Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System
Device Facts
| Record ID | K182596 |
|---|---|
| Device Name | Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System |
| Applicant | Canon Medical Systems Corporation |
| Product Code | IYN · Radiology |
| Decision Date | Nov 2, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The Diagnostic Ultrasound System Xario200G Model CUS-X200G and Xario100G Model CUS-X100G are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative(abdominal), laparoscopic, pediatric, small organs, neonalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal(superficial), cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.
Device Story
Mobile diagnostic ultrasound systems (Xario200G/Xario100G) for clinical imaging. Input: ultrasound signals from various probes (linear, convex, sector). Operation: digital beam formation, parallel processing, and quad summation. Output: diagnostic images/data on 21.5-inch LCD monitor. Used in clinical settings by healthcare professionals. Features include battery operation, wireless connectivity (Xario200G), and various imaging modes (B, M, PWD, CWD, Color Doppler, THI, etc.). Assists clinicians in visualizing anatomy and dynamic processes for diagnosis, potentially improving patient management through non-invasive imaging.
Clinical Evidence
Bench testing only. No clinical studies were required to demonstrate safety and efficacy. Testing included risk analysis, verification/validation, and conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, AIUM RTD2-2004, and ISO 10993-1 standards.
Technological Characteristics
Mobile ultrasound system; 21.5-inch LED-backlit LCD; 128 (Xario200G) or 64 (Xario100G) transmission channels; digital beam formation with parallel processing and quad summation. Probes: linear, convex, sector, pencil. Connectivity: wired/wireless (Xario200G), ECG, footswitch. Battery-powered. Conformance: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 10993-1.
Indications for Use
Indicated for visualization of structures and dynamic processes in human body via ultrasound for diagnosis. Clinical applications: fetal, abdominal, intra-operative (abdominal), laparoscopic, pediatric, small organs (thyroid, breast, testicle), neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional/superficial), cardiac (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
- Xario 200 Diagnostic Ultrasound System V6.0 (K172276)
Related Devices
- K162155 — Xario 200 Diagnostic Ultrasound System V5.0 · Toshibamedical Systems Corporation · Nov 1, 2016
- K171579 — M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 18, 2017
- K093171 — VIAMO SSA-640A VERSION 1.2 · Toshiba America Medical Systems, In.C · Dec 4, 2009
- K082119 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0 · Toshiba America Medical Systems, In.C · Aug 12, 2008
- K050380 — XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A · Toshiba America Medical Systems, In.C · Feb 23, 2005
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
November 2, 2018
Canon Medical Systems Corporation Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs 2441 Michelle Drive TUSTIN, CA 92780
Re: K182596
Trade/Device Name: Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: September 18, 2018 Received: September 20, 2018
Dear Orlando Tadeo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known)
K182596
Device Name
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System
## Indications for Use (Describe)
The Diagnostic Ultrasound System Xario200G Model CUS-X200G and Xario100G Model CUS-X100G are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative(abdominal), laparoscopic, pediatric, small organs, neonalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal(superficial), cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.
| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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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) * | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | 4D | Other [Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | N | N | N | | N | 2 | N | N | N | | N | 4,5,6,7,8,9,11,12 |
| Abdominal | N | N | N | N | N | 2,3 | N | N | N | | N | 4,5,6,7,8,9,11,12,14 |
| Intra-operative (Abdominal) | N | N | N | | N | 2 | N | N | N | | | 5,6,7,8,11 |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | N | N | N | | N | 2 | N | N | N | | | 5,7 |
| Pediatric | N | N | N | N | N | 2,3 | N | N | N | | N | 4,5,6,7,8,9,11,12 |
| Small Organ (Note 1) | N | N | N | | N | 2 | N | N | N | | | 4,5,6,7,8,9,10,11,12 |
| Neonatal Cephalic | N | N | N | N | N | 2,3 | N | N | N | | | 5,6,7,8,11 |
| Adult Cephalic | N | N | N | N | N | 3 | N | N | N | | | 7 |
| Trans-rectal | N | N | N | | N | 2 | N | N | N | | N | 4,5,6,7,8,9,12 |
| Trans-vaginal | N | N | N | | N | 2 | N | N | N | | N | 4,5,6,7,8,9,12 |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | N | N | N | | N | 2 | N | N | N | | | 4,5,6,7,8,9,10,11,12 |
| Musculo-skeletal (Superficial) | N | N | N | | N | 2 | N | N | N | | | 4,5,6,7,8,9,10,11,12 |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | N | N | N | N | N | 3 | N | N | N | | | 4, 7, 13 |
| Cardiac Pediatric | N | N | N | N | N | 3 | N | N | N | | | 4, 7, 13 |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | N | N | N | N | N | 3 | N | | | | | 4, 7, 13 |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | N | N | N | N | N | 2 | N | N | N | | | 4,5,6,7,8,9,10,11,12 |
| 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
- Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
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Transducer: __ PSU-25BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) * | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | 4D | Other<br>[Note] |
|------------------------------------------------|---|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-----------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Small Organ (Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Adult Cephalic | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | P | P | | | 4, 7, 13 |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | | | 4, 7, 13 |
| 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 Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM Note 11 Smart 3D
- Note 12 SMI
-
- Note 13 2D Wall Motion Tracking Note 14 Shear Wave
{5}------------------------------------------------
Transducer: __ PSU-30BT
| | | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
|--|--|--------------------------------------------------------------------------------------------------|
| | | |
| | | |
| Clinical Application<br>Specific<br>(Tracks 3) | Mode of Operation | | | | | | | | | | | |
|------------------------------------------------|-------------------|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-----------------|
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) * | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Small Organ (Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Adult Cephalic | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | P | P | | | 4, 7, 13 |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | | | 4, 7, 13 |
| 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 Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM Note 11 Smart 3D
- Note 12 SMI
-
- Note 13 2D Wall Motion Tracking Note 14 Shear Wave
{6}------------------------------------------------
Transducer: PSU-50BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Specific<br>(Tracks 3) | Mode of Operation | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) * | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | 4D | Other<br>[Note] |
|------------------------------------------------|-------------------|---|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-----------------|
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Small Organ (Note 1) | | | | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Adult Cephalic | | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | P | P | P | P | P | 3 | P | P | P | | | 4, 7, 13 |
| Cardiac Pediatric | | P | P | P | P | P | 3 | P | P | P | | | 4, 7, 13 |
| 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 Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM Note 11 Smart 3D
- Note 12 SMI
-
- Note 13 2D Wall Motion Tracking Note 14 Shear Wave
{7}------------------------------------------------
Transducer: __ PSU-70BT
| | | | 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) * | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Small Organ (Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Adult Cephalic | P | P | P | P | P | 3 | P | P | P | | | 7 |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | 3 | P | P | P | | | 4, 7, 13 |
| Cardiac Pediatric | P | P | P | P | P | 3 | P | P | P | | | 4, 7, 13 |
| 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 Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
{8}------------------------------------------------
## System: __Xario200G and Xario100G, Software V1.1 Transducer: _ PVU-375BT
| | | | 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) * | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | 4D | Other [Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | | 4,5,6,7,8,9,11,12 |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 4,5,6,7,8,9,11,12,1- |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | | 4,5,6,7,8,9,11,12 |
| Small Organ (Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | | | | |
| Musculo-skeletal<br>(Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI Note 9 Elastography
Note 9 Elastograp
No. 10 BEAM
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave
{9}------------------------------------------------
## System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-382BT
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) * | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8,11 |
| Abdominal | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8,11 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8,11 |
| Small Organ (Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
{10}------------------------------------------------
#### System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-674BT
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) * | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11,12 |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11,12 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Small Organ (Note 1) | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11,12 |
| 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) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
{11}------------------------------------------------
### System: __Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-674MV
Transducer. F V U-074MV
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | |
|--------------------------------------------------------------------------------------------------|--|--|--|--|--|
| | | | | | |
| Clinical Application<br>Specific<br>(Tracks 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) * | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | 4D | Other<br>[Note] |
|------------------------------------------------|---|---|-----|-----|------------------|-------------------------|-----|-----------------------------|-------|-----|----|-----------------|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | 2 | P | P | P | | P | 5,6,7,8 |
| Abdominal | P | P | P | | P | 2 | P | P | P | | P | 5,6,7,8 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | 2 | P | P | P | | P | 5,6,7,8 |
| Small Organ (Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Intra-cardiac | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM
- Note 11 Smart 3D
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
{12}------------------------------------------------
Transducer: PVU-712BT
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) * | 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 | | | 5,6,7,8,11 |
| Intra-operative (Abdominal) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8,11 |
| Small Organ (Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8,11 |
| 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) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM Note 11 Smart 3D
- Note 12 SMI
-
- Note 13 2D Wall Motion Tracking Note 14 Shear Wave
{13}------------------------------------------------
#### System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-745BTF
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) * | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8,11 |
| Intra-operative (Abdominal) | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8,11 |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Note 1) | P | P | P | P | P | 2 | P | P | P | | | 5,6,7,8,11 |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| 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) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducers: K172276
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
- Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
- Note 4 TDI
- Note 5 ApliPure
- Note 6 ApliPure Plus
- Note 7 Precision Imaging
- Note 8 Differential THI
- Note 9 Elastography
- Note 10 BEAM Note 11 Smart 3D
-
- Note 12 SMI
- Note 13 2D Wall Motion Tracking
- Note 14 Shear Wave
{14}------------------------------------------------
#### System: Xario200G and Xario100G, Software V1.1 Transducer: __ PVU-745BTH
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) * | THI | Advanced<br>Dynamic<br>Flow | Power | CHI | 4D | Other<br>[Note] |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11 |
| Intra-operative (Abdominal) | P | P | P | | P | 2 | P | P | P | | | 5,6,7,8,11 |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | |…
