Who is the manufacturer of Xario 100, V3.0?

Toshibamedical Systems Corporation filed the 510(k) submission for Xario 100, V3.0 (K143046).

What is the FDA product code for Xario 100, V3.0?

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 100, V3.0?

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

What are the predicate devices for Xario 100, V3.0?

Xario100 Model TUS-X100, TUS-X100S, v1.0 (K133277); MicroMaxx High Resolution Ultrasound System (C3 Series) (K053069).

Who can help prepare an FDA 510(k) submission like Xario 100, V3.0?

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 100, V3.0

K143046 · Toshibamedical Systems Corporation · IYN · Nov 19, 2014 · Radiology

Device Facts

Record ID	K143046
Device Name	Xario 100, V3.0
Applicant	Toshibamedical Systems Corporation
Product Code	IYN · Radiology
Decision Date	Nov 19, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Diagnostic Ultrasound System Xario 100 Model TUS-X100 and Xario 100 Model TUS-X100S 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.

Device Story

Mobile diagnostic ultrasound system (TUS-X100/TUS-X100S V3.0) for clinical imaging. Inputs: ultrasound signals from wide array of probes (linear, convex, sector; 2-12 MHz). Processing: system performs signal/image processing to generate diagnostic images; includes BEAM feature for needle visualization enhancement during biopsy. Output: real-time ultrasound images displayed for physician/clinician. Used in clinical settings (OR, clinic) by trained professionals. Output aids in diagnosis and procedural guidance (e.g., needle placement). Benefits: improved visualization of anatomical structures and dynamic processes; enhanced needle visibility during interventional procedures.

Clinical Evidence

Bench testing only. Performance testing included a comparative study of an existing imaging mode versus the BEAM needle enhancement feature, confirming improved needle visualization. Software validation and acoustic output testing (UD3, 2004) were performed to verify system modifications.

Technological Characteristics

Mobile diagnostic ultrasound system using linear, convex, and sector array transducers (2-12 MHz). Features include B-mode, M-mode, PWD, CWD, Color Doppler, THI, Advanced Dynamic Flow, Power Doppler, CHI, 4D, TDI, ApliPure, Precision Imaging, and BEAM. Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, and ISO 10993-1. Sterilization: N/A (transducers are reusable).

Indications for Use

Indicated for visualization of structures and dynamic processes in the human body using ultrasound for diagnostic imaging. 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

Xario100 Model TUS-X100, TUS-X100S, v1.0 (K133277)
MicroMaxx High Resolution Ultrasound System (C3 Series) (K053069)

Related Devices

K143027 — Xario 200, V3.0 · Toshibamedical Systems Corporation · Nov 20, 2014
K122387 — VOLUSON P6, VOLUSON P8 · GE Healthcare · Sep 11, 2012
K133277 — XARIO 100 · Toshibamedical Systems Corporation · Jan 17, 2014
K141459 — APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0 · Toshibamedical Systems Corporation · Oct 28, 2014
K093171 — VIAMO SSA-640A VERSION 1.2 · Toshiba America Medical Systems, In.C · Dec 4, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 19, 2014 Toshiba Medical Systems Corporation % Mr. Orlando Tadeo. Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780 Re: K143046 Trade/Device Name: Xario 100. V3.0 (Models: TUS-X100 and TUS-X100S) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN Dated: October 21, 2014 Received: October 22, 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 100 TUS-X100, TUS-X100S 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) ### K143046 Device Name Xario 100 TUS-X100 and TUS-X100S, V3.0 ### Indications for Use (Describe) The Diaqnostic Ultrasound System Xario 100 Model TUS-X100 and Xario 100 Model TUS-X100S 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) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Toshiba America Medical Systems, Inc. ### System: _Xario 100 TUS-X100, TUS-X100S V3.0 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 | P | P | | P | P | P | 2 | P | P | P | | P | 4,5,6,7,8 | | Abdominal | P | P | | P | P | P | 2,3 | P | P | P | | P | 4,5,6,7,8 | | Intra-operative (Abdominal) | N | N | | N | N | N | 2 | N | N | N | | | 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 | | Small Organ (Note 1) | P | P | | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,1 | | Neonatal Cephalic | P | P | | P | P | P | 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 | 4,5,6,7,8 | | Trans-vaginal | P | P | | P | P | P | 2 | P | P | P | | N | 4,5,6,7,8 | | Trans-urethral | | | | | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | | | | | Musculo-skeletal (Conventional) | P | P | | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,1 | | Musculo-skeletal (Superficial) | P | P | | P | P | P | 2 | P | P | P | | | 4,5,6,7,8,9,1 | | Intravascular | | | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | | | | Cardiac Adult | P | P | | P | P | P | 3 | P | P | P | | | 4, 7 | | Cardiac Pediatric | P | P | | P | P | P | 3 | P | P | P | | | 4, 7 | | Intravascular (Cardiac) | | | | | | | | | | | | | | | Trans-esoph. (Cardiac) | N | N | | N | N | N | 3 | N | | | | | 4,7 | | Intra-cardiac | | | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | | | | Peripheral vascular | P | P | | P | N | P | 2 | P | P | P | | | 4,5,6,7,8,9,1 | | 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 Note 9 Elastography Note 10 BEAM {4}------------------------------------------------ System: _ Xario 100 TUS-X100, TUS-X100S V3.0 Transducer: PSU-25BT Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | 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 vessel | | | | | | | | | | | | | | | | 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/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}------------------------------------------------ ### Xario 100 TUS-X100,TUS-X100S V3.0 System: _ Transducer:_ PSU-30BT | Clinical Application | Mode of Operation | | | | | | | | | | | | |------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----|----|-----------------| | Specific (Tracks 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) * | THI | Advanced Dynamic Flow | Power | CHI | 4D | Other [Note] | | Ophthalmic | | | | | | | | | | | | | | Fetal | | | | | | | | | | | | | | Abdominal | P | P | P | P | P | 3 | P | P | P | | | 7 | | Intra-operative (Abdominal) | | | | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | | Pediatric | P | P | P | P | P | 3 | P | P | P | | | 7 | | Small Organ (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 (Conventional) | | | | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | | | | Cardiac Adult | P | P | P | P | P | 3 | P | P | P | | | 4, 7 | | Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | | | 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 Previous 510(k) of the transducers: K133277 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 100 TUS-X100, TUS-X100S V3.0 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 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 {7}------------------------------------------------ #### System: _Xario 100 TUS-X100,TUS-X100S V3.0 Transducer: PVU-375BT | Clinical Application | Mode of Operation | | | | | | | | | | | | |------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----|----|-----------------| | Specific (Tracks 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) * | THI | Advanced Dynamic Flow | Power | CHI | 4D | Other [Note] | | Ophthalmic | | | | | | | | | | | | | | Fetal | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7 | | Abdominal | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7 | | Intra-operative (Abdominal) | | | | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | | Pediatric | P | P | P | P | P | 2 | P | P | P | | | 4,5,6,7 | | 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 Previous 510(k) of the transducers: K133277 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 100 TUS-X100, TUS-X100S V3.0 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 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 {9}------------------------------------------------ #### System: Xario 100 TUS-X100, TUS-X100S V3.0 Transducer: PVU-674BT | 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 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 {10}------------------------------------------------ #### System: _Xario 100 TUS-X100,TUS-X100S V3.0 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 | P | P | P | P | P | 2 | P | P | P | | P | 5,6,7 | | Abdominal | P | P | P | P | P | 2 | P | P | P | | P | 5,6,7 | | Intra-operative (Abdominal) | | | | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | | Pediatric | P | P | P | P | P | 2 | P | P | P | | P | 5,6,7 | | 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 Previous 510(k) of the transducers: K133277 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 100 TUS-X100, TUS-X100S V3.0 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 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 {12}------------------------------------------------ #### System: Xario 100 TUS-X100, TUS-X100S V3.0 Transducer: PVU-745BTF | Clinical Application | Mode of Operation | | | | | | | | | | | | |------------------------------------|-------------------|---|-----|-----|------------------|----------------------------|-----|-----------------------------|-------|-----|----|-----------------| | Specific (Tracks 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) * | THI | Advanced Dynamic Flow | Power | CHI | 4D | Other [Note] | | Ophthalmic | | | | | | | | | | | | | | Fetal | | | | | | | | | | | | | | Abdominal | 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 (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 {13}------------------------------------------------ #### System: Xario 100 TUS-X100, TUS-X100S V3.0 Transducer: PVU-745BTH | 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 | 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 (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 100 TUS-X100, TUS-X100S V3.0 Transducer: PVU-745BTV | 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 | 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…