow | Power | CHI 2D | 4D | Other [Note] | | Ophthalmic | | | | | | | | | | | | | | Fetal | | | | | | | | | | | | | | Abdominal | N | N | N | N | N | 2 | N | N | N | | | 5,6,7,8 | | Intra-operative (Abdominal) | | | | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | | Pediatric | N | N | N | N | N | 2 | N | N | N | | | 5,6,7,8 | | Small Organ (Specify) (1) | | | | | | | | | | | | | | Neonatal Cephalic | N | N | N | N | N | 2 | N | N | N | | | 5,6,7,8 | | 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 vascular | | | | | | | | | | | | | | 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 {11}------------------------------------------------ ### System: _Xario 200 TUS-X200, TUS-X200S V1.0 Transducer: PVU-745BTV | Clinical Application Specific (Tracks 3) | Mode of Operation | | | | | | | | | | | Other [Note] | |------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----|----|-----------------| | | B | M | PWD | CWD | Color Doppler | Combined (Specify) * | THI | Advanced Dynamic Flow | Power | CHI | 4D | | | Ophthalmic | | | | | | | | | | | | | | Fetal | | | | | | | | | | | | | | Abdominal | N | N | N | | N | 2 | N | N | N | | | 5,6,7,8 | | Intra-operative (Abdominal) | 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 | 2 | N | N | N | | | 5,6,7,8 | | 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 vascular | | | | | | | | | | | | | | 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 {12}------------------------------------------------ #### System: _Xario 200 TUS-X200, TUS-X200S V1.0 Transducer: PVU-770ST | 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 | | | | | | | | | | | | | | | Intra-operative (Abdominal) | | | | | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | | | Pediatric | | | | | | | | | | | | | | | Small Organ (Specify) (1) | | | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | | | Trans-rectal | N | N | N | N | N | 2 | N | N | N | | | 5,6,7,8 | | | Trans-vaginal | N | N | N | N | N | 2 | N | N | N | | | 5,6,7,8 | | | 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 vascular | | | | | | | | | | | | | | | 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 {13}------------------------------------------------ ### System: _Xario 200 TUS-X200, TUS-X200S V1.0 Transducer:_ PLU-704BT | 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 | | | | | | | | | | | | | | | Intra-operative (Abdominal) | | | | | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | | | Pediatric | | | | | | | | | | | | | | | Small Organ (Specify) (1) | N | N | N | N | N | 2 | N | N | N | | | 5,6,7, | | | Neonatal Cephalic | | | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | | | Trans-rectal | | | | | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | | | | | Trans-urethral | | | | | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | Musculo-skeletal (Conventional) | N | N | N | N | N | 2 | N | N | N | | | 5,6,7, | | | Musculo-skeletal (Superficial) | N | N | N | N | N | 2 | N | N | N | | | 5,6,7, | | | Intravascular | | | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | | | | Cardiac Adult | | | | | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | | | | Peripheral vascular | N | N | N | N | N | 2 | N | N | N | | | 5,6,7, | | | 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 {14}------------------------------------------------ System: Xario 200 TUS-X200, TUS-X200S V1.0 Transducer: PET-512MC | 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 | | | | | | | | | | | | | | Intra-operative (Abdominal) | | | | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | | Pediatric | | | | | | | | | | | | | | Small Organ (Specify) (1) | | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | | Trans-rectal | | | | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | | | | Trans-urethral | | | | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | |…